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Key Documents

Y0000668

Tibolone for system suitability

European Pharmacopoeia (EP) Reference Standard

Sinónimos:

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

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About This Item

Fórmula empírica (notación de Hill):
C21H28O2
Número de CAS:
5630-53-5
Peso molecular:
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

signalword

Warning

hcodes

H319

Hazard Classifications

Eye Irrit. 2

Storage Class

11 - Combustible Solids

wgk_germany

WGK 3

flash_point_f

Not applicable

flash_point_c

Not applicable

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Certificados de análisis (COA)

Lot/Batch Number

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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
John Studd
Menopause international, 18(2), 65-67 (2012-05-23)
The understanding of the cause and treatment of premenstrual disorders is confused but it is essentially the result of cyclical ovarian activity, usually ovulation, and an effective treatment should be by suppressing ovulation. This can be done by an oral
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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