Description

Lercanidipine Impurity 1 is a designated impurity standard used in the analytical profiling and quality control of the antihypertensive active pharmaceutical ingredient (API) Lercanidipine Hydrochloride. This high-purity reference material is critical for pharmaceutical manufacturers and analytical laboratories to ensure product safety, efficacy, and regulatory compliance. It is primarily used for method development, validation, and routine testing in the pharmaceutical industry.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the identification and quantification of related substances in Lercanidipine Hydrochloride API and its finished dosage forms.
• Analytical Method Development & Validation: Essential for developing and validating stability-indicating HPLC, UPLC, or LC-MS methods to monitor impurity profiles.
• Quality Control & Assurance (QC/QA): Used in routine batch release testing to confirm that impurity levels are within ICH (International Council for Harmonisation) and pharmacopeial (e.g., USP, EP) limits.
• Stability Studies: Employed as a marker to track the formation of degradation products under various stress conditions (e.g., heat, light, humidity) during drug substance and product stability testing.
• Regulatory Submissions: Provides necessary impurity characterization data for regulatory filings (e.g., ANDA, NDA, CTA) to health authorities like the FDA and EMA.
• Research & Development: Utilized in synthetic chemistry R&D to understand and control impurity formation during the manufacturing process of Lercanidipine.

Basic Information

Product Name	Lercanidipine Impurity 1
CAS No.	89267-42-5
Molecular Formula	C36H41N3O6
Molecular Weight	611.73 g/mol
Synonyms	Lercanidipine Related Compound A; Lercanidipine Impurity A; 1,4-Dihydro-2,6-dimethyl-4-(3-nitrophenyl)-3,5-pyridinedicarboxylic acid 2-[(3,3-diphenylpropyl)methylamino]ethyl 1-methylethyl ester; (RS)-2-[(3,3-Diphenylpropyl)methylamino]-1,1-dimethylethyl methyl 1,4-dihydro-2,6-dimethyl-4-(3-nitrophenyl)pyridine-3,5-dicarboxylate; Lercanidipine Des-isopropyl Impurity; Lercanidipine N-Desisopropyl Impurity
EINECS	Contact for details

Quality Control

Our Lercanidipine Impurity 1 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 HPLC, NMR, and MS analyses. The material is suitable for use as a pharmaceutical reference standard in compliance with ICH Q3A/B 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 compound is hygroscopic (moisture-sensitive); the container must be kept tightly sealed in a dry environment to prevent absorption of moisture.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Any individual impurity: ≤ 0.5% Total Impurities: ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 1.0% w/w

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