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Merck

PHR1480

Supelco

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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About This Item

Fórmula empírica (notación de Hill):
C20H24O2
Número de CAS:
Peso molecular:
296.40
Beilstein/REAXYS Number:
2419975
EC Number:
MDL number:
UNSPSC Code:
41116107
PubChem Substance ID:
NACRES:
NA.24

grade

certified reference material
pharmaceutical secondary standard

Quality Level

agency

traceable to BP 421
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

SMILES string

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

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

InChI key

BFPYWIDHMRZLRN-SLHNCBLASA-N

Gene Information

human ... ESR1(2099)

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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.

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.

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 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_germany

WGK 3

flash_point_f

Not applicable

flash_point_c

Not applicable


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Los clientes también vieron

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)
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)
Simultaneous Determination of Gestodene and Ethinyl Estradiol in Contraceptive Formulations by RP?HPLC.
Laban A, et al.
Analytical Letters, 37(2), 273-282 (2004)
Hongjian Zhang et al.
Clinical pharmacokinetics, 46(2), 133-157 (2007-01-27)
17alpha-Ethinylestradiol (EE) is widely used as the estrogenic component of oral contraceptives (OC). In vitro and in vivo metabolism studies indicate that EE is extensively metabolised, primarily via intestinal sulfation and hepatic oxidation, glucuronidation and sulfation. Cytochrome P450 (CYP)3A4-mediated EE

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