Tibolone EP Impurity A(10-β-Hydroxy 4-Tibolone) CAS 105186-35-4

Purity >95%In StockPharmacopoeial Impurity Standards
CAS No.105186-35-4
Molecular FormulaC21H28O3
Molecular Weight328.45 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Tibolone EP Impurity A(10-β-Hydroxy 4-Tibolone) CAS 105186-35-4 chemical structure

Description

This reference standard supports related-substances testing and method development in line with ICH Q3A/Q3B guidance on impurity control, and is suitable for system suitability testing and forced-degradation studies.

Tibolone EP Impurity A(10-β-Hydroxy 4-Tibolone) (CAS 105186-35-4) is a certified pharmaceutical impurity reference standard with the molecular formula C21H28O3 and a molecular weight of 328.45 g/mol.

Based on its molecular formula C21H28O3, Tibolone EP Impurity A(10-β-Hydroxy 4-Tibolone) contains a steroid core, a hydroxyl group, an ether linkage; these features give the compound characteristic absorption bands in UV spectroscopy. The molecular weight of 328.45 g/mol is directly relevant to the identification of the molecular ion in mass spectrometry. The aromatic system may exhibit native fluorescence, enabling detection with a fluorescence detector (FLD).

CATO manufactures Tibolone EP Impurity A(10-β-Hydroxy 4-Tibolone) under ISO 17034:2016 accreditation with dual CNAS and ANAB accreditation. Each batch is characterized by orthogonal methods and supplied with a full Certificate of Analysis (COA), ensuring metrological traceability.

Physical & Chemical Properties

Molecular FormulaC21H28O3
Molecular Weight328.45 g/mol
AppearancePale yellow to yellow crystalline powder
Purity>95%
StorageStore at 2-8°C, protect from light, keep sealed and dry
Solubility (reference)Soluble in chloroform, dichloromethane, ethyl acetate, DMSO
StabilityMay oxidize slowly on prolonged air exposure; Light-sensitive; avoid direct strong light
Degree of Unsaturation (DBE)8.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
CAS Registry Year (est.)1987

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