PHR2814

Tibolone

certified reference material, pharmaceutical secondary 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: certified reference material; pharmaceutical secondary standard
• Quality Level: 300
• Agency: traceable to BP; traceable to Ph. Eur.
• API family: tibolone
• packaging: pkg of 200 mg
• mp: 165-169 °C
• application(s): pharmaceutical
• 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

Pharmaceutical secondary standards for application in quality control provide pharma laboratories and manufacturers with a convenient and cost-effective alternative to the preparation of in-house working standards

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

These Secondary Standards are qualified as Certified Reference Materials. These are suitable for use in several analytical applications including but not limited to pharma release testing, pharma method development for qualitative and quantitative analyses, food and beverage quality control testing, and other calibration requirements.

Analysis Note

These secondary standards offer multi-traceability to the USP, EP and BP primary standards, where they are available.

Other Notes

This Certified Reference Material (CRM) is produced and certified in accordance with ISO 17034 and ISO/IEC 17025. All information regarding the use of this CRM can be found on the certificate of analysis.

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