Tibolone

CAS number: 5630-53-5

Molecular formula: C21H28O2

molecular weight: 312.446 g/mol

Chemical structure:

Sr No.TestSpecificationsResult
1DescriptionWhite to almost white crystalline powder or CrystalsA almost White Crystalline Powder.
2SolubilityPractically insoluble in water, soluble in Acetone & In   Methanol.Practically insoluble in water, soluble in Acetone & In   Methanol.
3Identification

a) By IR absorptionInfrared absorption spectrum should be Concordant with working   standard.Complies
4Specific Optical rotation+100 to + 106 (Dried Substance)+103
5Related substances (By HPLC)
Impurity ANMT 0.1 %Not Detected
Impurity BNMT 0.4 %0.22%
Impurity CNMT 0.5 %0.04%
Impurity DNMT 0.2 %Not Detected
Impurity E
NMT 0.1 %Not Detected
Unspecified ImpuritiesNMT 0.10 %0.05%
Total ImpuritiesNMT 1.0 %0.31%
6Loss of DryingNot more than 0.5%0.24%
7Sulphated AshNot more than 0.1%0.02%
8Assay99.0% - 101.0% (dried substnace)99.37%