5.10. CONTROL OF IMPURITIES IN SUBSTANCES …

EUROPEAN PHARMACOPOEIA IMPURITIES in SUBSTANCES for pharmaceutical use01/2005 CONTROL OF IMPURITIESIN SUBSTANCES FORPHARMACEUTICAL USEP reambleThe monographs of the European Pharmacopoeia onsubstances for pharmaceutical use are designed to ensureacceptable quality for users. The role of the Pharmacopoeiain public health protection requires that adequate controlof IMPURITIES be provided by monographs. The qualityrequired is based on scientific, technical and concerning IMPURITIES are given in specificmonographs and in the general monographSubstancesfor pharmaceutical use (2034). Specific monographsand the general monograph are complementary: specificmonographs prescribe acceptance criteria for impuritieswhereas the general monograph deals with the need forqualification, identification and reporting of any organicimpurities that occur inactive thresholds for reporting, identification and qualificationcontained in the general monographSubstances forpharmaceutical use (2034)apply to all related , if a monograph does not contain a relatedsubstances test based on a quantitative method, any newimpurities occurring above a threshold may be overlookedsince the test is not capable to detect those provisions of the Related SUBSTANCES section of thegeneral monographSubstances for pharmaceuticaluse (2034), notably those concerning thresholds, do notapply to excipients; also excluded from the provisionsof this section are: biological and biotechnologicalproducts; peptides.

5.10. Impurities in substances for pharmaceutical use EUROPEAN PHARMACOPOEIA 5.0 It should be noted that specific thresholds are applied to substances exclusively for veterinary use.

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  Pharmaceutical, Veterinary, Impurities, Substance, Impurities in substances for pharmaceutical

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