Description

Acamprosate Impurity 1 Potassium Salt is a high-purity reference standard critical for pharmaceutical research and development. This compound is essential for the identification, quantification, and control of process-related impurities during the manufacturing of Acamprosate Calcium, ensuring final drug product quality and regulatory compliance. It is primarily required by analytical laboratories, quality control departments, and R&D scientists in the pharmaceutical and fine chemical industries for method development and validation.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for analytical method development and validation in compliance with ICH guidelines.
• Quality Control & Assurance: Used for the identification and quantification of this specific impurity in Acamprosate Calcium active pharmaceutical ingredient (API) batches.
• Regulatory Compliance & Filing: Critical for preparing regulatory submission documents (e.g., for FDA, EMA) that require detailed impurity profiles.
• Process Chemistry Research: Employed in R&D to study and optimize synthesis pathways to minimize the formation of this impurity.
• Stability Studies: Used as a marker in forced degradation and long-term stability testing of Acamprosate drug products.
• Contract Research & Testing: Supplied to CROs and analytical service laboratories for client-specific impurity testing projects.

Basic Information

Product Name	Acamprosate Impurity 1 Potassium Salt
CAS No.	741659-31-4
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Acamprosate Related Compound 1 Potassium Salt; Potassium 3-Acetamidopropane-1-sulfonate Impurity; Homotaurine Impurity Potassium Salt; 3-Acetamidopropanesulfonic Acid Potassium Salt Impurity; Calcium Acamprosate Impurity 1 Potassium Salt; Campral Impurity 1 Potassium Salt; (3-Acetamidopropyl)sulfonic Acid Potassium Salt
EINECS	Contact for details

Quality Control

Our Acamprosate Impurity 1 Potassium Salt is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC for purity and identity confirmation via spectroscopic methods (IR, NMR), to ensure it meets the stringent requirements for use as a reference standard. A detailed Certificate of Analysis (COA) providing batch-specific data is supplied with every 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. For long-term storage, consider desiccants or inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms
Identification (IR)	Conforms to reference spectrum
Purity (HPLC)	≥ 95.0%
Water Content (KF)	≤ 5.0%
Residual Solvents (GC)	Complies with ICH limits

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