美国药典USP官网问答：常见问题问答

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应网友要求发布如下，官网英文原链接http://www.usp.org/frequently-asked-questions/compliance-usp-nf

FAQs: Compliance with the USP–NF 常见问题：USP-NF符合性

1. What does compliance withUSP–NF standards mean? 符合USP-NF标准是什么意思？

An article of commerce that is recognized in the USP–NF complies withUSP–NF standards when it meets all of the requirements stated in the article’smonograph, 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–NF, including manufacturers, buyers,or regulatory authorities. (General Notices, section 3.10)

如果一个商品符合该品种的各论、适用通则和凡例（如要求有差异时，则为取代通则和凡例的各论要求），则该商品就被认为是符合USP-NF标准。适用标准适用于该商品的所有生命时长，即从生产至到达效期。因此，如果检测，则应符合药典标准的所有正式内容，按相关各论中要求实际检测的正式商品必须符合这些标准以证明符合性。检测和取样频次则由执行符合性测试的优选方法或指导意见，以及USP-NF的其它用户，包括生产商、买方和药监机构来决定。（凡例，3.10）

2. Do all tests specified in amonograph have to be performed to ensure compliance?是否必须检测各论中所列所有项目以确保符合性？

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’s 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–NF, including manufacturers, buyers,or regulatory authorities.

适用标准适用于商品从生产到失效的所有生命时间段。因此，所有正式的商品如果测试则均应符合药典标准，按相关各论中要求实际检测的正式商品必须符合这些标准以证明符合性。一个生产商经FDA批准的质量标准，以及FDA法规（21 CFR Parts 210, 211）要求药品遵守的相关CGMP，所有这些都有助于确保一件商品符合并持续符合药典标准。正如凡例中所写（第3.10部分），所有的取样的检测频次，以及所有批次检测必要性和适当的频次，在药典里均未指定或描述，是否检测以及什么时间检测是由实施符合性测试的优选方法或指导意见，以及USP-NF的其它用户，包括生产商、买方和药监机构来决定。

3. Are adjustments toquantities and concentrations specified in the monograph allowed? 是否可以对各论中所指定的数量和浓度进行调整？

Some adjustments may be made. In the current USP–NF 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.”

有些调整是可以的。在当前的USP-NF凡例6.60中，有以下陈述“除另有规定外，应取足够数量单位样品以确保获得适当的分析结果”。另外，在第6.50.20.1部分说“如果在一个检验方法里指定了一个浓度，也可以使用其它当量浓度或摩尔浓度的溶液，但这种浓度差异和改变不得增加测量的误差。

4. Must the specificationsdescribed in the Description and Solubility section of the USP–NF be met? 是否必须符合USP-NF的描述和溶解性部分所述标准？

(See also General Notices, section 5.30. 也参见通则5.30)

5.30. Description and Solubility 描述和溶解度

Only where a quantitative solubility test is given in a monograph and isdesignated as such is it a test for purity.

只有在各论中规定了定量溶解度测试并且指定如此时，它才是一个纯度检测。

A monograph may include information regarding the article’s description.Information about an article’s “description and solubility” 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.

各论中可能会包括一些该物品描述方面的信息。关于物品“描述和溶解性”方面的信息也在USP和NF描述与相对溶解性对照表中列出。该对照表只是指示物品符合各论标准的属性，原意是提供给那些使用、制备和发放药品和/或相关物品的人参考。尽管在各论中所提供的信息以及在对照表中的信息可能会间接帮助对物品做出初步评估，但它并不是用来作为标准或纯度检测。

The approximate solubility of a compendial substance is indicated by oneof the following descriptive terms:

药典物质的近似溶解性采用以下描述性术语来指示：

5. Can a USP scientist reviewdata to confirm that a product complies with the USP requirements? USP科学家是否会审核数据以确认一个产品是否符合USP要求？

USP scientists cannot review and interpret data, per the OfficialStatements and Interpretations policy: “USP 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.”

USP科学家并不会审核数据并对之进行解释，依据官方声明和解释政策：“USP不应提供官方观点对评价某个特定的物品是否符合药典要求，作为USP认证程序和其它符合性评估程序的一部分者除外，这些程序是独立于USP的标准设定活动而实施的”。

6. 每月USP问答汇编

2015-2月问题：

《美国药典-国家处方集》(USP-NF)中的通用检测方法收录在通则(General Chapter)中，所有的通则都是强制执行的吗？

回答：

在USP37-NF32 第二增补本的凡例(General Notice)中“2.OFFICIAL STATUS AND LEGAL RECOGNITION”项下有如下规定：

“2.10. Official Text

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. 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.”

