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.
D000336:Aerosols; D004340:Drug Contamination; D010316:Particle Size; D004364:Pharmaceutical Preparations / Q000592:standards; D006113:United Kingdom; D014481:United States
D000336:Aerosols; D004364:Pharmaceutical Preparations