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C E Kendall

Publications and source records attributed to C E Kendall.

8 recordsLinked to original sources

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 is would be desirable to use limits based on measurement of both 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.

Aerosols

Uniformity of content requirements for tablets and capsules.

Present pharmacopoeial requirements for uniformity of content of tablets and capsules are based on tests by attributes. A test for uniformity of content based on the root mean square deviation about target (ST) is more reliable than the pharmacopoeial tests and has the added convenience of using a single statistic to control both the mean content and the variation about the mean. Implications of the use of the statistic ST in uniformity requirements are discussed.

Capsules