{"id":5591,"date":"2018-06-11T01:00:00","date_gmt":"2018-07-27T07:08:31","guid":{"rendered":"http:\/\/www.05921.net\/index.php\/2018\/07\/27\/%e7%be%8e%e5%9b%bd%e8%8d%af%e5%85%b8usp%e5%ae%98%e7%bd%91%e9%97%ae%e7%ad%94%ef%bc%9a%e5%b8%b8%e8%a7%81%e9%97%ae%e9%a2%98%e9%97%ae%e7%ad%94\/"},"modified":"2018-07-27T15:08:31","modified_gmt":"2018-07-27T07:08:31","slug":"%e7%be%8e%e5%9b%bd%e8%8d%af%e5%85%b8usp%e5%ae%98%e7%bd%91%e9%97%ae%e7%ad%94%ef%bc%9a%e5%b8%b8%e8%a7%81%e9%97%ae%e9%a2%98%e9%97%ae%e7%ad%94","status":"publish","type":"post","link":"https:\/\/www.05921.net\/index.php\/5591\/","title":{"rendered":"\u7f8e\u56fd\u836f\u5178USP\u5b98\u7f51\u95ee\u7b54\uff1a\u5e38\u89c1\u95ee\u9898\u95ee\u7b54"},"content":{"rendered":"
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\"\u7f8e\u56fd\u836f\u5178USP\u5b98\u7f51\u95ee\u7b54\uff1a\u5e38\u89c1\u95ee\u9898\u95ee\u7b54\"<\/p>\n

\u258d<\/span><\/strong><\/span><\/strong><\/span>\u6765\u6e90\uff1aJulia\u535a\u5ba2<\/span><\/span><\/p>\n

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\"\u7f8e\u56fd\u836f\u5178USP\u5b98\u7f51\u95ee\u7b54\uff1a\u5e38\u89c1\u95ee\u9898\u95ee\u7b54\"<\/section>\n
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\u5916\u8d44\u5927\u578b\u5236\u836f\u516c\u53f8\u6280\u672f\u3001\u7814\u53d1\u3001\u8d28\u91cf\u603b\u76d1\uff0c\u9a8c\u8bc1\u7ba1\u7406\u8d44\u6df1\u4e13\u5bb6\uff0c\u591a\u5bb6\u5236\u836f\u516c\u53f8\u987e\u95ee\uff0c\u836f\u5b66\u7855\u58eb\u3002\u56fd\u5bb6\u5de5\u827a\u6838\u5bf9\u672a\u96e8\u7ef8\u7f2a\u4e4b\u9645\uff0c\u6210\u529f\u89e3\u51b3\u4e86\u591a\u5bb6\u5728\u4ea7\u4ea7\u54c1\u5904\u65b9\u3001\u5de5\u827a\u95ee\u9898\u3002\u5904\u65b9\u5de5\u827a\u7684\u4e8c\u6b21\u5f00\u53d1\uff0c\u514d\u8d39\u54a8\u8be2\uff0c\u5168\u7a0b\u4fdd\u5bc6\u3002\u90ae\u7bb1\uff1a1193686015@qq.com\u3002<\/span>
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\u5e94\u7f51\u53cb\u8981\u6c42\u53d1\u5e03\u5982\u4e0b\uff0c\u5b98\u7f51\u82f1\u6587\u539f\u94fe\u63a5http:\/\/www.usp.org\/frequently-asked-questions\/compliance-usp-nf<\/span><\/p>\n

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<\/span><\/strong><\/p>\n<\/section>\n

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FAQs: Compliance with the USP\u2013NF <\/span><\/span><\/strong>\u5e38\u89c1\u95ee\u9898\uff1a<\/span><\/strong>USP-NF<\/span><\/strong>\u7b26\u5408\u6027<\/span><\/strong><\/p>\n

1. What does compliance withUSP\u2013NF standards mean? <\/span><\/span><\/strong>\u7b26\u5408<\/span><\/strong>USP-NF<\/span><\/strong>\u6807\u51c6\u662f\u4ec0\u4e48\u610f\u601d\uff1f<\/span><\/strong><\/p>\n

An article of commerce that is recognized in the USP\u2013NF complies withUSP\u2013NF standards when it meets all of the requirements stated in the article\u2019smonograph, applicable General Chapters, and the General Notices (with monographrequirements superseding those of the General Chapters and General Notices, inany cases where requirements differ). Applicable standards apply at all timesin the life of an article, from production to expiration. Thus, any officialarticle is expected to meet the compendial standards if tested, and anyofficial article actually tested as directed in the relevant monograph mustmeet such standards to demonstrate compliance. Frequency of testing andsampling are left to the preferences or direction of those performingcompliance testing, and other users of USP\u2013NF, including manufacturers, buyers,or regulatory authorities. (General Notices, section 3.10)<\/span><\/p>\n

\u5982\u679c\u4e00\u4e2a\u5546\u54c1\u7b26\u5408\u8be5\u54c1\u79cd\u7684\u5404\u8bba\u3001\u9002\u7528\u901a\u5219\u548c\u51e1\u4f8b\uff08\u5982\u8981\u6c42\u6709\u5dee\u5f02\u65f6\uff0c\u5219\u4e3a\u53d6\u4ee3\u901a\u5219\u548c\u51e1\u4f8b\u7684\u5404\u8bba\u8981\u6c42\uff09\uff0c\u5219\u8be5\u5546\u54c1\u5c31\u88ab\u8ba4\u4e3a\u662f\u7b26\u5408<\/span>USP-NF<\/span>\u6807\u51c6\u3002\u9002\u7528\u6807\u51c6\u9002\u7528\u4e8e\u8be5\u5546\u54c1\u7684\u6240\u6709\u751f\u547d\u65f6\u957f\uff0c\u5373\u4ece\u751f\u4ea7\u81f3\u5230\u8fbe\u6548\u671f\u3002\u56e0\u6b64\uff0c\u5982\u679c\u68c0\u6d4b\uff0c\u5219\u5e94\u7b26\u5408\u836f\u5178\u6807\u51c6\u7684\u6240\u6709\u6b63\u5f0f\u5185\u5bb9\uff0c\u6309\u76f8\u5173\u5404\u8bba\u4e2d\u8981\u6c42\u5b9e\u9645\u68c0\u6d4b\u7684\u6b63\u5f0f\u5546\u54c1\u5fc5\u987b\u7b26\u5408\u8fd9\u4e9b\u6807\u51c6\u4ee5\u8bc1\u660e\u7b26\u5408\u6027\u3002\u68c0\u6d4b\u548c\u53d6\u6837\u9891\u6b21\u5219\u7531\u6267\u884c\u7b26\u5408\u6027\u6d4b\u8bd5\u7684\u4f18\u9009\u65b9\u6cd5\u6216\u6307\u5bfc\u610f\u89c1\uff0c\u4ee5\u53ca<\/span>USP-NF<\/span>\u7684\u5176\u5b83\u7528\u6237\uff0c\u5305\u62ec\u751f\u4ea7\u5546\u3001\u4e70\u65b9\u548c\u836f\u76d1\u673a\u6784\u6765\u51b3\u5b9a\u3002\uff08\u51e1\u4f8b\uff0c<\/span>3.10<\/span>\uff09<\/span><\/p>\n

2. Do all tests specified in amonograph have to be performed to ensure compliance?<\/span><\/strong>\u662f\u5426\u5fc5\u987b\u68c0\u6d4b\u5404\u8bba\u4e2d\u6240\u5217\u6240\u6709\u9879\u76ee\u4ee5\u786e\u4fdd\u7b26\u5408\u6027\uff1f<\/span><\/strong><\/p>\n

Applicable standards apply at all times in the life of an article, fromproduction to expiration. Thus, any official article is expected to meet thecompendial standards if tested, and any official article actually tested asdirected in the relevant monograph must meet such standards to demonstrate compliance.A manufacturer\u2019s specifications that have been approved by FDA, and relatedcurrent good manufacturing practices (GMPs) for drugs and finishedpharmaceuticals required by FDA regulations (21 CFR Parts 210, 211), all canhelp ensure that an article will be in and stay in compliance with compendialstandards. As noted in the General Notices (section 3.10), the frequency of anytesting and sampling, as well as the necessity and appropriate frequency of anybatch testing, are neither specified nor prescribed by the compendia; whetherand when to test is left to the preferences or direction of those performingcompliance testing, and other users of USP\u2013NF, including manufacturers, buyers,or regulatory authorities.<\/span><\/p>\n

\u9002\u7528\u6807\u51c6\u9002\u7528\u4e8e\u5546\u54c1\u4ece\u751f\u4ea7\u5230\u5931\u6548\u7684\u6240\u6709\u751f\u547d\u65f6\u95f4\u6bb5\u3002\u56e0\u6b64\uff0c\u6240\u6709\u6b63\u5f0f\u7684\u5546\u54c1\u5982\u679c\u6d4b\u8bd5\u5219\u5747\u5e94\u7b26\u5408\u836f\u5178\u6807\u51c6\uff0c\u6309\u76f8\u5173\u5404\u8bba\u4e2d\u8981\u6c42\u5b9e\u9645\u68c0\u6d4b\u7684\u6b63\u5f0f\u5546\u54c1\u5fc5\u987b\u7b26\u5408\u8fd9\u4e9b\u6807\u51c6\u4ee5\u8bc1\u660e\u7b26\u5408\u6027\u3002\u4e00\u4e2a\u751f\u4ea7\u5546\u7ecf<\/span>FDA<\/span>\u6279\u51c6\u7684\u8d28\u91cf\u6807\u51c6\uff0c\u4ee5\u53ca<\/span>FDA<\/span>\u6cd5\u89c4\uff08<\/span>21 CFR Parts 210, 211<\/span>\uff09\u8981\u6c42\u836f\u54c1\u9075\u5b88\u7684\u76f8\u5173<\/span>CGMP<\/span>\uff0c\u6240\u6709\u8fd9\u4e9b\u90fd\u6709\u52a9\u4e8e\u786e\u4fdd\u4e00\u4ef6\u5546\u54c1\u7b26\u5408\u5e76\u6301\u7eed\u7b26\u5408\u836f\u5178\u6807\u51c6\u3002\u6b63\u5982\u51e1\u4f8b\u4e2d\u6240\u5199\uff08\u7b2c<\/span>3.10<\/span>\u90e8\u5206\uff09\uff0c\u6240\u6709\u7684\u53d6\u6837\u7684\u68c0\u6d4b\u9891\u6b21\uff0c\u4ee5\u53ca\u6240\u6709\u6279\u6b21\u68c0\u6d4b\u5fc5\u8981\u6027\u548c\u9002\u5f53\u7684\u9891\u6b21\uff0c\u5728\u836f\u5178\u91cc\u5747\u672a\u6307\u5b9a\u6216\u63cf\u8ff0\uff0c\u662f\u5426\u68c0\u6d4b\u4ee5\u53ca\u4ec0\u4e48\u65f6\u95f4\u68c0\u6d4b\u662f\u7531\u5b9e\u65bd\u7b26\u5408\u6027\u6d4b\u8bd5\u7684\u4f18\u9009\u65b9\u6cd5\u6216\u6307\u5bfc\u610f\u89c1\uff0c\u4ee5\u53ca<\/span>USP-NF<\/span>\u7684\u5176\u5b83\u7528\u6237\uff0c\u5305\u62ec\u751f\u4ea7\u5546\u3001\u4e70\u65b9\u548c\u836f\u76d1\u673a\u6784\u6765\u51b3\u5b9a\u3002<\/span><\/p>\n

