Description

Oxandrolone Related Compound B Ciii (20 Mg) (17 β-Hydroxy-17 α-Methyl-4-Oxa-5 α-Androsta-3-One) is a high-purity analytical reference standard, specifically identified as a related compound of the anabolic steroid Oxandrolone. This compound is critical for pharmaceutical research and development, serving as a key marker for impurity profiling and method validation in quality control laboratories. It is essential for scientists and QC professionals in the pharmaceutical and analytical chemistry sectors who require reliable reference materials to ensure product safety, efficacy, and regulatory compliance.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference standard for the identification and quantification of specified impurities in Oxandrolone Active Pharmaceutical Ingredient (API) and finished drug products.
• Analytical Method Development and Validation (HPLC/GC): Serves as a critical component for developing, calibrating, and validating chromatographic methods to ensure accuracy and specificity.
• Quality Control & Assurance (QC/QA): Provides a benchmark for routine quality testing in pharmaceutical manufacturing to monitor batch-to-batch consistency and purity.
• Regulatory Compliance and Submissions: Supports regulatory filings (e.g., for FDA, EMA) by providing definitive proof of impurity characterization and control strategies.
• Research and Development: Utilized in metabolic studies, stability testing, and degradation pathway analysis of steroid-based pharmaceuticals.
• Forensic and Doping Control Analysis: Acts as a reference material in forensic laboratories and anti-doping agencies for the precise detection of anabolic steroid derivatives.

Basic Information

Product Name	Oxandrolone Related Compound B Ciii (20 Mg) (17 β-Hydroxy-17 α-Methyl-4-Oxa-5 α-Androsta-3-One)
CAS No.	4424-45-7
Molecular Formula	C20H30O3
Molecular Weight	318.45 g/mol
Synonyms	17β-Hydroxy-17α-methyl-4-oxa-5α-androstan-3-one; 17-Methyl-4-oxa-5α-androstane-3,17β-diol-3-one; Oxandrolone Impurity B; Oxandrolone Related Substance B; 4-Oxa-5α-androstane-3,17-dione, 17-methyl-; 17α-Methyl-17β-hydroxy-4-oxa-5α-androstan-3-one; Anavar Related Compound B; (5α)-17-Hydroxy-17-methyl-4-oxaandrostan-3-one
EINECS	Contact for details

Quality Control

Every batch of Oxandrolone Related Compound B Ciii is manufactured and analyzed under strict quality management systems. The product undergoes rigorous testing to ensure it meets high-purity standards suitable for use as an analytical reference material. A comprehensive Certificate of Analysis (COA) is provided with each unit, detailing results for identity, purity, and related substances as determined by validated methods like HPLC and IR spectroscopy. Our quality commitment aligns with the expectations of GMP/GLP environments and supports global regulatory requirements.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This product is hygroscopic (moisture-sensitive); ensure the container is sealed immediately after use to prevent degradation from atmospheric humidity. For long-term stability, consider storage under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white 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% Any single unknown impurity ≤ 0.5%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%

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