Amoxicillin API Manufacturer China | ≥98% Aminopenicillin Beta-Lactam Antibiotic Powder CAS 26787-78-0

Key Selling Points

✓ Broad-Spectrum Aminopenicillin β-Lactam - Bactericidal Against Gram+ & Gram- Pathogens

✓ High Oral Bioavailability (~90%) - Better Absorbed Than Ampicillin, Food-Independent

✓ Time-Dependent Killer - PBP Binding, Cell Wall Peptidoglycan Synthesis Inhibition

✓ Well-Established Veterinary Use - Dogs, Cats, Cattle, Pigs, Poultry (Respiratory, UTI, Skin)

✓ Low Protein Binding (~17%) - Wide Tissue Distribution, Rapid Absorption (Cmax ~2h)

✓ Clavulanate-Compatible - Amoxicillin-Clavulanate Restores Activity Against β-Lactamase Strains

What Is Amoxicillin Powder?

Amoxicillin Powder (CAS 26787-78-0) is a semi-synthetic aminopenicillin β-lactam antibiotic API widely used in pharmaceutical and veterinary manufacturing. As an ampicillin derivative with improved acid stability, amoxicillin provides broad-spectrum antibacterial activity against many susceptible Gram-positive and Gram-negative bacteria.

Amoxicillin Powder is supplied as a pharmaceutical raw material for the production of oral suspensions, tablets, capsules, injectable formulations, and veterinary preparations. In veterinary applications, it is used in authorized products for susceptible bacterial infections in livestock and companion animals.

For API procurement, key quality attributes include identity, assay/purity, related substances, moisture content, and batch-to-batch consistency. Amoxicillin activity may be affected by β-lactamase-producing bacteria, which can hydrolyze the β-lactam ring and reduce antibacterial effectiveness.

How Does Amoxicillin Powder Work?

Amoxicillin Powder works by inhibiting bacterial cell wall synthesis through binding to penicillin-binding proteins (PBPs). This blocks peptidoglycan cross-linking, weakens the bacterial cell wall, and leads to cell lysis in susceptible bacteria.

As a time-dependent β-lactam antibiotic, its antibacterial activity is related to maintaining effective exposure above the minimum inhibitory concentration (MIC). Resistance mainly occurs through β-lactamase production, which can inactivate amoxicillin.

For pharmaceutical manufacturing, important evaluation parameters include potency, stability, impurity profile, and compliance with the applicable product specification.

What Are the Applications of Amoxicillin Powder?

Human Medicine: Used for respiratory tract infections, urinary tract infections, skin and soft tissue infections, H. pylori eradication, Lyme disease and endocarditis prophylaxis.
Canine/Feline: Used for respiratory, urinary tract (cystitis), skin and soft tissue infections, wounds, abscesses and bacterial gastroenteritis.
Bovine: Used for respiratory disease (Mannheimia, Pasteurella), mastitis, metritis, retained placenta and navel ill.
Porcine/Poultry: Used for respiratory infections, neonatal colibacillosis, streptococcosis, fowl cholera, E. coli infections and secondary bacterial respiratory infections.
Pharmaceutical Manufacturing: Raw material for tablets, capsules, oral suspensions, injectable powders, premixes and amoxicillin-clavulanate combinations.

What Is the Difference Between Amoxicillin and Ampicillin?

Feature	Amoxicillin	Ampicillin
CAS (anhydrous)	26787-78-0	69-53-4
Para-Substituent	Hydroxyl (-OH)	Hydrogen (-H)
Molecular Formula	C₁₆H₁₉N₃O₅S	C₁₆H₁₉N₃O₄S
Molecular Weight	365.40	349.41
Oral Bioavailability	~90% (high)	~30–50% (low)
Food Effect	Minimal	Reduced absorption
Acid Stability	Higher (para-OH)	Lower
Spectrum	Identical (both aminopenicillins)	Identical
β-Lactamase Susceptibility	Yes	Yes
Typical Formulations	Oral suspensions, tablets, Clavamox	IV/IM injection, oral (less common)
Cost	Higher	Lower
Veterinary Use	Very common (oral)	Common (injectable)

How Does Amoxicillin Compare With Other Veterinary β-Lactams?

