Amoxicillin Sodium API Manufacturer China | ≥98% Beta-Lactam Antibiotic Powder CAS 34642-77-8

Key Selling Points

✓ Semi-Synthetic Broad-Spectrum Aminopenicillin - Gram-Positive & Gram-Negative Coverage

✓ Highly Water-Soluble Sodium Salt - Ideal for Injectable & Oral Solution Formulations

✓ β-Lactam PBP Inhibitor - Bactericidal Cell Wall Disruption (Time-Dependent Killing)

✓ Porin-Crossing Amino Side Chain - Extended Gram-Negative Spectrum vs Penicillin G

✓ Gold-Standard Veterinary Respiratory API - BRD (Mannheimia/Pasteurella), Swine, Poultry

✓ Clavulanate-Compatible - β-Lactamase Inhibitor Combination Restores Resistant-Strain Activity

What Is Amoxicillin Sodium Powder?

Amoxicillin Sodium Powder is the water-soluble sodium salt of amoxicillin, a semi-synthetic broad-spectrum aminopenicillin β-lactam antibiotic (C₁₆H₁₈N₃NaO₅S, MW 387.39). Unlike amoxicillin trihydrate (oral form), the sodium salt is freely soluble in water, making it the preferred form for injectable solutions and water-soluble powders.

Active against Gram-positive (Streptococcus, Enterococcus, Listeria, non-penicillinase-producing Staphylococcus) and Gram-negative (E. coli, Salmonella, Pasteurella, Haemophilus, Proteus mirabilis) organisms. The amino side chain enables Gram-negative porin penetration, extending spectrum beyond natural penicillins, but it is susceptible to β-lactamase hydrolysis - clavulanate combination restores activity. Veterinary uses include bovine respiratory disease (Mannheimia/Pasteurella), swine respiratory infections, poultry colibacillosis/pasteurellosis, and canine/feline skin/respiratory/UTI. Penicillin hypersensitivity is the most serious risk (rash to anaphylaxis, cross-allergenicity across all β-lactams); each 1 g contains ~59.4 mg sodium.

How Does Amoxicillin Sodium Powder Work?

Amprolium Hydrochloride Powder acts as a competitive thiamine (vitamin B1) antagonist. Structurally analogous to thiamine, it is actively transported into coccidia via the thiamine uptake transporter, then blocks thiamine pyrophosphate (TPP) formation - TPP is an essential cofactor for carbohydrate metabolism decarboxylase enzymes.

Because Amprolium Hydrochloride Powder starves the parasite of functional thiamine, coccidial energy metabolism stalls, primarily arresting second-generation schizont development and merozoite formation (schizogony), with partial effects on sexual stages and oocyst sporulation. Eimeria spp. have a far higher thiamine requirement than the avian host, giving selective toxicity. The disrupted lifecycle gives the host immune system time to clear infection. No cross-resistance with ionophores or other anticoccidial classes. Excreted largely unchanged; low systemic toxicity in target species at recommended doses.

What Are the Applications of Amoxicillin Sodium Powder?

Bovine Respiratory Disease (BRD): Injectable treatment of Mannheimia haemolytica and Pasteurella multocida infections in cattle.
Swine Respiratory Infections: Streptococcus suis, Pasteurella and Actinobacillus pleuropneumoniae infections in pigs.
Poultry Infections: Drinking water administration for E. coli, Pasteurella multocida (fowl cholera) and Salmonella infections in chickens, turkeys and ducks.
Canine & Feline Infections: Skin and soft tissue, respiratory tract and urinary tract infections caused by susceptible organisms.
Human Pharmaceutical API: Raw material for injectable amoxicillin and amoxicillin-clavulanate formulations (respiratory, urinary, skin, H. pylori eradication, endocarditis prophylaxis).

What Is the Difference Between Amoxicillin Sodium and Amoxicillin Trihydrate?

