Details

Autor(en) / Beteiligte

• Setnikar, Ivo
• Fontani, Febo

Titel

Content Uniformity in Rectal Suppositories

Ist Teil von

• Journal of pharmaceutical sciences, 1970-09, Vol.59 (9), p.1319-1324

Ort / Verlag

Washington: Elsevier Inc

Erscheinungsjahr

1970

Quelle

Wiley Online Library - AutoHoldings Journals

Beschreibungen/Notizen

• The content variability in five types of suppositories was evaluated in terms of coefficient of variation. The observed content variability had a coefficient of variation in the range of 1.2-4.5; the method variability had a coefficient of variation in the range of 0.3-4.3. Method variability interferes with the assessment of the actual content variability and, according to the official content uniformity specifications, may lead to the rejection of complying samples or to the acceptance of noncomplying samples. The rationale and the structure of the official content uniformity specifications were studied. The performance of official content uniformity specifications declines as method variability increases. An alternative approach for the evaluation and the restriction of content variability, based on the coefficient of variation, may be advantageous in some instances.