Specification of limits for particulate contamination in pharmaceutical dosage forms

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.

[1]  R. Drew,et al.  Tests for foreign particles in metered‐dose aerosols , 1982, The Journal of pharmacy and pharmacology.

[2]  D. M. Hailey,et al.  Uniformity of content requirements for tablets and capsules , 1981, The Journal of pharmacy and pharmacology.

[3]  J. Wildsmith.  Techniques of Intravenous Infusion , 1978, Scottish medical journal.

[4]  B. Flann.  Comparison of criteria for content uniformity. , 1974, Journal of pharmaceutical sciences.

[5]  S. Turco,et al.  Detrimental effects of particulate matter on the pulmonary circulation. , 1971, JAMA.

[6]  C. E. Kendall.  COMPARATIVE DATA AND REQUIREMENTS FOR DETERMINATION OF PARTICLE SIZE DISTRIBUTION IN AUSTRALIAN PHARMACEUTICALS , 1969, Annals of the New York Academy of Sciences.