Omeprazole

Omeprazole

Parameter Specification
Product Name Omeprazole
CAS Number 73590-58-6
Molecular Formula C17H19N3O3S
Molecular Weight 345.42 g/mol
Appearance White to off-white crystalline powder
Assay (HPLC) 98.0% – 102.0% (on dried basis)
Solubility Sparingly soluble in water, freely soluble in methanol, slightly soluble in ethanol
Package 25 kg fiber drum with double polyethylene liners

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Omeprazole Structure

Synonyms: Losec, Prilosec, Antra, Zegerid, H 168/68, 5-Methoxy-2-[(4-methoxy-3,5-dimethyl-2-pyridinyl)methyl]sulfinyl]-1H-benzimidazole

Omeprazole has been a cornerstone of acid-related disorder management for decades, and demand from generic drug manufacturers and nutraceutical formulators remains steady. As the first proton pump inhibitor approved for clinical use, it continues to be a high-volume API in both prescription and OTC markets, particularly for delayed-release capsules and tablets.

Chemically, omeprazole is a substituted benzimidazole that acts as a prodrug. It is a racemic mixture of two enantiomers, though the S-enantiomer (esomeprazole) is also marketed separately. The compound is synthesized through multi-step organic reactions, yielding a white to off-white crystalline powder that is practically insoluble in water but soluble in organic solvents.

The API is typically supplied in various polymorphic forms, with Form I being the most common for pharmaceutical use. Manufacturers must control particle size and polymorphic purity to ensure consistent bioavailability in finished dosage forms. Our omeprazole is produced under cGMP conditions, with full documentation supporting regulatory submissions.

Product Overview & Composition

Omeprazole is a weak base that accumulates in the acidic environment of gastric parietal cells, where it is activated to a sulfenamide intermediate. This active form covalently binds to the H+/K+-ATPase enzyme, inhibiting the final step of gastric acid secretion. The API is often formulated with enteric coatings to protect it from degradation in the stomach, ensuring delivery to the small intestine for absorption.

In terms of composition, omeprazole is a single active ingredient, but it may contain trace impurities from synthesis, such as omeprazole sulfone and omeprazole N-oxide. These are controlled through stringent quality standards. The product is available in different grades, including micronized and non-micronized forms, to suit various formulation needs.

Applications & Product Lines

  • Generic Prescription Drugs: Used in delayed-release capsules and tablets for treating gastroesophageal reflux disease (GERD), peptic ulcers, and Zollinger-Ellison syndrome.
  • OTC Medications: Formulated as immediate-release or delayed-release products for frequent heartburn relief.
  • Combination Products: Often combined with antibiotics for Helicobacter pylori eradication therapy.
  • Veterinary Medicine: Employed in veterinary formulations for acid-related conditions in animals.
  • Research & Development: Used as a reference standard in analytical studies and as a starting material for derivative synthesis.

Quality Control Standards

Test Item Specification
Identification IR absorption spectrum conforms to reference standard
Loss on Drying ≤ 0.5%
Heavy Metals ≤ 20 ppm
Organic Impurities Omeprazole sulfone ≤ 0.2%, any unspecified impurity ≤ 0.1%, total impurities ≤ 0.5%
Microbial Limits Total aerobic count ≤ 1000 CFU/g, yeast and mold ≤ 100 CFU/g, absence of E. coli and Salmonella
Residue on Ignition ≤ 0.1%

Bulk Packaging & Supply

  • Packaging: 25 kg fiber drums with double polyethylene liners, or as per customer request.
  • MOQ: 1 kg for trial orders, 25 kg for standard orders.
  • Lead time: 3-5 business days (stock items).
  • Documentation: COA, MSDS, TDS, and regulatory support available upon request.

Frequently Asked Questions

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

Our MOQ is 1 kg for trial orders and 25 kg for standard orders. For larger quantities, please contact us for a quotation.

What is the delivery time?

For stock items, the lead time is 3-5 business days after order confirmation.

Can you provide a COA and samples?

Yes, we provide a COA for each batch. Samples are available upon request; please contact our sales team for details.

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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