Description

Amlodipine Impurity 55 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of the active pharmaceutical ingredient (API) amlodipine besylate. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and quality control testing.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the identification and quantification of related substances in Amlodipine API and finished drug products.
• Analytical Method Development: Essential for developing and validating HPLC, UPLC, or GC methods to monitor impurities during the drug manufacturing process.
• Quality Control & Assurance (QC/QA): Serves as a benchmark in routine quality control testing to ensure amlodipine batches meet pharmacopeial specifications (e.g., USP, EP, ICH guidelines).
• Stability Studies: Employed in forced degradation and long-term stability studies to track impurity profiles and ensure drug product shelf-life.
• Regulatory Compliance & Filing: A necessary component for regulatory submissions (e.g., ANDA, NDA) to demonstrate comprehensive impurity control strategies to agencies like the FDA and EMA.
• Research & Development: Used in R&D to study the degradation pathways, synthesis impurities, and metabolic profiles of amlodipine.

Basic Information

Product Name	Amlodipine Impurity 55
CAS No.	144380-91-6
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 impurity; Amlodipine Related Compound; Amlodipine Nitro Impurity; 3-Nitroamlodipine; Amlodipine Nitro Analog; Amlodipine Nitro Derivative; Amlodipine Impurity N; 3-Nitrophenyl DHP derivative of Amlodipine
EINECS	Contact for details

Quality Control

Every batch of Amlodipine Impurity 55 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and assay testing using advanced analytical techniques such as HPLC, GC-MS, and NMR to ensure compliance with pharmacopeial standards. 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 at controlled room temperature (15-25°C) in a dry environment. The material is light-sensitive and should be handled under appropriate conditions to maintain stability.

Specification

Item	Specification
Appearance	White to off-white solid
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 unknown impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
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.