Description

Amlodipine D4 Maleate 9 (Racemic) is a high-purity, isotopically labeled internal standard critical for modern analytical chemistry. This deuterated compound is essential for ensuring the accuracy and reliability of quantitative analyses in pharmaceutical research and development. It is primarily utilized by analytical chemists, QC/QA laboratories, and research scientists working on method development and validation for the cardiovascular drug amlodipine.

Application

• Internal Standard for LC-MS/MS: Used as a stable, isotopically labeled internal standard for the precise quantification of amlodipine in biological matrices (plasma, serum) during pharmacokinetic and bioequivalence studies.
• Pharmaceutical R&D Method Development: Critical for developing and validating robust, high-sensitivity analytical methods (HPLC, UPLC) in drug discovery and development pipelines.
• Quality Control & Impurity Profiling: Enables accurate assay and impurity determination in active pharmaceutical ingredient (API) and finished drug product quality control.
• Metabolite Studies: Aids in the identification and quantification of amlodipine metabolites in complex biological samples.
• Regulatory Submissions: Supports data packages for regulatory filings (e.g., FDA, EMA) where method accuracy and precision must be rigorously demonstrated.
• Clinical Trial Analysis: Ensures data integrity in clinical trial sample analysis for amlodipine-based therapeutics.

Basic Information

Product Name	Amlodipine D4 Maleate 9 (Racemic)
CAS No.	1185246-15-4
Molecular Formula	C26H30D4ClN2O8
Molecular Weight	Approx. 525.0 g/mol (Contact for details)
Synonyms	3-Ethyl 5-methyl (RS)-2-[(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-6-methyl-1,4-dihydropyridine-3,5-dicarboxylate D4 maleate; Amlodipine-d4 Maleate; Deuterated Amlodipine Maleate; Amlodipine (phenyl-d4) Maleate; 1,4-Dihydro-2,6-dimethyl-4-(2-chlorophenyl)-3,5-pyridinedicarboxylic acid 3-ethyl 5-methyl ester D4 maleate salt; Isotopic Internal Standard for Amlodipine; Amlodipine D4 (Racemic) Maleate Salt.
EINECS	Contact for details

Quality Control

Every batch of Amlodipine D4 Maleate 9 (Racemic) is manufactured and analyzed under strict quality systems to ensure it meets the exacting standards required for analytical internal standards. Our products undergo rigorous quality testing to ensure compliance with industry standards. Certificates of Analysis (COA) are available upon request, providing detailed data on isotopic purity, chemical purity, and identity confirmation.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label. This material is hygroscopic (moisture-sensitive) and must be kept in a dry environment. For long-term storage, consider desiccated conditions.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference
Purity (HPLC)	≥ 98.0%
Isotopic Purity (D-content)	≥ 98.0 atom % D
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%

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