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市售Chlorpheniramine maleate錠劑之溶離度試驗及其品質調查

A Study on the Dissolution Quality of Commercial Chlorpheniramine Maleate Tablets in Taiwan Area

並列摘要


Fifty three samples of chlorpheniramine maleate tablets purchased from drug stores in Taiwan area were subject to testings concerning dissolution, weight variation, disintegration, and assay according to methods and criteria described in USP XXI. Only four samples were products imported from abroad but all were belong to one manufacturer and they all met the USP criteria. The other 49 samples were products manufactured by 31 local factories and three samples from two local manufacturers did not meet all criteria fully. Overall, three of the fifty three samples, 5.7%, did not meet all requirements. Two of the fifty three smaples, 3.8%, did not meet the criteria for the dissolution.

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