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PHR1634

Supelco

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:
Molecular Weight:
296.40
MDL number:
PubChem Substance ID:
NACRES:
NA.24

Quality Level

grade

certified reference material
pharmaceutical secondary standard

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

pharmacopeia traceability

traceable to USP 1269050

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)

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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

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

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.

Pictograms

Health hazardEnvironment

Signal Word

Danger

Hazard Statements

Hazard Classifications

Aquatic Chronic 2 - Repr. 1B

Storage Class Code

6.1C - Combustible, acute toxic Cat.3 / toxic compounds or compounds which causing chronic effects

WGK

WGK 3

Flash Point(F)

Not applicable

Flash Point(C)

Not applicable

Certificate of Analysis

Certificate of Origin

Exemestane: a review of its clinical efficacy and safety
Lonning PE
The Breast Journal, 10(3), 198-208 (2001)
A novel validated stability-indicating RP-HPLC method for the determination of Exemestane (steroidal aromatase inhibitor)
Mukthinuthalapati MA and Bukkapatnam V
Journal of Bioequivalence & Bioavailability, 7(6), 288-288 (2015)
Analytical method validation for HPLC assay of oral anticancer drug exemestane
Yavuz B
FABAD Journal of Pharmaceutical Sciences, 32(1), 15-15 (2007)

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