Description

Sodium 4-Aminosalicylate Dihydrate is the sodium salt dihydrate form of 4-aminosalicylic acid, a compound of significant pharmaceutical importance. This high-purity chemical is valued for its consistent quality and reliable performance in critical manufacturing processes. It serves as a key active pharmaceutical ingredient (API) and intermediate, primarily demanded by manufacturers in the pharmaceutical, biotechnology, and fine chemical synthesis sectors for producing anti-tuberculosis medications and other therapeutic agents.

Application

• Pharmaceutical API: Primary use as an active pharmaceutical ingredient in the formulation of second-line anti-tuberculosis drugs.
• Chemical Synthesis Intermediate: Serves as a crucial building block for the synthesis of more complex salicylate derivatives and prodrugs.
• Research & Development: Used in biochemical and pharmacological research to study mycobacterial inhibition and drug mechanisms of action.
• Veterinary Pharmaceuticals: Employed in the development of treatments for bacterial infections in animals.
• Reference Standard: Utilized as a high-purity analytical standard in quality control laboratories for HPLC, titration, and spectroscopic methods.

Basic Information

Product Name	Sodium 4-Aminosalicylate Dihydrate
CAS No.	6018-19-5
Molecular Formula	C7H8NNaO5 • 2H2O
Molecular Weight	233.14 g/mol (Anhydrous basis: 197.13 g/mol)
Synonyms	4-Aminosalicylic Acid Sodium Salt Dihydrate; Sodium PAS Dihydrate; PAS-Na Dihydrate; Para-Aminosalicylate Sodium Salt Dihydrate; 4-ASA Sodium Salt Dihydrate; Aminosalicylate Sodium Dihydrate; Sodium 4-Amino-2-hydroxybenzoate Dihydrate; P-Aminosalicylic Acid Sodium Salt Dihydrate
EINECS	227-895-6

Quality Control

Our Sodium 4-Aminosalicylate Dihydrate is manufactured under strict quality management systems to ensure it meets the stringent requirements of pharmaceutical applications. Each batch is subjected to comprehensive analytical testing, including identification, assay, impurity profiling, and residual solvent analysis. A Certificate of Analysis (COA) detailing all test results against relevant pharmacopeial standards (such as USP/EP) is provided with every shipment to guarantee traceability and compliance.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry, and well-ventilated area at a controlled room temperature (15-25°C). Due to its hygroscopic (moisture-sensitive) nature, the container must be kept tightly sealed after opening to prevent absorption of atmospheric moisture. For long-term storage, consider using desiccants or storing under an inert atmosphere to minimize the risk of oxidation.

Specification

Item	Specification
Appearance	White to off-white crystalline powder
Identification (IR)	Conforms to standard
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Water Content (KF)	13.0% - 16.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single impurity ≤ 0.5%
Residue on Ignition	≤ 0.1%
Heavy Metals	≤ 20 ppm
Microbial Enumeration	Meets Ph. Eur. 2.6.12 / USP <61> requirements

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