FDA于2015年4月3日发布《兽药中残留溶剂行业指南》的问答，官网下载网址为
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Guidance for Industry Residual Solvents in Animal Drug Products Questions and Answers
兽药中残留溶剂行业指南---问答
Submit comments on this guidance at any time. Submit electronic comments to http://www.regulations.gov. Submit written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. All comments should be identified with the Docket No. FDA-2010-D-0566. For further information regarding this document, contact Heather Longstaff, Center for Veterinary Medicine, (HFV-145), Food and Drug Administration, 7500 Standish Place, Rockville, MD 20855, 240-402-0651, e-mail:heather.longstaff@fda.hhs.gov.
U.S. Department of Health and Human Services
Food and Drug Administration
Center for Veterinary Medicine
April 2015
Table of Contents 目录
INTRODUCTION................................................................................................................... 3
DRUG PRODUCT.................................................................................................................. 3
Q1. What information should be submitted to demonstrate compliance with USP <467>?..... 3
Q2. Are commitments to submit residual solvent data in a future submission allowed?.......... 4
Q3. If a formulation of a drug product contains a solvent, is that solvent held to the limits in USP <467>?............................... 4
Q4. There are currently some differences in solvent classifications/limits between USP <467> and VICH GL18(R). How should differences in USP and VICH classifications be addressed? ................................................................................................................... 4
Q5. There are situations where the USP monograph for the active ingredient in a formulation includes a specification for a class 2 or class 3 solvent. If the active ingredient is the only source for the solvent in the formulation, and the active ingredient meets the specifications of the USP monograph, does the drug product still have to comply with the limits in USP <467> for this solvent?....... 4
Q6. When is it acceptable to use a Class 1 solvent? ......................................................... 5
Q7. How should the acceptance criterion be established for a residual solvent that is not classified (as Class 1, 2 or 3) in USP <467>?................................................................. 5
Q8. If a drug product utilizes raw materials supplied in solvents and the solvent is then driven off during the drug product manufacturing steps, does the final drug product need to be tested and do all the limits in USP <467> apply? ................................ 5
DRUG PRODUCT TESTING ................................................................................... 5
Q9. Should residual solvent test methods used for testing of the drug product be validated or verified?............................................. 5
Q10. Would it be acceptable to use a high purity solvent in place of the USP reference standard?................................................... 5
Q11. Can loss on drying (LOD) be used to control Class 3 solvents even if Class 2 solvents are present providing that the total of both classes is <0.5%?........................... 5
RAW MATERIALS................................................................................................... 6
Q12. Are raw materials required to meet the residual solvent levels stated in USP <467>? ...... 6
Q13. What should a raw material manufacturer’s statement regarding residual solvents contain? ............................................... 6
Q14. How does CVM define “likely to be present”? ............................................... 7
Q15. Sometimes excipient manufacturers do not provide information in a customary Certificate of Analysis. Many firms obtain this information through surveys of their suppliers. Is this an acceptable format to demonstrate compliance with USP <467? ........ 7
Q16. How can a sponsor verify raw material manufacturer statements? ................. 7
Q17. What information should be submitted by a sponsor if the raw material manufacturer will not provide any residual solvent information? ........................ 8
Q18. How should residual solvents in coating materials, colorants, flavors, capsules, and imprinting inks be characterized?............. 8
Guidance for Industry Residual Solvents in Animal Drug Products Questions and Answers
兽药中残留溶剂行业指南----问答
This guidance represents the Food and Drug Administration’s (FDAor Agency) current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. You can use an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations. If you want to discuss an alternative approach, contact the FDA staff responsible for implementing this guidance using the contact information on the title page of this guidance. 本指南中表达了FDA目前对该主题的想法。指南并未创建或赋予任何个人任何权力，并未对FDA或公众形成任何束缚。你可以使用满足适用法规要求的替代方法。如果你想讨论任何替代方法，请根据本指南题目页上所列的联系信息来联系负责本指南的FDA人员。 |
INTRODUCTION 概述
On July 1, 2008, the United States Pharmacopeia (USP) implemented a requirement for the control of residual solvents in drug products marketed in the United States. Once implemented, the requirement, USP General Chapter <467> Residual Solvents, became a statutory requirement under section 501(b) of the Federal Food, Drug, and Cosmetic Act.