Feature	Amoxicillin Sodium	Amoxicillin Trihydrate
CAS	34642-77-8	61336-70-7
Molecular Formula	C₁₆H₁₈N₃NaO₅S	C₁₆H₁₉N₃O₅S · 3H₂O
Molecular Weight	387.39	419.45
Water Solubility	Freely soluble	Slightly soluble
Primary Dosage Form	Injection, water-soluble powder	Oral tablets, capsules, suspension
Sodium Content	High (~59.4 mg/g)	None
Stability	Less stable (hygroscopic)	More stable
Typical Use	Severe infection / non-oral patients	Routine oral therapy
Storage	2–8°C preferred	Room temperature

How Does Amoxicillin Compare With Other Penicillins?

Feature	Amoxicillin	Ampicillin	Penicillin G	Penicillin V
CAS (sodium)	34642-77-8	69-52-3	113-98-4 (K)	-
Class	Aminopenicillin	Aminopenicillin	Natural penicillin	Natural penicillin
Gram-Negative	Broad (porin-crossing)	Broad	Narrow	Narrow
Oral Absorption	Excellent (~90%)	Moderate (~40%)	Poor (acid-labile)	Good (acid-stable)
β-Lactamase	Susceptible	Susceptible	Susceptible	Susceptible
Typical Use	Respiratory, UTI, skin	Similar (IV)	Gram-positive, syphilis	Oral Gram-positive
Clavulanate Combo	Yes (Augmentin)	Yes (Unasyn)	No	No

How Is Amoxicillin Sodium Powder Manufactured?

Amoxicillin Sodium Powder is manufactured by first synthesizing amoxicillin (via 6-APA acylation with D-p-hydroxyphenylglycine), then converting to the sodium salt via reaction with sodium hydroxide or sodium isooctanoate, followed by lyophilization or crystallization.

Raw Material QC → 6-APA Preparation → Acylation with D-p-Hydroxyphenylglycine Derivative → Amoxicillin Formation → Purification → Sodium Salt Formation (NaOH / Sodium Isooctanoate) → Lyophilization / Crystallization → Drying → Milling → Final QC → Aseptic Packaging

HDM BIO controls key acylation, salt formation and lyophilization parameters to maintain consistent purity, water solubility and β-lactam ring integrity.

Quality Specifications

Test Item	Standard	Typical Result
Appearance	White to off-white powder	Consistent
Assay (as amoxicillin, anhydrous)	≥98.0%	99.0%
Identity (IR / HPLC)	Conforms to reference standard	Confirmed
Water Solubility	Freely soluble, clear solution	Compliant
pH (10% solution)	8.0–10.0	9.0
Water Content (Karl Fischer)	≤2.0%	0.8%
Specific Optical Rotation	+240° to +290°	+265°
Related Substances	Within specification	Pass
Amoxicillin Dimer	≤1.0%	Compliant
Heavy Metals	≤10 ppm	Compliant
Residual Solvents	Within specification	Pass
Sterility (injectable grade)	Sterile	Compliant
Bacterial Endotoxins (injectable grade)	≤0.15 EU/mg	Compliant

What Quality Control Tests Are Performed for Amoxicillin Sodium Powder?

Each batch undergoes multi-step quality control before release to verify identity, purity, β-lactam integrity and sterility (injectable grade).

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

Key evaluations include HPLC assay (≥98% as amoxicillin), IR identity, water solubility, pH, Karl Fischer water content, specific optical rotation, related substances with specific amoxicillin dimer limit, 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 Sodium Powder Bulk Price?

Amoxicillin Sodium Powder bulk pricing is driven by several key factors:

Raw Material Costs: 6-APA (6-aminopenicillanic acid) and D-p-hydroxyphenylglycine feedstock prices directly influence manufacturing expenses.
Purity & Grade: Injectable grade (sterile, endotoxin-controlled) commands a significant premium over oral/technical 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 demand a higher price.
Order Volume: Large-scale pharmaceutical contracts (tonnage) receive steeper per-kilogram discounts.
Logistics & Geography: Cool storage / light-protected / moisture-proof packaging and customs compliance add to the landed cost.

