Description

Propoxyphene Related Compound B (50 Mg) (α-D-2-Acetoxy-4-Dimethylamino-1,2-Diphenyl-3-Methylbutane) is a high-purity analytical reference standard, essential for pharmaceutical research and quality control. This compound is critical for the accurate identification, quantification, and impurity profiling of propoxyphene and its derivatives in drug substances and finished products. It is primarily required by analytical laboratories, pharmaceutical manufacturers, and regulatory bodies engaged in method development, validation, and compliance testing. Supplied as a precisely weighed 50 mg quantity, it ensures reliability and reproducibility in chromatographic and spectroscopic analyses.

Application

• Pharmaceutical Impurity Profiling: Serves as a certified reference material for the identification and quantification of specific impurities and degradation products in propoxyphene active pharmaceutical ingredients (APIs) and formulations.
• Analytical Method Development & Validation: Used as a critical standard to develop, optimize, and validate HPLC, UPLC, GC, or LC-MS/MS methods for potency and purity assays.
• Quality Control & Assurance (QC/QA): Employed in routine quality control testing to ensure batch-to-batch consistency and compliance with pharmacopeial specifications (e.g., USP, EP).
• Stability Studies: Acts as a marker compound in forced degradation and long-term stability studies to monitor the formation of related substances over time.
• Forensic and Clinical Toxicology: Used as a calibration standard in forensic laboratories for the precise analysis of propoxyphene and its metabolites in biological samples.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., with FDA, EMA) to demonstrate analytical control strategies for drug substances.
• Research and Development: Supports chemical and pharmacological R&D for studying the metabolism, pharmacokinetics, and structure-activity relationships of opioid analgesics.

Basic Information

Product Name	Propoxyphene Related Compound B (50 Mg) (α-D-2-Acetoxy-4-Dimethylamino-1,2-Diphenyl-3-Methylbutane)
CAS No.	53990-51-5
Molecular Formula	C23H29NO2
Molecular Weight	351.49 g/mol
Synonyms	α-D-2-Acetoxy-4-dimethylamino-1,2-diphenyl-3-methylbutane; Propoxyphene Impurity B; Dextropropoxyphene Related Compound B; (2S,3R)-4-(Dimethylamino)-3-methyl-1,2-diphenyl-2-butanol acetate; 1,2-Diphenyl-4-dimethylamino-3-methyl-2-butanol acetate; α-d-Acetoxy-4-dimethylamino-1,2-diphenyl-3-methylbutane; NSC 113926
EINECS	Contact for details

Quality Control

This high-grade reference standard is manufactured and controlled under a strict quality management system. Each batch undergoes comprehensive analytical testing, including chromatographic purity assessment and structural confirmation, to ensure identity, potency, and consistency. A detailed Certificate of Analysis (COA) is provided, listing batch-specific results for purity, assay, and related substances. Our quality protocols are designed to support compliance with cGMP and relevant pharmacopeial guidelines for reference standards.

Storage

Preserve in the original tightly closed container, protected from light. Store at controlled room temperature, ideally between 15°C and 25°C (59°F and 77°F). Keep the container in a dry, cool place and ensure proper inventory management to maintain the integrity of the material over time.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Assay	95.0% - 105.0% (on dried basis)
Related Substances (HPLC)	Individual impurity: ≤ 1.0% Total impurities: ≤ 2.0%
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.