3. Are adjustments toquantities and concentrations specified in the monograph allowed? <\/span><\/span><\/strong>\u662f\u5426\u53ef\u4ee5\u5bf9\u5404\u8bba\u4e2d\u6240\u6307\u5b9a\u7684\u6570\u91cf\u548c\u6d53\u5ea6\u8fdb\u884c\u8c03\u6574\uff1f<\/span><\/strong><\/p>\n

Some adjustments may be made. In the current USP\u2013NF General Noticessection 6.60, the following is stated: “Unless otherwise specified, asufficient number of units to assure a suitable analytical result shall betaken.” Furthermore, section 6.50.20.1 states that “When a specifiedconcentration is called for in a procedure, a solution of other normality ormolarity may be used, provided that allowance is made for the difference inconcentration and that the change does not increase the error ofmeasurement.”<\/span><\/p>\n

\u6709\u4e9b\u8c03\u6574\u662f\u53ef\u4ee5\u7684\u3002\u5728\u5f53\u524d\u7684<\/span>USP-NF<\/span>\u51e1\u4f8b<\/span>6.60<\/span>\u4e2d\uff0c\u6709\u4ee5\u4e0b\u9648\u8ff0\u201c\u9664\u53e6\u6709\u89c4\u5b9a\u5916\uff0c\u5e94\u53d6\u8db3\u591f\u6570\u91cf\u5355\u4f4d\u6837\u54c1\u4ee5\u786e\u4fdd\u83b7\u5f97\u9002\u5f53\u7684\u5206\u6790\u7ed3\u679c\u201d\u3002\u53e6\u5916\uff0c\u5728\u7b2c<\/span>6.50.20.1<\/span>\u90e8\u5206\u8bf4\u201c\u5982\u679c\u5728\u4e00\u4e2a\u68c0\u9a8c\u65b9\u6cd5\u91cc\u6307\u5b9a\u4e86\u4e00\u4e2a\u6d53\u5ea6\uff0c\u4e5f\u53ef\u4ee5\u4f7f\u7528\u5176\u5b83\u5f53\u91cf\u6d53\u5ea6\u6216\u6469\u5c14\u6d53\u5ea6\u7684\u6eb6\u6db2\uff0c\u4f46\u8fd9\u79cd\u6d53\u5ea6\u5dee\u5f02\u548c\u6539\u53d8\u4e0d\u5f97\u589e\u52a0\u6d4b\u91cf\u7684\u8bef\u5dee\u3002<\/span><\/p>\n

4. Must the specificationsdescribed in the Description and Solubility section of the USP\u2013NF be met? <\/span><\/span><\/strong>\u662f\u5426\u5fc5\u987b\u7b26\u5408<\/span><\/strong>USP-NF<\/span><\/strong>\u7684\u63cf\u8ff0\u548c\u6eb6\u89e3\u6027\u90e8\u5206\u6240\u8ff0\u6807\u51c6\uff1f<\/span><\/strong><\/p>\n

(See also General Notices, section 5.30. <\/span><\/span>\u4e5f\u53c2\u89c1\u901a\u5219<\/span>5.30<\/span>)<\/span><\/p>\n

5.30. Description and Solubility <\/span><\/span>\u63cf\u8ff0\u548c\u6eb6\u89e3\u5ea6<\/span><\/p>\n

Only where a quantitative solubility test is given in a monograph and isdesignated as such is it a test for purity.<\/span><\/p>\n

\u53ea\u6709\u5728\u5404\u8bba\u4e2d\u89c4\u5b9a\u4e86\u5b9a\u91cf\u6eb6\u89e3\u5ea6\u6d4b\u8bd5\u5e76\u4e14\u6307\u5b9a\u5982\u6b64\u65f6\uff0c\u5b83\u624d\u662f\u4e00\u4e2a\u7eaf\u5ea6\u68c0\u6d4b\u3002<\/span><\/p>\n

A monograph may include information regarding the article’s description.Information about an article’s \u201cdescription and solubility\u201d also is provided inthe reference table Description and Relative Solubility of USP and NF Articles.The reference table merely denotes the properties of articles that comply withmonograph standards. The reference table is intended primarily for those whouse, prepare, and dispense drugs and\/or related articles. Although theinformation provided in monographs and the information in the reference tablemay indirectly assist in the preliminary evaluation of an article, it is notintended to serve as a standard or test for purity.<\/span><\/p>\n

\u5404\u8bba\u4e2d\u53ef\u80fd\u4f1a\u5305\u62ec\u4e00\u4e9b\u8be5\u7269\u54c1\u63cf\u8ff0\u65b9\u9762\u7684\u4fe1\u606f\u3002\u5173\u4e8e\u7269\u54c1\u201c\u63cf\u8ff0\u548c\u6eb6\u89e3\u6027\u201d\u65b9\u9762\u7684\u4fe1\u606f\u4e5f\u5728<\/span>USP<\/span>\u548c<\/span>NF<\/span>\u63cf\u8ff0\u4e0e\u76f8\u5bf9\u6eb6\u89e3\u6027\u5bf9\u7167\u8868\u4e2d\u5217\u51fa\u3002\u8be5\u5bf9\u7167\u8868\u53ea\u662f\u6307\u793a\u7269\u54c1\u7b26\u5408\u5404\u8bba\u6807\u51c6\u7684\u5c5e\u6027\uff0c\u539f\u610f\u662f\u63d0\u4f9b\u7ed9\u90a3\u4e9b\u4f7f\u7528\u3001\u5236\u5907\u548c\u53d1\u653e\u836f\u54c1\u548c<\/span>\/<\/span>\u6216\u76f8\u5173\u7269\u54c1\u7684\u4eba\u53c2\u8003\u3002\u5c3d\u7ba1\u5728\u5404\u8bba\u4e2d\u6240\u63d0\u4f9b\u7684\u4fe1\u606f\u4ee5\u53ca\u5728\u5bf9\u7167\u8868\u4e2d\u7684\u4fe1\u606f\u53ef\u80fd\u4f1a\u95f4\u63a5\u5e2e\u52a9\u5bf9\u7269\u54c1\u505a\u51fa\u521d\u6b65\u8bc4\u4f30\uff0c\u4f46\u5b83\u5e76\u4e0d\u662f\u7528\u6765\u4f5c\u4e3a\u6807\u51c6\u6216\u7eaf\u5ea6\u68c0\u6d4b\u3002<\/span><\/p>\n

The approximate solubility of a compendial substance is indicated by oneof the following descriptive terms:<\/span><\/p>\n

\u836f\u5178\u7269\u8d28\u7684\u8fd1\u4f3c\u6eb6\u89e3\u6027\u91c7\u7528\u4ee5\u4e0b\u63cf\u8ff0\u6027\u672f\u8bed\u6765\u6307\u793a\uff1a<\/span><\/p>\n\n\n\n\n\n\n\n\n\n\n
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Descriptive Term<\/span><\/strong><\/p>\n<\/td>\n

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\u7528\u8bcd<\/span><\/strong><\/p>\n<\/td>\n

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Parts of Solvent Required for 1 Part of Solute<\/span><\/strong><\/p>\n<\/td>\n

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\u6bcf\u4e00\u4efd\u6eb6\u8d28\u6240\u9700\u6eb6\u5242\u4efd\u6570<\/span><\/strong><\/p>\n<\/td>\n<\/tr>\n

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Very soluble<\/span><\/p>\n<\/td>\n

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\u6781\u6613\u6eb6<\/span><\/p>\n<\/td>\n

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Less than 1<\/span><\/p>\n<\/td>\n

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\u4f4e\u4e8e<\/span>1<\/span><\/p>\n<\/td>\n<\/tr>\n

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Freely soluble<\/span><\/p>\n<\/td>\n

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\u6613\u6eb6<\/span><\/p>\n<\/td>\n

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From 1 to 10<\/span><\/p>\n<\/td>\n

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1-10<\/span><\/p>\n<\/td>\n<\/tr>\n

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Soluble<\/span><\/p>\n<\/td>\n

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\u53ef\u6eb6<\/span><\/p>\n<\/td>\n

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From 10 to 30<\/span><\/p>\n<\/td>\n

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10-30<\/span><\/p>\n<\/td>\n<\/tr>\n

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Sparingly soluble<\/span><\/p>\n<\/td>\n

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\u7565\u6eb6<\/span><\/p>\n<\/td>\n

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From 30 to 100<\/span><\/p>\n<\/td>\n

\n

30-100<\/span><\/p>\n<\/td>\n<\/tr>\n

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Slightly soluble<\/span><\/p>\n<\/td>\n

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\u5fae\u6eb6<\/span><\/p>\n<\/td>\n

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From 100 to 1,000<\/span><\/p>\n<\/td>\n

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100-1000<\/span><\/p>\n<\/td>\n<\/tr>\n

