〈905〉 UNIFORMITY OF DOSAGE The test for Content Uniformity is required for all dosage forms not meeting the above conditions for the Weight Variation test. 1

905 uniformity of dosage units NOTE— In this chapter, unit and dosage unit are synonymous. To ensure the consistency of dosage units, each unit in a batch should have a drug substance content within a narrow range around the label claim.

11/21/2016 32(6) Sixth Interim Revision Announcement: <905> UNIFORMITY OF DOSAGE UNITS ) [1 + ...

〈905〉 Uniformity of Dosage Units This general chapter is harmonized with the corresponding texts of the European Pharmacopoeia and the Japanese Pharmacopoeia . Portions of the general chapter text that are national USP text, and are not part of the harmonized text, are marked with symbols ( ⧫ ⧫ ) to specify this fact.

USP published a revised, harmonized General Chapter <905> on pages 2505–2510 of USP 28–NF 23 with an implementation date of April 1, 2006. This chapter contains the global harmonized text approved by the Pharmacopeial Discussion Group (PDG) as well as USP–specific national text.

(USP 1-Aug-2023) suspensions, emulsions, or gels in unit-dose containers intended for local action following (USP 1-Aug-2023) external, cutaneous administration. The term “uniformity of dosage unit” is defined as the degree of uniformity in the amount of …

USP 905 - Uniformity of Dosage Units - Free download as PDF File (.pdf), Text File (.txt) or read online for free. Uniformity of Dosage Units can be demonstrated by either of two methods. Average of the 12 units (a1 + a2) is not more than 10% dissolved.

422 〈905〉 Uniformity of Dosage Units / Physical Tests USP 35 Table 2 (Continued) Variable Definition Conditions Value L2 Maximum allowed range for On the low side, no dosage unit L2 = 25.0 unless otherwise specified deviation of each dosage unit result can be less than tested from the calculated value [1–(0.01)(L2)]M, while on the

The <905> Uniformity of Dosage Units General Chapter was incorporated into and became official with the Second Supplement to USP 34–NF 29. Should you have any questions about this General Chapter, please contact Will Brown (301-816-8380 or [email protected]).

Dosage Units, JP 6.02 Uniformity of Dosage Units, and USP General Chapter <905> Uniformity of Dosage Units, can be used as interchangeable in the ICH regions subject to the following...