Description

Benidipine Impurity CAS NO 52604-00-9 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of the active pharmaceutical ingredient (API) Benidipine. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and research institutions engaged in method development, validation, and impurity profiling. The availability of this well-characterized impurity standard is essential for maintaining stringent quality control in pharmaceutical production.

Application

• Pharmaceutical Impurity Profiling and Identification: Used as a certified reference material (CRM) to identify and quantify this specific impurity in Benidipine API and finished dosage forms.
• Analytical Method Development and Validation: Serves as a critical standard for developing, optimizing, and validating HPLC, UPLC, or LC-MS methods for impurity detection.
• Quality Control (QC) and Quality Assurance (QA): Employed in routine QC testing to monitor impurity levels against International Council for Harmonisation (ICH) guidelines and pharmacopeial standards (e.g., USP, EP).
• Stability Studies: Used to track the formation and growth of this impurity during forced degradation and long-term stability testing of Benidipine products.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., ANDA, NDA) to demonstrate comprehensive impurity control strategies to agencies like the FDA and EMA.
• Research and Development: Utilized in synthetic chemistry research to study degradation pathways and to support the development of robust manufacturing processes.

Basic Information

Product Name	Benidipine Impurity
CAS No.	52604-00-9
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Benidipine Related Compound; Benidipine Impurity Standard; Benidipine Specified Impurity; (±)-3-(1-Benzyl-3-piperidinyl) 5-methyl 2,6-dimethyl-4-(3-nitrophenyl)-1,4-dihydropyridine-3,5-dicarboxylate (Benidipine Impurity A); 1,4-Dihydro-2,6-dimethyl-4-(3-nitrophenyl)-3,5-pyridinedicarboxylic acid 3-(1-benzyl-3-piperidinyl) ester 5-methyl ester; 3-(1-Benzylpiperidin-3-yl) 5-methyl 4-(3-nitrophenyl)-2,6-dimethyl-1,4-dihydropyridine-3,5-dicarboxylate
EINECS	Contact for details

Quality Control

Our Benidipine Impurity is manufactured under strict quality systems and undergoes rigorous analytical testing to ensure identity, purity, and consistency. Each batch is supplied with a comprehensive Certificate of Analysis (COA) detailing results from advanced chromatographic and spectroscopic methods. We support compliance with ICH Q3A/B, USP, and EP guidelines for impurities in new drug substances and products. Certificates of Analysis are available for review and are provided with every shipment.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C (59-77°F), in a dry environment. Keep the container sealed to protect the material from moisture and contamination.

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)	Single unspecified impurity ≤ 1.0% Total impurities ≤ 3.0%
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.