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Very slightly soluble<\/span><\/p>\n<\/td>\n

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\u96be\u6eb6<\/span><\/p>\n<\/td>\n

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From 1,000 to 10,000<\/span><\/p>\n<\/td>\n

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1000-10000<\/span><\/p>\n<\/td>\n<\/tr>\n

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Practically insoluble, or
 Insoluble<\/span><\/p>\n<\/td>\n

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\u4e0d\u6eb6<\/span><\/p>\n<\/td>\n

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Greater than or equal to
 10,000<\/span><\/p>\n<\/td>\n

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\u2265<\/span>10,000<\/span><\/p>\n<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n

5. Can a USP scientist reviewdata to confirm that a product complies with the USP requirements? <\/span>USP<\/span><\/span><\/strong>\u79d1\u5b66\u5bb6\u662f\u5426\u4f1a\u5ba1\u6838\u6570\u636e\u4ee5\u786e\u8ba4\u4e00\u4e2a\u4ea7\u54c1\u662f\u5426\u7b26\u5408<\/span><\/strong>USP<\/span><\/strong>\u8981\u6c42\uff1f<\/span><\/strong><\/p>\n

USP scientists cannot review and interpret data, per the OfficialStatements and Interpretations policy: \u201cUSP shall not provide an officialopinion as to whether a particular article does or does not comply withcompendial requirements, except as part of an established USP verification orother conformity assessment program that is conducted separately from andindependent of USP’s standards-setting activities.\u201d<\/span><\/p>\n

USP<\/span>\u79d1\u5b66\u5bb6\u5e76\u4e0d\u4f1a\u5ba1\u6838\u6570\u636e\u5e76\u5bf9\u4e4b\u8fdb\u884c\u89e3\u91ca\uff0c\u4f9d\u636e\u5b98\u65b9\u58f0\u660e\u548c\u89e3\u91ca\u653f\u7b56\uff1a\u201c<\/span>USP<\/span>\u4e0d\u5e94\u63d0\u4f9b\u5b98\u65b9\u89c2\u70b9\u5bf9\u8bc4\u4ef7\u67d0\u4e2a\u7279\u5b9a\u7684\u7269\u54c1\u662f\u5426\u7b26\u5408\u836f\u5178\u8981\u6c42\uff0c\u4f5c\u4e3a<\/span>USP<\/span>\u8ba4\u8bc1\u7a0b\u5e8f\u548c\u5176\u5b83\u7b26\u5408\u6027\u8bc4\u4f30\u7a0b\u5e8f\u7684\u4e00\u90e8\u5206\u8005\u9664\u5916\uff0c\u8fd9\u4e9b\u7a0b\u5e8f\u662f\u72ec\u7acb\u4e8e<\/span>USP<\/span>\u7684\u6807\u51c6\u8bbe\u5b9a\u6d3b\u52a8\u800c\u5b9e\u65bd\u7684\u201d\u3002<\/span><\/p>\n

6. \u6bcf\u6708USP\u95ee\u7b54\u6c47\u7f16<\/span><\/p>\n

<\/span><\/strong><\/span><\/p>\n

2015-<\/strong><\/span>2\u6708\u95ee\u9898\uff1a<\/strong><\/span><\/span><\/p>\n

\u300a\u7f8e\u56fd\u836f\u5178-\u56fd\u5bb6\u5904\u65b9\u96c6\u300b(USP-NF)\u4e2d\u7684\u901a\u7528\u68c0\u6d4b\u65b9\u6cd5\u6536\u5f55\u5728\u901a\u5219(General Chapter)\u4e2d\uff0c\u6240\u6709\u7684\u901a\u5219\u90fd\u662f\u5f3a\u5236\u6267\u884c\u7684\u5417\uff1f<\/span><\/p>\n

\u56de\u7b54\uff1a<\/span><\/strong><\/span><\/p>\n

\u5728USP37-NF32 \u7b2c\u4e8c\u589e\u8865\u672c\u7684\u51e1\u4f8b(General Notice)\u4e2d\u201c2.OFFICIAL STATUS AND LEGAL RECOGNITION\u201d\u9879\u4e0b\u6709\u5982\u4e0b\u89c4\u5b9a\uff1a<\/span><\/p>\n

\u201c2.10. Official Text<\/span><\/p>\n

Official text is text contained in USP and NF, including monographs, general chapters, and these General Notices. Revisions to official text are provided in Supplements, Interim Revision Announcements, and Revision Bulletins. <\/span>General chapters numbered from 1000 to 1999 are considered interpretive and are intended to provide information on, give definition to, or describe a particular subject. They contain no mandatory requirements applicable to any official article unless specifically referenced in General Notices, a monograph, or a general chapter numbered below 1000. General chapters numbered above 2000 apply only to articles that are intended for use as dietary ingredients and dietary supplements.\u201d<\/span><\/span><\/p>\n

———————————————————————-<\/span><\/p>\n

3\u6708\u95ee\u9898\uff1a<\/strong><\/span><\/p>\n

\u5728”\u70bd\u707c\u6b8b\u6e23 (Residue on Ignition)”\u548c”\u5e72\u71e5\u5931\u91cd (Loss on Drying)”\u6d4b\u8bd5\u4e2d\uff0c\u4f1a\u6709\u8981\u6c42”\u6052\u91cd(Constant Weight)”\uff0c\u6839\u636e\u300a\u7f8e\u56fd\u836f\u5178-\u56fd\u5bb6\u5904\u65b9\u96c6\u300b(USP-NF)\u7684\u89c4\u5b9a\uff1a”\u6052\u91cd”\u8868\u793a\u6837\u54c1\u8fde\u7eed\u4e24\u6b21\u70bd\u707c\u6216\u5e72\u71e5\u540e\u79f0\u91cd\u7684\u5dee\u5f02\u4e0d\u5f97\u8d85\u8fc7\u591a\u5c11\u91cd\u91cf\u5462\uff1f<\/span><\/p>\n

\u56de\u7b54\uff1a<\/span><\/strong><\/span><\/p>\n

\u5728USP37-NF32 \u7b2c\u4e8c\u589e\u8865\u672c\u7684\u51e1\u4f8b(General Notice)\u4e2d\u201c6. TESTING PRACTICES AND  PROCEDURES\u201d\u9879\u4e0b\u6709\u5982\u4e0b\u89c4\u5b9a\uff1a<\/span><\/p>\n

6.40.10. Ignite to Constant Weight<\/span><\/strong><\/span><\/p>\n

“<\/span>Ignite to constant weight\u201d means that ignition shall be continued at 800 \u00b1 25, unless otherwise indicated, until two consecutive weighings, the second of which is taken after an additional period appropriate to the nature and quantity of the residue, <\/span>do not differ by more than 0.50 mg per g of substance taken.<\/span><\/strong><\/span><\/p>\n

<\/span><\/p>\n

6.40.20. Dried to Constant Weight<\/span><\/strong><\/span><\/p>\n

“Dried to constant weight\u201d means that drying shall be continued until two consecutive weighings, the second of which is taken after an additional drying period appropriate to the nature and quantity of the residue, <\/span>do not differ by more than 0.50 mg per g of substance taken.<\/strong><\/span><\/span><\/p>\n

————————————————————–<\/span><\/p>\n

4\u6708\u95ee\u9898\uff1a<\/strong><\/span><\/p>\n


<\/p>\n

USP\u4f1a\u5bf9\u836f\u5178\u6d4b\u8bd5\u5373\u5c06\u4e0d\u518d\u6709\u6548\u7684\u524d\u4e00\u6279\u6b21\uff08Previous Lot\uff09\u6807\u51c6\u54c1\u8d4b\u4e88\u6709\u6548\u4f7f\u7528\u65e5\u671f\uff08Valid Use Date\uff09\u3002<\/span><\/p>\n

\u95ee\u98981:\u901a\u8fc7\u4ec0\u4e48\u9014\u5f84\u53ef\u4ee5\u67e5\u8be2\u5230\u5148\u524d\u6279\u6b21\uff08Previous Lot\uff09USP\u6807\u51c6\u54c1\u7684\u6709\u6548\u4f7f\u7528\u65e5\u671f\uff1f<\/span><\/p>\n

\u95ee\u98982: \u82e5\u67d0\u6279\u6b21USP\u6807\u51c6\u54c1\u6807\u660e\u201cValid Use Date:11\/12\u201d\uff0c\u5373\u8868\u793a\u6b64\u6279\u6b21\u6807\u51c6\u54c1\u6709\u6548\u4f7f\u7528\u65e5\u671f\u662f\u622a\u6b62\u5230\u54ea\u4e00\u5929\u5462\uff1f<\/span><\/p>\n


<\/p>\n

\u56de\u7b54\uff1a<\/span><\/strong><\/span><\/p>\n

\u95ee\u98981\u7b54\u6848:<\/strong><\/span>(1)\u767b\u5f55USP\u5b98\u65b9\u7f51\u7ad9www.usp.org,\u8f93\u5165\u641c\u7d22\u6807\u51c6\u54c1(\u82f1\u6587\u540d)\u6216Catalog No.,\u4f8b\u5982\u641c\u7d22”Sucrose”\u6216\u5176Catalog No.:1623637,\u5373\u53ef\u67e5\u8be2\u5230\u5982\u4e0b\u4fe1\u606f:<\/span><\/p>\n

\"\u7f8e\u56fd\u836f\u5178USP\u5b98\u7f51\u95ee\u7b54\uff1a\u5e38\u89c1\u95ee\u9898\u95ee\u7b54\"<\/p>\n

<\/span><\/p>\n

(2)\u767b\u5f55USP\u5b98\u65b9\u7f51\u7ad9www.usp.org,\u5728”Reference Standards”\u9879\u4e0b\u4e0b\u8f7d\u201cUSP Daily Reference Standards Catalog”<\/span><\/p>\n

(3)\u8ba2\u9605USP Email Notice\uff0c\u5b9a\u671f\u63a5\u6536\u6765\u81eaUSP\u7684\u90ae\u4ef6\u901a\u77e5<\/span><\/p>\n

