Description

3α-Hydroxy Tibolone is a key pharmaceutical intermediate and active metabolite of the synthetic steroid Tibolone. This compound is of significant commercial importance in the development and production of advanced hormone replacement therapies (HRT). It is primarily required by pharmaceutical manufacturers and research institutions focused on women's health, osteoporosis treatment, and metabolic regulation. Our supply ensures high purity and consistency, critical for meeting stringent regulatory standards in drug formulation.

Application

• Pharmaceutical Intermediate: A critical building block in the synthesis of the active pharmaceutical ingredient (API) Tibolone.
• Hormone Replacement Therapy (HRT): Used in research and production of medications for managing menopausal and post-menopausal symptoms.
• Osteoporosis Treatment: Serves as a key component in developing drugs aimed at preventing bone loss.
• Metabolic Disorder Research: Employed in preclinical and clinical studies investigating effects on lipid metabolism and tissue selectivity.
• Reference Standard: Used as a high-purity analytical standard in quality control laboratories for HPLC, LC-MS, and other chromatographic methods.
• Active Metabolite Studies: Essential for pharmacokinetic and pharmacodynamic research to understand the in vivo activity of Tibolone.

Basic Information

Product Name	3α-Hydroxy Tibolone
CAS No.	100239-44-9
Molecular Formula	C21H28O2
Molecular Weight	312.45 g/mol
Synonyms	7α,17α-17-Hydroxy-7-methyl-19-norpregn-5(10)-en-20-yn-3-one; Org-4094; δ4-3α-OH-Tibolone; 3α-Hydroxy-7α-methyl-19-nor-17α-pregn-5(10)-en-20-yn-17-ol; Tibolone 3α-Hydroxy Metabolite; Livial Metabolite (3α-OH); 3α-OH Tibolone
EINECS	Contact for details

Quality Control

Our 3α-Hydroxy Tibolone is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC for purity and identity confirmation (IR, NMR), to ensure it meets the high standards required for pharmaceutical development. Certificates of Analysis (COA) are provided with each shipment, detailing all specified parameters. We support compliance with cGMP, ICH Q7 guidelines, and relevant pharmacopeial standards.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). The product is light-sensitive and should be handled under appropriate conditions to maintain stability.

Specification

Item	Specification
Appearance	White to off-white crystalline powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Assay (HPLC)	≥98.0%
Related Substances (HPLC)	Total impurities ≤2.0%
Single Unknown Impurity	≤0.5%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Loss on Drying	≤0.5%

Note: Specifications can be tailored. Please contact us for the detailed technical data sheet of a specific grade.