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Key Documents

Y0000725

Norgestimate for system suitability

European Pharmacopoeia (EP) Reference Standard

Synonym(s):

Norgestimate, (17α)-17-(Acetyloxy)-13-ethyl-18,19-dinorpregn-4-en-20-yn-3-one 3-oxime, Dexnorgestrel acetime

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About This Item

Empirical Formula (Hill Notation):
C23H31NO3
CAS Number:
Molecular Weight:
369.50
Beilstein:
6440219
UNSPSC Code:
41116107
NACRES:
NA.24

grade

pharmaceutical primary standard

API family

norgestimate

manufacturer/tradename

EDQM

application(s)

pharmaceutical (small molecule)

format

neat

storage temp.

2-8°C

SMILES string

CC[C@]12CC[C@H]3[C@@H](CCC4=C\C(CC[C@H]34)=N/O)[C@@H]1CC[C@@]2(OC(C)=O)C#C

InChI

1S/C23H31NO3/c1-4-22-12-10-19-18-9-7-17(24-26)14-16(18)6-8-20(19)21(22)11-13-23(22,5-2)27-15(3)25/h2,14,18-21,26H,4,6-13H2,1,3H3/b24-17+/t18-,19+,20+,21-,22-,23-/m0/s1

InChI key

KIQQMECNKUGGKA-NMYWJIRASA-N

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General description

This product is provided as delivered and specified by the issuing Pharmacopoeia. All information provided in support of this product, including SDS and any product information leaflets have been developed and issued under the Authority of the issuing Pharmacopoeia.For further information and support please go to the website of the issuing Pharmacopoeia.

Application

Norgestimate for system suitability EP Reference standard, intended for use in laboratory tests only as specifically prescribed in the European Pharmacopoeia.

Packaging

The product is delivered as supplied by the issuing Pharmacopoeia. For the current unit quantity, please visit the EDQM reference substance catalogue.

Other Notes

Sales restrictions may apply.

Pictograms

Health hazardExclamation mark

Signal Word

Warning

Hazard Statements

Hazard Classifications

Acute Tox. 4 Oral - Eye Irrit. 2 - Repr. 2 - Skin Irrit. 2

Storage Class Code

11 - Combustible Solids

WGK

WGK 3

Flash Point(F)

Not applicable

Flash Point(C)

Not applicable


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Monique P Curran et al.
Treatments in endocrinology, 1(2), 127-129 (2005-03-16)
The focus of this review is hormone replacement therapy (HRT) with continuous administration of micronized, oral 17beta-estradiol 1 mg/day (herein referred to as continuous estradiol) plus micronized, oral norgestimate 90 microg/day administered for 3 days then withdrawn for 3 days
Norgestimate: overview of a monophasic formulation.
F D Anderson et al.
International journal of fertility and menopausal studies, 38 Suppl 3, 126-132 (1993-01-01)
Norgestimate: a preclinical profile.
F D Anderson
International journal of fertility, 37 Suppl 1, 27-35 (1992-01-01)
S L Corson
American journal of obstetrics and gynecology, 170(5 Pt 2), 1556-1561 (1994-05-01)
Both monophasic and triphasic formulations of ethinyl estradiol plus norgestimate, a progestin with marked progesterone-receptor affinity and minimal androgen-receptor affinity, have been evaluated in numerous clinical studies designed to determine if norgestimate's receptor-binding profile provides enhanced safety without a reduction
J L McGuire et al.
American journal of obstetrics and gynecology, 163(6 Pt 2), 2127-2131 (1990-12-01)
Biotransformation, pharmacologic, and pharmacokinetic studies of norgestimate and its metabolites indicate that 17-deacetyl norgestimate, along with the parent drug, contributes to the biologic response. The postulated metabolic pathway, which is based on the identification of urinary products had indicated that

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