(4)\u5173\u6ce8USP\u5b98\u65b9\u5fae\u4fe1\u548c\u5fae\u535a\uff0c\u6bcf\u6708\u4e86\u89e3USP\u6807\u51c6\u54c1\u66f4\u65b0<\/span><\/p>\n


<\/p>\n

\u95ee\u98982\u7b54\u6848<\/strong>\uff1a<\/span>“Valid Use Date\uff1aMM\/YY”\u4e2d\uff0cMM\u8868\u793a”\u6708”,YY\u8868\u793a”\u5e74”,\u6709\u6548\u671f\u4e3a\u622a\u6b62\u81f3\u8be5\u5e74\u8be5\u6708\u7684\u6700\u540e\u4e00\u5929\u3002\u6240\u4ee5\uff0c\u82e5\u67d0\u6279\u6b21USP\u6807\u51c6\u54c1\u6807\u660e\u201cValid Use Date:11\/12\u201d\uff0c\u5373\u8868\u793a\u6b64\u6279\u6b21\u6807\u51c6\u54c1\u6709\u6548\u4f7f\u7528\u65e5\u671f\u662f\u622a\u6b62\u52302012\u5e7411\u670830\u65e5\u3002<\/span><\/p>\n

————————————————————–<\/span><\/p>\n

5\u6708\u95ee\u9898\uff1a<\/strong><\/span><\/p>\n

\u5728\u4f9d\u636eUSP\u5404\u8bba\u53ca\u76f8\u5173\u901a\u5219\u8fdb\u884c\u8272\u8c31\u6cd5\u6d4b\u8bd5\u65f6\uff0c\u6837\u54c1\u6eb6\u6db2\u4e2d\u67d0\u7ec4\u5206\u7684\u76f8\u5bf9\u4fdd\u7559\u65f6\u95f4\u5fc5\u987b\u4e0e\u5404\u8bba\u89c4\u5b9a\u7684\u76f8\u5bf9\u4fdd\u7559\u65f6\u95f4\u5b8c\u5168\u4e00\u81f4\u5417?\u4e3a\u4ec0\u4e48?<\/span><\/p>\n

\u56de\u7b54\uff1a<\/span><\/strong><\/span><\/p>\n

\u5728\u901a\u5219<621>\u8272\u8c31\u6cd5\u7684\u7cfb\u7edf\u9002\u7528\u6027(SYSTEM SUITABILITY)\u9879\u4e0b\u6709\u5982\u4e0b\u63cf\u8ff0:<\/span><\/p>\n

“Relative retention times may be provided in monographs for informational purposes only to aid in peak identification.There are no acceptance criteria applied to relative retention times.”<\/span><\/p>\n

\u5373\u5404\u8bba\u4e2d\u63d0\u53ca\u7684\u76f8\u5bf9\u4fdd\u7559\u65f6\u95f4\u4ec5\u4f9b\u53c2\u8003\uff0c\u65e8\u5728\u8f85\u52a9\u8bc6\u522b\u8272\u8c31\u5cf0\uff0c\u5e76\u6ca1\u6709\u5173\u4e8e\u76f8\u5bf9\u4fdd\u7559\u65f6\u95f4\u7684\u53ef\u63a5\u53d7\u6807\u51c6”\u3002<\/span><\/p>\n

————————————————————–<\/span><\/p>\n

6\u6708\u95ee\u9898\uff1a<\/strong><\/span><\/p>\n

USP\u5bf9\u8d2e\u5b58\u6761\u4ef6\u7684\u63cf\u8ff0\u4e2d\uff0c\u201cCold\u201d\u662f\u6307\u6e29\u5ea6\u57282\u2103\uff5e8\u2103\u4e4b\u95f4\u3002\u8fd9\u79cd\u8bf4\u6cd5\u662f\u6b63\u786e\u7684\u5417\uff1f<\/span><\/p>\n

\u56de\u7b54\uff1a<\/span><\/strong><\/span><\/p>\n

\u6b64\u8bf4\u6cd5\u662f\u9519\u8bef\u7684\u3002\u5728USP38-NF33\u7684\u901a\u5219<659>\u5305\u88c5\u548c\u8d2e\u5b58\u8981\u6c42(PACKAGING AND STORAGE REQUIREMENTS) \u201cSTORAGE CONDITIONS\u201d\u9879\u4e0b\u6709\u5982\u4e0b\u63cf\u8ff0:<\/span><\/p>\n

“Cold:<\/span> Any temperature not exceeding <\/span>8<\/strong>\"\u7f8e\u56fd\u836f\u5178USP\u5b98\u7f51\u95ee\u7b54\uff1a\u5e38\u89c1\u95ee\u9898\u95ee\u7b54\"(46 F).”<\/span><\/strong><\/span><\/p>\n

<\/span><\/p>\n

\u7279\u522b\u63d0\u9192:<\/span><\/strong><\/em><\/span><\/p>\n

       \u5f88\u591a\u670b\u53cb\u5728\u56de\u7b54\u65f6\u63d0\u5230”\u6839\u636eUSP\u51e1\u4f8b10\u4e2d\u7684\u89c4\u5b9a\u3002\u3002\u3002”\uff0c\u5c0f\u7f16\u5728\u6b64\u7279\u522b\u63d0\u9192\uff0c\u4e8b\u5b9e\u4e0a\uff0c\u6700\u65b0\u751f\u6548\u7684USP38-NF33 \u5df2\u5bf9\u6b64\u7ae0\u8282\u4fee\u8ba2: \u9664\u975e\u5404\u8bba\u6709\u5176\u4ed6\u8981\u6c42\uff0c\u51e1\u4f8b10.10\u4e2d\u5173\u4e8e\u5305\u88c5\u548c\u8d2e\u5b58\u8981\u6c42\u7684\u5185\u5bb9\u5747\u5df2”\u642c\u5bb6”\u81f3\u901a\u5219<659>PACKAGING AND STORAGE REQUIREMENTS\u3002\u5c0f\u7f16\u5728\u6b64\u7279\u522b\u63d0\u9192\uff0c\u5e76\u5efa\u8bae\u5927\u5bb6\u53c2\u8003\u6700\u65b0\u751f\u6548\u7684\u836f\u5178\u5185\u5bb9\u3002<\/span><\/em><\/p>\n

————————————————————–<\/span><\/p>\n

7\u6708\u95ee\u9898\uff1a<\/strong><\/span><\/p>\n

\u5728\u6267\u884cUSP-NF\u65b9\u6cd5\u65f6\uff0c\u82e5\u9700\u505a\u7ea2\u5916\u9274\u522b\uff0c\u9700\u7528\u6837\u54c1\u7684\u7ea2\u5916\u56fe\u8c31\u4e0eUSP\u7684\u7ea2\u5916\u6807\u51c6\u56fe\u8c31\u96c6\u8fdb\u884c\u6bd4\u8f83\uff0c\u8fd9\u79cd\u8bf4\u6cd5\u6b63\u786e\u5417\uff1f<\/span><\/p>\n

\u56de\u7b54\uff1a<\/span><\/strong><\/span><\/p>\n

\u6b64\u8bf4\u6cd5\u662f\u9519\u8bef\u7684\u3002\u6839\u636e\u901a\u5219\u201c<197> SPECTROPHOTOMETRIC IDENTIFICATION TESTS\u201d\u89c4\u5b9a:<\/span><\/p>\n

“Record the spectra of the test specimen and the corresponding USP Reference Standard over the range from about 2.6 \u00b5m to 15 \u00b5m (3800 cm\u20131<\/span> to 650 cm\u20131<\/span>) unless otherwise specified in the individual monograph.The IR absorption spectrum of the preparation of the test specimen, previously dried under conditions specified for the corresponding Reference Standard unless otherwise specified, or unless the Reference Standard is to be used without drying, exhibits maxima only at the same wavelengths as that of a similar preparation of the corresponding USP Reference Standard……”<\/span><\/p>\n

       \u53e6\u5916\uff0c\u5728\u901a\u5219”<851> SPECTROPHOTOMETRY AND LIGHT-SCATTERING”\u4e2d\u5bf9\u4e8eUSP\u6807\u51c6\u54c1\u7528\u4e8e\u836f\u5178\u5206\u5149\u5149\u5ea6\u6cd5\u6d4b\u8bd5\u4e5f\u6709\u76f8\u5e94\u89c4\u5b9a\u548c\u63cf\u8ff0\u3002<\/span>
————————————————————–<\/span><\/p>\n

8\u6708\u95ee\u9898\uff1a<\/strong><\/span><\/p>\n

\u60f3\u4e86\u89e3\u7f8e\u56fd\u836f\u5178\u4e2d\u5bf9\u67d0\u54c1\u79cd\u7684\u6027\u72b6\u3001\u6c14\u5473\u548c\u6eb6\u89e3\u6027\u7684\u63cf\u8ff0\uff0c\u4f46\u5728\u8be5\u54c1\u79cd\u5404\u8bba\u4e2d\u5374\u627e\u4e0d\u5230\uff0c\u8bf4\u660eUSP-NF\u672a\u6536\u5f55\u4ea7\u54c1\u6027\u72b6\uff0c\u6c14\u5473\u548c\u6eb6\u89e3\u6027\u7684\u4fe1\u606f\u3002\u8fd9\u79cd\u8bf4\u6cd5\u662f\u6b63\u786e\u7684\u5417\uff1f<\/span><\/p>\n

\u56de\u7b54\uff1a<\/span><\/strong><\/span><\/p>\n

\u6b64\u8bf4\u6cd5\u662f\u9519\u8bef\u7684\u3002\u9664\u5404\u8bba\u6709\u5176\u4ed6\u89c4\u5b9a\u5916\uff0c\u201cDescription and Solubility\u201d\u4fe1\u606f\u5747\u6536\u8f7d\u4e8e\u201cReference Table\u201d\u9879\u4e0b\uff0c\u4e14\u6b64\u4fe1\u606f\u4ec5\u4f5c\u4e3a\u7269\u8d28\u7279\u6027\u521d\u6b65\u8bc4\u4f30\u7684\u8f85\u52a9\u53c2\u8003\uff0c\u800c\u975e\u836f\u5178\u6807\u51c6\u548c\u7eaf\u5ea6\u6d4b\u8bd5\u8981\u6c42\u3002\u539f\u6587\u5982\u4e0b\uff1a<\/span><\/p>\n

