Uniformity of dosage units[1]is one of the most commonly employed compendial tests to evaluate the dosage units.In the test,the acceptance value(AV)is the key statistics-based acceptance parameter with the limit of no...Uniformity of dosage units[1]is one of the most commonly employed compendial tests to evaluate the dosage units.In the test,the acceptance value(AV)is the key statistics-based acceptance parameter with the limit of not more than 15 to measure the uniformity degree of the dosage units in terms of content uniformity or weight variation as applicable.With quality assurance(QA)principle,there should be some kinds of predetermined acceptance limits,like Bergum method introduced by James S.Bergum in 1990[2]and 2007[3]and recently recognized by ASTM 2709[4]and ASTM 2810[5]to ensure that the AV results for any future quality control(QC)samples will not exceed the compendial limit(NMT 15).展开更多
文摘Uniformity of dosage units[1]is one of the most commonly employed compendial tests to evaluate the dosage units.In the test,the acceptance value(AV)is the key statistics-based acceptance parameter with the limit of not more than 15 to measure the uniformity degree of the dosage units in terms of content uniformity or weight variation as applicable.With quality assurance(QA)principle,there should be some kinds of predetermined acceptance limits,like Bergum method introduced by James S.Bergum in 1990[2]and 2007[3]and recently recognized by ASTM 2709[4]and ASTM 2810[5]to ensure that the AV results for any future quality control(QC)samples will not exceed the compendial limit(NMT 15).
