Description

Amlodipine Impurity 29 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 widely prescribed antihypertensive drug, Amlodipine. 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 reference material (CRM) for the identification and quantification of impurities in Amlodipine Besylate and related drug substances and products.
• Analytical Method Development: Essential for developing and validating HPLC, UPLC, and LC-MS methods to monitor and control impurity profiles in accordance with ICH Q3A(R2) and Q3B(R2) guidelines.
• Quality Control & Assurance (QC/QA): Serves as a system suitability standard and for routine batch release testing in pharmaceutical manufacturing to ensure product purity and compliance with pharmacopeial monographs (USP, EP, BP).
• Regulatory Submissions: Supports the preparation of regulatory documentation (e.g., Drug Master Files, CMC sections) by providing characterized impurity data for FDA, EMA, and other health authority filings.
• Stability Studies: Employed in forced degradation and long-term stability studies to track the formation and levels of this specific impurity over time.
• Research & Development: Utilized in academic and industrial R&D for studying the degradation pathways, synthesis, and chemical behavior of Amlodipine and its related compounds.

Basic Information

Item	Details
Product Name	Amlodipine Impurity 29
CAS No.	93848-82-9
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	1,4-Dihydro-2,6-dimethyl-4-(3-nitrophenyl)-3,5-pyridinedicarboxylic acid 3-ethyl 5-methyl ester; Amlodipine Nitro Impurity; Amlodipine Related Compound; Nitroamlodipine; 3-Nitroamlodipine; Amlodipine Impurity N; Amlodipine Nitro Analog
EINECS	Contact for details

Quality Control

Every batch of Amlodipine Impurity 29 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced analytical techniques (HPLC, GC, NMR, MS) to ensure compliance with industry and pharmacopeial standards. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). Due to its hygroscopic nature, the container must be kept tightly sealed in a dry environment to prevent moisture absorption.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 1.0%

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