“The \u201cdescription\u201d and \u201csolubility\u201d statements pertaining to an  article (formerly included in the individual monograph) are general in nature.  The information is provided for those who use, prepare, and dispense drugs,  solely to indicate descriptive and solubility properties of an article complying  with monograph standards. The properties are not in themselves standards or  tests for purity even though they may indirectly assist in the preliminary  evaluation of the integrity of an article…..”<\/span><\/p>\n

\u53e6\u5916\uff0c\u5728USP38-NF33 \u7b2c\u4e00\u589e\u8865\u672c\u7684\u51e1\u4f8b(General Notices: 5. MONOGRAPH COMPONENTS)\u4e2d\u201c5.30 Description and Solubility\u201d \u9879\u4e0b\u4e5f\u6709\u8be6\u7ec6\u8bf4\u660e\u3002<\/span><\/p>\n

————————————————————–<\/span><\/p>\n

9\u6708\u95ee\u9898\uff1a<\/strong><\/span><\/p>\n

USP\u836f\u5178\u8bba\u575b(Pharmacopeia Forum)\u4e0a\u63d0\u8bae\u4fee\u8ba2\u7684\u5185\u5bb9\u90fd\u4f1a\u6309\u8ba1\u5212\u6536\u5f55\u4e8e\u300a\u7f8e\u56fd\u836f\u5178-\u56fd\u5bb6\u5904\u65b9\u96c6\u300b\u5417\uff1f\u5982\u679c\u4e0d\u662f\uff0c\u5728\u54ea\u91cc\u53ef\u4ee5\u4e86\u89e3\u8fd9\u4e9b\u4fee\u8ba2\u7684\u8fdb\u5c55\u548c\u72b6\u6001\u5462\uff1f<\/span><\/p>\n

\u56de\u7b54\uff1a<\/span><\/strong><\/span><\/p>\n

USP\u836f\u5178\u8bba\u575b\u4e0a\u63d0\u8bae\u4fee\u8ba2\u7684\u5185\u5bb9\u4e0d\u90fd\u4f1a\u6309\u8ba1\u5212\u6536\u5f55\u4e8e\u300a\u7f8e\u56fd\u836f\u5178-\u56fd\u5bb6\u5904\u65b9\u96c6\u300b\u4e2d\uff0c\u6709\u5173\u4fee\u8ba2\u7684\u8fdb\u5c55\u548c\u72b6\u6001\u53ef\u5728USP\u5b98\u65b9\u7f51\u7ad9\u67e5\u8be2\uff1a\u767b\u5f55<\/span>www.usp.org\u2192USP-NF\u2192Official Test\u2192Proposal status and commentary<\/span><\/p>\n

————————————————————–<\/span><\/p>\n

10\u6708\u95ee\u9898\uff1a<\/strong><\/span><\/p>\n

USP\u901a\u5219<467>\u5217\u51fa\u4e86\u6b8b\u7559\u6eb6\u5242\u7684\u5206\u7c7b\u548c\u9650\u5ea6\uff0c\u8fd9\u4e9b\u9650\u5ea6\u662f\u9488\u5bf9\u5236\u5242\u4ea7\u54c1\u800c\u975e\u539f\u6599\u3001\u8f85\u6599\u8bbe\u5b9a\u7684\u3002\u8fd9\u4e2a\u8bf4\u6cd5\u662f\u6b63\u786e\u7684\u5417\uff1f<\/span><\/p>\n

\u56de\u7b54\uff1a<\/strong><\/span><\/p>\n

\u6b64\u8bf4\u6cd5\u662f\u6b63\u786e\u7684\u3002USP\u901a\u5219<467>\u5217\u51fa\u7684\u6b8b\u7559\u6eb6\u5242\u9650\u5ea6\u662f\u9488\u5bf9\u5236\u5242\u4ea7\u54c1\u800c\u975e\u539f\u6599\u3001\u8f85\u6599\u8bbe\u5b9a\u7684\u3002<\/span><\/p>\n

————————————————————–<\/span><\/p>\n

11\u6708\u95ee\u9898\uff1a<\/strong><\/span><\/p>\n

        <\/span><\/strong><\/strong><\/span>\u836f\u5178\u8bba\u575b (Pharmacopeial Forum,PF)\u662f USP \u6807\u51c6\u4fee\u8ba2\u7684\u516c\u5171\u5e73\u53f0\uff0c\u5b83\u662f\u4e00\u4e2a\u514d\u8d39\u7f51\u7edc\u53cc\u6708\u520a\uff0c\u53d1\u5e03\u540e\u6709 90\u5929\u7684\u516c\u4f17\u8bc4\u8bae\u671f\uff0c\u5b83\u7684\u5185\u5bb9\u662f\u6cd5\u5b9a\u751f\u6548\u6587\u4ef6\uff0c\u7528\u6237\u53ef\u76f4\u63a5\u5c06\u5176\u7b49\u540c\u4e8eUSP-NF\u4f7f\u7528\uff0c\u8fd9\u4e2a\u8bf4\u6cd5\u662f\u6b63\u786e\u7684\u5417\uff1f<\/span><\/p>\n

\u56de\u7b54\uff1a<\/span><\/strong><\/span><\/p>\n

\u6b64\u8bf4\u6cd5\u662f\u4e0d\u6b63\u786e\u7684\u3002 \u836f\u5178\u8bba\u575b (Pharmacopeial Forum,PF)\u662f USP \u6807\u51c6\u4fee\u8ba2\u7684\u516c\u5171\u5e73\u53f0\uff0c\u5b83\u662f\u4e00\u4e2a\u514d\u8d39\u7f51\u7edc\u53cc\u6708\u520a\uff0cUSP\u5728\u836f\u5178\u8bba\u575b (Pharmacopeial Forum,PF)\u4e0a\u53d1\u5e03\u5173\u4e8e\u300a\u7f8e\u56fd\u836f\u5178-\u56fd\u5bb6\u5904\u65b9\u96c6\u300b(USP-NF)\u4e2d\u7684\u6807\u51c6\u4fee\u8ba2\u63d0\u6848\uff0c\u4f9b\u516c\u4f17\u8bc4\u8bae\uff0c\u53d1\u5e03\u540e\u6709 90\u5929\u7684\u516c\u4f17\u8bc4\u8bae\u671f\uff0c\u901a\u8fc7PF\uff0c\u7528\u6237\u53ef\u4ee5\u56de\u987e\u548c\u8ffd\u8e2a\u63d0\u8bae\u4fee\u8ba2\u7684\u8fdb\u7a0b\u5e76\u63d0\u4ea4\u4fee\u8ba2\u610f\u89c1\u3002\u4fee\u8ba2\u63d0\u6848\u5e76\u975e\u6cd5\u5b9a\u751f\u6548\u6587\u4ef6\uff0c\u4e0d\u53ef\u7b49\u540c\u4e8eUSP-NF\u4f7f\u7528\u3002<\/span><\/p>\n

\u836f\u5178\u8bba\u575b:www.usppf.com<\/span><\/p>\n

————————————————————–<\/span><\/p>\n

12\u6708\u95ee\u9898\uff1a<\/strong><\/span><\/p>\n

  <\/span><\/strong><\/strong><\/span>    USP\u63d0\u4f9b\u4e86\u836f\u5178\u65b9\u6cd5\u4e2d\u4f7f\u7528\u7684HPLC\u548cGC\u8272\u8c31\u67f1\u54c1\u724c\u53c2\u6570\u7b49\u4fe1\u606f\u4f9b\u7528\u6237\u53c2\u8003\uff0c\u8fd9\u4e2a\u8bf4\u6cd5\u662f\u6b63\u786e\u7684\u5417\uff1f<\/span><\/p>\n

\u56de\u7b54\uff1a<\/span><\/strong><\/span><\/p>\n

\u6b64\u8bf4\u6cd5\u662f\u6b63\u786e\u7684\u3002USP-NF\u65b9\u6cd5\u5f00\u53d1\u4e2d\u7528\u5230\u7684\u8272\u8c31\u67f1\u54c1\u724c\u4fe1\u606f\u6536\u5f55\u4e8e\u514d\u8d39\u5728\u7ebf\u7248www.uspchromcolumns.com\u7f51\u7ad9\u4e2d\uff0c\u6ce8\u518c\u540e\u5373\u53ef\u767b\u5f55\u3002\u8be5\u6570\u636e\u5e93\u53ef\u8282\u7701\u7528\u6237\u5bfb\u627e\u9002\u7528\u4e8e\u6d4b\u8bd5\u7684\u8272\u8c31\u67f1\u7684\u5b9d\u8d35\u65f6\u95f4\uff0c\u8ffd\u8e2a\u4ece\u4fee\u8ba2\u9636\u6bb5\u5230\u751f\u6548\u72b6\u6001\u7684\u65b9\u6cd5\u4e2d\u4f7f\u7528\u7684\u8272\u8c31\u67f1\uff0c\u67e5\u627e\u8272\u8c31\u67f1\u54c1\u724c\u548c\u751f\u4ea7\u5546\uff0c\u627e\u5230\u53ef\u4f7f\u7528\u7684\u5907\u9009\uff08\u6216\u66ff\u4ee3\uff09\u8272\u8c31\u67f1\u7b49\u3002\u6ce8:\u8272\u8c31\u67f1\u54c1\u724c\u540d\u79f0\u4ec5\u4e3a\u4fbf\u4e8e\u7528\u6237\u53c2\u8003\u4fe1\u606f\uff0c\u4e0d\u5305\u542b\u4efb\u4f55\u6697\u793a\uff0c\u6279\u51c6\uff0c\u8ba4\u53ef\u6216\u8ba4\u8bc1\u3002<\/span><\/p>\n

\u8272\u8c31\u67f1\u5728\u7ebf\u6570\u636e\u5e93:www.uspchromcolumns.com<\/span><\/p>\n

<\/span><\/strong><\/span><\/p>\n

2016<\/strong><\/span>-1\u6708\u95ee\u9898\uff1a<\/strong><\/span><\/span><\/p>\n

