PHR1583

Megestrol Acetate

Pharmaceutical Secondary Standard; Certified Reference Material

• Synonym(s): Megestrol acetate, 17α-Acetoxy-6-methyl-4,6-pregnadiene-3,20-dione, 17α-Hydroxy-6-methyl-4,6-pregnadiene-3,20-dione 17-acetate, 17α-Hydroxy-6-methyl-6-dehydroprogesterone 17-acetate, Megestrol 17-acetate
• Empirical Formula (Hill Notation): C₂₄H₃₂O₄
• CAS Number: 595-33-5
• Molecular Weight: 384.51
• Beilstein/REAXYS Number: 1917291
• EC Number: 209-864-5
• MDL number: MFCD00056470
• UNSPSC Code: 41116107
• PubChem Substance ID: 329823491
• NACRES: NA.24

Properties

• grade: certified reference material; pharmaceutical secondary standard
• Quality Level: 300
• agency: traceable to BP 223; traceable to Ph. Eur. Y0001514; traceable to USP 1379106
• API family: megesterol
• CofA: current certificate can be downloaded
• packaging: pkg of 1 g
• technique(s): HPLC: suitable; gas chromatography (GC): suitable
• application(s): pharmaceutical (small molecule)
• format: neat
• storage temp.: 2-8°C

Description

General description

Pharmaceutical secondary standards for application in quality control, provide pharma laboratories and manufacturers with a convenient and cost-effective alternative to the preparation of in-house working standards. Megestrol Acetate is a progestogen drug indicated for the palliative treatment of endometrial carcinoma and breast cancer. The administration of the drug is usually done orally as a solid dosage form.[1]

Application

Megestrol Acetate may be used as a pharmaceutical reference standard for the determination of the analyte in pharmaceutical formulations, oral contraceptives and suspensions by chromatography techniques.[2][3][4][5]

These Secondary Standards are qualified as Certified Reference Materials. These are suitable for use in several analytical applications including but not limited to pharma release testing, pharma method development for qualitative and quantitative analyses, food and beverage quality control testing, and other calibration requirements.

Footnote

To see an example of a Certificate of Analysis for this material enter LRAA4562 in the slot below. This is an example certificate only and may not be the lot that you receive.

Safety Information

• pictograms: GHS08
• signalword: Danger
• hcodes: H360FD
• pcodes: P201 - P202 - P280 - P308 + P313 - P405 - P501
• Hazard Classifications: Repr. 1B
• Storage Class: 6.1C - Combustible acute toxic Cat.3 / toxic compounds or compounds which causing chronic effects
• wgk_germany: WGK 3
• flash_point_f: Not applicable
• flash_point_c: Not applicable