Feature	Amoxicillin	Penicillin G	Ceftiofur	Cefquinome
CAS	26787-78-0	61-33-6 (Na)	103980-44-5	84957-30-2
Class	Aminopenicillin	Natural penicillin	3rd-gen cephalosporin	4th-gen cephalosporin
Spectrum	Gram+ & some Gram-	Narrow (mostly Gram+)	Broad (Gram+ & Gram-)	Very broad (incl. Pseudomonas)
β-Lactamase Stability	No	No	Moderate	High
Oral Route	Yes (high BA)	No (acid-labile)	No (injection)	No (injection)
Veterinary Use	Dogs, cats, cattle, pigs, poultry	Cattle, pigs, horses (injection)	Cattle, pigs (injection)	Cattle, pigs (injection)
Key Safety	Penicillin allergy, not for rodents	Penicillin allergy, sodium load	Injection site reaction	Injection site reaction

How Is Amoxicillin Powder Manufactured?

Amoxicillin Powder is manufactured through semi-synthetic processes involving 6-APA acylation and purification.

Raw Material QC → 6-Aminopenicillanic Acid (6-APA) → Side Chain Activation (D-(-)-p-Hydroxyphenylglycine) → Acylation (6-APA + Side Chain) → Crude Amoxicillin → Purification (Crystallization) → Trihydrate Formation (controlled hydration) → Centrifugation → Vacuum Drying → Milling → Final QC → Light-Protected Packaging

HDM BIO controls key acylation, crystallization and hydration parameters to maintain consistent purity, particle size and batch quality.

Quality Specifications

Test Item	Standard	Typical Result
Appearance	White to off-white powder	Consistent
Assay (HPLC, anhydrous basis)	95.0–102.0%	99.5%
Identity (IR / HPLC)	Conforms to reference standard	Confirmed
Water Content (trihydrate)	11.5–14.0%	12.8%
pH (0.2% solution)	3.5–6.0	4.8
Related Substances	Within specification	Pass
Heavy Metals	≤10 ppm	Compliant
Residual Solvents	Within specification	Pass
Sterility (injectable grade)	Sterile	Compliant
Bacterial Endotoxins (injectable grade)	≤0.5 EU/mg	Compliant

What Quality Control Tests Are Performed for Amoxicillin Powder?

Each batch undergoes multi-step quality control before release to verify identity, purity and key quality attributes.

Raw Material QC → In-Process Control → HPLC Assay (anhydrous basis) → IR Identity Verification → Water Content (Karl Fischer) → pH Determination → Related Substances (HPLC) → Heavy Metals → Residual Solvents → Sterility Test (injectable grade) → Bacterial Endotoxin Test (LAL, injectable grade) → Final Batch Release

Key evaluations include HPLC assay (95.0–102.0%), IR identity, water content, pH, related substances, heavy metals, residual solvents, and for injectable grade: sterility and bacterial endotoxin (LAL) testing. Every commercial batch is supported by a batch-specific COA and relevant analytical documentation for incoming QC and supplier qualification.

What Factors Affect Amoxicillin Powder Bulk Price?

Amoxicillin Powder bulk pricing is driven by several key factors:

Raw Material Costs: 6-APA and D-p-hydroxyphenylglycine side chain directly influence synthesis expenses.
Form (Anhydrous vs Trihydrate): Trihydrate (most common oral grade) and anhydrous/injectable grade have different pricing.
Purity & Grade: Injectable grade (sterile, endotoxin-controlled) commands a significant premium over oral grade.
Sterility & Endotoxin Specification: Aseptic processing and LAL-tested batches for injection carry higher production costs.
Regulatory Compliance & Certification: GMP-standard API with DMF/CEP and consistent COA demands a higher price.
Order Volume: Large-scale pharmaceutical contracts receive steeper per-kilogram discounts.

Contact HDM BIO for a current quotation and volume-based pricing.

Why Choose HDM BIO as Your Amoxicillin Powder Supplier?

