Gabexate API | Pharmaceutical API Manufacturer in India

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Gabexate API

Gabexate is a synthetic serine protease inhibitor used as a pharmaceutical active ingredient. It is a synthetic ester derivative that inhibits several proteolytic enzymes, including trypsin, kallikrein, thrombin and other serine proteases. Gabexate has been investigated and used clinically in conditions involving excessive protease activity, particularly in acute pancreatitis and certain coagulation-related disorders.

Gabexate API Manufacturer in India

Gabexate is a specialized pharmaceutical API belonging to the protease inhibitor class. It is commonly encountered as gabexate mesilate (gabexate mesylate), a water-soluble methanesulfonate salt used for injectable pharmaceutical preparations.

Chemical Information

CAS Number: 39492-94-9
Molecular Formula: C16H23N3O4·CH4O3S
Molecular Weight: 417.48 g/mol
Common Form: Gabexate Mesilate
Drug Class: Serine Protease Inhibitor
Therapeutic Class: Protease Inhibitor
Therapeutic Area: Gastroenterology / Critical Care

Mechanism of Action

Gabexate inhibits serine proteases by interacting with the catalytic site of these enzymes. Its inhibitory activity can reduce proteolytic processes involving enzymes such as trypsin, kallikrein, thrombin and plasmin. This mechanism is relevant to research and clinical applications involving pancreatic enzyme activation and coagulation pathways.

Pharmaceutical Applications

Gabexate mesilate has been used in pharmaceutical preparations for acute pancreatitis and has also been investigated in disseminated intravascular coagulation and other conditions involving excessive protease activity.

Gabexate Mesilate

Gabexate mesilate is the methanesulfonate salt form of gabexate. The salt form improves water solubility and is suitable for preparation of injectable pharmaceutical formulations.

Physical and Chemical Properties

Gabexate mesilate is a synthetic small-molecule protease inhibitor. It contains ester and guanidino functional groups and a methanesulfonate counterion. The molecular weight of gabexate mesilate is approximately 417.48 g/mol.

Quality and Analytical Testing

Gabexate API quality evaluation may include identification by IR and HPLC, assay by HPLC, related substances, water content, residual solvents, residue on ignition and elemental impurity testing. Appropriate validated analytical methods should be used for pharmaceutical quality control.

Storage

Gabexate should be stored in a tightly closed container under controlled pharmaceutical conditions and protected from excessive heat, moisture and direct light. Storage requirements should follow the applicable validated stability data and material-specific specification.

Pharmaceutical Research and Development

Gabexate is relevant to pharmaceutical research involving serine protease inhibition, pancreatic enzyme activity and coagulation pathways. Its pharmacological profile has supported investigation of protease inhibition in inflammatory and coagulation-related conditions.

Gabexate API Summary

Gabexate is a synthetic serine protease inhibitor commonly used in its mesilate salt form. Gabexate mesilate has CAS Number 39492-94-9 and molecular weight 417.48 g/mol. It has been used particularly in pharmaceutical preparations associated with acute pancreatitis and has also been investigated for coagulation-related applications.

Detailed Specifications

Parameter Specification
Appearance White to off-white crystalline powder
Identification IR & HPLC compliant
Loss on Drying NMT 1.0%
Heavy Metals NMT 20 ppm
pH (1% Solution) 3.0 – 5.0
Individual Impurity ≤ 0.5%
Total Impurities NMT 2.0%
Water Content NMT 2.0%
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