Description

Manidipine Impurity 5 is a designated impurity standard used in the analytical profiling and quality control of the antihypertensive active pharmaceutical ingredient, Manidipine. This compound is critical for ensuring the purity, safety, and efficacy of pharmaceutical formulations by serving as a reference marker in chromatographic methods. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for research, method development, and compliance testing.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Manidipine API and finished dosage forms.
• Analytical Method Development & Validation: Essential for developing, optimizing, and validating HPLC, UPLC, or GC methods to monitor impurity profiles.
• Quality Control & Assurance (QC/QA): A critical component in routine batch release testing to ensure API and drug product specifications are met according to ICH guidelines.
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., DMF, CMC sections) by providing impurity characterization data for agencies like the FDA and EMA.
• Stability Studies: Employed to track the formation and levels of this specific impurity under various stress conditions (e.g., heat, light, humidity).
• Research & Development: Used in synthetic chemistry research to understand degradation pathways and to develop purification processes for Manidipine.

Basic Information

Product Name	Manidipine Impurity 5
CAS No.	89226-51-7
Molecular Formula	C35H38N4O6
Molecular Weight	610.70 g/mol
Synonyms	Manidipine Related Compound 5; Manidipine EP Impurity 5; Manidipine USP Impurity 5; 1,4-Dihydro-2,6-dimethyl-4-(3-nitrophenyl)-3,5-pyridinedicarboxylic acid 2-[4-(diphenylmethyl)-1-piperazinyl]ethyl methyl ester; 2-[4-(Benzhydryl)piperazin-1-yl]ethyl methyl 2,6-dimethyl-4-(3-nitrophenyl)-1,4-dihydropyridine-3,5-dicarboxylate
EINECS	Contact for details

Quality Control

Our Manidipine Impurity 5 is manufactured and handled under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC for purity confirmation and identity verification by spectroscopic methods (IR, NMR, MS). We provide comprehensive Certificates of Analysis (COA) with detailed chromatographic data, ensuring compliance with relevant pharmacopeial standards (USP, EP) and ICH Q3A/B guidelines for impurities in new drug substances and products.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, 15-25°C (59-77°F). This material is hygroscopic (moisture-sensitive) and must be kept in a dry environment. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	Yellow to light brown powder
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Any individual impurity ≤ 1.0%
Water Content (KF)	≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C

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