在2008年7月1日，美国药典（USP）对在美国上市的药品实施了残留溶剂的控制。在实施后，USP通论<467>残留溶剂中的要求就成为根据联邦食品药品和化妆品法案501(b)款所需满足的法定要求。
The USP General Chapter <467> Residual Solvents applies to both human and veterinary drugs and to compendial and non-compendial drug products. Because the drug products CVM regulates are administered to a number of different animal species, CVM allows for a flexible approach to the implementation of USP <467> Residual Solvents. This document answers questions regarding CVM’s implementation of USP <467> Residual Solvents.
USP通论<467>残留溶剂适用于人药和兽药，药典药品和非药典药品。由于CVM所管理的兽药会被不同动物品种摄入，因此CVM在实施USP<467>残留溶剂时允许一种弹性的方法。本文件回答了关于CVM实施USP<467>残留溶剂的一些问题。
FDA’s guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe the Agency’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word “should” in Agency guidances means that something is suggested or recommended, but not required.
FDA的指南文件，包括本指南，并未建立法定强制义务。指南中说明了药监当局目前对某一问题的想法，除了所引用的特定法规或法定要求外，应仅作为是建议来看待。在官方指南中所用的“应该”一词表示建议或推荐做某事，但并不是必须的。
Drug Product 制剂
Q1. WHAT INFORMATION SHOULD BE SUBMITTED TO DEMONSTRATE COMPLIANCE WITH USP <467>?
要提交什么资料来证明符合USP<467>?
A. For each raw material in a formulation, you should submit the following information:
? Raw material manufacturer’s statement regarding residual solvents (See Q13, 14, and 15)
? Sponsor's verification of raw material manufacturer’s statement (See Q15, 16, 17)
制剂处方中用到的每种原料均需要提交以下资料：
l 原料生产商关于残留溶剂的声明（参见问题13、14和15）
l 申报人对原料生产商声明的核实（参见问题15、16和17）
For the drug product, information in the submission should include:
? A finished product specification or certificate of analysis stating “complies with USP <467>”
? For each residual solvent identified by the drug substance manufacturer, raw material manufacturer, or used by the sponsor:
l 制剂质量标准或分析报告，其中声明“符合USP<467>要求”
l 制剂生产、原料生产商识别出的每一种残留溶剂，或申报人使用的每一种溶剂，需要提交：
l A statement that indicates which option was used to demonstrate compliance with USP <467> and a summary of the appropriate calculation, if Option 2 or 3 was used, indicate the source of data used in the calculation;
l The results of any residual solvent testing on the drug product, if applicable, and
l Method validation if the finished product is tested (See Q8)
l 说明使用哪个方法来证明符合USP<467>要求的声明，如果使用的第2和第3种方法，则应提交适当计算的总结，来说明计算中所用数据的来源
l 制剂中所有残留溶剂的检测结果，适用时
l 如果检测的是制剂成品，则提交方法验证（参见问题8）
l Suitable information to support the safety of residual solvents that are not defined as being Class 1, Class 2, or Class 3 solvents (See Q6)
l 如果有溶剂不属于1、2或3类溶剂，则提交用以支持该残留溶剂安全性的适当的资料（参见问题6）
Q2. ARE COMMITMENTS TO SUBMIT RESIDUAL SOLVENT DATA IN A FUTURE SUBMISSION ALLOWED?
是不是可以承诺在将来的申报资料中提交残留溶剂数据呢？
A. CVM stopped accepting commitments on July 1, 2010, and will incomplete any submissions that do not include data that demonstrate compliance with USP <467> or do not reference a previous commitment to provide this data.
CVM自2010年7月1日开始停止接受承诺函，所有未包括证明符合USP<467>要求的申报，以及未引用之前的提供数据承诺函的申报将被认为是不完整的。
Q3. IF A FORMULATION OF A DRUG PRODUCT CONTAINS A SOLVENT, IS THAT SOLVENT HELD TO THE LIMITS IN USP <467>?
如果一个制剂的处方中含有一种溶剂，那这个溶剂含量是否需要符合USP<467>中的限度要求呢？
A. No, USP <467> does not apply to the actual component in the formulation; however, any residual solvents in that component should meet USP <467> limits.
不需要。USP<467>限度不适用于处方的实际成分。但是，这个溶剂成分中的所有残留溶剂需要符合USP<467>限度。
Q4. THERE ARE CURRENTLY SOME DIFFERENCES IN SOLVENT CLASSIFICATIONS/LIMITS BETWEEN USP <467> AND VICH GL18(R). HOW SHOULD DIFFERENCES IN USP AND VICH CLASSIFICATIONS BE ADDRESSED?