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3月问题：

在”炽灼残渣 (Residue on Ignition)”和”干燥失重 (Loss on Drying)”测试中，会有要求”恒重(Constant Weight)”，根据《美国药典-国家处方集》(USP-NF)的规定：”恒重”表示样品连续两次炽灼或干燥后称重的差异不得超过多少重量呢？

回答：

在USP37-NF32 第二增补本的凡例(General Notice)中“6. TESTING PRACTICES AND  PROCEDURES”项下有如下规定：

6.40.10. Ignite to Constant Weight

“Ignite to constant weight” means that ignition shall be continued at 800 ± 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, do not differ by more than 0.50 mg per g of substance taken.

6.40.20. Dried to Constant Weight

“Dried to constant weight” 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, do not differ by more than 0.50 mg per g of substance taken.

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4月问题：

USP会对药典测试即将不再有效的前一批次（Previous Lot）标准品赋予有效使用日期（Valid Use Date）。

问题1:通过什么途径可以查询到先前批次（Previous Lot）USP标准品的有效使用日期？

问题2: 若某批次USP标准品标明“Valid Use Date:11/12”，即表示此批次标准品有效使用日期是截止到哪一天呢？

回答：

问题1答案:(1)登录USP官方网站www.usp.org,输入搜索标准品(英文名)或Catalog No.,例如搜索”Sucrose”或其Catalog No.:1623637,即可查询到如下信息:

(2)登录USP官方网站www.usp.org,在”Reference Standards”项下下载“USP Daily Reference Standards Catalog”

(3)订阅USP Email Notice，定期接收来自USP的邮件通知

(4)关注USP官方微信和微博，每月了解USP标准品更新

问题2答案：“Valid Use Date：MM/YY”中，MM表示”月”,YY表示”年”,有效期为截止至该年该月的最后一天。所以，若某批次USP标准品标明“Valid Use Date:11/12”，即表示此批次标准品有效使用日期是截止到2012年11月30日。

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5月问题：

在依据USP各论及相关通则进行色谱法测试时，样品溶液中某组分的相对保留时间必须与各论规定的相对保留时间完全一致吗?为什么?

回答：

在通则<621>色谱法的系统适用性(SYSTEM SUITABILITY)项下有如下描述:

“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.”

即各论中提及的相对保留时间仅供参考，旨在辅助识别色谱峰，并没有关于相对保留时间的可接受标准”。

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6月问题：

USP对贮存条件的描述中，“Cold”是指温度在2℃～8℃之间。这种说法是正确的吗？

回答：

此说法是错误的。在USP38-NF33的通则<659>包装和贮存要求(PACKAGING AND STORAGE REQUIREMENTS) “STORAGE CONDITIONS”项下有如下描述:

“Cold: Any temperature not exceeding 8(46 F).”

特别提醒:

       很多朋友在回答时提到”根据USP凡例10中的规定。。。”，小编在此特别提醒，事实上，最新生效的USP38-NF33 已对此章节修订: 除非各论有其他要求，凡例10.10中关于包装和贮存要求的内容均已”搬家”至通则<659>PACKAGING AND STORAGE REQUIREMENTS。小编在此特别提醒，并建议大家参考最新生效的药典内容。

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7月问题：

在执行USP-NF方法时，若需做红外鉴别，需用样品的红外图谱与USP的红外标准图谱集进行比较，这种说法正确吗？

回答：

此说法是错误的。根据通则“<197> SPECTROPHOTOMETRIC IDENTIFICATION TESTS”规定:

“Record the spectra of the test specimen and the corresponding USP Reference Standard over the range from about 2.6 µm to 15 µm (3800 cm–1 to 650 cm–1) 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……”

       另外，在通则”<851> SPECTROPHOTOMETRY AND LIGHT-SCATTERING”中对于USP标准品用于药典分光光度法测试也有相应规定和描述。
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8月问题：

想了解美国药典中对某品种的性状、气味和溶解性的描述，但在该品种各论中却找不到，说明USP-NF未收录产品性状，气味和溶解性的信息。这种说法是正确的吗？

回答：

此说法是错误的。除各论有其他规定外，“Description and Solubility”信息均收载于“Reference Table”项下，且此信息仅作为物质特性初步评估的辅助参考，而非药典标准和纯度测试要求。原文如下：

“The “description” and “solubility” 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…..”

