Description

Pholcodine-n-Oxide is a key pharmaceutical intermediate and a significant metabolite of the antitussive agent pholcodine. This compound is of critical importance for research and development in the pharmaceutical sector, particularly for metabolic studies, impurity profiling, and the synthesis of reference standards. It is primarily utilized by pharmaceutical manufacturers, analytical laboratories, and research institutions focused on respiratory therapeutics and drug safety evaluation.

Application

• Pharmaceutical Intermediate: Serves as a crucial building block in the synthesis and research of cough suppressant medications.
• Metabolite Reference Standard: Used as an analytical standard in pharmacokinetic and metabolism studies of pholcodine.
• Impurity Profiling: Essential for the identification and quantification of related substances in pholcodine Active Pharmaceutical Ingredient (API) to ensure product purity and safety.
• Biomedical Research: Employed in in vitro and in vivo studies to understand the pharmacological and toxicological profile of pholcodine derivatives.
• Quality Control: Acts as a certified reference material (CRM) in analytical laboratories for method development and validation.
• Regulatory Submissions: Provides necessary data and reference compounds for drug registration dossiers submitted to agencies like the FDA and EMA.

Basic Information

Product Name	Pholcodine-n-Oxide
CAS No.	433308-89-5
Molecular Formula	C23H30N2O4
Molecular Weight	398.50 g/mol
Synonyms	Pholcodine N-Oxide; Morphinan-6-ol, 7,8-didehydro-4,5-epoxy-17-methyl-3-(2-morpholinoethoxy)-, 17-oxide; Pholcodine N-Oxide (Major Metabolite); 3-(2-Morpholin-4-ylethoxy)-17-methyl-17-oxidomorphinan-6-ol
EINECS	Contact for details

Quality Control

Our Pholcodine-n-Oxide is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC for purity, identity confirmation by IR and MS, and residual solvent analysis, to ensure it meets the stringent requirements for pharmaceutical research and development. Certificates of Analysis (COA) with detailed chromatograms 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). The product is light-sensitive and should be handled accordingly to maintain stability.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single impurity ≤ 0.5%
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.