Testing for uniformity: Sampling plans in pharmacopeias for weight, volume, and content uniformity

✍ Scribed by Valeria Pietra; Ivo Setnikar

• Book ID: 102914491
• Publisher: John Wiley and Sons
• Year: 1970
• Tongue: English
• Weight: 640 KB
• Volume: 59
• Category: Article
• ISSN: 0022-3549
• DOI: 10.1002/jps.2600590419

✦ Synopsis

A procedure for analyzing the unit-to-unit uniformity specifications given by several pharmacopeias and for translating them into coefficients of variation is presented. Since the pharmacopeias fail to give the probability level of the compliance with the specifications, two largely adopted probability levels were considered: the 95% level which is important to the producer and the 10% level which is important to the consumer. The coefficients of variation implied by official uniformity specifications for the weights of tablets, capsules, miscellaneous oral forms, and sterile solids; for injection volume; and for content were calculated. The examined pharmacopeias show remarkable differences, both with regard to the sampling strategy and to the allowed variability of the considered dosage forms.

Keyphrases 0 Pharmacopeias, dosage form uniformity testingcomparison 0 Uniformity specifications-coefficient of variation calculations Coefficient of variation, dosage forms-quations 0 Variability determination-dosage form units