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Merck

PHR1480

17α-etinilestradiol

Pharmaceutical Secondary Standard; Certified Reference Material

Sinónimos:

17α-etinil-1,3,5(10)-estratrieno-3,17β-diol, 19-Nor-1,3,5(10),17α-pregnatrien-20-ino-3,17-diol, Etinilestradiol

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Fórmula empírica (notación de Hill):
C20H24O2
Número CAS:
57-63-6
Peso molecular:
296.40
UNSPSC Code:
41116107
NACRES:
NA.24
PubChem Substance ID:
329823408
EC Number:
200-342-2
Beilstein/REAXYS Number:
2419975
MDL number:
MFCD00003690

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InChI key

BFPYWIDHMRZLRN-SLHNCBLASA-N

InChI

1S/C20H24O2/c1-3-20(22)11-9-18-17-6-4-13-12-14(21)5-7-15(13)16(17)8-10-19(18,20)2/h1,5,7,12,16-18,21-22H,4,6,8-11H2,2H3/t16-,17-,18+,19+,20+/m1/s1

SMILES string

[H][C@]12CC[C@@]3(C)[C@@]([H])(CC[C@@]3(O)C#C)[C@]1([H])CCc4cc(O)ccc24

grade

certified reference material, pharmaceutical secondary standard

agency

traceable to Ph. Eur. E1900000, traceable to USP 1260001

API family

ethinyl estradiol

CofA

current certificate can be downloaded

packaging

pkg of 200 mg

technique(s)

HPLC: suitable, gas chromatography (GC): suitable

mp

182-183 °C (lit.)

application(s)

pharmaceutical (small molecule)

format

neat

storage temp.

2-30°C

Quality Level

300

Gene Information

human ... ESR1(2099)

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Analysis Note

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

Application

Ethinyl Estradiol may be used as a pharmaceutical reference standard for the determination of the analyte in pharmaceutical formulations by various chromatography techniques.
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.

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.

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 LRAB9196 in the slot below. This is an example certificate only and may not be the lot that you receive.

signalword

Danger

Hazard Classifications

Acute Tox. 4 Oral - Aquatic Chronic 1 - Carc. 2 - Repr. 1A

Clase de almacenamiento

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

Certificados de análisis (COA)

Busque Certificados de análisis (COA) introduciendo el número de lote del producto. Los números de lote se encuentran en la etiqueta del producto después de las palabras «Lot» o «Batch»

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Determination of Ethinyl Estradiol in Solid Dosage Forms by High-Performance Liquid Chromatography.
Strusiak SH, et al.
Journal of Pharmaceutical Sciences, 71(6), 636-640 (1982)
Norethindrone acetate (NA) and ethinyl estradiol (EE) related oxidative transformation products in stability samples of formulated drug product: synthesis of authentic references.
Ekhato I, et al.
Steroids, 67(3-4), 165-174 (2002)
Quantitative analysis of ethynodiol diacetate and ethinyl estradiol/mestranol in oral contraceptive tablets by high?performance liquid chromatography.
Carignan G, et al.
Journal of Pharmaceutical Sciences, 71(2), 264-266 (1982)
Simultaneous Determination of Gestodene and Ethinyl Estradiol in Contraceptive Formulations by RP?HPLC.
Laban A, et al.
Analytical Letters, 37(2), 273-282 (2004)
Lisa Baumann et al.
Toxicology and applied pharmacology, 278(3), 230-237 (2014-05-17)
The aim of the present study was to investigate the persistence of the feminizing effects of discontinued 17α-ethinylestradiol (EE2) exposure on zebrafish (Danio rerio). An exposure scenario covering the sensitive phase of sexual differentiation, as well as final gonad maturation
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