Bulk Cefixime Trihydrate antibiotic API
Cefixime Trihydrate is an oral third‑generation cephalosporin API, a semi‑synthetic β‑lactam antibiotic. It inhibits bacterial cell wall synthesis and exhibits broad-spectrum bactericidal activity against many Gram‑negative and selected Gram‑positive pathogens. It shows good stability against many β‑lactamase enzymes, which makes it widely used for community bacterial infection treatment. Our supplied Cefixime Trihydrate complies with USP / EP / BP pharmacopoeia standards, with well-controlled related substances, stable crystal form and suitable particle size distribution. It is highly suitable for oral tablets, capsules, chewable tablets and paediatric oral dry suspension. We provide sample testing service and complete quality documentation for drug registration, GMP audit and regulatory submission.
How to Choose Cefixime Trihydrate API
When selecting Cefixime Trihydrate API, first confirm pharmacopoeia grade matching your target market (USP for North America, EP for EU). Review COA for assay, water content and related substances; impurity control is critical for cephalosporin antibiotics. Check particle size and bulk density: fine powder for oral suspension, free-flowing grade for tablet and capsule production. Verify supplier GMP traceability and full audit document package. Run lab test and formulation trial before bulk purchase, pay special attention to hygroscopicity and stability test data.
COA
| Item | Specification | Result | Test Method |
| Appearance | White to light yellow, crystalline powder. | Conforms | Visual Inspection |
| Solubility | Soluble in methanol and acetone; slightly soluble in ethanol; very slightly soluble in ethyl acetate; practically insoluble in ether, in heptane, in methanol, in acetone, and in water. | Conforms | Visual solubility test |
| Identification by IR | The sample spectrum must match with the standard spectrum. | Conforms | Infrared Spectrophotometry |
| Water | 9.0% ~ 12.0% | 11.00% | Karl Fischer Titration |
| Specific optical rotation | −75° ~ −88° | −83° | Polarimetry |
| Crystallinity | Meets the requirements | Conforms | / |
| pH | 2.6 ~ 4.1 | 3.2 | pH Meter |
| Related substances | Individual impurities: ≤1.0%; Total impurities: ≤2.0% | Individual: 0.22%; Total: 1.38% | HPLC |
| Assay | Cephalosporin C equivalent, calculated on the anhydrous basis | 98.1 μg/mg | HPLC |
Testimonials
★★★★★We purchase EP grade cefixime trihydrate for paediatric oral suspension. Particle size meets our specification, impurity levels are stable within EP limits. Complete audit documents are ready for registration. Stable supplier for cephalosporin API."
- Carlos Ruiz, Procurement Manager, PharmaKids Labs, Spain
★★★★★ 1kg sample trial for our tablet formulation. Good flow property, no caking after proper storage. HPLC test passed our internal QC requirement. Technical team responds fast. - Dr. Emma Clark, Formulation Scientist, Oralcare Pharma, South Africa
★★★★★ USP grade cefixime trihydrate passed our incoming lab release test. Moisture control is well managed. They fully understand US antibiotic registration requirements. - Michael Wang, Quality Head, US Generics Pharma Inc., USA
Applications of Cefixime Trihydrate
1.Adult oral solid formulation: manufacture cefixime tablets, capsules for respiratory tract, urinary tract, biliary tract susceptible bacterial infections
2.Paediatric formulation: dry oral suspension, chewable tablets for children's bacterial infections
3.Combination formulation R&D: compound antibiotic prescription development under local regulatory approval
4.Community infection treatment API: otitis media, pharyngitis, tonsillitis, bronchitis, uncomplicated urinary tract infection
5.Veterinary formulation: veterinary antibiotic premix/soluble powder (only under local veterinary regulation)
6.Pharmaceutical R&D: antibacterial susceptibility testing, formulation screening, stability and compatibility research
Benefits OF bulk cefixime trihydrate
1.Bulk supply solution for large-scale generic antibiotic production, helps buyers reduce unit procurement cost significantly
2.Stable long-term bulk allocation, dedicated production scheduling to avoid stock-out risk for mass manufacturing
3.Flexible bulk batch release, can match your monthly production forecast and framework contract plan
4.Consistent quality control across large commercial batches, stable impurity profile and uniform particle size for continuous formulation
5.Optimized bulk drum packaging, moisture-proof and light-shield design suitable for sea freight and long-distance bulk logistics
6.Complete batch documentation for every bulk consignment, COA, BPR and stability data supplied together with bulk shipment
7.Bulk order priority arrangement for production and inspection, reasonable lead time planning for big volume demand
8.Support consolidated loading and container shipment, lower logistics cost per kilogram compared with small trial orders
9.Bulk lots with traceable production history, easy for incoming QC sampling and factory audit for your mass production
Side Effects & Safety Warning
1.Common gastrointestinal adverse reactions: diarrhoea, nausea, abdominal pain, dyspepsia, flatulence.
2.Hypersensitivity risk: cross-allergy risk with penicillins and other cephalosporins; rash, urticaria, rarely anaphylaxis, severe skin reactions such as SJS/TEN.
3.Clostridioides difficile-associated diarrhoea / pseudomembranous colitis may occur after antibiotic use.
4.Rare haematological reactions: thrombocytopenia, eosinophilia, haemolytic anaemia.
5.Handling precaution: avoid inhalation of powder, skin and eye contact. Wear dust mask, safety goggles and nitrile gloves during operation.
6.This is prescription-only β-lactam antibiotic API; finished product requires prescription control.
FAQ
Q: What packaging materials and protective measures are used during international shipping?
A: To prevent moisture degradation and light exposure during global transit, our Cefixime Trihydrate is double-packaged in pharmaceutical-grade polyethylene (PE) bags, vacuum-sealed within an outer moisture-barrier layer, and secured in a sturdy fiber drum with desiccants.
Q: What is your MOQ?
A:MOQ 1kg for R&D trial; bulk 25kg/drum for commercial formulation.
Q: Is Cefixime Trihydrate sensitive to moisture?
A: Yes, it is hygroscopic. Must be sealed and stored in dry, cool and light-protected environment.
Q: What pharmacopoeia grades can you supply for Cefixime Trihydrate?
A: USP, EP, BP and CP grade available. COA fully matches the selected pharmacopoeia monograph.
Q: How can I request a sample kit, technical dossier, or formal commercial quotation?
A: Qualified procurement managers, R&D directors, and regulatory affairs officers can submit an inquiry through our corporate portal or click below to connect directly with our global pharmaceutical sales and technical support team.
CONTACT PAGE
We are reliable bulk supplier of Cefixime Trihydrate API CAS 125110-14-7. Send us your required quantity, pharmacopoeia grade, dosage form requirement and target market regulatory rules. We will prepare formal quotation plus COA and full supporting files for your registration and factory audit.
1.Inquiry methods：
Email:alice@xaheshun.com
Whatspp:+8618509260106
Online instant messaging
2.Contact Information：
Name：Alice
Telephone :+8618509260106
Email:alice@xaheshun.com
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