另外，在USP38-NF33 第一增补本的凡例(General Notices: 5. MONOGRAPH COMPONENTS)中“5.30 Description and Solubility” 项下也有详细说明。

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9月问题：

USP药典论坛(Pharmacopeia Forum)上提议修订的内容都会按计划收录于《美国药典-国家处方集》吗？如果不是，在哪里可以了解这些修订的进展和状态呢？

回答：

USP药典论坛上提议修订的内容不都会按计划收录于《美国药典-国家处方集》中，有关修订的进展和状态可在USP官方网站查询：登录www.usp.org→USP-NF→Official Test→Proposal status and commentary

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10月问题：

USP通则<467>列出了残留溶剂的分类和限度，这些限度是针对制剂产品而非原料、辅料设定的。这个说法是正确的吗？

回答：

此说法是正确的。USP通则<467>列出的残留溶剂限度是针对制剂产品而非原料、辅料设定的。

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11月问题：

        药典论坛 (Pharmacopeial Forum,PF)是 USP 标准修订的公共平台，它是一个免费网络双月刊，发布后有 90天的公众评议期，它的内容是法定生效文件，用户可直接将其等同于USP-NF使用，这个说法是正确的吗？

回答：

此说法是不正确的。 药典论坛 (Pharmacopeial Forum,PF)是 USP 标准修订的公共平台，它是一个免费网络双月刊，USP在药典论坛 (Pharmacopeial Forum,PF)上发布关于《美国药典-国家处方集》(USP-NF)中的标准修订提案，供公众评议，发布后有 90天的公众评议期，通过PF，用户可以回顾和追踪提议修订的进程并提交修订意见。修订提案并非法定生效文件，不可等同于USP-NF使用。

药典论坛:www.usppf.com

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12月问题：

      USP提供了药典方法中使用的HPLC和GC色谱柱品牌参数等信息供用户参考，这个说法是正确的吗？

回答：

此说法是正确的。USP-NF方法开发中用到的色谱柱品牌信息收录于免费在线版www.uspchromcolumns.com网站中，注册后即可登录。该数据库可节省用户寻找适用于测试的色谱柱的宝贵时间，追踪从修订阶段到生效状态的方法中使用的色谱柱，查找色谱柱品牌和生产商，找到可使用的备选（或替代）色谱柱等。注:色谱柱品牌名称仅为便于用户参考信息，不包含任何暗示，批准，认可或认证。

色谱柱在线数据库:www.uspchromcolumns.com

2016-1月问题：

根据USP-NF的要求，制剂产品的生产不一定要使用符合USP-NF标准的原辅料，即使USP-NF中收录了该原辅料的标准，这个说法正确吗？

回答：

此说法是错误的。在USP38-NF33第二增补本的凡例3. CONFORMANCE TO STANDARDS中有如下规定：“Official 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).”

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2月问题：

USP-NF中的”about”通常是指称量，体积，保留时间的正负偏差值为5%，这个说法正确吗？

回答：

此说法是错误的。在USP38-NF33第二增补本的凡例8. TERMS AND DEFINITIONS中有如下规定：““About” indicates a quantity within 10%.”

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3月问题：

当USP标准品标签上明确要求标准品在使用前进行干燥时，为便于操作，通常USP建议用户直接使用原始包装容器对标准品进行干燥，这个说法正确吗？

回答：

此说法是错误的。在USP38-NF33第二增补本的通则<11>USP REFERENCE STANDARDS中对“Dry Before Use”有如下规定:“Use 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.”

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4月问题：

如果有药典方法提供，用户不可使用自己开发的方法替代药典方法，这个说法正确吗？

回答：

此说法是错误的。在USP38-NF33第二增补本的凡例6.30 Alternative and Harmonized Methods and Procedures有如下描述:“Alternative 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 Validation of Compendial Procedures 1225 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..”

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5月问题：

USP标准品是经 USP 全面标定的高纯度物质，用户购买后可按各种需要使用，这个说法正确吗？

回答：

此说法是错误的。在USP39-NF34的通则<11>USP
REFERENCE STANDARDS中有如下描述:“Reference
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.”

另外，USP 标准品的Certificate中有如下说明:

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

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6月问题：

在USP-NF关于贮存条件的描述中，“Freezer”是指贮存在温度为−25°至−10°的条件下，而”Refrigerator”是指贮存在温度为2°至 8°的条件下，这个说法正确吗？

回答：

此说法是正确的。在USP39-NF34的通则General Chapters<659> PACKAGING AND STORAGE REQUIREMENTS的“STORAGE CONDITIONS”项下有如下描述:

“Freezer: A place in which the temperature is maintained between −25° and −10° (−13° and 14 °F).

Refrigerator: A cold place in which the temperature is maintained between 2° and 8° (36° and 46 °F).”

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7月问题：

如果各论中有机杂质检查项下存在多个测试内容(Procedures)，那必须完成每个测试内容并符合其接受标准，这个说法正确吗？

回答：

此说法是错误的。在凡例(General Notice) 4.10.10. Applicability of Test Procedures中有如下说明:

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.

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.

