Megestrol Acetate
Structure
Other Names & Identifiers
- BP MPA Impurity G
- BP Medroxyprogesterone Injection Impurity G
- BP Medroxyprogesterone Tablets Impurity G
CASRN
Molecular Formula
C24H32O4
Molecular Weight
384.516 g/mol
Structural Difference from API
The C6-C7 single bond of MPA is replaced with a C6=C7 double bond, resulting in loss of chirality at C6.
References
- British Pharmacopoeia 2017: Medroxyprogesterone Acetate monograph (View all citations for this reference)
Appearance
White or almost white, crystalline powder
References
- British Pharmacopoeia 2017: Medroxyprogesterone Acetate monograph (View all citations for this reference)
Melting Point
About 217° C; 218.0-220.0° C
References
- Online free access database provided by the United States National Institutes of Health (NIH). (View all citations for this reference)
- British Pharmacopoeia 2017: Medroxyprogesterone Acetate monograph (View all citations for this reference)
Water Solubility
2 μg/mL (at 37° C for the acetate salt)
Organic Solubility
Soluble in acetone, sparingly soluble in ethanol (96 per cent). Dissolves in methylene chloride (2.50 g/25.0 mL)
References
- British Pharmacopoeia 2017: Medroxyprogesterone Acetate monograph (View all citations for this reference)
Octanol-Water Partition Coefficient (logP)
3.2
Specific Optical Rotation
+14 to +17 (dried substance)
References
- British Pharmacopoeia 2017: Medroxyprogesterone Acetate monograph (View all citations for this reference)
Storage Conditions
Protected from light
References
- British Pharmacopoeia 2017: Medroxyprogesterone Acetate monograph (View all citations for this reference)
Source of Impurity
Oxidation of MPA; removal of H2 from MPA
References
Reaxys ID #
1917291
Limits
0.2%
References
- British Pharmacopoeia 2014: Medroxyprogesterone Acetate API (View all citations for this reference)
- European Pharmacopoeia 8.0 Medroxyprogesterone Acetate API (View all citations for this reference)
- British Pharmacopoeia 2017: Medroxyprogesterone Injection monograph (View all citations for this reference)
- British Pharmacopoeia 2017: Medroxyprogesterone Tablets monograph (View all citations for this reference)