\u6839\u636eUSP-NF\u7684\u8981\u6c42\uff0c\u5236\u5242\u4ea7\u54c1\u7684\u751f\u4ea7\u4e0d\u4e00\u5b9a\u8981\u4f7f\u7528\u7b26\u5408USP-NF\u6807\u51c6\u7684\u539f\u8f85\u6599\uff0c\u5373\u4f7fUSP-NF\u4e2d\u6536\u5f55\u4e86\u8be5\u539f\u8f85\u6599\u7684\u6807\u51c6\uff0c\u8fd9\u4e2a\u8bf4\u6cd5\u6b63\u786e\u5417\uff1f<\/span><\/p>\n

\u56de\u7b54\uff1a<\/span><\/strong><\/span><\/p>\n

\u6b64\u8bf4\u6cd5\u662f\u9519\u8bef\u7684\u3002\u5728USP38-NF33\u7b2c\u4e8c\u589e\u8865\u672c\u7684\u51e1\u4f8b3. CONFORMANCE TO STANDARDS\u4e2d\u6709\u5982\u4e0b\u89c4\u5b9a\uff1a<\/span>\u201cOfficial products are prepared according to recognized principles of  good manufacturing practice and from ingredients that meet USP or NF standards, where standards for such ingredients exist (for dietary supplements,  see section 3.10.20).\u201d<\/span><\/p>\n

————————————————————–<\/span><\/p>\n

2\u6708\u95ee\u9898\uff1a<\/strong><\/span><\/p>\n

USP-NF\u4e2d\u7684”about”\u901a\u5e38\u662f\u6307\u79f0\u91cf\uff0c\u4f53\u79ef\uff0c\u4fdd\u7559\u65f6\u95f4\u7684\u6b63\u8d1f\u504f\u5dee\u503c\u4e3a5%\uff0c\u8fd9\u4e2a\u8bf4\u6cd5\u6b63\u786e\u5417\uff1f<\/span><\/p>\n

\u56de\u7b54\uff1a<\/span><\/strong><\/span><\/p>\n

\u6b64\u8bf4\u6cd5\u662f\u9519\u8bef\u7684\u3002\u5728USP38-NF33\u7b2c\u4e8c\u589e\u8865\u672c\u7684\u51e1\u4f8b8. TERMS AND DEFINITIONS\u4e2d\u6709\u5982\u4e0b\u89c4\u5b9a\uff1a\u201c\u201cAbout\u201d indicates a quantity within 10%.\u201d<\/span><\/p>\n

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3\u6708\u95ee\u9898\uff1a<\/strong><\/span><\/p>\n

\u5f53USP\u6807\u51c6\u54c1\u6807\u7b7e\u4e0a\u660e\u786e\u8981\u6c42\u6807\u51c6\u54c1\u5728\u4f7f\u7528\u524d\u8fdb\u884c\u5e72\u71e5\u65f6\uff0c\u4e3a\u4fbf\u4e8e\u64cd\u4f5c\uff0c\u901a\u5e38USP\u5efa\u8bae\u7528\u6237\u76f4\u63a5\u4f7f\u7528\u539f\u59cb\u5305\u88c5\u5bb9\u5668\u5bf9\u6807\u51c6\u54c1\u8fdb\u884c\u5e72\u71e5\uff0c\u8fd9\u4e2a\u8bf4\u6cd5\u6b63\u786e\u5417\uff1f<\/span><\/p>\n

\u56de\u7b54\uff1a<\/span><\/strong><\/span><\/p>\n

\u6b64\u8bf4\u6cd5\u662f\u9519\u8bef\u7684\u3002\u5728USP38-NF33\u7b2c\u4e8c\u589e\u8865\u672c\u7684\u901a\u5219<11>USP REFERENCE STANDARDS\u4e2d\u5bf9\u201cDry Before Use\u201d\u6709\u5982\u4e0b\u89c4\u5b9a:\u201cUse immediately after drying under stated conditions. Drying should not be  performed in the original container. A portion of the material should be  transferred to a separate drying vessel.\u201d<\/span><\/p>\n

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4\u6708\u95ee\u9898\uff1a<\/strong><\/span><\/p>\n

\u5982\u679c\u6709\u836f\u5178\u65b9\u6cd5\u63d0\u4f9b\uff0c\u7528\u6237\u4e0d\u53ef\u4f7f\u7528\u81ea\u5df1\u5f00\u53d1\u7684\u65b9\u6cd5\u66ff\u4ee3\u836f\u5178\u65b9\u6cd5\uff0c\u8fd9\u4e2a\u8bf4\u6cd5\u6b63\u786e\u5417\uff1f<\/span>
<\/p>\n

\u56de\u7b54\uff1a<\/span><\/strong><\/span><\/p>\n

\u6b64\u8bf4\u6cd5\u662f\u9519\u8bef\u7684\u3002\u5728USP38-NF33\u7b2c\u4e8c\u589e\u8865\u672c\u7684\u51e1\u4f8b6.30 Alternative and Harmonized Methods and Procedures\u6709\u5982\u4e0b\u63cf\u8ff0:\u201cAlternative methods and\/or procedures may be used if they provide advantages in  terms of accuracy, sensitivity, precision, selectivity, or adaptability to  automation or computerized data reduction, or in other special circumstances.  Such alternative procedures and methods shall be validated as described in the  general chapter <\/span>Validation<\/span> of Compendial Procedures 1225<\/span><\/span> <\/span>and must be shown to give equivalent or better  results. Only those results obtained by the methods and procedures given in the  compendium are conclusive..\u201d<\/span><\/p>\n

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5\u6708\u95ee\u9898\uff1a<\/strong><\/span><\/p>\n

USP\u6807\u51c6\u54c1\u662f\u7ecf USP \u5168\u9762\u6807\u5b9a\u7684\u9ad8\u7eaf\u5ea6\u7269\u8d28\uff0c\u7528\u6237\u8d2d\u4e70\u540e\u53ef\u6309\u5404\u79cd\u9700\u8981\u4f7f\u7528\uff0c\u8fd9\u4e2a\u8bf4\u6cd5\u6b63\u786e\u5417\uff1f<\/span>
<\/p>\n

\u56de\u7b54\uff1a<\/span><\/strong><\/span><\/p>\n

\u6b64\u8bf4\u6cd5\u662f\u9519\u8bef\u7684\u3002\u5728USP39-NF34\u7684\u901a\u5219<11>USP
REFERENCE STANDARDS\u4e2d\u6709\u5982\u4e0b\u63cf\u8ff0:\u201cReference
Standards for official articles in USP or NF are provided as pure materials oras mixtures of chemicals reflective of the corresponding drug substances orexcipients. The use of these materials is specified in the article’s monograph,and these materials generally are necessary for use in the Assay and\/or theIdentification tests. The suitability of a USP RS for uses outside thosespecified in a monograph is the responsibility of the user.”<\/span><\/p>\n


<\/p>\n

\u53e6\u5916\uff0cUSP \u6807\u51c6\u54c1\u7684Certificate\u4e2d\u6709\u5982\u4e0b\u8bf4\u660e:<\/span><\/p>\n

Instructions for Use:
Follow the instructions in the appropriate USP or NF Monographs and General Requirements for Tests and Assays of the current USP\u2013NF. In the event that instructions on the label of this lot differ from those found in the current USP\u2013NF, those on the label supersede any instructions listed in Chapter<11>.<\/span><\/p>\n

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6\u6708\u95ee\u9898\uff1a<\/strong><\/span><\/p>\n


<\/p>\n

\u5728USP-NF\u5173\u4e8e\u8d2e\u5b58\u6761\u4ef6\u7684\u63cf\u8ff0\u4e2d\uff0c\u201cFreezer\u201d\u662f\u6307\u8d2e\u5b58\u5728\u6e29\u5ea6\u4e3a\u221225\u00b0\u81f3\u221210\u00b0\u7684\u6761\u4ef6\u4e0b\uff0c\u800c”Refrigerator\u201d\u662f\u6307\u8d2e\u5b58\u5728\u6e29\u5ea6\u4e3a2\u00b0\u81f3 8\u00b0\u7684\u6761\u4ef6\u4e0b\uff0c\u8fd9\u4e2a\u8bf4\u6cd5\u6b63\u786e\u5417\uff1f<\/span>
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<\/p>\n

\u56de\u7b54\uff1a<\/span><\/strong><\/span><\/p>\n

\u6b64\u8bf4\u6cd5\u662f\u6b63\u786e\u7684\u3002\u5728USP39-NF34\u7684\u901a\u5219General Chapters<659> PACKAGING AND STORAGE REQUIREMENTS\u7684\u201cSTORAGE CONDITIONS\u201d\u9879\u4e0b\u6709\u5982\u4e0b\u63cf\u8ff0:<\/span><\/p>\n

“Freezer: <\/span><\/strong>A place in which the temperature is maintained between \u221225\u00b0 and \u221210\u00b0 (\u221213\u00b0 and 14 \u00b0F).<\/span><\/p>\n

Refrigerator:<\/span><\/strong> A cold place in which the temperature is maintained between 2\u00b0 and 8\u00b0 (36\u00b0 and 46 \u00b0F).”<\/span>
<\/p>\n

————————————————————–<\/span><\/span><\/span><\/p>\n

7\u6708\u95ee\u9898\uff1a<\/strong><\/span><\/p>\n

\u5982\u679c\u5404\u8bba\u4e2d\u6709\u673a\u6742\u8d28\u68c0\u67e5\u9879\u4e0b\u5b58\u5728\u591a\u4e2a\u6d4b\u8bd5\u5185\u5bb9(Procedures)\uff0c\u90a3\u5fc5\u987b\u5b8c\u6210\u6bcf\u4e2a\u6d4b\u8bd5\u5185\u5bb9\u5e76\u7b26\u5408\u5176\u63a5\u53d7\u6807\u51c6\uff0c\u8fd9\u4e2a\u8bf4\u6cd5\u6b63\u786e\u5417\uff1f<\/span>
<\/p>\n

\u56de\u7b54\uff1a<\/span><\/strong><\/strong><\/span><\/p>\n

\u6b64\u8bf4\u6cd5\u662f\u9519\u8bef\u7684\u3002\u5728\u51e1\u4f8b(General Notice) 4.10.10. Applicability of Test Procedures\u4e2d\u6709\u5982\u4e0b\u8bf4\u660e:<\/span><\/p>\n

