Description

n-Acetylprocainamide Hydrochloride is a high-purity pharmaceutical intermediate and reference standard of significant importance in research and development. Its primary value lies in its role as the major active metabolite of the antiarrhythmic drug procainamide, making it critical for pharmacokinetic studies and analytical method development. This compound is essential for pharmaceutical manufacturers, analytical laboratories, and academic researchers focused on cardiovascular drug metabolism, quality control, and bioanalytical validation.

Application

• Pharmaceutical Reference Standard: Used as a certified standard for the identification and quantification of procainamide and its metabolites in drug substance and finished product testing.
• Metabolite Research: Critical for in vitro and in vivo studies investigating the metabolism, pharmacokinetics, and pharmacodynamics of the parent drug procainamide.
• Analytical Method Development: Serves as a key component in developing and validating HPLC, LC-MS, and other chromatographic methods for bioanalysis and impurity profiling.
• Impurity Standard: Employed as a specified impurity standard to monitor and control the quality of procainamide hydrochloride active pharmaceutical ingredient (API) according to pharmacopeial guidelines.
• Preclinical & Clinical Studies: Utilized in toxicology and clinical trials to understand the safety profile and efficacy contributions of the acetylated metabolite.
• Chemical Synthesis: Acts as a building block or precursor for the synthesis of novel chemical entities or labeled analogs for tracer studies.

Basic Information

Product Name	n-Acetylprocainamide Hydrochloride
CAS No.	34118-92-8
Molecular Formula	C15H24N3O2•HCl
Molecular Weight	307.83 g/mol (Free base: 271.37)
Synonyms	N-Acetylprocainamide HCl; NAPA Hydrochloride; Acecainide Hydrochloride; Procainamide N-Acetyl Metabolite Hydrochloride; 4-Amino-N-[2-(diethylamino)ethyl]benzamide, N-acetyl-, hydrochloride; N-Acetyl Procainamide HCl; Acetylprocainamide Hydrochloride
EINECS	Contact for details

Quality Control

Our n-Acetylprocainamide Hydrochloride is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing to ensure identity, purity, and consistency, meeting the stringent requirements for use as a reference material. A detailed Certificate of Analysis (COA) is provided with each shipment, documenting results for assay, related substances, residual solvents, and other critical parameters. We support compliance with ICH guidelines and can supply material suitable for use under cGMP for pharmaceutical development.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). Due to its hygroscopic nature, the container should be kept in a desiccated environment to prevent moisture absorption. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white crystalline powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	≥98.0%
Related Substances (HPLC)	Total impurities ≤2.0% Any single unknown impurity ≤0.5%
Water Content (KF)	≤1.0%
Residue on Ignition	≤0.1%
Heavy Metals	≤20 ppm

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