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Merck
CN

PHR1634

依西美坦

Pharmaceutical Secondary Standard; Certified Reference Material

别名:

Exemestane, 6-Methyleneandrosta-1,4-diene-3,17-dione

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关于此项目

经验公式（希尔记法）:
C20H24O2
化学文摘社编号:
107868-30-4
分子量:
296.40
NACRES:
NA.24
PubChem Substance ID:
329823524
UNSPSC Code:
41116107
MDL number:
MFCD00866994

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产品名称

依西美坦, Pharmaceutical Secondary Standard; Certified Reference Material

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

SMILES string

C[C@]12CC[C@H]3[C@@H](CC(=C)C4=CC(=O)C=C[C@]34C)[C@@H]1CCC2=O

InChI key

BFYIZQONLCFLEV-DAELLWKTSA-N

grade

certified reference material
pharmaceutical secondary standard

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

Quality Level

300

Gene Information

human ... CYP19A1(1588)

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Analysis Note

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

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.
Exemestane is a steroidal antiestrogen; aromatase inhibitor.

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.

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.
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
GHS08,GHS09

signalword

Danger

hcodes

H360,H411

Hazard Classifications

Aquatic Chronic 2 - Repr. 1B

存储类别

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

法规信息

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Exemestane: a review of its clinical efficacy and safety
Lonning PE
The Breast Journal, 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)
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)

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