Stability of Oral Oxytocics in Tropical Climates - Results of Simulation Studies on Oral Ergometrine, Oral Methylergometrine, Buccal Oxytocin and Buccal Desamino-Oxytocin - EDM Research Series No. 012
(1994; 52 pages) Voir le document au format PDF
Table des matières
Afficher le documentAbbreviations
Afficher le documentSummary
Ouvrir ce répertoire et afficher son contenuIntroduction
Fermer ce répertoireMaterials and methods
Afficher le documentDefinitions used in the study
Afficher le documentSimulated tropical conditions
Afficher le documentMaterials
Afficher le documentAssay method
Afficher le documentStatistics
Ouvrir ce répertoire et afficher son contenuResults
Ouvrir ce répertoire et afficher son contenuDiscussion
Afficher le documentConclusions and recommendations
Afficher le documentReferences
Ouvrir ce répertoire et afficher son contenuAnnexes
 

Definitions used in the study

Table I: Definitions used in the study

Stability: The ability of a drug to retain its properties within specified limits throughout its shelf-life. The following aspects of stability are to be considered: chemical, physical, microbiological and biopharmaceutical.

Shelf-life: The period of time during which a drug product is expected, if stored correctly, to remain within specifications as determined by stability studies on a number of batches of the product. The shelf-life is used to establish the expiry date of each batch.

Source: WHO Expert Committee on Specifications for Pharmaceutical Preparations. Geneva: 1990; Tech Rep Series 790:30

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