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PHR1714

Supelco

Norethindrone (Norethisterone)

Pharmaceutical Secondary Standard; Certified Reference Material

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Synonym(s):
Norethindrone, 17α-Ethynyl-17β-hydroxy-19-nor-4-androsten-3-one, 17α-Ethynyl-19-nortestosterone, 17-Hydroxy-19-nor-17α-4-pregnen-20-yn-3-one, 19-Nor-17α-ethynyl-4-androsten-17β-ol-3-one, 19-Norethindrone, 19-Norethisterone
Empirical Formula (Hill Notation):
C20H26O2
CAS Number:
68-22-4
Molecular Weight:
298.42
EC Number:
200-681-6
MDL number:
MFCD00067596
UNSPSC Code:
41116107
PubChem Substance ID:
329823570
NACRES:
NA.24

grade

certified reference material
pharmaceutical secondary standard

Quality Level

300

Agency

traceable to BP 266
traceable to Ph. Eur. N1200000
traceable to USP 1469005

API family

norethindrone

CofA

current certificate can be downloaded

packaging

pkg of 1 g

technique(s)

HPLC: suitable
gas chromatography (GC): suitable

application(s)

pharmaceutical (small molecule)

format

neat

storage temp.

2-30°C

InChI

1S/C20H26O2/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/h1,12,15-18,22H,4-11H2,2H3/t15-,16+,17+,18-,19-,20-/m0/s1

InChI key

VIKNJXKGJWUCNN-XGXHKTLJSA-N

Gene Information

human ... PGR(5241)

Related Categories

General description

Norethindrone (Norethisterone) is a progestin medication, widely used to treat gynecological irregularities such as premenstrual syndrome, painful periods, abnormal heavy bleeding, irregular periods, and menopausal syndrome.
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

Dexamethasone may be used as a pharmaceutical reference standard for the quantification of the analyte in pharmaceutical formulations using UV spectrophotometric technique.
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 LRAA7302 in the Documents 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.

Pictograms

Health hazardEnvironment
GHS08,GHS09

Signal Word

Danger

Hazard Statements

H351,H360FD,H362,H410

Hazard Classifications

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

WGK

WGK 3

Flash Point(F)

Not applicable

Flash Point(C)

Not applicable

Regulatory Information

监管及禁止进口产品

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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UV spectrophotometric method for the estimation of norethindrone in immediate release tablet
Bansal K, et al.
International Journal of Pharmaceutical Sciences and Drug Research, 3(2), 127-129 (2011)
Simultaneous determination of norethindrone and ethinyl estradiol in human plasma by high performance liquid chromatography with tandem mass spectrometry?experiences on developing a highly selective method using derivatization reagent for enhancing sensitivity.
Li W, et al.
Journal of Chromatography. B, Biomedical Sciences and Applications, 825(2), 223-232 (2005)

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