A single monograph may include more than one test, procedure, and\/or acceptance criterion for the same attribute. Unless otherwise specified in the monograph, all tests are requirements. In some cases, monograph instructions allow the selection of tests that reflect attributes of different manufacturers’ articles, such as different polymorphic forms, impurities, hydrates, and dissolution. Monograph instructions indicate the tests, procedures, and\/or acceptance criteria to be used and the required labeling.<\/span><\/p>\n

The order in which the tests are listed in the monograph is based on the order in which they are approved by the relevant Expert Committee for inclusion in the monograph. Test 1 is not necessarily the test for the innovator or for the reference product. Depending on monograph instructions, a labeling statement is not typically required if Test 1 is used.<\/span><\/p>\n

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8\u6708\u95ee\u9898\uff1a<\/strong><\/span><\/p>\n

\u201c\u4fee\u8ba2\u516c\u544a(Revision Bulletins, RB)\u201d\u662f\u4e00\u79cdUSP\u836f\u5178\u52a0\u901f\u4fee\u8ba2\u7a0b\u5e8f\uff0c\u5373\u5bf9\u4e8e\u4e0e\u60a3\u8005\u5b89\u5168\u6027\u4ee5\u53ca\u6709\u5176\u4ed6\u91cd\u8981\u5f71\u54cd\u76f8\u5173\u7684\u4fee\u8ba2\u5185\u5bb9\uff0cUSP\u4f1a\u5c06\u5176\u5feb\u901f\u53d1\u5e03\u5e76\u901a\u5e38\u5728\u77ed\u65f6\u95f4\u5185\u751f\u6548\uff0c\u6b64\u4fee\u8ba2\u5185\u5bb9\u5c06\u53d6\u4ee3\u5f53\u65f6\u751f\u6548\u7684\u836f\u5178\u51fa\u7248\u7269\u4e2d\u76f8\u5e94\u6587\u672c\uff0c\u5e76\u5c06\u6536\u5f55\u4e8e\u4e0b\u4e00\u7248\u836f\u5178\u51fa\u7248\u7269\u4e2d\u3002\u90a3\u4e48\u95ee\u9898\u6765\u4e86\uff0c\u60a8\u77e5\u9053\u5728\u54ea\u91cc\u53ef\u4ee5\u770b\u5230\u201c\u4fee\u8ba2\u516c\u544a\u201d\u7684\u5185\u5bb9\u5417\uff1f<\/span><\/p>\n

1.\u836f\u5178\u8bba\u575b(Pharmacopeial Forum (PF))<\/span><\/p>\n

2. USP\u5b98\u65b9\u7f51\u7ad9(www.usp.org)<\/span><\/p>\n

\u56de\u7b54\uff1a<\/span><\/strong><\/strong><\/span><\/p>\n

\u6b63\u786e\u7b54\u6848\u662f\u201c2.USP\u5b98\u65b9\u7f51\u7ad9(www.usp.org)\u201d\u3002<\/span><\/p>\n

\u5728USP39-NF34\u7b2c\u4e00\u589e\u8865\u672c\u7684\u51e1\u4f8b(General Notices)” 1. TITLE AND REVISION\u201d\u4e2d\u6709\u660e\u786e\u8bf4\u660e:\u201cAccelerated Revisions, published periodically on the Official Text section of USP’s website(http:\/\/www.usp.org\/usp-nf\/official-text), are designed to make revisions official more quickly than through the routine process for publishing standardsin the USP\u2013NF<\/span>
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9\u6708\u95ee\u9898\uff1a<\/span><\/strong><\/span><\/p>\n

USP\u901a\u5219<621>CHROMATOGRAPHY(\u8272\u8c31\u6cd5)\u7684\u201cSYSTEM SUITABILITY\u201d\u9879\u4e0b\u5bf9\u6eb6\u6db2\u8fdb\u6837\u9488\u6570\u6709\u5982\u4e0b\u89c4\u5b9a:\u9664\u975e\u5404\u8bba\u4e2d\u53e6\u6709\u8bf4\u660e\uff0c\u5f53\u89c4\u5b9aRSD\u5c0f\u4e8e2.0%\u65f6\uff0c\u987b\u91cd\u590d\u8fdb\u68375\u9488\uff1b\u5f53\u89c4\u5b9aRSD\u5927\u4e8e2.0%\uff0c\u987b\u91cd\u590d\u8fdb\u68376\u9488\u3002\u8fd9\u4e2a\u8bf4\u6cd5\u6b63\u786e\u5417\uff1f<\/span><\/p>\n

\u56de\u7b54\uff1a<\/span><\/strong><\/span><\/strong><\/span><\/strong><\/span><\/p>\n

\u4e0d\u5b8c\u5168\u6b63\u786e\u3002\u5728USP39-NF34\u7b2c\u4e00\u589e\u8865\u672c\u7684\u901a\u5219General Chapters: <621> CHROMATOGRAPHY\u6709\u5982\u4e0b\u89c4\u5b9a:”Replicate injections of a standard preparation or other standard solutions are compared to ascertain whether requirements for precision are met. Unless otherwise specified in the individual monograph, data from five replicate injections of the analyte are used to calculate the relative standard deviation, %RSD, if the requirement is 2.0% or less; data from six replicate injections are used if the relative standard deviation requirement is more than 2.0%.”<\/span>
<\/p>\n

————————————————————–<\/span><\/p>\n

10\u6708\u95ee\u9898\uff1a<\/strong><\/span><\/p>\n

\u5728USP\u5404\u8bba\u4e2d\uff0c\u5f53\u542b\u91cf\u5747\u5300\u5ea6\u6d4b\u5b9a\u65b9\u6cd5\u4e0e\u542b\u91cf\u6d4b\u5b9a\u5206\u6790\u65b9\u6cd5\u4e00\u81f4\u65f6\uff08\u53ef\u5141\u8bb8\u6837\u54c1\u5236\u5907\u6709\u5dee\u5f02\uff09\uff0c\u542b\u91cf\u5747\u5300\u5ea6\u6d4b\u5b9a\u7ed3\u679c\u7684\u5e73\u5747\u503c\u662f\u5426\u53ef\u4f5c\u4e3a\u542b\u91cf\u6d4b\u5b9a\u7ed3\u679c\u503c\u5462\uff1f<\/span><\/p>\n

\u56de\u7b54\uff1a<\/strong><\/span><\/p>\n

\u53ef\u4ee5\u3002\u5728USP39-NF34\u7b2c\u4e00\u589e\u8865\u672c\u7684\u51e1\u4f8bGeneral Notices: 5. MONOGRAPH COMPONENTS\u4e2d\u6709\u5982\u4e0b\u89c4\u5b9a:”5.70. Performance Tests: Where content uniformity determinations have been made using the same analytical methodology specified in the Assay, with appropriate allowances made for differences in sample preparation, the average of all of the individual content <\/span>uniformity determinations may be used as the Assay value.”<\/span>
<\/span><\/p>\n

————————————————————–<\/span><\/p>\n

11\u6708\u95ee\u9898\uff1a<\/strong><\/span><\/p>\n

USP-NF\u6536\u8f7d\u7684\u5404\u8bba(monograph)\u4e2d\uff0c\u201cUSP monograph\u201d\u6536\u5f55\u836f\u7528\u6d3b\u6027\u6210\u5206\u836f\u7269\u5236\u5242\u6807\u51c6\uff0c\u8bf7\u95ee\u201cNF monograph\u201d \u6536\u5f55\u7684\u662f\u54ea\u4e00\u7c7b\u4ea7\u54c1\u6807\u51c6\u5462\uff1f<\/span>
<\/p>\n

\u56de\u7b54\uff1a<\/strong><\/span><\/p>\n

\u201cNF monograph\u201d \u6536\u5f55\u7684\u662f\u836f\u7528\u8f85\u6599\u6807\u51c6<\/span><\/p>\n

————————————————————–<\/span><\/p>\n

12\u6708\u95ee\u9898\uff1a<\/strong> 
<\/span><\/p>\n

USP-NF\u4e2d\u6709\u5173\u201c\u5143\u7d20\u6742\u8d28\u201d\u7684\u91cd\u8981\u901a\u5219\u201cElemental Impurities\u2014Limits <232>\u201d\u548c\u201cElemental Contaminants in Dietary Supplements<2232>\u201d \u7684\u6b63\u5f0f\u751f\u6548\u65e5\u671f\u662f\uff1f<\/span><\/p>\n

A:2018\u5e741\u67081\u65e5<\/span><\/p>\n

B:2018\u5e7412\u67081\u65e5<\/span>
<\/p>\n

\u56de\u7b54\uff1a<\/strong><\/span><\/p>\n

A:2018\u5e741\u67081\u65e5<\/span><\/p>\n

\u5728USP39-NF34 \u7b2c\u4e8c\u589e\u8865\u672c\u7684\u51e1\u4f8b(General Notices)5.60.30. \u4e2d\u6709\u89c4\u5b9a\uff1a<\/span><\/p>\n

“Effective January 1, 2018, elemental impurities will be controlled in official drug products according to the principles defined and requirements specified in Elemental Impurities\u2014Limits<232>. Effective January 1, 2018, elemental contaminants are controlled in official dietary supplements according to the principles defined and requirements specified in Elemental Contaminants in Dietary Supplements<2232>……” <\/span>
<\/p>\n

2017-<\/strong><\/span>1\u6708\u95ee\u9898\uff1a<\/strong><\/span><\/p>\n

\u5f53\u836f\u5178\u542b\u91cf\u5206\u6790\u4e2d\u8981\u6c42\u201c\u51c6\u786e\u79f0\u91cf\u201d (Accurately Weighed)\u65f6\uff0c\u610f\u5473\u7740\u6240\u4f7f\u7528\u7684\u79f0\u91cf\u4eea\u5668\u7684\u91cd\u590d\u6027\u548c\u51c6\u786e\u6027\u5747\u5e94\u5728 0.1% \u4e4b\u5185\u3002\u8fd9\u79cd\u8bf4\u6cd5\u662f\u6b63\u786e\u7684\u5417\uff1f<\/span><\/p>\n

