Description

Iso Promethazine-D3 Hydrochloride CAS NO 1329835-09-7 is a high-purity, isotopically labeled internal standard critical for advanced analytical chemistry. This deuterated compound is essential for ensuring the accuracy and reliability of quantitative mass spectrometry analyses, particularly in pharmacokinetic and metabolic studies. It is primarily required by pharmaceutical research laboratories, contract research organizations (CROs), and regulatory testing facilities for method development and validation.

Application

• Internal Standard for LC-MS/MS: Used as a quantitative reference standard in Liquid Chromatography-Tandem Mass Spectrometry for the analysis of promethazine and its metabolites.
• Pharmacokinetic Research: Enables precise tracking and measurement of drug absorption, distribution, metabolism, and excretion (ADME) in biological matrices.
• Forensic Toxicology: Supports accurate quantification of promethazine in forensic and clinical toxicology screenings.
• Drug Metabolism Studies: Facilitates the identification and quantification of drug metabolites in in vitro and in vivo studies.
• Method Development & Validation: Serves as a critical component in developing and validating robust, GLP-compliant analytical methods.
• Quality Control in Pharmaceutical Manufacturing: Used in QC labs to monitor the presence and quantity of promethazine in active pharmaceutical ingredients (APIs) and finished drug products.

Basic Information

Product Name	Iso Promethazine-D3 Hydrochloride
CAS No.	1329835-09-7
Molecular Formula	C₁₇H₁₇D₃N₂S•HCl
Molecular Weight	320.87 g/mol (approx.)
Synonyms	Promethazine-d3 Hydrochloride; 10H-Phenothiazine-10-ethanamine, N,N,α-trimethyl-, hydrochloride (d3); Deuterated Promethazine HCl; (2RS)-N,N-Dimethyl-1-(10H-phenothiazin-10-yl)propan-2-amine-d3 hydrochloride; Isotopically Labeled Promethazine HCl; Internal Standard Promethazine-d3; IS for Promethazine Analysis
EINECS	Contact for details

Quality Control

Our Iso Promethazine-D3 Hydrochloride is manufactured under strict quality systems to ensure the high chemical and isotopic purity required for sensitive analytical applications. Each batch is accompanied by a comprehensive Certificate of Analysis (COA) detailing results for identity, assay, isotopic enrichment, and impurity profile. We support compliance with GLP and GMP guidelines for reference standards.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This product is hygroscopic (moisture-sensitive) and must be kept in a desiccated environment. For long-term stability, consider storage at 2-8°C.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (MS)	Conforms to structure
Purity (HPLC)	≥ 98.0%
Isotopic Enrichment	≥ 99.0 atom % D
Chemical Purity (NMR)	Conforms
Residual Solvents (GC)	Complies with ICH limits
Water Content (KF)	≤ 1.0%

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