Specification of limits for particulate contamination in pharmaceutical dosage forms
- 1 October 1982
- journal article
- research article
- Published by Oxford University Press (OUP) in Journal of Pharmacy and Pharmacology
- Vol. 34 (10) , 615-620
- https://doi.org/10.1111/j.2042-7158.1982.tb04688.x
Abstract
Limits for the control of particulate contamination in large volume parenteral solutions and metered-dose aerosols are discussed. It is suggested that it would be desirable to use limits based on measurement of both the mean and the standard deviation of the particle counts obtained for each of the containers tested. Use of the statistic sT, assuming a target value of zero, is considered to be an appropriate means of measuring the container to container variation in particulate contamination.This publication has 7 references indexed in Scilit:
- Tests for foreign particles in metered-dose aerosolsJournal of Pharmacy and Pharmacology, 1982
- Uniformity of content requirements for tablets and capsulesJournal of Pharmacy and Pharmacology, 1981
- Techniques of Intravenous InfusionScottish Medical Journal, 1978
- Comparison of Criteria for Content UniformityJournal of Pharmaceutical Sciences, 1974
- Detrimental Effects of Particulate Matter on the Pulmonary CirculationPublished by American Medical Association (AMA) ,1971
- COMPARATIVE DATA AND REQUIREMENTS FOR DETERMINATION OF PARTICLE SIZE DISTRIBUTION IN AUSTRALIAN PHARMACEUTICALSAnnals of the New York Academy of Sciences, 1969