Comparative Data and Requirements for Determination of Particle Size Distribution in Australian Pharmaceuticals

Kendall, C. E.

doi:10.1111/j.1749-6632.1969.tb56186.x

Cited by 10 publications

(3 citation statements)

References 5 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…The container to container variation in counts of particles greater than 100 pm was narrower than the distribution typically found in containers of large volume parenterals (Kendall 1969). The samples tested, with one exception, would have complied with the limit x + 2s < 200; x < 150 where x is the mean count (ten containers) of particles greater than 100 pm and s is the standard deviation.…”

Section: Results a N D Discussionmentioning

confidence: 86%

Tests for foreign particles in metered-dose aerosols

Lea

Drew

Wong

et al. 1982

Journal of Pharmacy and Pharmacology

View full text Add to dashboard Cite

A simple method for the determination of foreign particular matter in metered-dose aerosols (MDA's) has been developed. The method compares favourably with a procedure currently used in pharmaceutical industry and has the advantage of providing information on container to container variation. A linear relationship between log particle count and particle size was found for a number of MDA's, although there was considerable product-to-product variation. On the basis of the results obtained in this study, commercially available MDS's would in general comply with a limit for foreign particles greater than 100 micrometers of not more than 150 particles per container with the sum of the mean count and twice the standard deviation not more than 200.

show abstract

Section: Results a N D Discussionmentioning

confidence: 86%

Tests for foreign particles in metered-dose aerosols

Lea

Drew

Wong

et al. 1982

Journal of Pharmacy and Pharmacology

View full text Add to dashboard Cite

show abstract

“…The approach adopted at National Biological Standards Laboratory (NBSL) has been to consider the mean and standard deviation of the results from ten individual containers, and has been discussed by Kendall (1969). The limit at present in use for particles which have effective diameters greater than 5 Fm is that the mean particle count is not more than 100 particles m1-l and that the sum of the mean and twice the standard deviation is not more than 200…”

mentioning

confidence: 99%

“…The NBSL specification attempts to take into account the appreciable variation in particulate contamination which frequently occurs in samples of LVP's. The results of testing this type of product at NBSL indicate that the standard deviation for a sample of ten containers is commonly of the order of half the mean particle count (Kendall 1969). The pharmacopoeial requirements for content of particulate matter in LVP's give no indication of actual distribution of levels of contamination between containers and imply that all containers with particle counts above the specified limits are equally bad while all those passing the test are equally good.…”

mentioning

confidence: 99%

Specification of limits for particulate contamination in pharmaceutical dosage forms

Hailey

Lea

Kendall

1982

Journal of Pharmacy and Pharmacology

View full text Add to dashboard Cite

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.

show abstract