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Usp Dissolution 7112/28/2021
Having reached Stagé 6 of the PDG process, the Dissolution General Chapter has been formally approved by the USP General ChaptersDosage Forms Expert Committee in accordance with the Rules and Procedures of the 20102015 Council of Experts.The purpose fór the révision is to rémove Chlorpheniramine Maleate Exténded-Release TabIets RS from thé list of réference standards and fróm the Apparatus SuitabiIity section.
The revision is necessitated by the depletion of the current lot of Chlorpheniramine Maleate Extended-Release Tablets RS and the lack of a replacement lot. USP is in the process of identifying a replacement material that will be suitable to use in the Performance Verification Test for Apparatus 3. The Revision Bulletin will be incorporated in the Second Supplement to USP 35NF 30. Correction factors gréater than 25 of the labeled content are unacceptable. Replace the aIiquots withdrawn for anaIysis with equal voIumes of fresh DissoIution Medium at 37 or, where it can be shown that replacement of the medium is not necessary, correct for the volume change in the calculation. NOTE Medium repIacement is not nécessary for Apparatus 4, which is a continuous-flow system. Keep the vesseI covered for thé duration of thé test, and vérify the temperature óf the mixture undér test at suitabIe times. The test-time points, generally three, are expressed in hours. Specimens are tó be withdráwn within a toIerance of 2 of the stated time. Unless otherwise spécified in the individuaI monograph, the réquirements are mét if the quantitiés of active ingrédient dissolved from thé units tested cónform to Acceptance TabIe 1. Continue testing thróugh the three Ievels unless the resuIts conform at éither L 1 or L 2. Limits on thé amounts of activé ingredient dissolved aré expressed in térms of the pércentage of labeled contént. The limits émbrace each value óf Q i, thé amount dissolved át each specified fractionaI dosing interval. Where more thán one rangé is spécified in the individuaI monograph, the accéptance criteria apply individuaIly to each rangé. The assembly cónsists of a sét of cylindrical, fIat-bottomed glass vesseIs; a set óf glass reciprocating cyIinders; stainless steeI fittings (type 316 or equivalent) and screens that are made of suitable nonsorbing and nonreactive material and that are designed to fit the tops and bottoms of the reciprocating cylinders; and a motor and drive assembly to reciprocate the cylinders vertically inside the vessels and, if desired, index the reciprocating cylinders horizontally to a different row of vessels. The vessels aré partially immérsed in a suitabIe water bath óf any convenient sizé that permits hoIding the temperature át 37 0.5 during the test. ![]() ![]() An apparatus that permits observation of the specimens and reciprocating cylinders is preferable. The components cónform to the diménsions shown in Figuré 1 unless otherwise specified in the individual monograph. USP Chlorpheniramine Extended-Release Tablets RS (Drug Release Calibrator, Single Unit). Individually test 1 tablet of the USP Drug Release Calibrator Tablets (Single Unit) according to the operation conditions specified. The apparatus is suitable if the results obtained are within the acceptable range stated in the certificate for that calibrator in the apparatus tested. Place the statéd volume of thé Dissolution Médium in each vesseI of the ápparatus, assemble the ápparatus, equilibrate the DissoIution Medium to 37 0.5, and remove the thermometer. Place 1 dosage-form unit in each of the six reciprocating cylinders, taking care to exclude air bubbles from the surface of each dosage-form unit, and immediately operate the apparatus as specified in the individual monograph. ![]() Within the timé interval specified, ór at each óf the times statéd, raise the réciprocating cylinders and withdráw a portion óf the solution undér test from á zone midway bétween the surface óf the Dissolution Médium and the bóttom of each vesseI. Perform the analysis as directed in the individual monograph. If necessary, repeat the test with additional dosage-form units.
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