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Merck

PHR1480

Ethinyl Estradiol

Pharmaceutical Secondary Standard; Certified Reference Material

Synonym(s):

17α-Ethynylestradiol, EE, 17α-Ethynyl-1,3,5(10)-estratriene-3,17β-diol, 19-Nor-1,3,5(10),17α-pregnatrien-20-yne-3,17-diol, Ethinylestradiol

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About This Item

Empirical Formula (Hill Notation):
C20H24O2
CAS Number:
57-63-6
Molecular Weight:
296.40
UNSPSC Code:
41116107
NACRES:
NA.24
PubChem Substance ID:
329823408
EC Number:
200-342-2
Beilstein/REAXYS Number:
2419975
MDL number:
MFCD00003690

Product Name

Ethinyl Estradiol, Pharmaceutical Secondary Standard; Certified Reference Material

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

Storage Class

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

Certificates of Analysis (COA)

Search for Certificates of Analysis (COA) by entering the products Lot/Batch Number. Lot and Batch Numbers can be found on a product’s label following the words ‘Lot’ or ‘Batch’.

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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)
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)
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)
Simultaneous Determination of Gestodene and Ethinyl Estradiol in Contraceptive Formulations by RP?HPLC.
Laban A, et al.
Analytical Letters, 37(2), 273-282 (2004)
Tomás Cajthaml et al.
Environmental pollution (Barking, Essex : 1987), 157(12), 3325-3335 (2009-07-25)
Natural estrogens such as estrone, 17beta-estradiol, estriol, and the particularly recalcitrant synthetic estrogen 17alpha-ethinylestradiol used as oral contraceptive, accumulate in the environment and may give rise to health problems. The processes participating in their removal from soil, wastewater, water-sediments, groundwater-aquifer
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