Description

Trazodone Hydrochloride BP Impurity H Dihydrochloride is a high-purity reference standard critical for pharmaceutical quality control and analytical research. This compound serves as a specified impurity for the antidepressant drug Trazodone Hydrochloride, enabling precise monitoring and quantification to ensure drug safety and efficacy. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and compliance testing in accordance with pharmacopeial standards.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference material for the identification and quantification of Impurity H in Trazodone Hydrochloride active pharmaceutical ingredient (API) and finished dosage forms.
• Analytical Method Development & Validation: Essential for developing and validating HPLC, UPLC, or LC-MS methods to meet ICH Q3A(R2) and Q3B(R2) guidelines for impurities in new drug substances and products.
• Quality Control & Batch Release: Employed in routine QC laboratories to establish impurity limits and ensure batch-to-batch consistency and compliance with British Pharmacopoeia (BP), United States Pharmacopeia (USP), or other monographs.
• Stability Studies: Used to track the formation of this specific degradation product under various stress conditions (e.g., heat, light, humidity) as part of forced degradation and shelf-life studies.
• Regulatory Submissions: Critical for preparing impurity data packages for regulatory filings with agencies like the FDA, EMA, and PMDA to demonstrate product quality and control strategy.
• Research & Development: Supports synthetic chemistry research for impurity synthesis, isolation, and characterization during API process development and optimization.

Basic Information

Product Name	Trazodone Hydrochloride BP Impurity H Dihydrochloride
CAS No.	2408971-27-5
Molecular Formula	C19H23Cl3N5O
Molecular Weight	443.77 g/mol
Synonyms	Trazodone Impurity H Dihydrochloride; Trazodone Related Compound H Dihydrochloride; 2-{3-[4-(3-Chlorophenyl)piperazin-1-yl]propyl}[1,2,4]triazolo[4,3-a]pyridin-3(2H)-one Dihydrochloride; Desmethyl Trazodone Dihydrochloride; Trazodone HCl Impurity H; Trazodone EP Impurity H Dihydrochloride; Trazodone USP Impurity H
EINECS	Contact for details

Quality Control

Every batch of Trazodone Hydrochloride BP Impurity H Dihydrochloride is manufactured and analyzed under strict quality management systems. The product undergoes comprehensive testing, including advanced chromatographic and spectroscopic techniques, to ensure identity, purity, and conformity to stringent specifications. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment, supporting compliance with cGMP and relevant pharmacopeial guidelines.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). Due to its hygroscopic nature, the container should be kept in a desiccated environment to prevent moisture absorption. Handle and store in accordance with good laboratory practices.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	≥ 95.0%
Purity (HPLC)	≥ 98.0%
Water Content (KF)	≤ 5.0%
Residue on Ignition	≤ 0.5%
Heavy Metals	≤ 20 ppm
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.5% Total impurities: ≤ 2.0%

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