Description

Cisapride Impurity 7 CAS NO 86718-76-5 is a high-purity reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of pharmaceutical products containing cisapride. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and impurity profiling. The availability of this well-characterized impurity standard is essential for maintaining stringent quality control in drug development and production.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in cisapride active pharmaceutical ingredient (API) and finished dosage forms.
• Analytical Method Development & Validation: Serves as a critical component in developing and validating HPLC, UPLC, or GC methods for impurity detection and separation.
• Quality Control & Assurance (QC/QA): Employed in routine batch testing within pharmaceutical QC laboratories to monitor impurity levels and ensure product specifications are met.
• Regulatory Compliance & Documentation: Essential for generating impurity profiles and regulatory submission documents required by agencies like the FDA, EMA, and ICH.
• Stability Studies: Used to track the formation of this specific degradation product during forced degradation and long-term stability testing of cisapride formulations.
• Research & Development: Utilized in pharmacokinetic, metabolic, and toxicological studies to understand the behavior and impact of this impurity.

Basic Information

Product Name	Cisapride Impurity 7
CAS No.	86718-76-5
Molecular Formula	C23H29ClFN3O4
Molecular Weight	465.95 g/mol
Synonyms	4-Amino-5-chloro-N-[1-[3-(4-fluorophenoxy)propyl]-3-methoxy-4-piperidinyl]-2-methoxybenzamide; 1H-Benzimidazol-2-amine, 5-chloro-1-[1-(4-fluorophenoxy)propyl]-N-methoxy-; Cisapride Related Compound; Cisapride Impurity B; Impurity of Cisapride
EINECS	Contact for details

Quality Control

Every batch of Cisapride Impurity 7 is manufactured and analyzed under strict quality management systems. The product undergoes comprehensive testing, including identification by spectroscopic methods (IR, NMR, MS), purity determination by HPLC, and control of related substances and residual solvents. A comprehensive Certificate of Analysis (COA) detailing all test results against predefined specifications is provided with each shipment, ensuring full traceability and compliance with ICH Q3A, Q3B, and current Good Manufacturing Practice (cGMP) 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 must be kept under inert conditions if the container is opened repeatedly. For long-term storage, consider storing under an inert atmosphere such as argon or nitrogen.

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 single unknown impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 1.0% w/w
Heavy Metals	≤ 20 ppm

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