Description

Sucralfate is a complex salt of sucrose octasulfate and aluminum hydroxide, primarily recognized for its potent gastroprotective and ulcer-healing properties. This compound matters significantly as a non-systemic medication that forms a protective barrier at ulcer sites, promoting healing and providing relief. It is essential for pharmaceutical manufacturers developing treatments for active duodenal ulcers, gastritis, and gastroesophageal reflux disease (GERD). Sucralfate CAS NO 54182-58-0 is a critical active pharmaceutical ingredient (API) for formulators requiring a reliable and effective cytoprotective agent.

Application

• Primary Active Pharmaceutical Ingredient (API) in prescription medications for treating and preventing the recurrence of duodenal ulcers.
• Key component in gastroprotective formulations for managing gastritis and stress-related mucosal damage.
• Used in oral suspension and tablet formulations for the symptomatic relief of gastroesophageal reflux disease (GERD).
• Investigated for use in veterinary medicine for treating gastrointestinal ulcers in companion animals and livestock.
• Employed in clinical research as a standard cytoprotective agent for comparative drug studies.
• Potential excipient or co-formulant in specialized drug delivery systems targeting the gastric mucosa.

Basic Information

Item	Details
Product Name	Sucralfate
CAS No.	54182-58-0
Molecular Formula	C12H54Al16O75S8
Molecular Weight	2086.74 g/mol
Synonyms	Sucrose octasulfate basic aluminum salt; Sucralfatum; Ulcerban; Ulcerlmin; Carafate; Sucralfato; Sucralfat; Antepsin; Alsucral; Sucral
EINECS	Contact for details

Quality Control

Our Sucralfate is manufactured and tested to meet stringent pharmacopeial standards, including USP-NF and EP monographs. Every batch undergoes comprehensive analytical testing for identity, potency, and purity, with strict limits on related substances and residual solvents. A comprehensive Certificate of Analysis (COA) documenting all test results against release specifications is provided with each shipment to ensure full traceability and regulatory compliance for our pharmaceutical partners.

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 must be kept in a low-humidity environment to prevent caking and degradation. The storage area should be well-ventilated and separate from strong oxidizing agents.

Specification

Item	Specification
Appearance	White to off-white, amorphous powder
Identification (IR)	Conforms to standard
Identification (Aluminum)	Conforms to standard
pH (2% suspension)	3.5 - 6.0
Assay (on dried basis)	96.0% - 102.0%
Loss on Drying	≤ 14.0%
Heavy Metals	≤ 20 ppm
Related Substances (HPLC)	Individual impurity ≤ 0.5%; Total impurities ≤ 2.0%
Residual Solvents	Complies with ICH Q3C
Microbial Enumeration	Meets USP <61> requirements

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