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Key Documents

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

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

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

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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.
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.

Application

Tibolone 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

Exclamation mark
GHS07

Signal Word

Warning

Hazard Statements

H319

Hazard Classifications

Eye 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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Certificates of Analysis (COA)

Lot/Batch Number

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I Lambrinoudaki et al.
Climacteric : the journal of the International Menopause Society, 16(2), 258-264 (2012-05-31)
To investigate the effect of tibolone and raloxifene on the serum apoptotic markers soluble Fas (sFas), soluble Fas ligand (sFasL) and cytochrome-c (cyt-c) in postmenopausal women. A total of 89 healthy postmenopausal women, attending the University Menopause Clinic, were randomly
Sarah Sæther et al.
Tidsskrift for den Norske laegeforening : tidsskrift for praktisk medicin, ny raekke, 132(11), 1330-1334 (2012-06-22)
The Norwegian "Women and cancer" study has shown that when combination hormone replacement products were used for more than five years the relative risk of breast cancer was almost tripled. The population attributable risk was 27 %. In a nested
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
James Samuel McLaren et al.
Menopause international, 18(2), 68-72 (2012-05-23)
Gonadotrophin receptor hormone analogues (GnRHa) have been used in a range of sex hormone-dependent disorders. In the management of premenstrual syndrome, they can completely abolish symptoms. The success of GnRHa in the treatment of endometriosis and adjuvant therapy in the
Ulviye Ceylan et al.
Neuro endocrinology letters, 33(5), 505-510 (2012-10-24)
To compare the effect exerted by oral tibolone or intramuscular 17β-estradiol administration on the expression of ZO-1, occludin, GFAP and c-fos levels in the brain cortex and hippocampus of ovariectomized rats. Immunostaining for ZO-1 and occludin revealed similar staining patterns
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