Description

n-Desmethyl Trifluoperazine Dihydrochloride is a key pharmaceutical intermediate and metabolite of the antipsychotic drug trifluoperazine. This compound is of significant value in analytical chemistry and pharmaceutical research, serving as a critical reference standard for method development and quality control. It is primarily required by pharmaceutical manufacturers, contract research organizations (CROs), and analytical laboratories involved in drug metabolism studies, pharmacokinetic analysis, and impurity profiling.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the quantification and identification of metabolites in bioanalytical studies.
• Impurity Profiling: Essential for monitoring and controlling the related substance n-Desmethyl Trifluoperazine in active pharmaceutical ingredient (API) batches of Trifluoperazine.
• Metabolite Research: A vital tool in preclinical and clinical research to understand the drug's metabolic pathways and pharmacokinetics.
• Method Development & Validation: Serves as a critical component in developing and validating HPLC, LC-MS, and other chromatographic methods for antipsychotic drug analysis.
• Quality Control (QC) Testing: Employed in in-house QC laboratories to ensure the purity and consistency of trifluoperazine-based drug products.
• Regulatory Submissions: Used to generate data for regulatory filings (e.g., with the FDA, EMA) to demonstrate thorough impurity characterization.

Basic Information

Product Name	n-Desmethyl Trifluoperazine Dihydrochloride
CAS No.	2804-16-2
Molecular Formula	C₂₁H₂₄F₃N₃S · 2HCl
Molecular Weight	504.42 g/mol
Synonyms	10-[3-(4-Methylpiperazin-1-yl)propyl]-2-(trifluoromethyl)-10H-phenothiazine Dihydrochloride; Desmethyltrifluoperazine Dihydrochloride; Nor-Trifluoperazine Dihydrochloride; Trifluoperazine Impurity C (Dihydrochloride); Trifluoperazine Metabolite Dihydrochloride; 2-Trifluoromethyl-10-[3-(4-methyl-1-piperazinyl)propyl]phenothiazine Dihydrochloride; NSC 113927
EINECS	Contact for details

Quality Control

Our n-Desmethyl Trifluoperazine Dihydrochloride is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including identification, assay, and related substances analysis by validated methods such as HPLC and IR spectroscopy. We provide a comprehensive Certificate of Analysis (COA) with each shipment, detailing all test results against predefined specifications. Our quality commitment ensures the material is suitable for use as a high-purity reference standard in regulated environments.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This product is hygroscopic (moisture-sensitive) and must be kept in a desiccated environment to maintain stability and purity. Avoid prolonged exposure to air and humidity.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Assay (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single unknown impurity ≤ 0.5%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%

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