TERMIUM Plus®

The Government of Canada’s terminology and linguistic data bank.

ALTERNATIVE EXCIPIENT [1 record]

Record 1 1991-11-20

English

Subject field(s)
  • Chemical Elements and Compounds
  • Pharmaceutical Manufacturing
CONT

Formula: ... Submit a copy of the proposed Master Formula for a typical batch size, including a quantitative list of all ingredients, regardless of whether they appear in the final product. Alternative excipients will be accepted with adequate supporting data, but ranges are not usually permitted....

OBS

Source: The Structure of a Veterinary New Drug Submission.

French

Domaine(s)
  • Éléments et composés chimiques
  • Fabrication des produits pharmaceutiques
CONT

Formule : (...) Soumettre un exemplaire de la formule-type proposée correspondant à un lot de fabrication typique, y compris une liste quantitative de tous les ingrédients, qu'ils apparaissent ou non dans le produit final. Les excipients de remplacement accompagnés d'une documentation suffisante à l'appui seront autorisés, mais non les intervalles (...)

OBS

Source : La structure d'une présentation de drogue nouvelle à usage vétérinaire.

Spanish

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