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Merck
CN

PHR1535

Estrone

Pharmaceutical Secondary Standard; Certified Reference Material

Synonym(s):

Estrone, 1,3,5(10)-Estratrien-3-ol-17-one, 3-Hydroxy-1,3,5(10)-estratrien-17-one, Folliculin

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About This Item

Empirical Formula (Hill Notation):
C18H22O2
CAS Number:
53-16-7
Molecular Weight:
270.37
UNSPSC Code:
41116107
NACRES:
NA.24
PubChem Substance ID:
329823447
EC Number:
200-164-5
Beilstein/REAXYS Number:
1915077
MDL number:
MFCD00003620

Key Documents

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Product Name

Estrone, Pharmaceutical Secondary Standard; Certified Reference Material

InChI key

DNXHEGUUPJUMQT-CBZIJGRNSA-N

InChI

1S/C18H22O2/c1-18-9-8-14-13-5-3-12(19)10-11(13)2-4-15(14)16(18)6-7-17(18)20/h3,5,10,14-16,19H,2,4,6-9H2,1H3/t14-,15-,16+,18+/m1/s1

SMILES string

C[C@]12CC[C@H]3[C@@H](CCc4cc(O)ccc34)[C@@H]1CCC2=O

grade

certified reference material
pharmaceutical secondary standard

agency

USP 1255001
traceable to Ph. Eur. E1700000

API family

estrone

CofA

current certificate can be downloaded

technique(s)

HPLC: suitable
gas chromatography (GC): suitable

mp

258-260 °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

Estrone 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.
Estrone is a degradation product of the endogenous estrogen steroid, estradiol.

Other Notes

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.
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 LRAC3933 in the slot below. This is an example certificate only and may not be the lot that you receive.

pictograms

Health hazard
GHS08

signalword

Danger

Hazard Classifications

Carc. 2 - Lact. - 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

Regulatory Information

涉药品监管产品
This item has

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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Separation and quantitation of esterified estrogens in bulk mixtures and combination drug preparations using high-performance liquid chromatography.
Capitano G., and Tscherne R
Journal of Pharmaceutical Sciences, 68(3), 311-314 (1979)
Lucie Havlíková et al.
Journal of chromatography. A, 1119(1-2), 216-223 (2006-02-10)
A novel HPLC method for simultaneous determination of estradiol and its seven degradation products in topical gel was developed. Zorbax SB-CN (150 mm x 4.6 mm, 5 microm) analytical column and mobile phase composed of acetonitrile, phosphoric acid 0.085%, and
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)
Shanshan Zhao et al.
Breast cancer research : BCR, 16(2), R30-R30 (2014-03-29)
Paradoxically, a breast cancer risk reduction with conjugated equine estrogens (CEE) and a risk elevation with CEE plus medroxyprogesterone acetate (CEE + MPA) were observed in the Women's Health Initiative (WHI) randomized controlled trials. The effects of hormone therapy on serum sex
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