Description

Dalfampridine D6 is a deuterated analog of the active pharmaceutical ingredient dalfampridine, serving as a critical stable isotope-labeled internal standard. This high-purity compound is essential for ensuring the accuracy and reliability of quantitative bioanalytical methods, particularly in pharmacokinetic and metabolism studies. It is primarily utilized by pharmaceutical R&D laboratories, contract research organizations (CROs), and analytical testing facilities specializing in mass spectrometry.

Application

• Internal Standard for LC-MS/MS Analysis: Used as a deuterium-labeled internal standard for the precise quantification of dalfampridine (4-aminopyridine) in biological matrices such as plasma, serum, and urine.
• Pharmacokinetic (PK) and Bioequivalence Studies: Enables accurate tracking of drug absorption, distribution, metabolism, and excretion (ADME) profiles in clinical and preclinical research.
• Drug Metabolism and Metabolite Identification: Facilitates the differentiation between drug-derived metabolites and endogenous compounds in complex biological samples.
• Method Development and Validation: Critical for developing robust, sensitive, and specific analytical methods compliant with regulatory guidelines (FDA, EMA).
• Quality Control in Pharmaceutical Manufacturing: Supports impurity profiling and assay validation of the active pharmaceutical ingredient (API).

Basic Information

Product Name	Dalfampridine D6
CAS No.	45498-20-2
Molecular Formula	C6D6N2
Molecular Weight	110.17 g/mol
Synonyms	4-Aminopyridine-d6; 4-AP-d6; 4-Pyridinamine-d6; Ampyra-d6 (labeled analog); Fampridine-d6; 4-Amino-D6-pyridine; Deuterated Dalfampridine; [2H6]-4-Aminopyridine
EINECS	Contact for details

Quality Control

Our Dalfampridine D6 is manufactured under strict quality control protocols to ensure the high chemical purity and isotopic enrichment required for sensitive analytical applications. Each batch is accompanied by a comprehensive Certificate of Analysis (COA) detailing parameters such as isotopic purity (D-enrichment), chemical purity by HPLC, and identity confirmation. We adhere to industry best practices suitable for research and development use.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and should be handled in a dry environment to maintain stability.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Purity (HPLC)	≥ 98.0%
Isotopic Purity (D-enrichment)	≥ 98 atom % D
Water Content (KF)	≤ 0.5%
Residue on Ignition	≤ 0.1%

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