Description

Promethazine Sulfoxide is a key pharmaceutical intermediate and metabolite of the antihistamine promethazine. This compound is of significant importance in analytical chemistry and pharmaceutical research for method development, impurity profiling, and stability studies. It is primarily utilized by research institutions, quality control laboratories, and pharmaceutical manufacturers engaged in the development and validation of analytical methods for promethazine-based drug products.

Application

• Pharmaceutical Reference Standard: Serves as a certified reference material (CRM) for the identification and quantification of promethazine sulfoxide, a known degradation product, in drug substances and finished products.
• Analytical Method Development: Used as a critical impurity standard to develop and validate stability-indicating HPLC, UPLC, or GC methods for promethazine.
• Pharmacokinetic & Metabolic Studies: Employed in research to study the metabolic pathways, bioavailability, and excretion profiles of promethazine.
• Quality Control & Assurance: Essential for routine quality control testing to monitor impurity levels and ensure drug product stability and shelf-life.
• Regulatory Compliance: Supports regulatory filings (e.g., for FDA, EMA) by providing data on impurity identification and control strategies.

Basic Information

Product Name	Promethazine Sulfoxide
CAS No.	7640-51-9
Molecular Formula	C17H20N2OS
Molecular Weight	300.42 g/mol
Synonyms	Promethazine S-Oxide; 10H-Phenothiazine-10-ethanamine, N,N,α-trimethyl-, 5-oxide; Phenergan Sulfoxide; N,N-Dimethyl-1-phenothiazin-10-ylpropan-2-amine S-Oxide; Promethazine Sulfoxide Impurity; Promethazine Related Compound A; Promethazine Oxidation Product
EINECS	Contact for details

Quality Control

Our Promethazine Sulfoxide is produced under strict quality management systems. Each batch is subjected to comprehensive analytical testing, including identification by spectroscopic methods (IR, NMR), purity assay by HPLC, and control of related substances. A detailed Certificate of Analysis (COA) is provided with each shipment, confirming compliance with in-house specifications suitable for use as a reference standard.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. For long-term storage, consider storing under inert atmosphere to minimize further oxidation.

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 unknown impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH guidelines
Water Content (KF)	≤ 0.5% w/w

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