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Merck

Y0000668

Tibolone for system suitability

European Pharmacopoeia (EP) Reference Standard

Synonym(s):

Tibolone, (7α,17α)-17-Hydroxy-7-methyl-19-norpregn-5(10)-en-20-yn-3-one

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About This Item

Empirical Formula (Hill Notation):
C21H28O2
CAS Number:
5630-53-5
Molecular Weight:
312.45
UNSPSC Code:
41116107
NACRES:
NA.24

Key Documents

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Product Name

Tibolone for system suitability, European Pharmacopoeia (EP) Reference Standard

SMILES string

O[C@@]1([C@@]2([C@H]([C@H]3[C@H](CC2)C4=C(C[C@H]3C)CC(=O)CC4)CC1)C)C#C

InChI

1S/C21H28O2/c1-4-21(23)10-8-18-19-13(2)11-14-12-15(22)5-6-16(14)17(19)7-9-20(18,21)3/h1,13,17-19,23H,5-12H2,2-3H3/t13-,17-,18+,19-,20+,21+/m1/s1

InChI key

WZDGZWOAQTVYBX-XOINTXKNSA-N

grade

pharmaceutical primary standard

API family

tibolone

manufacturer/tradename

EDQM

drug control

regulated under CDSA - not available from Sigma-Aldrich Canada

mp

165-169 °C

application(s)

pharmaceutical (small molecule)

format

neat

storage temp.

2-8°C

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Application

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

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.
Tibolone is a synthetic steroid with weak estrogenic, androgenic, and progestogenic activity used in the treatment of menopausal syndrome. Tibolone and its metabolites induce prolactin production in human endometrial stromal cells in vitro. Sulfation plays a major role in the metabolism and regulation of the tissue-specific activity of tibolone and its metabolites.

Other Notes

Sales restrictions may apply.

Packaging

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

pictograms

Exclamation mark
GHS07

signalword

Warning

hcodes

H319

Hazard Classifications

Eye Irrit. 2

Storage Class

11 - Combustible Solids

wgk

WGK 3

flash_point_f

Not applicable

flash_point_c

Not applicable

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Certificates of Analysis (COA)

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Mariana Hulchiy et al.
Menopause (New York, N.Y.), 19(11), 1253-1259 (2012-06-21)
Thyroid gland dysfunction is associated with menstrual cycle disturbances, infertility, and increased risk of miscarriage, but the mechanisms are poorly understood. However, little is known about the regulation of these receptors in the uterus. The aim of this study was
C Zografou et al.
Clinical and experimental obstetrics & gynecology, 39(3), 337-340 (2012-11-20)
The aim of the present study was to evaluate the effects of tibolone on inter-cellular adhesion molecule-1 (ICAM-1), vascular cell adhesion molecule-1 (VCAM-1), inter-cellular adhesion molecule-2 (ICAM-2) and P-selectin levels in healthy postmenopausal women. This prospective study included 25 postmenopausal
Ana Raquel Santos de Medeiros et al.
Regulatory peptides, 179(1-3), 55-60 (2012-09-15)
Cardiovascular and immune system abnormalities have been reported in females with estrogen deficiency. To control these disorders in post-menopausal women, hormone replacement therapy (HRT) has been used. Tibolone has been used as a HRT, but the effects of tibolone on
Ana Carolina Bergmann de Carvalho et al.
Acta cirurgica brasileira, 27(3), 217-222 (2012-03-31)
To verify the effects of tibolone administration on trabecular and cortical bone of ovariectomized female rats by computed radiography system (CRS). The experiment was performed on two groups of rats previously ovariectomized, one received tibolone (OVX+T) while the other did
N Köşüş et al.
Journal of obstetrics and gynaecology : the journal of the Institute of Obstetrics and Gynaecology, 32(3), 294-297 (2012-03-01)
The aim of this study was to examine the hearing levels of menopausal and premenopausal women of the same age and to evaluate the effect of tibolone on hearing. The study involved 83 postmenopausal women. Cases using tibolone were grouped
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