Description

Amlodipine Impurity 44 is a high-purity chemical reference standard used in the analytical profiling of the active pharmaceutical ingredient, Amlodipine. This compound is critical for ensuring the quality, safety, and efficacy of Amlodipine-based drug products by serving as a benchmark in impurity identification and quantification. It is an essential material for pharmaceutical R&D laboratories, quality control units, and regulatory affairs departments focused on method development and validation.

Application

• Primary use as a certified reference standard for the identification and quantification of Amlodipine Impurity 44 in Amlodipine Besylate and Amlodipine Maleate API batches.
• Critical component in analytical method development and validation (HPLC, UPLC, LC-MS) for pharmaceutical quality control.
• Used in stability studies and forced degradation studies to understand the degradation pathways of Amlodipine.
• Essential for regulatory compliance and filing, supporting ICH guidelines (Q3A, Q3B) on impurities in new drug substances and products.
• Serves as a key impurity marker in the pharmacopoeial testing and specification setting for Amlodipine.
• Utilized by contract research organizations (CROs) and analytical testing laboratories for client projects.

Basic Information

Product Name	Amlodipine Impurity 44
CAS No.	58535-38-9
Molecular Formula	C26H31ClN2O8S
Molecular Weight	567.05 g/mol
Synonyms	1,4-Dihydro-2,6-dimethyl-4-(3-nitrophenyl)-3,5-pyridinedicarboxylic Acid 3-Ethyl 5-Methyl Ester; Amlodipine Nitroso Impurity; Amlodipine Related Compound C; Amlodipine Nitro Derivative; 3-Nitroamlodipine; Amlodipine Impurity C; Amlodipine Nitro Impurity
EINECS	Contact for details

Quality Control

Every batch of Amlodipine Impurity 44 is manufactured and controlled under a strict quality management system. The product undergoes comprehensive analytical testing, including HPLC purity assay, related substance profiling, and confirmatory identification (IR, NMR, MS) to ensure it meets the high standards required for pharmaceutical reference materials. A detailed Certificate of Analysis (COA) is provided with each shipment, confirming identity, purity, and traceability.

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 in a desiccated environment to maintain stability and purity. Handle and store under an inert atmosphere if specified for long-term storage.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual unknown impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
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.