USP905含量均匀度中英文.doc

905 UNIFORMITY OF DOSAGE UNITS Content Uniformity The 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) suppositories Select 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 a