Description

Amlodipine Impurity 32 is a high-purity chemical reference standard used in the pharmaceutical development and quality control processes. This compound is critical for ensuring the safety and efficacy of amlodipine-based drug products by enabling accurate identification and quantification of related substances. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method validation, stability studies, and compliance testing. The availability of this well-characterized impurity is essential for maintaining stringent quality standards in the production of cardiovascular medications.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the qualitative and quantitative analysis of amlodipine besylate and related drug substances.
• Method Development and Validation: Essential for developing and validating analytical methods, particularly HPLC and LC-MS, to monitor impurities in active pharmaceutical ingredients (APIs).
• Stability Studies: Employed in forced degradation and long-term stability studies to identify and track impurity profiles in drug formulations over time.
• Quality Control (QC) Testing: Serves as a system suitability standard in routine QC laboratories to ensure the accuracy and precision of impurity testing for batch release.
• Regulatory Compliance and Filing: Supports regulatory submissions (e.g., to FDA, EMA) by providing necessary data on impurity identification and qualification as per ICH Q3A and Q3B guidelines.
• Research and Development: Used in pharmaceutical R&D to understand the degradation pathways and synthesis by-products of amlodipine.

Basic Information

Product Name	Amlodipine Impurity 32
CAS No.	1621516-91-3
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Amlodipine Related Compound 32; Amlodipine Besylate Impurity 32; 3-Ethyl 5-Methyl 4-(2-Chlorophenyl)-2-[(2-Aminoethoxy)methyl]-6-methyl-1,4-dihydropyridine-3,5-dicarboxylate Impurity; 1,4-Dihydropyridine Derivative Impurity; Amlodipine Process Impurity; Norvasc Impurity; Amlodipine Degradant
EINECS	Contact for details

Quality Control

Every batch of Amlodipine Impurity 32 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous quality testing, including advanced chromatographic and spectroscopic techniques, to ensure compliance with industry standards and customer specifications. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing purity, identity, and impurity profile. We support compliance with relevant pharmacopeial guidelines (USP, EP) and ICH regulatory requirements.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or COA. Keep the container in a dry, cool, and well-ventilated place. Protect from moisture.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms
Identification (IR)	Conforms to reference spectrum
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 0.5%

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