Guidance on nitrosamine impurities in medications.: H164-327/2023E-1-PDF

"Evaluating and managing the risks of N-nitrosamine impurities in human pharmaceutical, biological and radiopharmaceutical products"--Cover.

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Publication information
Department/Agency Canada. Health Canada, issuing body.
Title Guidance on nitrosamine impurities in medications.
Publication type Monograph
Language [English]
Other language editions [French]
Later edition Guidance on nitrosamine impurities in medications. October 20, 2023
Earlier edition Guidance on nitrosamine impurities in medications. April 17, 2023
Format Electronic
Electronic document
Note(s) Cover title.
"Date adopted: July 24, 2023. Effective date: July 24, 2023."
Issued also in French under title: Lignes directrices sur les impuretés de nitrosamine dans les médicaments.
Includes bibliographical references.
Publishing information Ottawa, ON : Health Canada = Santé Canada, 2023.
Description 1 online resource (iii, 64 pages) : illustrations
ISBN 9780660494265
Catalogue number
  • H164-327/2023E-1-PDF
Departmental catalogue number 230230
Subject terms Nitrosoamines -- Risk assessment -- Canada.
Drugs -- Risk assessment -- Canada.
Biologicals -- Risk assessment -- Canada.
Radiopharmaceuticals -- Risk assessment -- Canada.
Pharmaceutical policy -- Canada.
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