Description

Prochlorperazine Impurity 2 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for pharmaceutical quality control, specifically in the development and validation of analytical methods for the antipsychotic drug Prochlorperazine. It is primarily required by pharmaceutical manufacturers, contract research organizations (CROs), and analytical laboratories for impurity profiling, method development, and regulatory compliance testing.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference material for the identification and quantification of specific impurities in Prochlorperazine drug substance and finished products.
• Analytical Method Development & Validation: Serves as a critical standard for developing, optimizing, and validating HPLC, UPLC, or LC-MS methods to ensure accurate impurity detection.
• Quality Assurance & Control (QA/QC): Employed in routine quality control testing to monitor impurity levels and ensure batch-to-batch consistency of Prochlorperazine APIs.
• Regulatory Compliance & Submissions: Essential for generating data to meet the stringent requirements of regulatory bodies like the FDA, EMA, and ICH for drug approval and marketing.
• Stability Studies: Used as a marker to track the formation of degradation products during forced degradation and long-term stability studies of Prochlorperazine formulations.
• Research & Development: Supports chemical research into the metabolism, degradation pathways, and synthesis of Prochlorperazine and related phenothiazine derivatives.

Basic Information

Product Name	Prochlorperazine Impurity 2
CAS No.	879495-68-8
Molecular Formula	C20H24ClN3OS
Molecular Weight	389.94 g/mol
Synonyms	Prochlorperazine Related Compound; Prochlorperazine EP Impurity; 2-Chloro-10-[3-(4-methylpiperazin-1-yl)propyl]phenothiazine (related compound); Prochlorperazine Process Impurity; Phenothiazine Impurity; ICH Impurity; Pharmaceutical Secondary Standard; CRM for Prochlorperazine
EINECS	Contact for details

Quality Control

Every batch of Prochlorperazine Impurity 2 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity confirmation, purity analysis, and impurity screening to ensure they meet the exacting standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing results from HPLC, NMR, and MS analyses. We support compliance with ICH Q3A/B, USP, and EP guidelines.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. The material is light-sensitive and should be handled under appropriate conditions to maintain stability.

Specification

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

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