Description

Oxandrolone Usp Impurity B CAS NO 142793-21-3 is a specified impurity of the anabolic steroid Oxandrolone, as defined by the United States Pharmacopeia (USP) monographs. This high-purity reference standard is critical for pharmaceutical quality control and analytical method development, ensuring the safety and efficacy of the final drug product. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for research, method validation, and compliance testing.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Oxandrolone Usp Impurity B in active pharmaceutical ingredients (APIs) and finished drug products.
• Analytical Method Development & Validation: Essential for developing, optimizing, and validating chromatographic methods, such as HPLC and UPLC, to monitor impurities in Oxandrolone batches.
• Quality Control & Assurance (QC/QA): Serves as a system suitability standard and for routine impurity profiling in pharmaceutical manufacturing to ensure compliance with USP, ICH Q3A/B, and other regulatory guidelines.
• Stability Studies: Employed to track the formation of this specific degradation product under various stress conditions (e.g., heat, light, humidity) during drug stability testing.
• Regulatory Submissions: Provides necessary data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Research & Development: Used in metabolic studies, pharmacokinetic research, and to understand the degradation pathways of Oxandrolone.

Basic Information

Product Name	Oxandrolone Usp Impurity B
CAS No.	142793-21-3
Molecular Formula	C19H30O3
Molecular Weight	306.44 g/mol
Synonyms	17β-Hydroxy-17α-methyl-2-oxa-5α-androstan-3-one Impurity B; 2-Oxa-5α-androstane-3,17-dione, 17-methyl-; Oxandrolone Related Compound B; USP Oxandrolone Impurity B; 17-Methyl-2-oxa-5α-androstane-3,17β-diol-3-one; 17α-Methyl-17β-hydroxy-2-oxa-5α-androstan-3-one Impurity; Anavar Impurity B
EINECS	Contact for details

Quality Control

Every batch of Oxandrolone Usp Impurity B is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing to ensure compliance with United States Pharmacopeia (USP) standards and ICH Q3A/B guidelines. A comprehensive Certificate of Analysis (COA) detailing batch-specific results from advanced analytical techniques (HPLC, GC-MS, NMR) is provided with each shipment.

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 compound is hygroscopic (moisture-sensitive); therefore, the container must be kept tightly sealed in a dry environment to prevent degradation. For long-term storage, consider storing 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)	Individual impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 1.0%

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