现在USP<467>和VICH GL18(R)中关于溶剂分类和限度有一些差异。要怎么来处理这种差异呢？
A. Any proposed differences from USP classifications must be justified for compendial products. Where there are differences in residual solvent classification between USP <467> and VICH GL18(R), CVM will continue to accept the justification that residual solvent limits conform to recommendations contained in VICH GL18(R).
对于药典中的药品，凡与USP不同的分类标准均应进行论证。如果是UPS<467>和VICH GL18(R)之间有分类差异，CVM还是接受论证残留限度符合VICH GL18(R)建议的。
Q5. THERE ARE SITUATIONS WHERE THE USP MONOGRAPH FOR THE ACTIVE INGREDIENT IN A FORMULATION INCLUDES A SPECIFICATION FOR A CLASS 2 OR CLASS 3 SOLVENT. IF THE ACTIVE INGREDIENT IS THE ONLY SOURCE FOR THE SOLVENT IN THE FORMULATION, AND THE ACTIVE INGREDIENT MEETS THE SPECIFICATIONS OF THE USP MONOGRAPH, DOES THE DRUG PRODUCT STILL HAVE TO COMPLY WITH THE LIMITS IN USP <467> FOR THIS SOLVENT?
有时候USP中制剂所用活性成分各论包括了二类或三类溶剂的质量标准，如果活性成分是制剂中溶剂的唯一来源，并且活性成分符合USP各论中质量标准，那么制剂是否还必须符合USP<467>中该溶剂的限度要求呢？
A. In this case, it is sufficient to comply with the solvent limits in the USP monograph for the active ingredient for the drug product to demonstrate compliance with USP <467>.
这种情况下，要证明制剂符合USP<467>要求，只需要活成分符合USP各论中的溶剂限度就够了。
Q6. WHEN IS IT ACCEPTABLE TO USE A CLASS 1 SOLVENT?
什么时候使用一类溶剂是可以接受的？
A. Class 1 solvents should be avoided whenever possible. However, a sponsor or raw material manufacturer may use them if the user has diligently evaluated other solvents and provided valid reasons why alternative solvents are not appropriate. Compliance with USP <467> limits is not, in itself, considered adequate justification. The raw material manufacturer should provide a list of Class 1 solvents with specifications and data used in the manufacturing of raw materials.
应尽可能地避免使用一类溶剂。但是，如果申报人或原料生产商已经尽全力评估了其它溶剂，提供了有效的理由来说明为什么不能采用其它替代的溶剂，则他们还是可以使用一类溶剂的。仅仅只是符合USP<467>本身并不能作为是充分的论证方式。原料生产商应提供用于原料生产的一类溶剂的清单及质量标准和数据。
Q7. HOW SHOULD THE ACCEPTANCE CRITERION BE ESTABLISHED FOR A RESIDUAL SOLVENT THAT IS NOT CLASSIFIED (AS CLASS 1, 2 OR 3) IN USP <467>?
在USP<467>中未分类（一类二类或三类）的残留溶剂要如何建立可接受标准？
A. Scientific literature and toxicology data can be used to support the proposed acceptance criterion.
科学文献和毒性数据可用于支持所拟的可接受标准。
Q8. IF A DRUG PRODUCT UTILIZES RAW MATERIALS SUPPLIED IN SOLVENTS AND THE SOLVENT IS THEN DRIVEN OFF DURING THE DRUG PRODUCT MANUFACTURING STEPS, DOES THE FINAL DRUG PRODUCT NEED TO BE TESTED AND DO ALL THE LIMITS IN USP <467> APPLY?
如果一种药品使用的原料是在溶剂里的，而该溶剂在制剂生产步骤中被去除，那么最终制剂成品中是否需要进行检测，并需要符合USP<467>中所有限度要求呢？
A. For raw materials supplied in solutions, the solvent is considered a component in the drug product manufacturing process and therefore USP <467> applies to this solvent. The removal of the solvent by the drug product manufacturing process should be demonstrated by either drug product testing or an ICH Q8(R) Quality by Design (QbD)-based approach.
放在溶剂里供应的原料，溶剂会被认为是制剂生产工艺的一部分，因此USP<467>适用于该溶剂。可以通过对制剂进行测试，或ICH Q8(R)质量源于设计方法来证明制剂生产工艺可以去除该溶剂。
Drug Product Testing 制剂检测
Q9. SHOULD RESIDUAL SOLVENT TEST METHODS USED FOR TESTING OF THE DRUG PRODUCT BE VALIDATED OR VERIFIED?
