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Key Documents

PHR1894

Supelco

Exemestane Related Compound A

Pharmaceutical Secondary Standard; Certified Reference Material

Synonym(s):

6-Methyleneandrost-4-ene-3,17-dione

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About This Item

Empirical Formula (Hill Notation):
C20H26O2
CAS Number:
Molecular Weight:
298.42
UNSPSC Code:
41116107
NACRES:
NA.24

grade

certified reference material
pharmaceutical secondary standard

Quality Level

Agency

traceable to USP 1269061

API family

exemestane

CofA

current certificate can be downloaded

packaging

pkg of 30 mg

application(s)

pharmaceutical

format

neat

storage temp.

2-8°C

InChI

1S/C20H26O2/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/h11,14-16H,1,4-10H2,2-3H3/t14-,15-,16-,19+,20-/m0/s1

InChI key

KQRGETZTRARSMA-DAELLWKTSA-N

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General description

Exemestane Related Compound A is an impurity of the steroidal anticancer drug, exemestane. Exemestane belongs to the class of antiestrogens known as aromatase inhibitors. It is commonly used for the treatment of breast cancer.
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.

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.

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 LRAB0339 in the Documents slot below. This is an example certificate only and may not be the lot that you receive.

Pictograms

Health hazard

Signal Word

Warning

Hazard Statements

Precautionary Statements

Hazard Classifications

Repr. 2

Storage Class Code

11 - Combustible Solids

WGK

WGK 3

Flash Point(F)

Not applicable

Flash Point(C)

Not applicable


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Certificates of Analysis (COA)

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Development and validation of a stability indicating LC method for the assay and related substances determination of Exemestane, an aromatase inhibitor
Kumar RS, et al.
Journal of Pharmaceutical and Biomedical Analysis, 50(5), 746-752 (2009)
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)
Exemestane: a review of its clinical efficacy and safety
L?nning PE
Breast (Edinburgh, Scotland), 10(3), 198-208 (2001)
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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