moxicillin Trihydrate API | CAS 61336-70-7 | USP/EP Bulk Supplier
Amoxicillin trihydrate is a widely used semisynthetic broad-spectrum penicillin API, belonging to the β‑lactam antibiotic family. It works by inhibiting bacterial cell wall synthesis and shows bactericidal activity against susceptible Gram-positive and Gram-negative bacteria. It is listed on the WHO Essential Medicines List and is one of the most mainstream antibiotic raw materials for human and veterinary pharmaceutical production. Our supplied amoxicillin trihydrate meets USP / EP pharmacopoeia standards, with stable impurity profile, consistent particle size and good flowability, suitable for processing into capsules, tablets, oral suspension, soluble powder and veterinary premix. We support batch testing and provide full quality documentation for registration and audit purpose.
How to Choose Amoxicillin Trihydrate API
When choosing Amoxicillin Trihydrate API, first select the pharmacopoeia grade (USP/EP/BP/CP) matching your target market. Review COA for purity, water content and related impurities. Check particle size, bulk density and flowability to fit your dosage form process. Verify supplier GMP qualification and full supporting documents including COA, SDS, BSE/TSE statement. Always test samples in your lab and formulation trial before bulk purchase.
COA
| Item | Specification | Result | Test Method |
| Characters | white or almost white crystalline powder | white crystalline powder | Visual Inspection |
| Identification | Complies | conforms | A. The IR Spectrum is concordant with spectrum of R.S. |
| pH | 3.5 ~ 5.5 | 4.8 | pH Meter |
| Specific optical rotation | +290° ~ +315° | +305° | Polarimetry |
| Related substances (Maximum single impurity) | ≤1% | 0.07% | HPLC |
| N,N-Dimethylaniline | ≤20ppm | <20ppm | GC |
| Water | 11.5% ~ 14.5% | 13.00% | Karl Fischer Titration |
| Sulfated ash | ≤1.0% | 0.10% | Gravimetric method |
| Assay (on the anhydrous substance) | 95.0% ~ 102.0% | 100.40% | HPLC |
| Methanol | ≤3000ppm | <3000ppm | GC |
| Methylene chloride | ≤600ppm | <600ppm | GC |
| Isopropyl alcohol | ≤5000ppm | <5000ppm | GC |
| Particle size | 100% ≤ 15 μm | conforms | Laser Diffraction |
Recommended procurement workflow:
Request sample → 2. Internal lab test (assay, water, impurity, PSD) → 3. Formulation trial test (dissolution, stability) → 4. Supplier audit → 5. Formal bulk order
Applications
1.Human pharmaceutical formulation: manufacture amoxicillin capsules, tablets, oral dry suspension for upper respiratory tract infections, lower respiratory infections, urinary tract infections, skin soft tissue infections caused by susceptible strains
H. pylori triple / quadruple combination therapy raw material, combined with proton pump inhibitor and macrolide to eradicate Helicobacter pylori and reduce peptic ulcer recurrence
2.Veterinary API: produce veterinary soluble powder, premix for livestock, poultry, aquaculture bacterial infection control (follow regional veterinary regulation)
3.Combination formulation research: compound with potassium clavulanate (Amoxicillin-Clavulanate) to cover β‑lactamase producing resistant strains
4.Microbiology & pharmaceutical R&D: laboratory antibacterial susceptibility test, formulation development, stability study
Benefits
1.Broad-spectrum bactericidal activity against common susceptible bacteria, stable antibacterial effect
2.Meets major pharmacopoeia standards (USP/EP/BP/CP), easy for global drug registration
3.Good processability, suitable for multiple dosage forms: capsules, tablets, oral suspension, veterinary soluble powder
4.Reliable impurity control, low heavy metals, stable crystal form and consistent batch-to-batch quality
5.Complete supporting documents (COA, SDS, TDS, BSE/TSE statement) for factory audit and regulatory submission
6.Flexible bulk packaging, stable supply chain, fast delivery for pharmaceutical & veterinary manufacturers
Side Effects & Safety Warning
1.Hypersensitivity risk: Penicillin class allergen. May cause skin rash, urticaria; severe anaphylaxis in sensitive population. Dust inhalation may trigger respiratory allergy or asthma.
Gastrointestinal adverse reactions in finished drug: nausea, vomiting, diarrhea, pseudomembranous colitis.
2.Rare serious skin adverse reactions: Stevens-Johnson syndrome, toxic epidermal necrolysis.
3.Environmental hazard: Toxic to aquatic organisms, long-term persistent hazard. Waste disposal must follow environmental regulation.
4.Handling precaution: Wear dust mask, goggles and protective gloves; avoid inhaling powder.
customer FeedBack
★★★★★ Stable quality, complete COA & regulatory documents, on-time delivery. - Roberto, Pharma Buyer, Peru
★★★★★ Good flow property, no agglomeration, works well for our tablet & capsule line. - Emma, Production Manager, UK
FAQ
Q: What standard can you supply for Amoxicillin Trihydrate?
A: We provide USP, EP, BP, CP grade, COA matches corresponding pharmacopoeia monograph.
Q: Is this API for human or veterinary use?
A: It can be used for both human and veterinary formulation, buyers need to follow local regulatory approval and classification.
Q: What is the MOQ?
A: MOQ 1kg; bulk 25kg/drum for mass production.
Q: Are analytical reference standards or working standards available for laboratory testing?
A: Yes. For quality control laboratories and contract research organizations (CROs), we can supply analytical-grade secondary standards or assist in sourcing official pharmacopoeial primary reference standards (such as USP/EP reference standards) alongside our bulk API shipment to facilitate immediate internal method validation and HPLC testing.
Q: What pharmacopoeial standards do you comply with?
A:Manufactured strictly in compliance with USP, BP, and EP standards. Each batch comes with a full Certificate of Analysis (CoA), water content, and purity.
CONTACT PAGE
We are bulk supplier of Amoxicillin Trihydrate API CAS 61336-70-7. Send us your required quantity, pharmacopoeia standard and target market regulation document requirement. We will offer formal quotation together with 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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