Description

Lercanidipine Impurity 24 is a specified impurity and degradation product of the calcium channel blocker Lercanidipine Hydrochloride. This compound is critical for pharmaceutical research and development, serving as a key reference standard for analytical method development, validation, and quality control. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies to ensure the purity, safety, and efficacy of the active pharmaceutical ingredient (API).

Application

• Primary use as a certified reference standard (CRS) for the identification and quantification of impurities in Lercanidipine Hydrochloride API.
• Essential for analytical method development and validation (HPLC, LC-MS) in pharmaceutical quality control laboratories.
• Used in stability studies to monitor degradation pathways and establish shelf-life specifications for drug products.
• Critical for regulatory compliance and submissions (e.g., ICH guidelines Q3A, Q3B) to demonstrate thorough impurity profiling.
• Supports pharmaceutical research into the synthesis, metabolism, and degradation chemistry of Lercanidipine.
• Employed in the calibration of analytical equipment to ensure accurate and reproducible results.

Basic Information

Product Name	Lercanidipine Impurity 24
CAS No.	84977-36-6
Molecular Formula	C36H41N3O6
Molecular Weight	611.73 g/mol
Synonyms	Lercanidipine Related Compound 24; Lercanidipine EP Impurity D; Lercanidipine USP Impurity; 1,4-Dihydro-2,6-dimethyl-4-(3-nitrophenyl)-3,5-pyridinedicarboxylic acid 2-[(3,3-diphenylpropyl)methylamino]ethyl 1-methylethyl ester; Lercanidipine Nitro Impurity; Lercanidipine Degradation Product; Lercanidipine Nitrophenyl Analog
EINECS	Contact for details

Quality Control

Every batch of Lercanidipine Impurity 24 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous quality testing to ensure compliance with industry standards, including relevant pharmacopoeial guidelines (e.g., USP, EP). Comprehensive characterization is performed using advanced techniques such as HPLC, GC, NMR, and MS. Certificates of Analysis (COA) detailing purity, identity, and impurity profiles are available upon request.

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 material is hygroscopic (moisture-sensitive) and must be kept under dry, inert conditions to maintain stability and purity. Avoid exposure to excessive heat and humidity.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual impurity ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 1.0%

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