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Key Documents

PHR1142

Supelco

Progesterone

Pharmaceutical Secondary Standard; Certified Reference Material

Synonym(s):

4-Pregnene-3,20-dione

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About This Item

Empirical Formula (Hill Notation):
C21H30O2
CAS Number:
Molecular Weight:
314.46
Beilstein:
1915950
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 449
traceable to Ph. Eur. P3300000
traceable to USP 1568007

API family

progesterone

CofA

current certificate can be downloaded

technique(s)

HPLC: suitable
gas chromatography (GC): suitable

mp

128-132 °C (lit.)

application(s)

pharmaceutical (small molecule)

format

neat

storage temp.

2-30°C

SMILES string

CC(=O)[C@H]1CC[C@H]2[C@@H]3CCC4=CC(=O)CC[C@]4(C)[C@H]3CC[C@]12C

InChI

1S/C21H30O2/c1-13(22)17-6-7-18-16-5-4-14-12-15(23)8-10-20(14,2)19(16)9-11-21(17,18)3/h12,16-19H,4-11H2,1-3H3/t16-,17+,18-,19-,20-,21+/m0/s1

InChI key

RJKFOVLPORLFTN-LEKSSAKUSA-N

Gene Information

human ... PGR(5241)

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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

Progesterone may be used as a pharmaceutical reference standard for the determination of the analyte in pharmaceuticals and environmental samples by liquid chromatography (LC) and gas chromatography/mass spectrometry (GC/MS), liquid chromatography/mass spectrometry (LC/MS) and liquid chromatography/tandem mass spectrometry (LC/MS/MS), respectively.
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

Induces maturation and secretory activity of the uterine endothelium; suppresses ovulation. Progesterone is implicated in the etiology of breast cancer.

Other Notes

Steroid hormone produced by the corpus luteum.
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.
Values of analytes vary lot to lot.

Analysis Note

These secondary standards offer multi-traceability to the USP, EP (PhEur) and BP primary standards, where they are available.

Footnote

To see an example of a Certificate of Analysis for this material enter LRAA7142 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

Hazard Classifications

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


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Determination of anabolic steroids in pharmaceuticals by liquid chromatography with a microemulsion of sodium dodecyl sulfate and pentanol as mobile phase.
Cartas ST, et al.
Analytica Chimica Acta, 302(2-3), 163-172 (1995)
Determination of estrogens and progestogens by mass spectrometric techniques (GC/MS, LC/MS and LC/MS/MS).
Diaz?Cruz MS, et al.
Journal of Mass Spectrometry : Jms, 38(9), 917-923 (2003)
Danijela Konforte et al.
Clinical chemistry, 59(8), 1215-1227 (2013-05-03)
Pediatric endocrinopathies are commonly diagnosed and monitored by measuring hormones of the hypothalamic-pituitary-gonadal axis. Because growth and development can markedly influence normal circulating concentrations of fertility hormones, accurate reference intervals established on the basis of a healthy, nonhospitalized pediatric population
Rudolf Kaaks et al.
International journal of cancer, 134(8), 1947-1957 (2013-10-25)
Results from prospective studies on premenopausal serum hormone levels in relation to breast cancer risk have been inconclusive, especially with regard to tumor subtypes. Using a case-control study nested within the prospective European Prospective Investigation into Cancer and Nutrition (EPIC)
Rudolf Kaaks et al.
Journal of the National Cancer Institute, 97(10), 755-765 (2005-05-19)
Contrasting etiologic hypotheses about the role of endogenous sex steroids in breast cancer development among premenopausal women implicate ovarian androgen excess and progesterone deficiency, estrogen excess, estrogen and progesterone excess, and both an excess or lack of adrenal androgens (dehydroepiandrosterone

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