Description

Manidipine Impurity 2 is a designated impurity standard used in the analytical profiling and quality control of the active pharmaceutical ingredient (API) Manidipine. This compound is critical for ensuring the purity, safety, and efficacy of the final pharmaceutical product by serving as a reference marker in chromatographic analysis. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and routine batch 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: Essential for developing and optimizing HPLC, UPLC, or GC methods to separate and detect process-related impurities.
• Quality Control & Assurance: Employed in routine batch release testing to monitor impurity levels and ensure compliance with ICH Q3A(R2) and Q3B(R2) guidelines.
• Regulatory Submissions: Supports the filing of regulatory documents (e.g., DMF, CMC sections) by providing impurity characterization data.
• Stability Studies: Used to track the formation of degradation products in Manidipine formulations under various stress conditions.
• Research & Development: Aids in process chemistry research to understand and minimize impurity formation during API synthesis.

Basic Information

Product Name	Manidipine Impurity 2
CAS No.	216581-11-2
Molecular Formula	C35H38N4O6
Molecular Weight	610.70 g/mol
Synonyms	Manidipine Related Compound 2; Manidipine Impurity B; 1,4-Dihydro-2,6-dimethyl-4-(3-nitrophenyl)-3,5-pyridinedicarboxylic acid 2-[4-(diphenylmethyl)-1-piperazinyl]ethyl methyl ester; 2-{4-[(Diphenylmethyl)amino]-1-piperidinyl}ethyl methyl 1,4-dihydro-2,6-dimethyl-4-(3-nitrophenyl)-3,5-pyridinedicarboxylate; Methyl 1,4-dihydro-2,6-dimethyl-4-(3-nitrophenyl)-3,5-pyridinedicarboxylate 2-[4-(diphenylmethyl)-1-piperazinyl]ethyl ester
EINECS	Contact for details

Quality Control

Every batch of Manidipine Impurity 2 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and assay testing using advanced analytical techniques such as HPLC, NMR, and Mass Spectrometry to ensure compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment to support your regulatory and quality requirements.

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 prevent degradation.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any individual impurity ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 1.0%
Assay (HPLC)	95.0% - 105.0% on anhydrous basis

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