Description

Chlorpromazine Ep Impurity F is a high-purity reference standard critical for analytical method development and quality control in pharmaceutical manufacturing. This compound serves as a specified impurity for Chlorpromazine Hydrochloride, a key antipsychotic medication, ensuring product safety and regulatory compliance. It is essential for laboratories and manufacturers engaged in the synthesis, purification, and rigorous testing of active pharmaceutical ingredients (APIs) to meet stringent pharmacopeial standards.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of Chlorpromazine-related impurities in accordance with EP, USP, and ICH guidelines.
• Analytical Method Development: Crucial for developing, validating, and verifying HPLC, UPLC, and GC methods for impurity profiling.
• Quality Control & Assurance (QC/QA): Used in-house by API manufacturers and third-party testing labs to monitor batch-to-batch consistency and ensure impurity levels are within specified limits.
• Regulatory Compliance & Filings: Supports the preparation of regulatory documentation (e.g., CMC sections for FDA, EMA) by providing definitive impurity characterization data.
• Research & Development: Employed in stability studies, degradation pathway elucidation, and process chemistry optimization for Chlorpromazine and related phenothiazine derivatives.

Basic Information

Product Name	Chlorpromazine Ep Impurity F
CAS No.	13094-24-1
Molecular Formula	C17H19ClN2S
Molecular Weight	318.86 g/mol
Synonyms	Chlorpromazine Impurity F; Chlorpromazine Sulfoxide; 2-Chloro-10-[3-(methylamino)propyl]phenothiazine 5-Oxide; 5-Chloro-2-[[3-(methylamino)propyl]imino]-3H-phenothiazine 5-Oxide; Phenothiazine, 2-chloro-10-[3-(methylamino)propyl]-, 5-oxide; Chlorpromazine S-Oxide; Chlorpromazine EP Impurity F
EINECS	Contact for details

Quality Control

Every batch of Chlorpromazine Ep Impurity F is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced techniques like HPLC and NMR to ensure compliance with pharmacopeial standards (EP/ USP). A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment.

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 should be handled in a dry environment to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 1.0%

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