Description

Nicardipine Related Compound 2 is a designated impurity reference standard used in the analytical profiling and quality control of the calcium channel blocker Nicardipine. This compound is critical for ensuring the purity, safety, and efficacy of pharmaceutical formulations. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and compliance testing.

Application

• Pharmaceutical Impurity Profiling: Serves as a certified reference material for the identification and quantification of specific impurities in Nicardipine Active Pharmaceutical Ingredient (API) and finished drug products.
• Analytical Method Development & Validation: Used as a critical standard to develop, optimize, and validate HPLC, UPLC, or GC methods for purity analysis.
• Quality Control & Assurance (QC/QA): Essential for routine batch testing in pharmaceutical manufacturing to ensure compliance with pharmacopeial limits (e.g., USP, EP, ICH Q3A/B).
• Stability Studies: Employed to monitor the formation of degradation products in Nicardipine formulations under various stress conditions.
• Regulatory Compliance & Documentation: Provides necessary data for regulatory submissions (e.g., FDA, EMA) to demonstrate thorough impurity characterization.
• Research & Development: Used in chemical and pharmacological R&D to study the metabolism and degradation pathways of Nicardipine.

Basic Information

Product Name	Nicardipine Related Compound 2
CAS No.	64603-72-1
Molecular Formula	C26H29N3O6
Molecular Weight	479.53 g/mol
Synonyms	Nicardipine Impurity 2; 2,6-Dimethyl-4-(3-nitrophenyl)-1,4-dihydropyridine-3,5-dicarboxylic acid 3-[2-(N-benzyl-N-methylamino)]ethyl ester 5-methyl ester; 3-[N-Benzyl-N-methylamino]ethyl 5-methyl 2,6-dimethyl-4-(3-nitrophenyl)-1,4-dihydropyridine-3,5-dicarboxylate; Nicardipine EP Impurity B; Nicardipine USP Related Compound B; 1,4-Dihydro-2,6-dimethyl-4-(3-nitrophenyl)-3,5-pyridinedicarboxylic acid, 3-[2-(benzylmethylamino)ethyl] 5-methyl ester
EINECS	Contact for details

Quality Control

Our Nicardipine Related Compound 2 is manufactured and handled under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC purity assay, identity confirmation (IR, MS), and residual solvent analysis, to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) with batch-specific data is provided, supporting compliance with ICH and relevant pharmacopeial 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 product is hygroscopic (moisture-sensitive) and must be kept under dry conditions to maintain stability and purity.

Specification

Item	Specification
Appearance	Yellow to light brown powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual impurity ≤ 1.0% Total impurities ≤ 5.0%
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.