usp 711 dissolution 붕해시험법 해석

목차

1. APPARATUS
1)Apparatus 1 (Basket Apparatus)
2)Apparatus 2 (Paddle Apparatus)
3)Apparatus 3 (Reciprocating Cylinder)
4)Apparatus 4 (Flow-Through Cell)
5)apparatus suitability

2. PROCEDURE
1)Apparatus 1 and Apparatus 2
2)Apparatus 3 (Reciprocating Cylinder)
3)Apparatus 4 (Flow-Through Cell)

3. INTERPRETATION

본문내용

This general chapter is harmonized with the corresponding texts of the European Pharmacopoeia and/or the Japanese Pharmacopoeia. These pharmacopeias have undertaken not to make any unilateral change to this harmonized chapter.
Portions of the present general chapter text that are national USP text, and therefore not part of the harmonized text, are marked with symbols () to specify this fact.
This test is provided to determine compliance with the dissolution requirements where stated in the individual monograph for dosage forms administered orally. In this general chapter, a dosage unit is defined as 1 tablet or 1 capsule or the amount specified. Of the types of apparatus described herein, use the one specified in the individual monograph. Where the label states that an article is enteric-coated, and where a dissolution or disintegration test that does not specifically state that it is to be applied to delayed-release articles is included in the individual monograph, the procedure and interpretation given for Delayed-Release Dosage Forms is applied unless otherwise specified in the individual monograph.

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