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8月问题：

“修订公告(Revision Bulletins, RB)”是一种USP药典加速修订程序，即对于与患者安全性以及有其他重要影响相关的修订内容，USP会将其快速发布并通常在短时间内生效，此修订内容将取代当时生效的药典出版物中相应文本，并将收录于下一版药典出版物中。那么问题来了，您知道在哪里可以看到“修订公告”的内容吗？

1.药典论坛(Pharmacopeial Forum (PF))

2. USP官方网站(www.usp.org)

回答：

正确答案是“2.USP官方网站(www.usp.org)”。

在USP39-NF34第一增补本的凡例(General Notices)” 1. TITLE AND REVISION”中有明确说明:“Accelerated 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–NF

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9月问题：

USP通则<621>CHROMATOGRAPHY(色谱法)的“SYSTEM SUITABILITY”项下对溶液进样针数有如下规定:除非各论中另有说明，当规定RSD小于2.0%时，须重复进样5针；当规定RSD大于2.0%，须重复进样6针。这个说法正确吗？

回答：

不完全正确。在USP39-NF34第一增补本的通则General Chapters: <621> CHROMATOGRAPHY有如下规定:”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%.”

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10月问题：

在USP各论中，当含量均匀度测定方法与含量测定分析方法一致时（可允许样品制备有差异），含量均匀度测定结果的平均值是否可作为含量测定结果值呢？

回答：

可以。在USP39-NF34第一增补本的凡例General Notices: 5. MONOGRAPH COMPONENTS中有如下规定:”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 uniformity determinations may be used as the Assay value.”

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11月问题：

USP-NF收载的各论(monograph)中，“USP monograph”收录药用活性成分药物制剂标准，请问“NF monograph” 收录的是哪一类产品标准呢？

回答：

“NF monograph” 收录的是药用辅料标准

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12月问题： 

USP-NF中有关“元素杂质”的重要通则“Elemental Impurities—Limits <232>”和“Elemental Contaminants in Dietary Supplements<2232>” 的正式生效日期是？

A:2018年1月1日

B:2018年12月1日

回答：

A:2018年1月1日

在USP39-NF34 第二增补本的凡例(General Notices)5.60.30. 中有规定：

“Effective January 1, 2018, elemental impurities will be controlled in official drug products according to the principles defined and requirements specified in Elemental Impurities—Limits<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>……” 

2017-1月问题：

当药典含量分析中要求“准确称量” (Accurately Weighed)时，意味着所使用的称量仪器的重复性和准确性均应在 0.1% 之内。这种说法是正确的吗？

回答：

在USP39-NF34 第二增补本的通则41<Balance>(天平)中有规定：

“……Unless otherwise specified, when substances must be “accurately weighed,” the weighing shall be performed using a balance that is calibrated over the operating range and meets the requirements defined for repeatability and accuracy…….”

“……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%.”

“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.”

2月问题：

USP各论中列出的所有鉴别测试(Identification)都要执行，这种说法是正确的吗？

回答：

正确。

在USP39-NF34 第二增补本的凡例（General Notice）“5.40. Identity”中有明确说明：

“The 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.”

3月问题：

根据USP-NF的要求，制剂产品的生产不一定要使用符合USP-NF标准的原辅料, 即使USP-NF中收录了该原辅料的标准。这一说法是正确的吗？

回答：

错误。

在USP39-NF34 第二增补本的凡例（General Notice）“3.10. Applicability of Standards”中有明确说明：

“Official 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).”

4月问题：

USP中所说的“真空（vacuum）”指气压在25mm汞柱以下。这一说法是正确的吗？

回答：

错误。

在USP40-NF35 的凡例（General Notice）“8.210. Vacuum”中有明确说明：

“Vacuum” denotes exposure to a pressure of less than 20 mm of mercury (2.67 kPas), unless otherwise indicated.

5月问题：

容积量具（VOLUMETRIC APPARATUS）由于通常在25℃的实验室中使用，根据USP的要求，也应在 25 ℃下校正。这种说法是正确的吗？

回答：

错误。

在USP40-NF35 的通则（General Chapter）“ VOLUMETRIC APPARATUS”中有明确说明：

“Most of the volumetric apparatus available in the United States is calibrated at 20°, although the temperatures generally prevailing in laboratories more nearly approach 25°. 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.”

6月问题：

小明在执行药典方法中的色谱分析时，常常不能满足药典要求的系统适用性，于是他调整了药典中给出的色谱条件，结果令人满意。但是由于在此过程中小明并未完全按药典方法做，因此他需要对新的色谱方法进行验证。这种说法是正确的吗？

回答：

错误。

在USP40-NF35 通则<621>CHROMATOGRAPHY中，关于系统适用性（SYSTEM SUITABILITY），有相关描述，节选部分内容如下：

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 (“L” designation) of the stationary phase will be considered a modification to the method and will require full validation…….