PHR1634

Exemestane

Pharmaceutical Secondary Standard; Certified Reference Material

• Synonym(s): Exemestane, 6-Methyleneandrosta-1,4-diene-3,17-dione
• Empirical Formula (Hill Notation): C₂₀H₂₄O₂
• CAS Number: 107868-30-4
• Molecular Weight: 296.40
• MDL number: MFCD00866994
• UNSPSC Code: 41116107
• PubChem Substance ID: 329823524
• NACRES: NA.24

Properties

• grade: certified reference material; pharmaceutical secondary standard
• Quality Level: 300
• agency: traceable to USP 1269050
• API family: exemestane
• 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
• SMILES string: C[C@]12CC[C@H]3[C@@H](CC(=C)C4=CC(=O)C=C[C@]34C)[C@@H]1CCC2=O
• InChI: 1S/C20H24O2/c1-12-10-14-15-4-5-18(22)20(15,3)9-7-16(14)19(2)8-6-13(21)11-17(12)19/h6,8,11,14-16H,1,4-5,7,9-10H2,2-3H3/t14-,15-,16-,19+,20-/m0/s1
• InChI key: BFYIZQONLCFLEV-DAELLWKTSA-N
• Gene Information: human ... CYP19A1(1588)

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. Exemestane is a steroidal anticancer drug, that belongs to the class of antiestrogens known as aromatase inhibitors. It is commonly used for the treatment of breast cancer.

Application

Exemestane may be used as a pharmaceutical reference standard for the determination of the analyte in bulk drug and pharmaceutical formulations by chromatography.

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.

Biochem/physiol Actions

Exemestane is a steroidal antiestrogen and irreversible aromatase inhibitor. Exemestane acts as a false substrate for the aromatase enzyme. Exemestane also prevents the conversion of androgens to estrogens and is used to treat estrogen-dependent breast cancer.

Analysis Note

These secondary standards offer multi-traceability to the USP, EP and BP primary standards, where they are available.

Other Notes

This Certified Reference Material (CRM) is produced and certified in accordance with ISO 17034 and ISO/IEC 17025. All information regarding the use of this CRM can be found on the certificate of analysis.

Footnote

To see an example of a Certificate of Analysis for this material enter LRAC3262 in the slot below. This is an example certificate only and may not be the lot that you receive.

Safety Information

• pictograms: GHS08,GHS09
• signalword: Danger
• hcodes: H360,H411
• pcodes: P201 - P202 - P273 - P280 - P308 + P313 - P391
• Hazard Classifications: Aquatic Chronic 2 - 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