<\/strong>\u56de\u7b54\uff1a<\/strong><\/span><\/p>\n

\u5728USP39-NF34 \u7b2c\u4e8c\u589e\u8865\u672c\u7684\u901a\u521941<Balance>(\u5929\u5e73)\u4e2d\u6709\u89c4\u5b9a\uff1a<\/span><\/p>\n

“……Unless otherwise specified, when substances must be \u201caccurately weighed,\u201d the weighing shall be performed using a balance that is calibrated over the operating range and meets the requirements defined for repeatability and accuracy…….”<\/span><\/p>\n

“……Repeatability is satisfactory if two times the standard deviation of the weighed value, divided by the desired smallest net weight ……, does not exceed 0.10%. If the standard deviation obtained is less than 0.41d, …….,does not exceed 0.10%.”<\/span><\/p>\n

“The accuracy of a balance is satisfactory if its weighing value, when tested with a suitable weight(s), is within 0.10% of the test weight value.”<\/span><\/p>\n

2\u6708\u95ee\u9898\uff1a<\/strong><\/strong><\/span><\/p>\n

USP\u5404\u8bba\u4e2d\u5217\u51fa\u7684\u6240\u6709\u9274\u522b\u6d4b\u8bd5(Identification)\u90fd\u8981\u6267\u884c\uff0c\u8fd9\u79cd\u8bf4\u6cd5\u662f\u6b63\u786e\u7684\u5417\uff1f<\/span>
<\/p>\n

\u56de\u7b54\uff1a<\/strong><\/strong><\/span><\/p>\n

\u6b63\u786e\u3002<\/span><\/p>\n

\u5728USP39-NF34 \u7b2c\u4e8c\u589e\u8865\u672c\u7684\u51e1\u4f8b\uff08General Notice\uff09\u201c5.40. Identity\u201d\u4e2d\u6709\u660e\u786e\u8bf4\u660e\uff1a<\/span><\/p>\n

\u201cThe Identity or Identification test for a particular article may consist of one or more procedures. When a compendial test for Identity or Identification is undertaken, all requirements of all specified procedures in the test must be met to satisfy the requirements of the test. Failure of an article to meet all the requirements of a prescribed Identity or Identification test (i.e., failure to meet the requirements of all of the specified procedures that are components of that test) indicates that the article is mislabeled and\/or adulterated.\u201d<\/span><\/p>\n

3\u6708\u95ee\u9898\uff1a<\/strong><\/span><\/p>\n

\u6839\u636eUSP-NF\u7684\u8981\u6c42\uff0c\u5236\u5242\u4ea7\u54c1\u7684\u751f\u4ea7\u4e0d\u4e00\u5b9a\u8981\u4f7f\u7528\u7b26\u5408USP-NF\u6807\u51c6\u7684\u539f\u8f85\u6599, \u5373\u4f7fUSP-NF\u4e2d\u6536\u5f55\u4e86\u8be5\u539f\u8f85\u6599\u7684\u6807\u51c6\u3002\u8fd9\u4e00\u8bf4\u6cd5\u662f\u6b63\u786e\u7684\u5417\uff1f<\/span>
<\/p>\n

\u56de\u7b54\uff1a<\/strong><\/span><\/p>\n

\u9519\u8bef\u3002<\/span><\/p>\n

\u5728USP39-NF34 \u7b2c\u4e8c\u589e\u8865\u672c\u7684\u51e1\u4f8b\uff08General Notice\uff09\u201c3.10. Applicability of Standards”\u4e2d\u6709\u660e\u786e\u8bf4\u660e\uff1a<\/span><\/p>\n

\u201cOfficial products are prepared according to recognized principles of good manufacturing practice and from ingredients that meet USP or NF standards, where standards for such ingredients exist (for dietary supplements, see section 3.10.20).\u201d<\/span>
<\/strong><\/span><\/p>\n

4\u6708\u95ee\u9898\uff1a<\/strong><\/span><\/p>\n

USP\u4e2d\u6240\u8bf4\u7684\u201c\u771f\u7a7a\uff08vacuum\uff09\u201d\u6307\u6c14\u538b\u572825mm\u6c5e\u67f1\u4ee5\u4e0b\u3002\u8fd9\u4e00\u8bf4\u6cd5\u662f\u6b63\u786e\u7684\u5417\uff1f<\/span>
<\/p>\n

\u56de\u7b54\uff1a<\/strong><\/span><\/p>\n

\u9519\u8bef\u3002<\/span><\/p>\n

\u5728USP40-NF35 \u7684\u51e1\u4f8b\uff08General Notice\uff09\u201c8.210. Vacuum”\u4e2d\u6709\u660e\u786e\u8bf4\u660e\uff1a<\/span><\/p>\n

\u201cVacuum\u201d denotes exposure to a pressure of less than 20 mm of mercury (2.67 kPas), unless otherwise indicated.<\/span>
<\/strong><\/span><\/p>\n

5\u6708\u95ee\u9898\uff1a<\/strong><\/span><\/p>\n

\u5bb9\u79ef\u91cf\u5177\uff08VOLUMETRIC APPARATUS\uff09\u7531\u4e8e\u901a\u5e38\u572825\u2103\u7684\u5b9e\u9a8c\u5ba4\u4e2d\u4f7f\u7528\uff0c\u6839\u636eUSP\u7684\u8981\u6c42\uff0c\u4e5f\u5e94\u5728 25 \u2103\u4e0b\u6821\u6b63\u3002\u8fd9\u79cd\u8bf4\u6cd5\u662f\u6b63\u786e\u7684\u5417\uff1f<\/span>
<\/p>\n

\u56de\u7b54\uff1a<\/strong><\/span><\/p>\n

\u9519\u8bef\u3002<\/span><\/p>\n

\u5728USP40-NF35 \u7684\u901a\u5219\uff08General Chapter\uff09\u201c VOLUMETRIC APPARATUS”\u4e2d\u6709\u660e\u786e\u8bf4\u660e\uff1a<\/span><\/p>\n

\u201cMost of the volumetric apparatus available in the United States is calibrated at 20\u00b0, although the temperatures generally prevailing in laboratories more nearly approach 25\u00b0. To minimize volumetric error, the temperature should be the same for the volumetric apparatus, the material being prepared, the solvents being used to prepare the volumetric solutions, the area in which they are prepared, and the final volume adjustment.\u201d<\/span><\/p>\n

6\u6708\u95ee\u9898\uff1a<\/strong><\/span><\/p>\n

\u5c0f\u660e\u5728\u6267\u884c\u836f\u5178\u65b9\u6cd5\u4e2d\u7684\u8272\u8c31\u5206\u6790\u65f6\uff0c\u5e38\u5e38\u4e0d\u80fd\u6ee1\u8db3\u836f\u5178\u8981\u6c42\u7684\u7cfb\u7edf\u9002\u7528\u6027\uff0c\u4e8e\u662f\u4ed6\u8c03\u6574\u4e86\u836f\u5178\u4e2d\u7ed9\u51fa\u7684\u8272\u8c31\u6761\u4ef6\uff0c\u7ed3\u679c\u4ee4\u4eba\u6ee1\u610f\u3002\u4f46\u662f\u7531\u4e8e\u5728\u6b64\u8fc7\u7a0b\u4e2d\u5c0f\u660e\u5e76\u672a\u5b8c\u5168\u6309\u836f\u5178\u65b9\u6cd5\u505a\uff0c\u56e0\u6b64\u4ed6\u9700\u8981\u5bf9\u65b0\u7684\u8272\u8c31\u65b9\u6cd5\u8fdb\u884c\u9a8c\u8bc1\u3002\u8fd9\u79cd\u8bf4\u6cd5\u662f\u6b63\u786e\u7684\u5417\uff1f<\/span>
<\/strong><\/span><\/p>\n

\u56de\u7b54\uff1a<\/strong><\/strong><\/span><\/p>\n

\u9519\u8bef\u3002<\/span><\/p>\n

\u5728USP40-NF35 \u901a\u5219<621>CHROMATOGRAPHY\u4e2d\uff0c\u5173\u4e8e\u7cfb\u7edf\u9002\u7528\u6027\uff08SYSTEM SUITABILITY\uff09\uff0c\u6709\u76f8\u5173\u63cf\u8ff0\uff0c\u8282\u9009\u90e8\u5206\u5185\u5bb9\u5982\u4e0b\uff1a<\/span><\/p>\n

If adjustments of operating conditions are necessary in order to meet system suitability requirements, each of the items in the following list is the maximum variation that can be considered, unless otherwise directed in the monograph; these changes may require additional verification data…… In either case, changes in the chemical characteristics (\u201cL\u201d designation) of the stationary phase will be considered a modification to the method and will require full validation…….  <\/span>
<\/p>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n

\n

\u59cb\u53d1\u4e8e\u5fae\u4fe1\u516c\u4f17\u53f7\uff1a \u5236\u836f\u5de5\u7a0b\u8bba\u575b <\/p>\n<\/blockquote>\n<\/div>\n","protected":false},"excerpt":{"rendered":"

\u258d\u6765\u6e90\uff1aJulia\u535a\u5ba2 \u5916\u8d44\u5927\u578b\u5236\u836f\u516c\u53f8\u6280\u672f\u3001\u7814\u53d1\u3001\u8d28\u91cf\u603b\u76d1\uff0c\u9a8c\u8bc1\u7ba1\u7406\u8d44\u6df1\u4e13\u5bb6\uff0c\u591a\u5bb6\u5236\u836f\u516c\u53f8\u987e\u95ee\uff0c\u836f\u5b66\u7855\u58eb\u3002\u56fd […]<\/p>\n","protected":false},"author":1,"featured_media":5592,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":[],"categories":[2],"tags":[],"_links":{"self":[{"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/posts\/5591"}],"collection":[{"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/comments?post=5591"}],"version-history":[{"count":1,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/posts\/5591\/revisions"}],"predecessor-version":[{"id":5597,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/posts\/5591\/revisions\/5597"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/media\/5592"}],"wp:attachment":[{"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/media?parent=5591"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/categories?post=5591"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/tags?post=5591"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}