Cefixime

Cefixime

Parámetro Especificaciones
Nombre del producto Cefixime
Número CAS 79350-37-1
Fórmula molecular C16H15N5O7S2
Peso molecular 453.45 g/mol
Apariencia Polvo cristalino de color blanco a blanquecino
Ensayo (HPLC) ≥ 98.0% (on dried basis)
Solubilidad Slightly soluble in water; practically insoluble in ethanol and ether
Paquete 25 kg fiber drum with double polyethylene liner

Cefixime Structure

Sinónimos: 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.

Source & Standardization

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

Quality Specifications (QC Tests)

Test Item Especificaciones
Identificación IR and HPLC retention time conform to reference standard
Pérdida por secado ≤ 10.0%
Residuo tras la combustión ≤ 0,21 TP3T
Metales pesados ≤ 20 ppm
Límites microbianos Total aerobic count ≤ 1000 CFU/g; absence of E. coli, Salmonella
Organic Impurities Any individual impurity ≤ 1.0%; total impurities ≤ 3.0%
Disolventes residuales Meets ICH Q3C limits

Bulk Supply & Documentation

  • Monthly capacity: 5 metric tons
  • Plazo de entrega: 3-5 días laborables (artículos en stock)
  • Documentación: COA, MSDS, TDS, DMF (if applicable)
  • Embalaje: 25 kg fiber drum with double polyethylene liner; customized packaging available

Preguntas frecuentes

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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