用于制剂检测的残留溶剂方法要经过验证或确认么？
A. Non-USP methods should be validated. USP methods should be verified (see USP <1226>). The sponsor should submit summary data in support of the validation of a non-USP method or verification of the USP method.
非USP方法应进行验证，USP方法应进行确认（参见USP<1226>）。申报人应提交总结数据，用以支持非USP方法的验证或USP方法的确认。
Q10. WOULD IT BE ACCEPTABLE TO USE A HIGH PURITY SOLVENT IN PLACE OF THE USP REFERENCE STANDARD?
采用高纯度溶剂替代USP对照品是不是会被接受呢？
A. Yes, a high purity solvent may be used in lieu of the reference standard if the sponsor provides suitable documentation (i.e., certificate of analysis) of the purity and source.
是的。如果申报人提供了适当的纯度和来源文件（即分析报告），则可以用高纯度溶剂来替代对照品。
Q11. CAN LOSS ON DRYING (LOD) BE USED TO CONTROL CLASS 3 SOLVENTS EVEN IF CLASS 2 SOLVENTS ARE PRESENT PROVIDING THAT THE TOTAL OF BOTH CLASSES IS <0.5%?
如果二类溶剂和三为溶剂之和<0.5%，是否可以用干燥失重（LOD）来控制三类溶剂，即使其中会有二类溶剂？
A. Yes, provided that all Class 2 solvents “likely to be present” are addressed separately and suitable controls are in place to ensure that the “likely to be present” Class 2 solvents are below the Option 1 limits from USP <467>. Sponsors should be aware that unidentified Class 3 solvents may interfere with analytical methods to measure Class 2 solvents. See Q14 for a definition of “likely to be present.”
可以，如果所有“可能存在”的二类溶剂都单独进行了说明，并有适当的控制来保证“可能存在”的二类溶剂低于USP<467>中第一法的限度。申报人应明白未鉴别的三类溶剂可能会干扰对二类溶剂的检测方法。参见问题14中对“可能存在”的定义。
Raw Materials 原料
Q12. ARE RAW MATERIALS REQUIRED TO MEET THE RESIDUAL SOLVENT LEVELS STATED IN USP <467>?
原料是否需要符合USP<467>中的溶剂水平要求？
A. No, the residual solvent levels stated in USP <467> are specifically for finished dosage forms. Raw material manufacturers should provide a statement specifying the residual solvents likely to be present so the drug product manufacturer can demonstrate that the drug product complies with USP <467>. If all raw materials meet the residual solvent levels stated in USP <467>, then Option 1 can be used for the finished dosage form. If any raw material does not meet the residual solvent levels stated in USP <467>, then Options 2, 3, or finished dosage form testing can be used for the finished dosage form.
不需要。USP<467>中要求的残留溶剂水平是对制剂的要求。原料生产商应提供声明来指明可能存在的残留溶剂，这样制剂生产商可以证明制剂符合USP<467>的要求。如果所有原料均符合USP<467>中要求的残留溶剂限度，则制剂就可以使用方法一来证明其符合性。如果有任何原料不符合USP<467>中的残留溶剂要求，那么制剂可以使用第二法或第三方法，或者对制剂进行检测来证明其符合性。
Q13. WHAT SHOULD A RAW MATERIAL MANUFACTURER’S STATEMENT REGARDING RESIDUAL SOLVENTS CONTAIN?
原料生产商的残留溶剂声明应包括什么内容？
A. A raw material manufacturer’s statement regarding residual solvents should contain:
原料生产商的残留溶剂声明应包括：
? All Class 1 solvents used or generated,
? 所有使用的或产生的一类溶剂
? All Class 2 solvents “likely to be present,”
? 所有“可能存在“的二类溶剂
? Whether Class 3 solvents are “likely to be present” and the identity of all Class 3 solvents present at greater than 0.5%, and
? 三类溶剂是否是“可能存在”的，对所有大于0.5%的三类溶剂进行鉴别
? All other solvents “likely to be present,” as applicable.
