Description

Dextromethorphan Impurity A is a critical pharmaceutical reference standard used for the identification, qualification, and quantification of related substances in Dextromethorphan active pharmaceutical ingredient (API) and finished drug products. This compound is essential for ensuring the purity, safety, and efficacy of antitussive medications by enabling precise analytical control. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for research, method development, and rigorous quality control processes.

Application

• Pharmaceutical Impurity Profiling: Serves as a certified reference material for identifying and quantifying this specific impurity in Dextromethorphan API and formulations.
• Analytical Method Development & Validation: Used as a key standard to develop, optimize, and validate HPLC, UPLC, or GC methods for impurity analysis.
• Quality Control & Batch Release Testing: Critical for routine QC testing to ensure drug substance and product compliance with pharmacopeial (USP, EP, BP) and ICH Q3A/B guidelines.
• Stability Studies: Employed to monitor the formation of this impurity over time under various stress conditions (e.g., heat, light, humidity).
• Regulatory Submissions: Provides necessary data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Pharmacopeial Testing: Used for compliance testing against official monographs in USP, European Pharmacopoeia, and other international standards.

Basic Information

Item	Detail
Product Name	Dextromethorphan Impurity A
CAS No.	58496-77-8
Molecular Formula	C18H25NO
Molecular Weight	271.40 g/mol
Synonyms	3-Methoxy-17-methyl-9α,13α,14α-morphinan; Dextrorphan Impurity; (+)-3-Hydroxy-N-methylmorphinan Impurity; 9α,13α,14α-Morphinan-3-ol, 17-methyl-, (9α,13α,14α)-; Dextromethorphan Related Compound A; DM Impurity A
EINECS	Contact for details

Quality Control

Our Dextromethorphan Impurity A is manufactured and handled under strict quality management systems. Each batch is subjected to comprehensive analytical testing, including HPLC purity assay, identity confirmation (IR, NMR), and residual solvent analysis, to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results and confirming compliance with relevant specifications.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or COA. The material is hygroscopic (moisture-sensitive); keep the container tightly sealed in a dry environment.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual impurity ≤ 1.0%
Water Content (KF)	≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C

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