Invenza Research

Tibolone (CAS No. 5630-53-5), chemically known as 17-Hydroxy-7α-methyl-19-nor-17α-pregn-5(10)-en-20-yn-3-one; (7R,8R,9S,13S,14S,17R)-17-ethynyl-17-hydroxy-7,13-dimethyl-1,2,4,6,7,8,9,11,12,13,14,15,16,17-tetradecahydro-3H-cyclopenta[a]phenanthren-3-one, is a well-characterized pharmaceutical impurity reference standard associated with Tibolone. It is widely used by pharmaceutical research laboratories, analytical scientists, contract research organizations (CROs), and quality control laboratories to support impurity identification, chromatographic method development, analytical method validation, and stability studies.

This reference standard plays an important role in ensuring accurate impurity profiling during the development and quality assessment of Tibolone-based pharmaceutical products. It is suitable for use in analytical techniques such as HPLC, LC-MS, UPLC, and other validated chromatographic methods where reliable impurity characterization is required.

Tibolone has the molecular formula C21H28O2 and a molecular weight of 312.5 g/mol. It is also known by the chemical name 17-Hydroxy-7α-methyl-19-nor-17α-pregn-5(10)-en-20-yn-3-one; (7R,8R,9S,13S,14S,17R)-17-ethynyl-17-hydroxy-7,13-dimethyl-1,2,4,6,7,8,9,11,12,13,14,15,16,17-tetradecahydro-3H-cyclopenta[a]phenanthren-3-one and is identified by CAS No. 5630-53-5.

Researchers and analytical laboratories utilize this impurity reference standard during pharmaceutical development, quality control testing, method transfer, and regulatory compliance activities. Its use helps support the characterization and monitoring of related substances throughout the product lifecycle.