? 适用时，所有其它“可能存在”的溶剂。
Also, in all circumstances:
另外，在所有情形下：
? You should include numerical values for the limits of all solvents identified above. These results can be reported as equal to or less than the limits specified in USP <467> and need not be the actual values of the concentrations in the raw materials. For example: If the USP limit for a solvent is 20 ppm and the actual testing provides a result of 3 ppm present in the raw material, the numerical value for the result can be stated as < 20 ppm.
? 你应该包括上述所识别的所有溶剂的限度数值。这些结果中以报告为等于或小于USP<467>规定的限度，不需要提供其在原料中的实际浓度值。例如，如果USP对一个溶剂的限度值是20ppm，实际检测给出的是原料中有3ppm的结果，则该结果的数值可以声明为<20ppm。
We prefer that the raw material manufacturer’s statement regarding residual solvents be included in the raw material manufacturer’s COA, although a separate raw material manufacturer’s statement may be used. Examples of such statements include:
我们希望在原料生产商的COA中包括原料生产商的残留溶剂声明，尽管可能会采用一份单独的原料生产商声明。该声明的例子包括：
l Only Class 3 solvents are likely to be present. Loss on drying is less than 0.5 percent.
l 仅有三类溶剂可能存在。干燥失重小于0.5%。
l Only Class 2 solvents X and Y are likely to be present. All are below the Option 1 limit. (Here the raw material manufacturer should name the Class 2 solvents represented by X and Y and provide the Option 1 limit for each solvent).
l 仅二类溶剂X和Y可能存在。所有溶剂均低于方法一限度。（这里，原料生产商应列出二类溶剂的名称，填在X和Y的位置，提供每个溶剂的方法一限度）
l Only Class 2 solvents X and Y and Class 3 solvents are likely to be present. Residual Class 2 solvents are below the Option 1 limit and residual Class 3 solvents are below 0.5 percent.
l 仅二类溶剂X和Y和三类溶剂可能存在。残留的二类溶剂均低于方法一限度，残留的三类溶剂低于0.5%。
l No Class 1, Class 2, Class 3, or other solvents are used.
l 没有使用一类、二类、三类或其它溶剂。
Q14. HOW DOES CVMDEFINE “LIKELY TO BE PRESENT”?
CVM怎么定义“可能出现”？
A. “Likely to be present” refers to the solvents used or produced in the final manufacturing step and to solvents that are used or produced in earlier manufacturing steps and not removed consistently by a validated process. CVM would consider listed solvents which are removed or present in the raw materials at less than 10% of the listed limit to be “NOT likely to be present.” Therefore, these solvents do not have to be reported on the raw material vendor’s COA as part of the residual solvents compliance information in an application. Whenever possible, the raw material vendor should demonstrate that their process will consistently remove the residual solvents at the level they are purporting and justify why it is acceptable to omit the residual solvents testing.
“可能存在”指在最后生产步骤中使用或产生的溶剂，或在前期生产步骤中使用或产生，而所验证的工艺不能一致地除去的溶剂。CVM将被除去的溶剂，或在原料中出现在低于10%限度的溶剂作为“不可能存在”的溶剂。因此，这些溶剂在原料药供应商的COA中不需要作为残留溶剂来报告，作为申报资料中符合性资料。只要可能，原料供应商均应证明其工艺可以一致地除去其声称水平的残留溶剂，并论证为什么省略残留溶剂检测是可以接受的。
Q15. SOMETIMES EXCIPIENT MANUFACTURERS DO NOT PROVIDE INFORMATION IN A CUSTOMARY CERTIFICATE OF ANALYSIS. MANY FIRMS OBTAIN THIS INFORMATION THROUGH SURVEYS OF THEIR SUPPLIERS. IS THIS AN ACCEPTABLE FORMAT TO DEMONSTRATE COMPLIANCE WITH USP <467?
有时辅料生产商的常规分析报告中不能提供信息。许多公司通过对其供应商调查来获取此类信息。是否有可接受的格式来证明符合USP<467>？
A. Any format that has been used to obtain the information from the excipient supplier is acceptable. The supplier’s statement about the residual solvents likely to be present should be submitted to CVM as part of the application. The information included in the supplier’s statement is used to demonstrate compliance regardless of the format received from the supplier. The supplier’s information should be verified by the drug product sponsor. Note that the drug sponsor is ultimately responsible for the quality of all materials used to manufacture drugs. If residual solvent information is provided in a statement or survey rather than on the COA, the drug sponsor should demonstrate that they have an agreement with the supplier to update the statement regarding any changes in the residual solvents information and that this updated information will be provided to CVM.
