Description

Benidipine Impurity 6 is a specified impurity and degradation product of the calcium channel blocker Benidipine, identified by CAS NO 121138-43-0. This compound is critical for pharmaceutical research and development, serving as a key reference standard for analytical method development, validation, and quality control processes. It is essential for manufacturers and analytical laboratories in the pharmaceutical industry who require high-purity chemical reference materials to ensure the safety, efficacy, and regulatory compliance of their active pharmaceutical ingredients (APIs).

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of impurities in Benidipine API and finished dosage forms.
• Analytical Method Development: Crucial for developing and optimizing chromatographic methods, such as HPLC and UPLC, for impurity profiling.
• Quality Control & Assurance (QC/QA): Used in routine batch testing to monitor impurity levels and ensure product specifications are met according to ICH guidelines.
• Regulatory Compliance & Filing: Supports regulatory submissions (e.g., to FDA, EMA) by providing necessary impurity characterization data for drug master files (DMFs).
• Stability Studies: Employed to identify and track degradation products formed under various stress conditions during drug stability testing.
• Research & Development: Used in pharmacokinetic and metabolic studies to understand the degradation pathways of Benidipine.

Basic Information

Product Name	Benidipine Impurity 6
CAS No.	121138-43-0
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Benidipine Related Compound 6; Benidipine EP Impurity 6; Benidipine USP Impurity 6; Benidipine Degradation Product; 1,4-Dihydro-2,6-dimethyl-4-(3-nitrophenyl)-3,5-pyridinedicarboxylic acid 1-(diphenylmethyl)-3-azetidinyl methyl ester impurity; 3-(Diphenylmethyl)-1-[[(2,6-dimethyl-4-(3-nitrophenyl)-1,4-dihydropyridine-3,5-dicarbonyl]oxy]methyl]azetidine impurity
EINECS	Contact for details

Quality Control

Every batch of Benidipine Impurity 6 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous quality testing to ensure compliance with industry standards, including ICH Q3A/B guidelines for impurities. Comprehensive characterization is performed using advanced techniques like HPLC, GC-MS, and NMR. Certificates of Analysis (COA) detailing purity, identity, and impurity profiles are available upon request to support your regulatory and quality assurance needs.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (typically 15-25°C). Due to its hygroscopic (moisture-sensitive) nature, the container must be kept tightly sealed in a dry environment to prevent degradation. For long-term storage, consider storing under an inert atmosphere.

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
Water Content (KF)	≤ 5.0%

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