Description
Stereoisomers are molecules that are identical in atomic constitution and bonding, but differ in the three-dimensional arrangement of the atoms. For the purpose of this document, the stereoisomeric pairs of greatest interest are those with one or more asymmetric (chiral) centers whose enantiomers (individual stereoisomers) are mirror images. They have essentially identical physical (except for optical rotatory) and chemical (except in a chiral environment) properties.
Scope & Applicability
Product Classes
1drugs with one or more chiral centers
Regulatory Context
Attributes
1composition of a drug with a chiral center should be known
Identified Hazards
Hazards
1potential for isomers to convert into one another in the body
Related CFR Sections (1)
- 21CFR300.50§ 300.50 Fixed-combination prescription drugs for humans.
The Food and Drug Administration's policy in administering the new-drug, antibiotic, and other regulatory provisions of the Federal Food, Drug, and Cosmetic Act regarding fixed combination dosage form prescription drugs for humans is as follows:Read full regulation →
See Also (8)
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- Gingivitis: Development and Evaluation of Drugs for Treatment or Prevention (Status: Draft)
- Helicobacter pylori-Associated Duodenal Ulcer Disease in Adults: Developing Drugs for Treatment (Status: Draft)
- Influenza: Developing Drugs for Treatment and/or Prophylaxis (Status: Final)
- Codevelopment of Two or More New Investigational Drugs for Use in Combination (Status: Final)
- Chronic Fatigue Syndrome/Myalgic Encephalomyelitis: Developing Drug Products for Treatment (Status: Draft)