用来获取辅料生产商的相关信息的任何格式都是可以接受的。供应商关于残留溶剂的声明可以提交给CVM作为申报资料的一部分。供应商声明里包括的信息会被用来证明其符合性，而不管从供应商处收到的格式是怎么样的。供应商的信息应由制剂申报人进行核实。要注意的是制剂申报人是所有用于制剂生产的原料质量的最终负责人。如果所提交的残留溶剂资料是用的声明格式或调查方式，而不是COA的方式，则制剂申报人应证明他们持有与供应商的协议，会将其关于残留溶剂的变更信息进行更新，并将更新资料提交给CVM。
Q16. HOW CAN A SPONSOR VERIFY RAW MATERIAL MANUFACTURER STATEMENTS?
申请人如何能核实原料生产商的声明？
A. The sponsor tests the residual solvents as a part of the complete testing protocol in order to demonstrate that it is capable of performing the tests and to verify the raw material manufacturer’s data for each identified residual solvent.
申报人检测残留溶剂作为完整检测计划的一部分，用以证明有能力进行检测，会核实原料生产商提交的每个识别出的残留溶剂的数据。
Once the raw material manufacturer’s data is validated and verified, the sponsor can implement a vendor qualification program as set forth in 21 CFR 211.84(d)(2). The sponsor should submit complete COAs for all raw materials, including residual solvent data, to demonstrate verification and compliance with USP <467>[1]. 一旦原料生产商的数据被验证和核实，申报人可以按21CFR211.84(d)(2)中规定实施供应商确认计划。申报人应提交所有原料完整的COA，包括残留溶剂数据，来证明其核实情况，以及证明其符合USP<467>要求。
A raw material manufacturer’s statement that solvents are not used does not require the sponsor’s verification. However, the statement from the vendor should be referenced in the raw material specification.
如果一个原料生产商声明其没有使用任何溶剂，则申报人不需要核实。但是，供应商的声明应在原料质量标准中被引用。
Q17. WHAT INFORMATION SHOULD BE SUBMITTED BY A SPONSOR IF THE RAW MATERIAL MANUFACTURER WILL NOT PROVIDE ANY RESIDUAL SOLVENT INFORMATION?
如果原料生产商不愿意提供任何残留溶剂资料，申报人要提交哪些资料呢？
A. If the raw material manufacturer will not provide residual solvent information, then it is the sponsor’s responsibility to test for all residual solvents listed in USP <467> for each batch of material received. An appropriately validated LOD test may be used as an initial qualitative test only for Class 3 residual solvents, however, more extensive quantitative testing for Class 3 solvents will be required if the LOD indicates presence of solvents. An LOD test will not reveal Class 1 or 2 solvents above the USP <467> levels, and these should be tested for by a quantitative method.
如果原料生产商不愿意提供残留溶剂资料，则申报人有责任测试每一批收到的物料中在USP<467>里列出的所有残留溶剂。使用验证过的适当的LOD方法可以用于三类溶剂初始定性测试，但是，如果LOD结果显示有溶剂存在，则需要对三类溶剂进行定量测试。LOD检测不能发现超出USP<467>水平的一类和二类溶剂，因此需要采用定量方法来测试。
Q18. HOW SHOULD RESIDUAL SOLVENTS IN COATING MATERIALS, COLORANTS, FLAVORS, CAPSULES, AND IMPRINTING INKS BE CHARACTERIZED?
包衣材料、着色剂、香料、胶囊和印刷油墨里的残留溶剂要如何定性？
A. Information on residual solvents in flavors should be included. Information on residual solvents in coating materials, colorants, capsules, and imprinting inks is generally not needed unless Class 1 solvents are used in the manufacture of these components.
申报资料里要包括香料里的残留溶剂资料。一般不需要包衣材料、着色剂、胶囊和印刷油墨里的残留溶剂资料，除非在这些组分中使用了一类溶剂。
[1] The reasons for requesting sponsors to perform the complete testing protocol are twofold, i.e., to verify the actual testing results but, more importantly, to ensure that the sponsor is capable of performing the tests, so that it can run specific tests when problems arise. Without this capability, many firms are inadequately prepared when a problem does arise. 要求申报人进行完整检测的原因有两个，一个是核实实际检测结果，但更重要的是，保证申报人有能力实施检测，这样如果有问题发生时，可以进行特定的测试。如果没有这样的能力，许多公司就没办法处理发生的问题。
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