Ilaprazole API | Proton Pump Inhibitor API Manufacturer in India

Swapnroop Pharma · WHO-GMP Certified · +91 87670 62101

Ilaprazole API

Ilaprazole is a proton pump inhibitor (PPI) that reduces gastric acid secretion by inhibiting the H+/K+-ATPase proton pump in gastric parietal cells. It is developed for pharmaceutical applications involving acid-related gastrointestinal disorders.

Ilaprazole is an acid-suppressing benzimidazole derivative and is primarily associated with the management of conditions such as gastroesophageal reflux disease (GERD), peptic ulcer disease and other disorders involving excessive gastric acid secretion, depending on the approved indication.

Ilaprazole API Manufacturer in India

Ilaprazole is a specialized synthetic pharmaceutical API requiring controlled chemical synthesis, purification and analytical testing. Quality control generally focuses on identity, assay, related substances, residual solvents, water content, elemental impurities and stability-related degradation products.

Ilaprazole is particularly relevant to pharmaceutical development of oral solid dosage forms intended for acid suppression.

Chemical Information

CAS Number: 172152-36-2
Molecular Formula: C19H18N4O2S
Molecular Weight: 366.44 g/mol
Chemical Name: Ilaprazole
Drug Class: Proton Pump Inhibitor
Pharmacological Class: Gastric H+/K+-ATPase Inhibitor
Therapeutic Class: Antiulcer / Acid-Suppressing Agent
Therapeutic Area: Gastroenterology

Mechanism of Action

Ilaprazole belongs to the substituted benzimidazole class of proton pump inhibitors.

After reaching the acidic environment of gastric parietal cells, it undergoes activation and interacts with the H+/K+-ATPase proton pump. Inhibition of this final step of gastric acid secretion results in suppression of both basal and stimulated acid production.

This reduction in gastric acidity supports healing of acid-related gastrointestinal lesions and relief of symptoms associated with excessive gastric acid.

Pharmaceutical Applications

Ilaprazole is used or investigated in pharmaceutical formulations for acid-related gastrointestinal conditions such as:

  • Gastroesophageal reflux disease (GERD)
  • Peptic ulcer disease
  • Gastric and duodenal ulcers
  • Acid-related dyspeptic conditions
  • Other hyperacidity-associated gastrointestinal disorders

The exact approved indications vary according to country and product labeling.

Ilaprazole in Gastroenterology

Ilaprazole is designed to provide sustained suppression of gastric acid secretion through inhibition of the gastric proton pump. Like other PPIs, its therapeutic effect is associated with increasing gastric pH and reducing acid exposure.

Proton Pump Inhibition

The gastric H+/K+-ATPase is responsible for the final secretion of hydrogen ions into the stomach lumen. By inhibiting this enzyme, Ilaprazole acts at the final stage of gastric acid secretion.

This mechanism distinguishes PPIs from medicines that act primarily by neutralizing already-secreted acid or blocking histamine H2 receptors.

Physical and Chemical Properties

Ilaprazole is a synthetic benzimidazole derivative containing nitrogen and sulfur functional groups. It is generally supplied as a crystalline solid for pharmaceutical manufacturing.

As with other proton pump inhibitors, chemical stability and formulation design are important because benzimidazole-based PPIs can be sensitive to acidic conditions.

Quality and Analytical Testing

Ilaprazole API quality evaluation may include:

  • Identification by IR
  • Identification by HPLC
  • Assay by HPLC
  • Related substances
  • Degradation products
  • Water content
  • Residual solvents
  • Residue on ignition
  • Elemental impurities
  • Heavy metals
  • Melting range
  • Particle-size distribution where applicable
  • Polymorphic form, where relevant

Storage

Ilaprazole API should be stored in a tightly closed container under controlled pharmaceutical conditions and protected from excessive moisture, heat and direct light. Appropriate packaging and storage are important for maintaining chemical stability.

Pharmaceutical Research and Development

Ilaprazole is relevant to pharmaceutical research involving proton pump inhibition, gastric acid secretion, gastroesophageal reflux, peptic ulcer therapy and oral acid-suppressing formulations.

Ilaprazole API Summary

Ilaprazole is a proton pump inhibitor with CAS Number 172152-36-2, molecular formula C19H18N4O2S, and molecular weight 366.44 g/mol. It suppresses gastric acid secretion through inhibition of the gastric H+/K+-ATPase proton pump and is associated with pharmaceutical applications in acid-related gastrointestinal disorders.

Detailed Specifications

Parameter Specification
Appearance White to off-white crystalline powder
Identification IR & HPLC compliant
Assay (HPLC) 98.0% – 102.0%
Loss on Drying NMT 1.0%
Residue on Ignition NMT 0.5%
Heavy Metals NMT 20 ppm
Individual Impurity NMT 0.5%
Total Impurities NMT 1.0%
Water Content NMT 1.0%
Get Bulk Quote via WhatsApp