马来酸依那普利片usp20 mg的片剂评分研究

P. Patil, G. Patil, R. Marathe, Z. Khan, D. A. Patil
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引用次数: 1

摘要

目前对马来酸依那普利片剂USP 20mg片剂评分的研究是FDA行业指南片剂评分:命名、标签和评价数据的必要条件。这些片剂评分数据描述的结果是在对马来酸依那普利片剂USP 20mg进行测试时获得的。结果正在对展品批次进行测试。为这些片剂评分研究进行了各种测试,如低、最佳或高速(极限NMT 3%)下的质量损失,低、最佳或高速(极限NMT 1%)下的脆性,30分钟内用手和分离器进行溶解,含量均匀性也用手或分离器限制小于或等于15。各项参数结果均在可接受范围内。关键词:马来酸依那普利,易碎性,含量均匀性,评分
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Tablet scoring study of enalapril maleate tablets USP 20 mg
The present study of tablet scoring of Enalapril Maleate Tablets USP 20 mg it is necessary form FDA Guideline for Industry – Tablet Scoring: Nomenclature, Labeling and Data for Evaluation. These tablets scoring data described results are obtained during test performed on Enalapril Maleate Tablets USP 20 mg. The results are carrying out the test on exhibit batches. Various test are performed for these tablet scoring study like Loss of Mass on low, optimum or high speed (limit NMT 3%), Friability on low, optimum or high speed (limit NMT 1%), Dissolution is done by hand and splitter in 30 min., Content Uniformity is also done by hand or splitter limit is less than or equal to 15. Each and every parameter results are found within acceptable limit. Keywords: Enalapril Maleate, Friability, Content Uniformity, Scoring.
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