USP905含量均匀度中英文.docx

<905> UNIFORMITY OF DOSAGE UNITSContent UniformityThe test for Content Uniformity is based on the assay of the individual content of drug substance(s) in a number of individual dosage units to determine whether the individual content is within the limits set. The Content Uniformity method may be applied in all cases. The test for Content Uniformity is required for those dosage forms described in (C1) -C6) below:(C1) coated tablets, other than film-coated tablets containing 25 mg or more of a drug substance that comprises 25% or more (by weight) of one tablet.(C2) transdermal systems(C3) suspensions or emulsions or gels in single-unit containers or in soft capsules that are intended for systemic administration only (not for those drug products that are intended for topical administration);(C4) inhalations (other than solutions for inhalation packaged in glass or plastic ampuls and intended for use in nebulizers) packaged in premetered dosage units. For inhalers and premetered dosage units labeled for use with a named inhalation device, also see Aerosols, Nasal Sprays, Metered-Dose Inhalers, and Dry Powder Inhalers <601>(C5) solids (including sterile solids) that are packaged in single-unit containers and that contain active or inactive added substances, except that the test for Weight Variation may be applied in the special cases stated in (W3) below; and(C6) suppositoriesSelect not fewer than 30 units, and proceed as follows for the dosage form designated. Where the amount of drug substance in a single dosage unit differs from that required in the Assay, adjust the degree of dilution of the solutions and/or the volume of aliquots so that the concentration of the drug substances in the final solution is of the same order as that obtained in the Assay procedure; or, in the case of a titrimetric assay, use a titrant of a different concentration, if necessary, so that an adequate volume of titrant is required (see Titrimetry <541>); see also Procedures under Tests and Assays in the General Notices and Requirements. If any such modifications are made in the Assay procedure set 含量均匀度建立在通过测定一定数量的单个剂量的 原料药单个含量来确定单个含量是否符合限度要 求。

含量均匀度测试方法可以应用于所有的情况下 以下六种剂型要求测定含量均匀度：(C1)包衣片，除了含有25mg或更多原料药的薄膜 包衣片，其原料药组成占了片剂总重的25%C2)经皮系统(C3)单个剂量包装的或用仅于全身给药(而不是局 部给药)的软胶囊包装的混悬剂或乳剂或凝胶剂 (C4)包装于单位计量进过事先测量的过吸入剂(除 了包装于玻璃或塑料安甑中用于喷雾的溶液剂九对 于标签上标注需要使用到指定的吸入器的吸入剂和 事先测量过单位剂量，可参见喷雾器，鼻喷雾器， 定量吸入剂和干粉吸入剂＜ 601＞C5)包装于单个剂量容器中固体(包括无菌固体)， 含有活性或无活性的添加剂，除了重量差异的测试 中可以应用于(W3)所列举的特殊情况C6)栓剂选择不少于30个单位，按照剂型指定的操作进行 当单剂量中原料药的量与含量测定中所要求的不同 时，调整溶液稀释的程度以及等份的体积使得最终 得到溶液中含有的原料药浓度与含量测定中的浓度 在一个数量级上；再如在滴定的含量测定中，必要 时使用不同浓度的滴定液以得到合适的体积参见 滴定＜541＞);也可以参见总体注意事项中测试法和含 量测定如果在各论中关于含量测定法有任何的修 改，要对计算公式和滴定因子进行相应的改变。

forth in the individual monograph, make the appropriate corresponding changes in the calculation formula and titration factor.Where a special Procedure for content uniformity is specified in the test for Uniformity of dosage units in the individual monograph, make any necessary correction of the results obtained as follows.1. Prepare a composite specimen of a sufficient number of dosage units to provide the amount of specimen called for in the Assay in the individual monograph plus the amount required for the special Procedure for content uniformity in the monograph by finely powdering tablets or mixing the contents of capsules or oral solutions, suspensions, emulsions, gels, or solids in single-unit containers to obtain a homogeneous mixture. If a homogeneous mixture cannot be obtained in this manner, use suitable solvents or other procedures to prepare a solution containing all of the drug substance, and use appropriate aliquot portions of this solution for the specified procedures.2. Assay separate, accurately measured portions of the composite specimen of capsules or tablets or suspensions or inhalations or solids in single-unit containers, both (a) as directed in the Assay, and (b) using the special Procedure for content uniformity in the monograph.3. Calculate the weight of drug substance equivalent to 1 average dosage unit, by (a) using the results obtained by the Assay procedure, and by (b) using the results obtained by the special procedure.Calculate the correction factor, F, by the formula:F = W/Pin which W is the weight of drug substance equivalent to 1 average dosage unit obtained by the Assay procedure, and P is the weight of drug substance equivalent to 1 average dosage unit obtained by the special procedure. If当各论中指定了特殊的含量均匀度测定法时，按下 述方法对结果做任何必要的修正。

1 .准备足够数量的剂量单位的复合样本来提供给各 论中含量测定以及各论中含量均匀度测定测试法项 下特殊的数量要求用，这些测试法需要将片剂磨成 粉末或是将单个包装的胶囊、口服液体制剂、混悬 剂、乳剂、凝胶剂或固体制剂中内容物混合得到均 一的混合物如果不能通过上述方法得到均一的混 合物，使用合适的溶剂或其它的方法来制备含有所 有药物的溶液，并使用合适的溶液等份来为指定的 测试法制备供试品2.对准确测量的单个包装的胶囊、片剂、混悬剂、 吸入剂或固体制剂复合样品进行单独的测定，（1） 按照含量测定方法；（2）按照各论中含量测定测试 法项下的方法3 .通过下面两种方法计算等量于平均单剂量的药物 的重量，（1）使用含量测定法得到的结果；（2）使 用特殊测试法得到的结果计算校正因子F公式为：F = W/PW指通过含量测试法中得到的相当于平均单剂量的 药物重量；P通过特殊测试法中得到的指相当于平均单剂量的 药物重量如果：100|W PW的值大于10,使用这个校正因子是无效的。