All Photos(1)

PHR1353

Supelco

Estradiol

Pharmaceutical Secondary Standard; Certified Reference Material

Synonym(s):
17β-Estradiol, β-Estradiol, 3,17β-Dihydroxy-1,3,5(10)-estratriene, 1,3,5-Estratriene-3,17β-diol, Dihydrofolliculin
Empirical Formula (Hill Notation):
C18H24O2
CAS Number:
Molecular Weight:
272.38
Beilstein:
1914275
EC Number:
MDL number:
PubChem Substance ID:
NACRES:
NA.24

Quality Level

grade

certified reference material
pharmaceutical secondary standard

CofA

current certificate can be downloaded

application(s)

HPLC: suitable
gas chromatography (GC): suitable

mp

176-180 °C (lit.)

Featured Industry

Pharmaceutical (small molecule)

format

neat

pharmacopeia traceability

traceable to BP 729
traceable to PhEur E1620000
traceable to USP 1250008

SMILES string

O[C@H]1CC[C@@]2([H])[C@]3([H])CCC4=CC(O)=CC=C4[C@@]3([H])CC[C@@]21C

InChI

1S/C18H24O2/c1-18-9-8-14-13-5-3-12(19)10-11(13)2-4-15(14)16(18)6-7-17(18)20/h3,5,10,14-17,19-20H,2,4,6-9H2,1H3/t14-,15-,16+,17+,18+/m1/s1

InChI key

VOXZDWNPVJITMN-ZBRFXRBCSA-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.
Estradiol is a steroid hormone present naturally in the human body. The availability of this hormone is quintessential in older women as it is a determinant of menopausal syndromes. It is utilized for the prevention of cardiovascular diseases.

Application

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

Biochem/physiol Actions

The major estrogen secreted by the premenopausal ovary. Estrogens direct the development of the female phenotype in embryogenesis and during puberty by regulating gene transcription and, thus, protein synthesis. It also induces the production of gonadotropins which, in turn, induce ovulation. Exposure to estradiol increases breast cancer incidence and proliferation.

Analysis Note

These secondary standards offer multi-traceability to the USP, EP (PhEur) 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 LRAC3704 in the slot below. This is an example certificate only and may not be the lot that you receive.

Pictograms

Health hazard

Signal Word

Danger

Hazard Statements

Precautionary Statements

Hazard Classifications

Carc. 2 - Lact. - Repr. 1A

Storage Class Code

6.1D - Non-combustible, acute toxic Cat.3 / toxic hazardous materials or hazardous materials causing chronic effects

WGK

WGK 3

Flash Point(F)

Not applicable

Flash Point(C)

Not applicable

Certificate of Analysis

Certificate of Origin

High-efficiency liquid chromatography in pharmaceutical analysis
Bailey F. and Brittain PN
Journal of Chromatography A, 83(3), 431-437 (1973)
Prediction of internal standards in reversed-phase liquid chromatography: II. Selectivity optimization and internal standard prediction for the quantitation of estradiol and levonorgestrel in a transdermal drug delivery formulation based on the linear solvation energy relationships
Li, J and Shah DS
Journal of Chromatography A, 954(1), 159-171 (2002)
HPLC determination of estradiol, its degradation product, and preservatives in new topical formulation Estrogel HBF.
Novakova L, et al.
Analytical and Bioanalytical Chemistry, 379(5-6), 781-787 (2004)
Marie Mi Bonde et al.
Nucleic acids research, 42(20), 12847-12860 (2014-10-30)
Splicing reactions generally combine high speed with accuracy. However, some of the pre-mRNAs escape the nucleus with a retained intron. Intron retention can control gene expression and increase proteome diversity. We calculated the escape rate for the yeast PTC7 intron...
Advantages of application of UPLC in pharmaceutical analysis.
Novakova L, et al.
Talanta, 68(3), 908-918 (2006)

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Separation of Estriol 3-(β-D-glucuronide) sodium salt; β-Estradiol 3-(β-D-glucuronide) 17-sulfate dipotassium salt; Estriol 3-sulfate sodium salt; β-Estradiol 3,17-disulfate dipotassium salt, ≥95%; β-Estradiol 17-(β-D-glucuronide) sodium salt; β-Estradiol 3-(β-D-glucuronide) sodium salt; Estrone 3-(β-D-glucuronide) sodium salt; β-Estradiol 3-sulfate sodium salt, ≥93%; Estriol, ≥97%; Estrone 3-sulfate sodium salt, contains ~35% Tris as stabilizer; β-Estradiol, ≥98%; α-Estradiol, powder, ≥98% (TLC); Estrone, ≥99%

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