Lansoprazole

Lansoprazole

Parameter Specification
Product Name Lansoprazole
CAS Number 103577-45-3
Molecular Formula C16H14F3N3O2S
Molecular Weight 369.36 g/mol
Appearance White to off-white crystalline powder
Assay (HPLC) 98.0% – 102.0%
Solubility Soluble in methanol, slightly soluble in ethanol, practically insoluble in water
Package 25 kg fiber drum with double polyethylene liner

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Lansoprazole Structure

Synonyms: Lansoprazole, 103577-45-3, Prevacid, 2-[[[3-Methyl-4-(2,2,2-trifluoroethoxy)-2-pyridinyl]methyl]sulfinyl]-1H-benzimidazole, AG-1749, Lansoprazole API

Lansoprazole is a substituted benzimidazole that acts as a proton pump inhibitor (PPI). It is the active pharmaceutical ingredient (API) manufactured under cGMP conditions, available in USP/EP/BP grades. The compound works by irreversibly blocking the hydrogen/potassium adenosine triphosphatase enzyme system (the proton pump) of the gastric parietal cell, thereby suppressing gastric acid secretion.

As a second-generation PPI, lansoprazole offers reliable acid control and is widely prescribed for gastroesophageal reflux disease (GERD), peptic ulcers, and Zollinger-Ellison syndrome. Its favorable pharmacokinetic profile and rapid onset make it a preferred choice for both prescription and OTC formulations. We supply high-purity lansoprazole to pharmaceutical manufacturers and research institutions worldwide, ensuring consistent quality and regulatory compliance.

Product Highlights

  • High Purity: ≥99.5% purity, meeting USP/EP/BP specifications.
  • Regulatory Support: CEP, DMF, and cGMP documentation available for regulatory filings.
  • Stable Supply: Robust manufacturing with annual capacity exceeding 50 metric tons.
  • Quality Assurance: Each batch is fully tested and comes with a comprehensive COA.
  • Custom Packaging: Available in various pack sizes to suit R&D and production needs.
  • Technical Support: Experienced team to assist with formulation and regulatory queries.

Applications & Formulation Use

  • GERD and Ulcer Treatment: Core API for delayed-release capsules and tablets.
  • Combination Therapy: Used with antibiotics for H. pylori eradication regimens.
  • Pediatric Formulations: Suitable for oral suspensions and sprinkle capsules.
  • Research: Reference standard for analytical method development and stability studies.

Quality Specifications (QC Tests)

Test Item Specification
Identification IR, UV: complies with USP/EP
Loss on Drying ≤0.5%
Residue on Ignition ≤0.1%
Heavy Metals ≤20 ppm
Organic Impurities Meets USP/EP limits
Microbial Limits Total aerobic count ≤1000 cfu/g, Yeast & Mold ≤100 cfu/g, E. coli absent

Bulk Supply & Ordering

  • Packaging: 25 kg fiber drum with double polyethylene liner, or as per customer request.
  • MOQ: 1 kg for trial orders; 25 kg for commercial orders.
  • Lead time: 3-5 business days (stock items).
  • Documentation: COA, MSDS, TDS, and regulatory support (CEP, DMF) provided upon request.

Frequently Asked Questions

What is the minimum order quantity (MOQ) for Lansoprazole?

Our MOQ is 1 kg for trial orders and 25 kg for commercial orders. Larger quantities can be accommodated with flexible scheduling.

What is the delivery time?

For stock items, delivery is within 3-5 business days after order confirmation. Custom orders may require additional time, which will be communicated upon inquiry.

Can you provide a COA and samples?

Yes, we provide a COA for every batch. Samples are available upon request, typically shipped within 1-2 days.

Contact & Ordering Information

  • Company: LyvBio Co., Ltd.
  • Address: Room 5-0203, Courtyard 205, Lianhu District, Xi’an, Shaanxi, China
  • Email: info@lyvbio.com
  • Phone: +86-29-65816888

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Room,5-0203, Unit 5, Beiyuanmen Street,Xi'an,Shaanxi,China

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