Search results with tag "Uniformity of dosage"
905 UNIFORMITY OF DOSAGE UNITS USP34
www.usp.orgStage 6 Harmonization Official December 1, 2011 〈905〉 Uniformity of Dosage Units1 〈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 UNITS 2S (USP34) Table 1.
GENERAL GUIDANCE FOR INSPECTORS ON “HOLD-TIME” …
www.who.intUniformity of dosage units Moisture content Microbial test Hold-time data under specified conditions should demonstrate comparable stability to the dosage form in the marketed package. Interim storage of the dosage form in bulk containers should generally not exceed six months. ***
THE JAPANESE PHARMACOPOEIA - Pmda
www.pmda.go.jp6.02 Uniformity of Dosage Units .....147 6.03 Particle Size Distribution Test for Preparations.....150 6.04 Test for Acid-neutralizing Capacity of Gastrointestinal Medicines.....150 6.05 Test for Extractable Volume of Parenteral Preparations.....150 6.06 …
ICH guideline Q4B annex 6 to note for evaluation and ...
www.ema.europa.euICH guideline Q4B annex 6 to note for evaluation and recommendation of pharmacopoeial texts for use in the ICH regions on uniformity of dosage units – general chapter