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Lansoprazoleis (CAS 103577-45-3), a potent, substituted Benzimidazole Proton Pump Inhibitor (PPI) API classified as an antiulcer and antisecretory agent. As a prodrug, Lansoprazole's therapeutic potency is unleashed within the highly acidic environment (pH < 4) of the gastric parietal cell canaliculi. There, Lansoprazole undergoes an acid-catalysed transformation into its active form, a tetracyclic sulfenamide intermediate. This active metabolite achieves its profound acid suppression by forming stable, covalent disulfide bonds with specific cysteine residues on the gastric H⁺/K⁺-ATPase enzyme (as proton pump). This binding causes the irreversible inactivation of the pump, effectively blocking the final step of acid secretion into the stomach lumen, ensuring a prolonged therapeutic effect (up to 24-48 hours) necessary for the effective healing of GERD and ulcers, which is why the API must be meticulously formulated with enteric coating and alkaline stabilisers to survive gastric transit. Also called 'Prevacid' or ‘Lansoprazolum’ by Lansoprazole manufacturers. We are the leading Lansoprazole supplier worldwide with usp grade specifically ensuring comprehensive regulatory support & CoA traceability with global supply capability with reliable lead time.
Lansoprazoleis (CAS 103577-45-3), a potent, substituted Benzimidazole Proton Pump Inhibitor (PPI) API classified as an antiulcer and antisecretory agent. As a prodrug, Lansoprazole's therapeutic potency is unleashed within the highly acidic environment (pH < 4) of the gastric parietal cell canaliculi. There, Lansoprazole undergoes an acid-catalysed transformation into its active form, a tetracyclic sulfenamide intermediate. This active metabolite achieves its profound acid suppression by forming stable, covalent disulfide bonds with specific cysteine residues on the gastric H⁺/K⁺-ATPase enzyme (as proton pump). This binding causes the irreversible inactivation of the pump, effectively blocki...
Chemical Properties & Specifications
H315 (96.3%): Causes skin irritation
H319 (96.3%): Causes serious eye irritation
H335 (95.6%): May cause respiratory irritation
R36/37/38
S26; S36
P261, P264, P264+P265, P271, P280, P302+P352, P304+P340, P305+P351+P338, P319, P321, P332+P317, P337+P317, P362+P364, P403+P233, P405, and P501
(Gastric Acid Suppression) Short-term treatment and maintenance of Gastroesophageal Reflux Disease (GERD) and Erosive Esophagitis (EE)
(Ulcer Healing) Treatment of active Duodenal Ulcers, Gastric Ulcers, and those associated with NSAID use
(H. pylori Eradication) Key component in Triple Therapy regimens (Lansoprazole + two antibiotics) to treat H. pylori infections
(Acid Control Conditions) Management of pathological hypersecretory conditions, notably Zollinger-Ellison Syndrome (ZES)
Refrigerated Storage Recommended: Store at 2°C - 8°C (36°F - 46°F). Heat accelerates chemical breakdown (hydrolysis and oxidation)
Protect from Light, Air, and Moisture. The APl is light and moisture-sensitive, leading to the formation of impurities (Sulfone and Sulfide derivatives). Store under a protective inert gas (e.g., Nitrogen or Argon)
Store isolated from strong acids or acidic fumes to prevent pre-activation or degradation of the prodrug form
Strict control and retesting of materials nearing expiration are required due to potential degradation products
Lansoprazole API is chemically sensitive, requiring strict control over its exposure to heat, light, and humidity to prevent degradation and maintain assay purity
The long-lasting effect is achieved not by persistence in the blood, but by its covalent, irreversible binding to the Proton Pump ( Ht/Kt-ATPase). Acid secretion only resumes when the body synthesizes and incorporates new Proton Pumps into the cell membrane, which typically takes over 24 hours.
Lansoprazole is highly acid-labile (unstable in acid). Therefore, CDMOs must use sophisticated **Delayed-Release** formulation technologies, incorporating an enteric coating on the granules or pellets, often utilising alkaline stabilising excipients (e.g., magnesium carbonate) in the core to ensure the API survives the high-acid environment of the stomach to reach the small intestine for absorption.
Yes, it is critically important in the eradication of H. pylori. By potently suppressing gastric acid, Lansoprazole creates a favourable, higher- pH environment that significantly enhances the efficacy and stability of co-administered antibiotics (Amoxicillin and Clarithromycin or (Metronidazole), optimising treatment success.
Available globally as a prescription (R) and/or Over-The-Counter (OTC) drug, requiring GMP/ICH compliance and DMF documentation.
Long-term use is associated with a slight increase in the risk of osteoporosis-related fractures and hypomagnesemia (low magnesium levels).
HDPE Drums or Glass Containers with inner aluminum or polyethylene liners. Packaging must be airtight and opaque to prevent light and moisture ingress.
The container must be sealed under a nitrogen blanket after sampling or production packaging. Essential to minimize oxidation and maintain the stability of the sulfinyl group (S=O).
