Description

3Beta-Hydroxytibolone is a key pharmaceutical intermediate and reference standard of significant importance in the development and quality control of steroidal drugs. This compound is valued for its role as a precursor and analytical marker in the synthesis of advanced therapeutic agents. It is primarily utilized by research institutions and manufacturers in the pharmaceutical and biotechnology sectors for drug development, process optimization, and analytical validation.

Application

• Pharmaceutical Intermediate: A critical building block in the synthesis of novel steroidal pharmaceuticals and active pharmaceutical ingredients (APIs).
• Reference Standard: Used for analytical method development, validation, and quality control (QC) testing in pharmaceutical laboratories.
• Research & Development: Serves as a key compound in preclinical and clinical research for studying metabolic pathways and biological activity.
• Metabolite Studies: Employed in pharmacokinetic and pharmacodynamic research to understand the metabolism of related steroidal compounds.
• Impurity Profiling: Acts as a known impurity or degradation product standard for ensuring the purity and stability of final drug products.
• Academic Research: Utilized in university and institutional labs for chemical and biochemical studies related to steroid chemistry.

Basic Information

Product Name	3Beta-Hydroxytibolone
CAS No.	100239-45-0
Molecular Formula	C21H28O2
Molecular Weight	312.45 g/mol
Synonyms	7α-Methylnorethynodrel; Tibolone Impurity; 17β-Hydroxy-7α-methyl-19-nor-17α-pregn-5(10)-en-20-yn-3-one; 3β-Hydroxytibolone; 7α-Methyl-19-nor-17α-pregna-5(10)-en-20-yn-3β,17β-diol; Livial Intermediate; Org OD-14 Intermediate
EINECS	Contact for details

Quality Control

Our 3Beta-Hydroxytibolone is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC for purity and identity confirmation via spectroscopic methods, to ensure it meets the high standards required for pharmaceutical research and development. Certificates of Analysis (COA) with detailed chromatographic and spectral data are provided to guarantee traceability and batch-to-batch consistency.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). Keep the container sealed to protect from moisture.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single impurity ≤ 1.0%
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.