Description

Lercanidipine Impurity 26 is a designated pharmaceutical reference standard used in the quality control and analytical development of the antihypertensive drug Lercanidipine Hydrochloride. This compound is critical for ensuring the purity, safety, and efficacy of the final drug product by serving as a benchmark in chromatographic analysis. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method validation, stability studies, and impurity profiling.

Application

• Pharmaceutical Reference Standard for the identification and quantification of Lercanidipine Hydrochloride impurities.
• Method Development and Validation in HPLC and LC-MS analysis for quality control laboratories.
• Stability Indicating Studies to monitor impurity formation in drug substance and drug product under various storage conditions.
• Regulatory Compliance and Documentation, supporting filings with agencies like the FDA and EMA.
• Research and Development of Lercanidipine synthesis pathways and impurity isolation.
• Calibration of Analytical Instruments to ensure accurate and reproducible results in impurity analysis.

Basic Information

Product Name	Lercanidipine Impurity 26
CAS No.	890045-70-2
Molecular Formula	C36H41N3O6
Molecular Weight	611.73 g/mol
Synonyms	Lercanidipine Related Compound 26; Lercanidipine EP Impurity G; Lercanidipine Hydrochloride Impurity 26; (2E)-3-{3-[(3,3-Diphenylpropyl)amino]-1,1-dimethoxypropylidene}-5-methoxy-2-(3,4-dimethoxyphenyl)-4-(3-nitrophenyl)-6-methyl-1,4-dihydropyridine-3-carboxylate; Lercanidipine Nitro Impurity; Lercanidipine Nitro Analog
EINECS	Contact for details

Quality Control

Our Lercanidipine Impurity 26 is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC purity analysis, to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is provided, detailing identity, purity, and impurity profile, supporting compliance with ICH guidelines and pharmacopeial expectations.

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 in a desiccated environment to maintain stability and purity.

Specification

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

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