Description

Promethazine n-Glucuronide is a key glucuronide metabolite of the antihistamine and sedative promethazine. This reference standard is critical for pharmaceutical research and development, particularly in the study of drug metabolism and pharmacokinetics (DMPK). It is primarily used by analytical laboratories and pharmaceutical companies for method development, bioanalytical testing, and regulatory compliance in drug safety studies.

Application

• Pharmaceutical Reference Standard: Serves as a certified reference material (CRM) for the quantification and qualification of promethazine metabolites in biological matrices.
• Drug Metabolism & Pharmacokinetics (DMPK) Studies: Essential for investigating the metabolic pathways, bioavailability, and excretion profiles of promethazine.
• Bioanalytical Method Development: Used to develop and validate sensitive HPLC, LC-MS, or LC-MS/MS methods for therapeutic drug monitoring (TDM) and toxicology screening.
• Forensic and Clinical Toxicology: Acts as a critical calibrant in assays designed to detect and confirm promethazine and its metabolites in human samples.
• Impurity Profiling: Employed in the identification and control of glucuronide-related impurities during the manufacturing and quality control of promethazine-based pharmaceuticals.

Basic Information

Product Name	Promethazine n-Glucuronide
CAS No.	137908-81-7
Molecular Formula	C23H29N2O6S
Molecular Weight	461.55 g/mol
Synonyms	Promethazine N-Glucuronide; Promethazine Glucuronide; 10H-Phenothiazine-10-ethanamine, N,N,α-trimethyl-, 1-(β-D-glucopyranuronosyl)-; N-Glucuronylpromethazine; Promethazine β-D-Glucuronide; Promethazine N(β-D-Glucuronide); Promethazine Metabolite (Glucuronide)
EINECS	Contact for details

Quality Control

Our Promethazine n-Glucuronide is manufactured under strict quality management systems. Each batch is characterized and tested using advanced analytical techniques including NMR, MS, and HPLC to ensure high purity and structural identity. A comprehensive Certificate of Analysis (COA) detailing purity, assay, and impurity profiles is provided with every shipment to support your regulatory and research requirements.

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 product is light-sensitive and should be handled accordingly to maintain stability.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms
Identification (MS)	Conforms
Purity (HPLC)	≥ 95.0%
Water Content (KF)	≤ 5.0%
Residual Solvents (GC)	Meets ICH guidelines

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