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1. M7(R1) assessment and control of DNA reactive (mutagenic) impurities in pharmaceuticals to limit potential carcinogenic risk

Publication:

Silver Spring, MD : Center for Drug Evaluation and Research, March 2018

Subject(s):

Carcinogenicity Tests -- standards
Carcinogens
Chemistry, Pharmaceutical
DNA Damage -- genetics
Drug Contamination -- prevention & control
Mutagenicity Tests -- standards
Mutagens
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

2. Dangers associated with shared multidose vials

Publication:

[Harrisburg, Pa.] : Pennsylvania Patient Safety Authority, c2008

Subject(s):

Cross Infection -- etiology
Disease Transmission, Infectious
Dosage Forms
Drug Contamination -- prevention & control
Drug Packaging -- instrumentation
Equipment Reuse
Equipment Safety
Infection Control -- methods
Syringes -- economics
Pennsylvania
United States

3. On fungous growths in solutions for hypodermic medication, and their prevention by salicylic acid

Author(s):

Richardson, Joseph Gibbons, 1836-1886 author

Publication:

Philadelphia : [publisher not identified], 1877

Subject(s):

Morphine
Pharmaceutical Solutions
Drug Contamination -- prevention & control
Antifungal Agents
Blood Cells
Forensic Medicine

4. Q3D(R1) elemental impurities

Publication:

Silver Spring, MD : Center for Drug Evaluation and Research, March 2020

Subject(s):

Drug Contamination -- prevention & control
Quality Control
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

5. Control of nitrosamine impurities in human drugs

Publication:

Silver Spring, MD : Center for Drug Evaluation and Research, February 2021

Subject(s):

Drug Contamination -- prevention & control
Nitrosamines
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

6. Policy for testing of alcohol (ethanol) and isopropyl alcohol for methanol: guidance for industry

Publication:

Silver Spring, MD : Center for Drug Evaluation and Research, October 2023

Subject(s):

2-Propanol -- analysis
Drug Compounding -- standards
Drug Contamination -- prevention & control
Drug Industry
Ethanol -- analysis
Government Regulation
Methanol -- poisoning
United States

7. M7(R2) assessment and control of DNA reactive (mutagenic) impurities in pharmaceuticals to limit potential carcinogenic risk: guidance for industry

Publication:

Silver Spring, MD : Center for Drug Evaluation and Research, July 2023

Subject(s):

Carcinogens
Drug Contamination -- prevention & control
Drug Development
Drug Industry
Government Regulation
Mutagenicity Tests
Mutagens
United States
United States. Food and Drug Administration