Rabeprazole

Rabeprazole

Parameter Specification
Product Name Rabeprazole
CAS Number 117976-90-6
Molecular Formula C18H21N3O3S
Molecular Weight 359.44 g/mol
Appearance White to off-white crystalline powder
Assay (HPLC) ≥98.5%
Solubility Soluble in methanol, ethanol; practically insoluble in water
Package 25 kg net in fiber drum with double polyethylene liner

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Rabeprazole Structure

Synonyms: Rabeprazole sodium, AcipHex, Pariet, E3810, 2-[[[4-(3-Methoxypropoxy)-3-methyl-2-pyridinyl]methyl]sulfinyl]-1H-benzimidazole

Rabeprazole is a substituted benzimidazole derivative that functions as a proton pump inhibitor (PPI). It is the active pharmaceutical ingredient (API) in several brand and generic formulations used for the treatment of acid-related disorders, including gastroesophageal reflux disease (GERD), duodenal ulcers, and Zollinger-Ellison syndrome. Unlike some PPIs, rabeprazole shows less dependence on CYP2C19 metabolism, which contributes to its consistent pharmacokinetic profile across different patient populations.

First approved in the late 1990s, rabeprazole has become a mainstay in gastrointestinal therapy. It is often prescribed as the sodium salt, rabeprazole sodium, which is more stable and water-soluble. The compound’s ability to rapidly inhibit gastric acid secretion and its favorable safety profile have made it a preferred choice for both acute and maintenance treatment.

For pharmaceutical manufacturers, rabeprazole is available in high purity grades suitable for oral solid dosage forms. It is typically supplied as a white to off-white crystalline powder, with strict control over particle size and polymorphic form to ensure consistent bioavailability. The API is manufactured under cGMP conditions and is supported by comprehensive regulatory documentation.

Function & Mechanism

  • Proton pump inhibition: Irreversibly binds to H+/K+-ATPase in gastric parietal cells, blocking the final step of acid secretion.
  • Rapid onset: Achieves peak plasma concentration within 2–5 hours, providing fast symptom relief.
  • Acid suppression: Maintains intragastric pH above 4 for extended periods, promoting ulcer healing.
  • H. pylori eradication: Used in combination with antibiotics to eradicate Helicobacter pylori infection.

Source & Standardization

  • Source: Synthetic chemical process starting from 2,3-dimethylpyridine derivatives.
  • Manufacturing: Multi-step organic synthesis, followed by purification and salt formation (if applicable).
  • Standardization: ≥98.5% assay by HPLC; complies with EP, USP, and ICH guidelines.
  • Forms: White to off-white crystalline powder; also available as rabeprazole sodium.
  • Applications: Oral solid dosage forms (tablets, capsules), research, and formulation development.

Quality Specifications (QC Tests)

Test Item Specification
Identification IR, HPLC retention time conforms to reference
Loss on Drying ≤0.5%
Residue on Ignition ≤0.1%
Heavy Metals ≤20 ppm
Organic Impurities Total impurities ≤0.5%; any unspecified ≤0.2%
Residual Solvents Meets ICH Q3C limits
Microbial Limits Total aerobic count ≤1000 CFU/g; yeast & mold ≤100 CFU/g

Bulk Supply & Documentation

  • Monthly capacity: 500 kg
  • Lead time: 3-5 business days (stock items)
  • Documentation: COA, MSDS, TDS, DMF available upon request
  • Packaging: 25 kg fiber drums with double polyethylene liners; custom packaging available

Frequently Asked Questions

What is the minimum order quantity (MOQ)?

Our standard MOQ for Rabeprazole is 1 kg. For larger quantities, we offer competitive pricing and flexible scheduling.

What is the delivery time?

For stock items, delivery is 3-5 business days from order confirmation. We ship globally via express couriers.

Do you provide COA and samples?

Yes, we provide a Certificate of Analysis (COA) for each batch. Samples are available upon request for evaluation purposes.

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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