Description

Piperaquine Impurity B is a designated reference standard used in the analytical profiling and quality control of the antimalarial drug Piperaquine. This high-purity impurity standard is critical for pharmaceutical manufacturers and analytical laboratories to ensure drug safety, efficacy, and regulatory compliance. It is primarily utilized in research and development, method validation, and stability studies to monitor and control the presence of related substances in active pharmaceutical ingredients (APIs) and finished drug products.

Application

• Pharmaceutical Reference Standard: Serves as a certified reference material (CRM) for the identification and quantification of Piperaquine Impurity B in drug substances and products.
• Analytical Method Development & Validation: Essential for developing, calibrating, and validating chromatographic methods, such as HPLC and UPLC, for impurity profiling.
• Quality Control & Assurance (QC/QA): Used in routine batch testing to ensure Piperaquine API and formulations meet stringent pharmacopeial (e.g., USP, EP) and ICH guidelines for impurity limits.
• Stability Studies: Employed to track the formation and levels of this specific degradation product under various stress conditions (e.g., heat, light, humidity).
• Regulatory Submissions: Provides essential data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs) to demonstrate comprehensive impurity control.
• Research on Degradation Pathways: Aids in understanding the chemical stability and degradation mechanisms of Piperaquine.

Basic Information

Product Name	Piperaquine Impurity B
CAS No.	4039-00-3
Molecular Formula	C29H32Cl2N6
Molecular Weight	535.51 g/mol
Synonyms	1,3-Bis[4-(7-chloroquinolin-4-yl)piperazin-1-yl]propane; 1,3-Bis(4-(7-chloroquinolin-4-yl)piperazin-1-yl)propane; Bispiproquine; Piperaquine Related Compound B; 1,3-Di(4-(7-chloro-4-quinolyl)-1-piperazinyl)propane; M&B 38544; RP 20798
EINECS	Contact for details

Quality Control

Every batch of Piperaquine Impurity B is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and assay testing using advanced analytical techniques, including HPLC, GC, MS, and NMR, to ensure they meet the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment, supporting compliance with ICH Q3A/B, USP, and EP 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). This material is hygroscopic (moisture-sensitive) and light-sensitive; therefore, containers must be kept tightly sealed in a desiccated environment to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (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.