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

Properties

• 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

Description

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.

Safety Information

• Pictograms: GHS07
• Signal Word: Warning
• Hazard Statements: H319
• Precautionary Statements: P264 - P280 - P305 + P351 + P338 - P337 + P313
• Hazard Classifications: Eye Irrit. 2
• Storage Class Code: 11 - Combustible Solids
• WGK: WGK 3
• Flash Point(F): Not applicable
• Flash Point(C): Not applicable