Description

Promethazine-D4 Hydrochloride is a deuterium-labeled internal standard critical for ensuring the accuracy and reliability of quantitative analytical methods. This stable isotope-labeled compound is essential for researchers and quality control laboratories requiring precise measurement of promethazine in complex matrices. It is primarily used in pharmaceutical research, forensic toxicology, and clinical diagnostics for method development and validation.

Application

• Internal Standard for LC-MS/MS and GC-MS: Used as a quantitative reference standard in mass spectrometry-based bioanalysis for pharmacokinetic and metabolomic studies.
• Pharmaceutical Quality Control (QC): Ensures accurate assay and impurity profiling of promethazine hydrochloride in active pharmaceutical ingredient (API) and finished drug product testing.
• Forensic and Clinical Toxicology: Facilitates the precise quantification of promethazine in biological samples (e.g., blood, urine) for drug monitoring and forensic investigations.
• Metabolic Pathway Research: Aids in the study of promethazine's absorption, distribution, metabolism, and excretion (ADME) in preclinical and clinical research.
• Method Development and Validation: Serves as a critical tool for developing, optimizing, and validating robust analytical methods in compliance with ICH and FDA guidelines.

Basic Information

Product Name	Promethazine-D4 Hydrochloride
CAS No.	1173018-74-0
Molecular Formula	C17H16D4N2S•HCl
Molecular Weight	320.89 g/mol
Synonyms	Promethazine-d4 HCl; (2RS)-N,N-Dimethyl-1-(10H-phenothiazin-10-yl)propan-2-amine-d4 Hydrochloride; 10H-Phenothiazine-10-ethanamine, N,N,α-trimethyl-, d4 hydrochloride; Deuterated Promethazine Hydrochloride; Promethazine (phenyl-d4) Hydrochloride; Isotopic Labeled Promethazine HCl; Promethazine Internal Standard
EINECS	Contact for details

Quality Control

Our Promethazine-D4 Hydrochloride is manufactured under strict quality systems to ensure the high chemical purity and isotopic enrichment required for analytical applications. Each batch is supported by a comprehensive Certificate of Analysis (COA) detailing parameters such as assay, isotopic purity, and chemical purity by HPLC. We adhere to relevant industry standards for reference materials to ensure reliability and traceability in your analyses.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. This product is hygroscopic (moisture-sensitive); keep the container tightly sealed in a desiccated area to maintain stability.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (MS)	Conforms to structure
Assay (HPLC)	≥ 98.0%
Isotopic Purity	≥ 98 atom % D
Chemical Purity (HPLC)	≥ 95.0%
Water Content (KF)	≤ 2.0%
Residue on Ignition	≤ 0.5%

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