Cefixime

Cefixime

Tham số Thông số kỹ thuật
Tên sản phẩm Cefixime
Số CAS 79350-37-1
Công thức phân tử C16H15N5O7S2
Trọng lượng phân tử 453.45 g/mol
Hình thức Bột tinh thể màu trắng đến trắng ngà
Phương pháp phân tích (HPLC) ≥ 98.0% (on dried basis)
Độ hòa tan Slightly soluble in water; practically insoluble in ethanol and ether
Gói 25 kg fiber drum with double polyethylene liner

Cefixime Structure

Từ đồng nghĩa: Cefixime, Suprax, CFIX, FR-17027, Cefixima, Cefiximum, (6R,7R)-7-[[(2Z)-2-(2-Amino-1,3-thiazol-4-yl)-2-(carboxymethoxyimino)acetyl]amino]-3-ethenyl-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid

Cefixime is a third-generation cephalosporin antibiotic developed by Fujisawa Pharmaceutical (now Astellas) and launched in 1989. It belongs to the aminothiazolyl cephalosporin family and is characterized by a broad spectrum of activity against both Gram-positive and Gram-negative bacteria, with particular efficacy against β-lactamase-producing strains. Unlike many earlier cephalosporins, cefixime is orally active, making it a convenient option for outpatient therapy.

Chemically, cefixime features a 7-aminocephalosporanic acid core with a 2-aminothiazol-4-yl methoxyiminoacetyl side chain and a vinyl group at the 3-position. This structure confers stability to hydrolysis by various β-lactamases and enhances its affinity for penicillin-binding proteins. The compound is typically produced via semi-synthetic routes from 7-ACA, with stringent control of stereochemistry and impurities.

In clinical practice, cefixime is indicated for the treatment of uncomplicated urinary tract infections, otitis media, pharyngitis, and lower respiratory tract infections. It is also used in some regions for gonorrhea. The active pharmaceutical ingredient (API) is supplied as a white to off-white crystalline powder, with specifications aligned to pharmacopeial standards such as USP and EP. Our cefixime API is manufactured under cGMP conditions and is available for generic formulation development and commercial production.

Function & Mechanism

  • Bacterial cell wall synthesis inhibition: Binds to penicillin-binding proteins (PBPs) and blocks transpeptidation, leading to cell lysis.
  • Broad-spectrum activity: Effective against Escherichia coli, Klebsiella pneumoniae, Haemophilus influenzae, and Streptococcus pyogenes.
  • β-lactamase stability: The methoxyimino group provides resistance to hydrolysis by common plasmid-mediated β-lactamases.
  • Oral bioavailability: Approximately 40–50% in fasted state; food may slightly delay absorption but does not significantly affect extent.
  • Long half-life: Supports once-daily or twice-daily dosing regimens.

Nguồn gốc và tiêu chuẩn hóa

  • Nguồn: Semi-synthetic derivative of 7-aminocephalosporanic acid (7-ACA).
  • Manufacturing: Multi-step chemical synthesis under cGMP; final crystallization yields the trihydrate form.
  • Tiêu chuẩn hóa: Complies with USP/EP monograph; assay ≥ 98.0% (HPLC, on dried basis).
  • Forms: Crystalline powder, micronized grades available upon request.
  • Ứng dụng: Oral solid dosage forms (tablets, capsules, suspensions); generic drug development.

Quality Specifications (QC Tests)

Test Item Thông số kỹ thuật
Xác định IR and HPLC retention time conform to reference standard
Mất mát khi sấy khô ≤ 10.0%
Hàm lượng tro sau khi đốt ≤ 0.2%
Kim loại nặng ≤ 20 ppm
Giới hạn vi sinh vật Total aerobic count ≤ 1000 CFU/g; absence of E. coli, Salmonella
Organic Impurities Any individual impurity ≤ 1.0%; total impurities ≤ 3.0%
Chất dung môi còn lại Meets ICH Q3C limits

Bulk Supply & Documentation

  • Công suất hàng tháng: 5 metric tons
  • Thời gian thực hiện: 3-5 business days (stock items)
  • Tài liệu hướng dẫn: COA, MSDS, TDS, DMF (if applicable)
  • Bao bì: 25 kg fiber drum with double polyethylene liner; customized packaging available

Các câu hỏi thường gặp

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

Our standard MOQ is 25 kg. For smaller quantities, please contact our sales team to discuss your requirements.

How long does delivery take?

For stock items, we ship within 3-5 business days after order confirmation.

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

Yes, we provide a COA for each batch. Samples are available upon request; please specify your required quantity and shipping 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

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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