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PHR1353

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Estradiol

Pharmaceutical Secondary Standard; Certified Reference Material

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

grade

certified reference material
pharmaceutical secondary standard

Quality Level

Agency

traceable to BP 729
traceable to Ph. Eur. E1620000
traceable to USP 1250008

API family

estradiol

CofA

current certificate can be downloaded

technique(s)

HPLC: suitable
gas chromatography (GC): suitable

mp

176-180 °C (lit.)

application(s)

pharmaceutical (small molecule)

format

neat

storage temp.

2-30°C

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

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.

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.

Recommended products

Find a digital Reference Material for this product available on our online platform ChemisTwin® for NMR. You can use this digital equivalent on ChemisTwin® for your sample identity confirmation and compound quantification (with digital external standard). An NMR spectrum of this substance can be viewed and an online comparison against your sample can be performed with a few mouseclicks. Learn more here and start your free trial.

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Description
Pricing

Pictograms

Health hazardEnvironment

Signal Word

Danger

Hazard Classifications

Aquatic Acute 1 - Aquatic Chronic 1 - Carc. 2 - Lact. - Repr. 1A

Storage Class Code

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

Regulatory Information

监管及禁止进口产品

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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)
Advantages of application of UPLC in pharmaceutical analysis.
Novakova L, et al.
Talanta, 68(3), 908-918 (2006)
Amit Cohen et al.
Zebrafish, 11(5), 462-478 (2013-06-19)
Estrogen is a steroid hormone that has been implicated in a variety of cellular and physiological processes and in the development of diseases such as cancer. Here we show a remarkable widespread microRNA (miRNA) downregulation in the zebrafish (Danio rerio)

Articles

This study assesses the suitability of ultrapure water from a Milli-Q® water system for sensitive LC-MS analyses of hormones.

Milli-Q® ultrapure water systems deliver water free of organic contaminants , including hormones present in a lab's tap water, making it suitable for the most sensitive LC-MS/MS analyses.

Our team of scientists has experience in all areas of research including Life Science, Material Science, Chemical Synthesis, Chromatography, Analytical and many others.

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