Description

Lansoprazole CAS NO 103577-45-3 is a proton pump inhibitor (PPI) belonging to the benzimidazole class, widely recognized for its potent and long-lasting suppression of gastric acid secretion. This high-purity active pharmaceutical ingredient (API) is critical for the formulation of safe and effective anti-ulcer medications. It is primarily required by pharmaceutical manufacturers and research institutions engaged in the development and production of treatments for gastroesophageal reflux disease (GERD), peptic ulcers, and Zollinger-Ellison syndrome.

Application

• Pharmaceutical API: Core active ingredient in prescription and over-the-counter (OTC) medications for acid-related disorders.
• Solid Dosage Forms: Formulation into delayed-release capsules, tablets, and orally disintegrating tablets (ODTs).
• Combination Therapies: Used in fixed-dose combination drugs, often with antibiotics for Helicobacter pylori eradication regimens.
• Veterinary Medicine: Application in veterinary pharmaceuticals for treating gastric ulcers in animals.
• Clinical Research: Serves as a reference standard and key material in pharmacokinetic and pharmacodynamic studies.
• Generic Drug Manufacturing: Essential for the production of bioequivalent generic versions of branded lansoprazole drugs.

Basic Information

Product Name	Lansoprazole
CAS No.	103577-45-3
Molecular Formula	C16H14F3N3O2S
Molecular Weight	369.36 g/mol
Synonyms	AG-1749; Lanzor; Prevacid; Takepron; Zoton; 2-[[[3-Methyl-4-(2,2,2-trifluoroethoxy)-2-pyridinyl]methyl]sulfinyl]-1H-benzimidazole; (±)-Lansoprazole
EINECS	Contact for details

Quality Control

Our Lansoprazole is manufactured under strict quality management systems. Each batch is tested to ensure it meets high-purity standards suitable for pharmaceutical use, with specifications typically referencing USP, EP, or in-house pharmacopeial guidelines. Comprehensive testing includes identification, assay, and control of related substances and residual solvents. A Certificate of Analysis (COA) documenting all test results is provided with every shipment.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). The product is light-sensitive and should be handled under appropriate conditions to maintain stability and potency.

Specification

Item	Specification
Appearance	White to slightly yellowish crystalline powder
Identification (IR)	Conforms
Identification (HPLC)	Conforms
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Related Substances (HPLC)	Individual impurity: NMT 0.5% Total impurities: NMT 1.5%
Water (KF Titration)	NMT 0.5%
Residue on Ignition	NMT 0.1%
Heavy Metals	NMT 20 ppm
Residual Solvents (GC)	Complies with ICH Q3C

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