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

Why Choose HDM BIO as Your Amoxicillin Sodium Powder Supplier?

High-purity (≥98% / typical 99%) water-soluble broad-spectrum aminopenicillin for injectable and oral solution formulations
Verified high water solubility and β-lactam ring integrity; injectable grade with sterility and endotoxin control available
Extended Gram-negative spectrum via porin-crossing amino side chain; clavulanate-compatible for resistant strains
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; sterile, moisture-proof fiber drums or HDPE containers for bulk injectable grade; light-protected packaging.
Custom Packaging: OEM labeling available; sterile/aseptic packaging on request.
Shipping Documents: COA, MSDS/SDS, commercial invoice, packing list and customs documentation available according to order requirements.
Storage: Store tightly sealed in a dry, light-protected environment at 2–8°C (preferred) or room temperature. Shelf life: 24 months.
Handling: For pharmaceutical/veterinary raw material use only. Handle with appropriate PPE (gloves, mask, eye protection), avoid inhalation/dust exposure. Penicillin hypersensitivity risk - personnel with known penicillin allergy should avoid direct contact; dust inhalation may trigger allergic reactions. Hygroscopic - protect from moisture. Not for direct clinical administration.

Frequently Asked Questions About Amoxicillin Sodium Powder

Q1: What is Amoxicillin Sodium Powder?

A: The water-soluble sodium salt of amoxicillin, a semi-synthetic broad-spectrum aminopenicillin β-lactam antibiotic. Its high water solubility makes it the preferred form for injectable solutions and water-soluble powders.

Q2: What is the CAS number?

A: 34642-77-8.

Q3: How does amoxicillin sodium work?

A: It inhibits penicillin-binding proteins (PBPs), blocking the final transpeptidation step in bacterial cell wall peptidoglycan synthesis, causing osmotic lysis. It is bactericidal and time-dependent. The amino side chain extends Gram-negative coverage via porin penetration. It is susceptible to β-lactamase.

Q4: What is the difference between amoxicillin sodium and amoxicillin trihydrate?

A: Amoxicillin sodium (MW 387.39) is freely water-soluble and used for injections; amoxicillin trihydrate (MW 419.45) is slightly soluble and used for oral tablets/capsules. The sodium salt contains ~59.4 mg sodium per gram.

Q5: What is amoxicillin sodium used for?

A: Veterinary: bovine respiratory disease (Mannheimia/Pasteurella), swine respiratory infections, poultry colibacillosis/pasteurellosis (drinking water), canine/feline skin/respiratory/UTI. Human: injectable amoxicillin and amoxicillin-clavulanate for respiratory, urinary, skin infections and H. pylori eradication.

Q6: What documents are provided with each batch?

A: Batch-specific COA, HPLC assay report, IR identity records, water solubility, pH, Karl Fischer water content, optical rotation, related substances (incl. dimer), heavy metals, residual solvents, and for injectable grade: sterility and LAL endotoxin results, MSDS/SDS.

Q7: What purity do you supply?

A: Standard ≥98% (as amoxicillin, anhydrous basis); typical batch result 99%. Injectable grade with sterility and endotoxin specification available on request.

Q8: Where can I buy it from China?

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

Q9: How much does Amoxicillin Sodium Powder cost?

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

Q10: Are there any safety concerns?

A: Penicillin hypersensitivity is the most serious risk - allergic reactions range from rash to anaphylaxis, with cross-allergenicity across all β-lactams. Personnel with known penicillin allergy should avoid direct contact. Gastrointestinal side effects (diarrhea, nausea) and rare C. difficile colitis may occur. Sodium load (~59.4 mg/g) relevant for restricted patients. Hygroscopic - protect from moisture. Not for direct clinical administration.