Description

n-Monodesmethyl Promethazine is a key pharmaceutical intermediate and metabolite of the antihistamine promethazine. This compound is of significant value in research and development for the synthesis of active pharmaceutical ingredients (APIs) and for analytical reference standards in pharmacokinetic studies. It is primarily required by pharmaceutical manufacturers, contract research organizations (CROs), and analytical laboratories engaged in drug development, quality control, and metabolic pathway investigation.

Application

• Pharmaceutical Intermediate: Critical building block in the synthesis of promethazine and related phenothiazine-derived active pharmaceutical ingredients (APIs).
• Reference Standard: Used as a certified reference material (CRM) in analytical laboratories for method development, validation, and quality control testing of pharmaceutical products.
• Metabolite Studies: Essential for pharmacokinetic and pharmacodynamic research to understand the metabolism, bioavailability, and excretion profile of promethazine.
• Impurity Profiling: Serves as a known impurity standard to monitor and control the quality of promethazine drug substances and finished dosage forms according to ICH guidelines.
• Biomedical Research: Utilized in preclinical and clinical studies to investigate the pharmacological activity and safety profile of promethazine metabolites.

Basic Information

Product Name	n-Monodesmethyl Promethazine
CAS No.	37707-23-6
Molecular Formula	C₁₇H₂₀N₂S
Molecular Weight	284.42 g/mol
Synonyms	10H-Phenothiazine-10-ethanamine, N,N,α-trimethyl-; Desmethylpromethazine; Norpromethazine; Promethazine Desmethyl Metabolite; Promethazine Monodesmethyl; 1-Methyl-2-(10H-phenothiazin-10-yl)propylamine; N-Desmethylpromethazine
EINECS	Contact for details

Quality Control

Our n-Monodesmethyl Promethazine is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including identification, purity assay, and impurity profiling via advanced techniques like HPLC and GC. We provide full traceability and Certificates of Analysis (COA) are available for all shipments, ensuring compliance with relevant pharmacopeial and ICH standards for impurities and residual solvents.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). The material is light-sensitive and should be handled under appropriate conditions to maintain stability.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	≥98.0%
Related Substances (HPLC)	Total impurities ≤2.0% Any single impurity ≤0.5%
Residual Solvents (GC)	Complies with ICH Q3C
Loss on Drying	≤0.5%

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