EPA06 CFR part 160 FIFRA供试品和对照品.ppt

1、Subpart FTest, control, and reference substance Subpart F供试品、对照品和参照品,Suzhou Research-LeoLiu 西山中科-刘振超, 160.105 Test, control, and reference substance characterization供试品、对照品和参照品的性质,(a) The identity, strength, purity, and composition, or other characteristics which will appropriately define the test,

2、control, or reference substance shall be determined for each batch and shall be documented before its use in a study. Methods of synthesis, fabrication, or derivation of the test, control, or reference substance shall be documented by the sponsor or the testing facility, and such location of documen

3、tation shall be specified. (a)在被应用到专题之前，应当测定供试品、对照品和参照物的成分、效力、纯度、组分和其他性质并记录。委托方或试验机构应当记录供试品、对照品和参照物的生产工艺变更，并指明这些记录的存放位置。, 160.105 Test, control, and reference substance characterization供试品、对照品和参照品的性质,(b) When relevant to the conduct of the study the solubility of each test, control, or reference sub

4、stance shall be determined by the testing facility or the sponsor before the experimental start date. The stability of the test, control or reference substance shall be determined before the experimental start date or concomitantly according to written standard operating procedures, which provide fo

5、r periodic analysis of each batch. (b)在试验开始之前，委托方或试验机构应当测定供试品、对照品和参照物的溶解度。每个批次的稳定性应当在试验开始之前测定，或者按SOP要求伴随试验进程定期分析（测定）。, 160.105 Test, control, and reference substance characterization供试品、对照品和参照品的性质,(c) Each storage container for a test, control, or reference substance shall be labeled by name, chemic

6、al abstracts service number (CAS) or code number, batch number, expiration date, if any, and, where appropriate, storage conditions necessary to maintain the identity, strength, purity, and composition of the test, control, or reference substance. Storage containers shall be assigned to a particular

7、 test substance for the duration of the study. (c)供试品、对照品和参照物的贮存容器上应贴有标签，标签信息显示名称、CAS号或代号、批号、有效期和贮存条件。在专题实施期间，为特定供试品指定（专用）容器。, 160.105 Test, control, and reference substance characterization供试品、对照品和参照品的性质,(d) For studies of more than 4 weeks experimental duration, reserve samples from each batch of

8、test, control, and reference substances shall be retained for the period of time provided by 160.195. (d)对于试验期超过4周的专题，应当对供试品、对照品和参照物留样，留样时间按照160.195规定。, 160.105 Test, control, and reference substance characterization供试品、对照品和参照品的性质,(e) The stability of test, control, and reference substances under st

9、orage conditions at the test site shall be known for all studies. (e)每个专题对应的供试品、对照品和参照物在贮存条件下的稳定性都应当被相关人员了解。, 160.107 Test, control, and reference substance handling供试品、对照品和参照品保管,(a)Procedures shall be established for a system for the handling of the test, control, and reference substances to ensure

10、 that: (a)应当建立SOP规定供试品、对照品和参照物保管系统的运行，以确保：, 160.107 Test, control, and reference substance handling供试品、对照品和参照品保管,(b)There is proper storage. (b)合适贮存。 (c)Distribution is made in a manner designed to preclude the possibility of contamination, deterioration, or damage. (c)分发过程避免污染、变质和损坏。, 160.107 Test,

11、 control, and reference substance handling供试品、对照品和参照品保管,(d)Proper identification is maintained throughout the distribution process. (d)分发过程中合理标识。 (e)The receipt and distribution of each batch is documented. Such documentation shall include the date and quantity of each batch distributed or returned.

12、 (e)记录每个批次的接收和发放。记录里应当体现每个批次发放和返还的量和日期。, 160.113 Mixtures of substances with carriers配制后的供试品和对照品,(a)For each test, control, or reference substance that is mixed with a carrier, tests by appropriate analytical methods shall be conducted: (a)应当使用合适的分析方法对配制后的供试品和对照品进行检测：,(a)(1)To determine the uniformi

13、ty of the mixture and to determine, periodically, the concentration of the test, control, or reference substance in the mixture. (a)(1)检测均一性，定期检测物质浓度（含量）。, 160.113 Mixtures of substances with carriers配制后的供试品和对照品,(a)(2)When relevant to the conduct of the study, to determine the solubility of each tes

14、t, control, or reference substance in the mixture by the testing facility or the sponsor before the experimental start date. (a)(2)在试验开始之前检测混合物中物质的溶解度。, 160.113 Mixtures of substances with carriers配制后的供试品和对照品, 160.113 Mixtures of substances with carriers配制后的供试品和对照品,(a)(3)When To determine the stabil

15、ity of the test, control, or reference substance in the mixture before the experimental start date or concomitantly according to written standard operating procedures, which provide for periodic analysis of each batch. (a)(3)在试验开始之前检测混合物中物质的稳定性，或根据SOP规定伴随着试验实施定期测定每个批次物质的稳定性。, 160.113 Mixtures of sub

16、stances with carriers配制后的供试品和对照品,(b)Where any of the components of the test, control, or reference substance carrier mixture has an expiration date, that date shall be clearly shown on the container. If more than one component has an expiration date, the earliest date shall be shown. (b)如果物质的某个组分有有效期，应当在混合物容器的标签上显示该有效期，如果多个组分有有效期，标签上应当显示最短的有效期。, 160.113 Mixtures of substa