Control of nitrosamine impurities in human drugs

Control of nitrosamine impurities in human drugs

Collection:
Health Policy and Services Research
Series Title(s):
Guidance for industry
Contributor(s):
United States. Department of Health and Human Services, issuing body.
United States. Food and Drug Administration, issuing body.
Center for Drug Evaluation and Research (U.S.), issuing body.
Publication:
Silver Spring, MD : Center for Drug Evaluation and Research, February 2021
Language(s):
English
Format:
Text
Subject(s):
Drug Contamination -- prevention & control
Nitrosamines
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration
Genre(s):
Technical Report
Abstract:
This guidance recommends steps manufacturers of APIs and drug products should take to detect and prevent unacceptable levels of nitrosamine impurities in pharmaceutical products. The guidance also describes conditions that may introduce nitrosamine impurities. The recent unexpected finding of nitrosamine impurities, which are probable human carcinogens, in drugs such as angiotensin II receptor blockers (ARBs), ranitidine, nizatidine, and metformin, has made clear the need for a risk assessment strategy for potential nitrosamines in any pharmaceutical product at risk for their presence. This document revises the guidance of the same title issued in September 2020. This revision extends the time period for preparing initial risk assessments to March 31, 2021 (i.e., within 7 months of publication of the original guidance).
Copyright:
The National Library of Medicine believes this item to be in the public domain. (More information)
Extent:
1 online resource (1 PDF file (various pagings)).
NLM Unique ID:
9918232104106676 (See catalog record)
Permanent Link:
http://resource.nlm.nih.gov/9918232104106676