Oseltamivir

Oseltamivir

Tham số Thông số kỹ thuật
Tên sản phẩm Oseltamivir
Số CAS 196618-13-0
Công thức phân tử C16H28N2O4
Trọng lượng phân tử 312.41 g/mol
Hình thức Bột tinh thể màu trắng đến trắng ngà
Phương pháp phân tích (HPLC) ≥98,01 TP3T
Độ hòa tan Soluble in water, ethanol, methanol; practically insoluble in hexane
Gói 25 kg fiber drum with double polyethylene liner

Oseltamivir Structure

Từ đồng nghĩa: 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.

Nguồn gốc và tiêu chuẩn hóa

  • Nguồn: Synthetic chemical synthesis
  • Tiêu chuẩn hóa: ≥98.0% (HPLC), meets EP/USP monograph requirements
  • Forms: White to off-white crystalline powder
  • Ứng dụng: Antiviral drug manufacturing, pharmaceutical research, reference standard

Quality Specifications (QC Tests)

Test Item Thông số kỹ thuật
Xác định IR, HPLC retention time conforms to reference standard
Mất mát khi sấy khô ≤0.5%
Hàm lượng tro sau khi đốt ≤0.1%
Kim loại nặng ≤20 ppm
Organic Impurities Any individual impurity ≤0.5%; total impurities ≤2.0%
Chất dung môi còn lại Meets ICH Q3C limits
Giới hạn vi sinh vật Total aerobic count ≤1000 CFU/g; yeast and mold ≤100 CFU/g; absence of E. coli and Salmonella

Bulk Supply & Documentation

  • Công suất hàng tháng: 500 kg
  • Thời gian thực hiện: 3-5 business days (stock items)
  • Tài liệu hướng dẫn: COA, MSDS, TDS, DMF available upon request
  • Bao bì: 25 kg fiber drum with double polyethylene liner, or as per customer requirement

Các câu hỏi thường gặp

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

send us your specification for a quotation.

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

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