Description

Lercanidipine Impurity K 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 by accurately identifying and quantifying this specific impurity. It is essential for research and development, method validation, and routine batch release testing within the pharmaceutical industry.

Application

• Pharmaceutical Reference Standard: Primary use as a certified impurity standard for the qualitative and quantitative analysis of Lercanidipine API and its formulations.
• Method Development and Validation: Critical for developing, optimizing, and validating stability-indicating HPLC or UPLC methods according to ICH guidelines.
• Quality Control & Batch Release: Used in-house by API manufacturers and finished dosage form producers to monitor impurity levels against strict pharmacopeial limits (e.g., ICH Q3B).
• Stability Studies: Employed to track the formation and growth of this specific degradant under various stress conditions (heat, light, humidity) to establish shelf life.
• Regulatory Submissions: Provides essential data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDA).
• Contract Research Organization (CRO) Services: A key reagent for third-party testing labs offering analytical and compliance services to the pharma industry.

Basic Information

Product Name	Lercanidipine Impurity K
CAS No.	855592-30-2
Molecular Formula	C36H41N3O6
Molecular Weight	611.73 g/mol
Synonyms	1,4-Dihydro-2,6-dimethyl-4-(3-nitrophenyl)-3,5-pyridinedicarboxylic acid 2-[(3,3-diphenylpropyl)methylamino]ethyl 1-methylethyl ester; Lercanidipine Impurity K; Lercanidipine Related Compound K; (RS)-2-[(3,3-Diphenylpropyl)methylamino]-1,1-dimethylethyl methyl 1,4-dihydro-2,6-dimethyl-4-(3-nitrophenyl)pyridine-3,5-dicarboxylate; Degradant of Lercanidipine.
EINECS	Contact for details

Quality Control

Every batch of Lercanidipine Impurity K is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced techniques like HPLC, GC, and NMR to ensure compliance with pharmaceutical reference standard requirements. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results, and is 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 compound is hygroscopic (moisture-sensitive); therefore, 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 solid
Identification (HPLC)	Retention time matches reference standard
Identification (IR)	Spectrum conforms to 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)	≤ 0.5% w/w

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