Cefixime

Cefixime

매개변수 사양
제품명 Cefixime
CAS 번호 79350-37-1
분자식 C16H15N5O7S2
분자량 453.45 g/mol
외관 흰색에서 미백색의 결정성 분말
분석법 (HPLC) ≥ 98.0% (on dried basis)
용해도 Slightly soluble in water; practically insoluble in ethanol and ether
패키지 25 kg fiber drum with double polyethylene liner

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Cefixime Structure

동의어: 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.
  • 응용 분야: Oral solid dosage forms (tablets, capsules, suspensions); generic drug development.

Quality Specifications (QC Tests)

Test Item 사양
식별 IR and HPLC retention time conform to reference standard
건조 손실 ≤ 10.0%
소각 잔류물 ≤ 0.2%
중금속 ≤ 20 ppm
Microbial Limits Total aerobic count ≤ 1000 CFU/g; absence of E. coli, Salmonella
Organic Impurities Any individual impurity ≤ 1.0%; total impurities ≤ 3.0%
잔류 용매 Meets ICH Q3C limits

Bulk Supply & Documentation

  • Monthly capacity: 5 metric tons
  • 리드 타임: 3-5 business days (stock items)
  • 문서: COA, MSDS, TDS, DMF (if applicable)
  • 포장: 25 kg fiber drum with double polyethylene liner; customized packaging available

자주 묻는 질문

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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