Oseltamivir

Oseltamivir

Parameter Specification
Product Name Oseltamivir
CAS Number 196618-13-0
Molecular Formula C16H28N2O4
Molecular Weight 312.41 g/mol
Appearance White to off-white crystalline powder
Assay (HPLC) ≥98.0%
Solubility Soluble in water, ethanol, methanol; practically insoluble in hexane
Package 25 kg fiber drum with double polyethylene liner

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Oseltamivir Structure

Synonyms: Oseltamivir, Tamiflu, GS-4104, Ro 64-0796, ethyl (3R,4R,5S)-4-acetamido-5-amino-3-(pentan-3-yloxy)cyclohex-1-ene-1-carboxylate

Oseltamivir is a potent neuraminidase inhibitor that has become a first-line antiviral agent for the treatment and prophylaxis of influenza A and B. Developed by Gilead Sciences and later marketed by Roche as Tamiflu, it was approved by the FDA in 1999 and has since been stockpiled by governments worldwide as part of pandemic preparedness strategies. The compound is a prodrug that is rapidly converted by hepatic esterases to its active metabolite, oseltamivir carboxylate, which selectively inhibits the viral neuraminidase enzyme.

Chemically, oseltamivir is a cyclohexene derivative with a pentan-3-yloxy side chain and an ethyl ester group. Its structure mimics the natural substrate of neuraminidase, sialic acid, allowing it to bind with high affinity to the active site of the enzyme. This competitive inhibition prevents the release of newly formed virions from infected cells, thereby limiting the spread of the virus within the respiratory tract. The synthesis of oseltamivir is a multi-step process that has been optimized over the years to improve yield and reduce cost, with key steps including the formation of the cyclohexene ring and stereoselective introduction of the amino and acetamido groups.

Oseltamivir is available as the phosphate salt in pharmaceutical formulations, typically as capsules or oral suspension. The active pharmaceutical ingredient (API) is manufactured under cGMP conditions and is standardized to ≥98.0% purity by HPLC. It is widely used in the production of generic antiviral medications and is also employed as a reference standard in analytical laboratories. Our oseltamivir API is supplied as a white to off-white crystalline powder, freely soluble in water and common organic solvents, making it suitable for a range of formulation processes.

Function & Mechanism

  • Neuraminidase inhibition: Blocks the viral neuraminidase enzyme, preventing the release of new virus particles from infected cells.
  • Antiviral activity: Effective against influenza A and B viruses, including strains resistant to adamantanes.
  • Prodrug activation: Hepatic esterases convert oseltamivir to its active carboxylate form, which has a longer half-life and improved bioavailability.
  • Reduction of viral shedding: Limits the spread of infection and shortens the duration of symptoms when administered early.
  • Prophylactic use: Reduces the risk of influenza in close contacts and during outbreaks.

Source & Standardization

  • Source: Synthetic chemical synthesis
  • Standardization: ≥98.0% (HPLC), meets EP/USP monograph requirements
  • Forms: White to off-white crystalline powder
  • Applications: Antiviral drug manufacturing, pharmaceutical research, reference standard

Quality Specifications (QC Tests)

Test Item Specification
Identification IR, HPLC retention time conforms to reference standard
Loss on Drying ≤0.5%
Residue on Ignition ≤0.1%
Heavy Metals ≤20 ppm
Organic Impurities Any individual impurity ≤0.5%; total impurities ≤2.0%
Residual Solvents Meets ICH Q3C limits
Microbial Limits Total aerobic count ≤1000 CFU/g; yeast and mold ≤100 CFU/g; absence of E. coli and Salmonella

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 drum with double polyethylene liner, or as per customer requirement

Frequently Asked Questions

What is the minimum order quantity (MOQ) for Oseltamivir API?

Our standard MOQ is 1 kg. For larger quantities, please contact our sales team for a customized quote.

What is the delivery time for Oseltamivir API?

For stock items, the lead time is 3-5 business days from order confirmation. We maintain ample inventory to ensure prompt shipment.

Do you provide a Certificate of Analysis (COA) and samples?

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

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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