High-purity (95.0–102.0% anhydrous basis, typical 99.5%) aminopenicillin API for tablet, capsule, oral suspension, injectable and premix formulations
Verified consistent identity, water content, low related substances and reliable quality
Broad-spectrum bactericidal aminopenicillin with ~90% oral bioavailability and clavulanate-compatible formulation
GMP-aligned production, ISO & HACCP certified quality system
Full batch traceability and complete documentation (COA, MSDS, HPLC, sterility, LAL)
Flexible supply: kilogram samples to ton-level bulk API orders
Global export to 70+ countries with full customs support

Bulk Packaging, Shipping & Storage

Packaging: Foil bags for samples and moisture-proof fiber drums for bulk orders.
Custom Packaging: OEM labeling available.
Shipping Documents: COA, MSDS/SDS, commercial invoice, packing list and customs documentation available according to order requirements.
Storage: Store tightly sealed in a cool, dry, light-protected environment. Shelf life: 24 months.
Handling: For pharmaceutical/veterinary raw material use only; not for direct clinical administration.

Frequently Asked Questions About Amoxicillin Powder

Q1: What is Amoxicillin Powder?

A: Amoxicillin Powder (CAS 26787-78-0) is a semi-synthetic aminopenicillin β-lactam antibiotic API used in pharmaceutical and veterinary manufacturing. It works by inhibiting bacterial cell wall synthesis through penicillin-binding protein (PBP) interaction and is active against many susceptible Gram-positive and Gram-negative bacteria. Its activity may be reduced by β-lactamase-producing strains.

Q2: What is the CAS number?

A: 26787-78-0 (anhydrous amoxicillin); trihydrate CAS 61336-70-7; sodium salt CAS 34642-77-8.

Q3: How does amoxicillin work?

A: Amoxicillin works by binding to penicillin-binding proteins (PBPs) and inhibiting bacterial cell wall synthesis, leading to cell lysis in susceptible bacteria. As a time-dependent β-lactam antibiotic, its activity depends on maintaining effective exposure above the minimum inhibitory concentration (MIC). It is not effective against β-lactamase-producing strains or certain atypical bacteria.

Q4: What is Amoxicillin Powder used for?

A: Human: respiratory, UTI, skin/soft tissue infections, H. pylori eradication, Lyme disease. Veterinary: dogs/cats (respiratory, UTI, skin/wounds), cattle (BRD, mastitis, metritis), pigs (respiratory, colibacillosis, streptococcosis), poultry (E. coli, fowl cholera, respiratory). Raw material for tablets, capsules, oral suspensions, injectables, premixes and amoxicillin-clavulanate combinations.

Q5: What is the difference between amoxicillin and amoxicillin-clavulanate?

A: Amoxicillin is a β-lactam antibiotic API that may be affected by β-lactamase-producing bacteria. Amoxicillin-clavulanate combines amoxicillin with clavulanic acid, a β-lactamase inhibitor that helps protect amoxicillin from enzymatic degradation and expands activity against certain resistant strains.

Q6: What purity do you supply?

A: Standard 95.0–102.0% (HPLC, anhydrous basis); typical batch result 99.5%. Trihydrate form (most common) with water content 11.5–14.0%. Injectable grade with sterility and endotoxin specification available on request.

Q7: Where can I buy it from China?

A: HDM BIO supplies bulk Amoxicillin Powder with batch COA and global export support.

Q8: How much does Amoxicillin Powder cost?

A: Bulk pricing depends on raw material costs (6-APA, side chain), form (anhydrous vs trihydrate), purity/grade (oral vs injectable), sterility/endotoxin specification, regulatory compliance, order volume and logistics. Contact HDM BIO for a current quotation.

Q9: Are there any safety concerns?

A: Amoxicillin is generally well tolerated. Common concerns include gastrointestinal reactions such as nausea, vomiting, and diarrhea. Penicillin-class hypersensitivity reactions may occur in sensitive individuals. Use is contraindicated in animals with β-lactam allergy. Species restrictions and withdrawal periods should follow local veterinary regulations. Not for direct clinical administration.

Q10: Can amoxicillin be used for all bacterial infections?

A: No. Amoxicillin is active against susceptible Gram-positive and some Gram-negative bacteria, but it is not effective against β-lactamase-producing strains or certain organisms such as Mycoplasma, Chlamydia, and Pseudomonas. Selection of appropriate antibiotics should be based on bacterial susceptibility, formulation requirements, and applicable veterinary guidance.