Description

Amlodipine Impurity 27 Disodium Salt is a high-purity reference standard critical for analytical method development and quality control in pharmaceutical manufacturing. This compound is essential for the accurate identification, quantification, and monitoring of process-related impurities in Amlodipine Besylate and other related active pharmaceutical ingredients (APIs). It is primarily required by pharmaceutical R&D laboratories, quality assurance departments, and regulatory affairs teams to ensure drug safety, efficacy, and compliance with stringent pharmacopeial standards.

Application

• Pharmaceutical Reference Standard: Serves as a certified reference material (CRM) for the calibration of analytical instruments and validation of testing methods.
• Impurity Profiling & Characterization: Used in HPLC, LC-MS, and GC-MS analysis to identify and quantify Amlodipine Impurity 27 during API synthesis and finished product testing.
• Method Development & Validation: Critical for developing and validating stability-indicating assay methods as per ICH Q2(R1) guidelines.
• Regulatory Compliance & Filings: Supports the preparation of regulatory submission documents (e.g., for FDA, EMA) by providing impurity identification data.
• Quality Control (QC) Testing: Employed in routine QC laboratories to monitor batch-to-batch consistency and ensure impurity levels remain within specified limits.
• Stability Studies: Used as a marker in forced degradation and long-term stability studies to track impurity formation over time.

Basic Information

Product Name	Amlodipine Impurity 27 Disodium Salt
CAS No.	120289-11-4
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Amlodipine Related Compound 27 Disodium Salt; Amlodipine EP Impurity G Disodium Salt; Amlodipine USP Impurity Disodium Salt; 3-Ethyl 5-Methyl 4-(2-Chlorophenyl)-2-[(2-Aminoethoxy)methyl]-6-methyl-1,4-dihydropyridine-3,5-dicarboxylate Impurity Disodium Salt; Disodium 2-[(2-Aminoethoxy)methyl]-4-(2-chlorophenyl)-3-ethoxycarbonyl-5-methoxycarbonyl-6-methyl-1,4-dihydropyridine-3,5-dicarboxylate; Amlodipine Process Impurity Disodium Salt; Amlodipine Degradant Disodium Salt
EINECS	Contact for details

Quality Control

Every batch of Amlodipine Impurity 27 Disodium Salt is manufactured under controlled conditions and undergoes rigorous analytical testing to ensure the highest standards of identity, purity, and stability. Our quality system is designed to meet the exacting requirements of pharmaceutical reference standard applications. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing results from tests including identification (HPLC, IR), assay (HPLC), and related substance analysis. We support compliance with ICH, USP, and EP guidelines.

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 product is hygroscopic (moisture-sensitive) and must be kept in a desiccated environment to maintain stability and purity. Avoid repeated or prolonged exposure to ambient conditions.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Conforms
Identification (IR)	Conforms to reference spectrum
Assay (HPLC)	≥ 95.0%
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual impurity: ≤ 1.0% Total impurities: ≤ 2.0%
Water Content (KF)	≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C

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