Key Properties of Sucralfate
| Product Name: | Sucralfate |
| Synonyms: | Basic Aluminium Sucrose Sulphate, Aluminium Sucrose Octasulphate Complex |
| CAS No: | 54182-58-0 |
| Chemical Formula: | Al₈(OH)ₙ(C₁₂H₁₄O₃₅S₈)[Al(OH)₃]ₙ[H₂O]ₙ |
| Grade: | Pharmaceutical Grade |
| Appearance: | White or almost white, amorphous, odourless powder |
| Sucrose Octasulphate: | 30.0% to 38.0% |
| Aluminium Content: | 15.5% to 18.5% (as-is basis) |
| Solubility: | Not specified in the provided monograph |
Inquiry
WhatsappSucralfate Manufacturing process
Sucralfate is manufactured through a controlled reaction involving sucrose-derived sulfate and an aluminium source to produce the aluminium complex of sulfated sucrose.
The process generally begins with the preparation of a sulfated sucrose intermediate under controlled reaction conditions. The intermediate then reacts with a suitable aluminium compound to form the Sucralfate complex. The reaction mass undergoes controlled pH adjustment, purification and washing to remove soluble impurities and residual reactants.
The purified material is then separated by filtration or centrifugation, followed by controlled drying. The dried product is milled and sieved to achieve the required particle-size characteristics. The finished Sucralfate undergoes quality-control testing against the applicable pharmaceutical specification before packing.
Sucralfate Applications
Pharmaceutical Applications
Peptic Ulcer Formulations
Duodenal Ulcer Formulations
Gastric Mucosal Protection
Gastrointestinal Formulations
Oral Suspension Formulations
Tablet Formulations
Acid-Related Gastrointestinal Conditions
Sucralfate Specifications
Sucralfate IP Specification
Download Sucralfate IP Specification
| Sr. No. | Test | Specification |
|---|---|---|
| 1 | Description | A white or almost white, amorphous, odourless powder |
| 2 | Identification | Complies with the specified identification tests |
| 3 | Appearance of Solution | A 10.0% w/v solution in 1 M sulphuric acid is clear and colourless |
| 4 | Neutralising Capacity | Not less than 12.0 mEq of acid is consumed per g of sucralfate |
| 5 | Chloride | Not more than 0.5% |
| 6 | Arsenic | Not more than 4 ppm |
| 7 | Pyridine and 2-Methylpyridine | Not more than 0.05% each of pyridine and 2-methylpyridine |
| 8 | Sucrose Heptasulphate | Ratio of sucrose heptasulphate peak to sucrose octasulphate peak is not more than 0.1 |
| 9 | Aluminium | 15.5% to 18.5% of aluminium, calculated on an as-is basis |
| 10 | Assay (Sucrose Octasulphate) | Not less than 30.0% and not more than 38.0% of sucrose octasulphate |
Sucralfate USP Specification
Download Sucralfate USP Specification
| Sr. No. | Test | Specification |
|---|---|---|
| 1 | Description | A white or almost white, amorphous powder |
| 2 | Identification A | The retention time of the sucrose octasulfate peak in the chromatogram of the Assay preparation corresponds to that in the chromatogram of the Standard preparation |
| 3 | Identification B | Complies with the specified chemical identification test |
| 4 | Identification C – Aluminium | Meets the requirements of the tests for Aluminium |
| 5 | Acid-neutralizing Capacity | Not less than 12 mEq of acid is consumed per g of Sucralfate |
| 6 | Chloride | Not more than 0.50% |
| 7 | Arsenic | Not more than 4 ppm |
| 8 | Pyridine | Not more than 0.05% |
| 9 | 2-Methylpyridine | Not more than 0.05% |
| 10 | Limit of Sucrose Heptasulfate | Ratio of the sucrose heptasulfate peak to the sucrose octasulfate peak is not more than 0.1 |
| 11 | Aluminium Content | 15.5% to 18.5%, calculated on an “as is” basis |
| 12 | Assay – Sucrose Octasulfate | Not less than 30.0% and not more than 38.0% of sucrose octasulfate |
Sucralfate Packing and Storage condition
Packing:
Sucralfate can be packed in 25 kg HDPE drums or suitable HDPE bags with an inner polyethylene liner, or as per customer requirements. Use well-closed, moisture-resistant packaging to protect product quality.
Storage:
Store in a cool, dry and well-ventilated place in tightly closed containers. Protect from moisture, excessive heat, direct sunlight and contamination. Keep the original container securely closed when not in use.
Why Choose Chemignition for
Sucralfate Supply?
Quality Assurance
Grade Compliance
Sucralfate is manufactured in adherence to stringent global pharmaceutical standards.
In-House Quality Control
Each batch undergoes rigorous testing for purity, stability, and efficacy.
Regulatory Approvals
Certified for export and compliant with international regulatory requirements.
Large-Scale Manufacturing and Export
Grade Compliance
Sucralfate is manufactured in adherence to stringent global pharmaceutical standards.
In-House Quality Control
Each batch undergoes rigorous testing for purity, stability, and efficacy.
Regulatory Approvals
Certified for export and compliant with international regulatory requirements.
