Amoxicillin Powder

Pharmaceutical Grade Amoxicillin Powder for Veterinary and Human Healthcare | High Purity Antibiotic Solution

Shaanxi Hongda Phytochemistry Co., Ltd. is a leading producer and supplier of pharmaceutical grade Amoxicillin Powder, providing continuous quality and regulatory compliance for the worldwide healthcare industries. Over 20 years producing from 2001. 2001 production, 20 years & growing. Our plant is 20,000 square meters and is cGMP, FSSC22000, ISO9001, ISO22000, HALAL and KOSHER and Each batch meets USP/EP/CVP requirements. 100,000 level purification workshops and sophisticated SGS laboratory testing support our antibiotic production lines for 10% to 95% purity and complete control of heavy metals, microbial contaminants and moisture. With the pharma-grade method you have formulation stability, less regulatory risk and assurance of the medicinal efficacy of raw materials.

Introductory Product

The product is a dry crystalline powder of a semi-synthetic penicillin-type antibiotic, derived principally by fermentation and subsequent chemical modification. This white to off-white powder displays wide range antibacterial action against gram positive as well as selected gram negative pathogens by blocking bacterial cell wall production. The soluble powder format meets key formulation needs in human and veterinary medicine such as accurate dose control, long shelf-life stability and compatibility with a range of administration methods. We provide standardised specifications from 10% to 95% concentration to provide customised solutions for oral suspensions, injectable preparations and premix applications in pharmaceutical and animal health industries.

Third Test Report

Microbiological Verification: Total plate count < 1000 CFU/g, yeast & mould < 100 CFU/g, confirmed by independent testing by SGS to fulfil international pharmacopoeia for oral antibiotic powders.

Heavy Metal Testing: Under FDA and European Pharmacopoeia safety standards for medical medicines, independent laboratories verify lead levels below 2 ppm, arsenic below 1 ppm, and mercury below 0.1 ppm.

Eurofins' multi-residue study shows no detectable quantities of 500+ popular agricultural pesticides, proving our controlled fermentation and synthesis procedures work.

Product Specification

Physical & Chemical Analysis

Purity & Potency 

Microbiological Control 

Amoxicillin Powder Advantages

Pharmaceutical Grade Stability : Our regulated crystallisation process yields a consistent particle size distribution (80-120 mesh) that enhances dissolving rates, guaranteeing predictable bioavailability in a variety of formulation matrices.

Regulatory Compliance Portfolio: Your market entry in North America, Europe and Middle East areas made easy without further qualification constraints with a number of Certifications like as cGMP, HALAL, KOSHER and organic credentials.

Batch to Batch Consistency: The quality control technique is equipped with HPLC, UV spectrophotometry and automated titration devices to ensure that the assay variance is under ±2% which is the requirement for bioequivalence data by generic medicine makers.

Extended Shelf Stability: Special drying and packing methods ensure moisture content < 4% and shelf life of 24 months under optimal storage conditions, avoiding deterioration.

Application of Amoxicillin powder

Veterinary Medicine Formulations: Water-soluble powders for poultry and animals, mainly respiratory and gastrointestinal disorders, with exact dose flexibility for water-based administration systems.

Human oral suspension manufacturing: Active Pharmaceutical Ingredient in reconstitutable suspensions for children and adults, providing simple dosage titration for swallowing problems or weight-based dose demands.

Injectable Preparation Manufacturing: Creating sterile preparations for intramuscular and intravenous delivery using high-purity grades that exceed the most severe parenteral quality criteria for hospital and clinical contexts.

Manufacturing Process

Step 1 – Fermentation Cultivation Aerobically fermented in 5000L bioreactors for 168 hours under controlled conditions, Penicillium chrysogenum strains yielded penicillin G precursor with 95% substrate conversion efficiency Amoxicillin Powder.

Step 2 – Enzymatic side chain cleavage Penicillin acylase catalyses selective hydrolysis at pH 8.0 and 37°C to provide the 6-aminopenicillanic acid (6-APA) core structure with 98% purity by crystallisation recovery.

Step 3 - Chemical Acylation 6-APA is reacted with D-(-)-α-aminophenylacetic acid under anhydrous circumstances to provide amoxicillin trihydrate in 92-95% yield by controlled temperature gradient crystallisation.

Step 4 - Spray Drying and Micronization: Wet crystals are vacuum dried and jet-milled to a 100 mesh particle specification, moisture reduced to less than 4% while preserving antibiotic effectiveness.

Why Choose Us

Shaanxi Hongda Phytochemistry has superior technology for producing antibiotics, a complete set of quality assurance facilities, and climate-controlled storage of 3000 square meters. Our yearly capacity of 3000 tonnes and 150+ specialised experts provide dependable supply chains. Working directly with SGS and Eurofins laboratories ensures independent shipping verification. We deliver consistent pharmaceutical quality resources, reduce procurement risks, and accelerate antibiotic formulation time-to-market with 24 years of industry knowledge and smart raw material sourcing.

OEM / ODM Support

Custom Concentration Development: Our R&D team optimises excipient ratios to provide desirable dissolving properties and stability in tropical climates for test strengths from 10% to 95% amoxicillin.

Private Label Packaging Solutions: We provide 1kg aluminium foil bags to 25kg fibre drums with multilingual labelling, tamper-evident seals, and GMP compliance documentation for regulatory filings.

Formulation Technical Help Our 20+ university-trained pharmaceutical professionals can assist with suspension reconstitution, taste-masking, and bioavailability optimisation for your market positioning.

Regulatory Documentation: Create DMF (Drug Master File), stability study protocols, and analytical method transfer to ensure a seamless fit with your quality systems and regulatory filings.

FAQ

Q: What is the typical lead time for bulk orders?

A: Standard 25kg drum orders ship within 3-7 working days from payment confirmation, with expedited options available for urgent requirements.

Q: Can you provide samples for formulation testing?

A: Yes, we offer 20-100g samples in aluminum foil packaging with full COA documentation for qualified B2B customers.

Q: What storage conditions are recommended?

A: Store in sealed containers below 25°C with relative humidity under 60% to maintain 24-month shelf life stability.

Q: Do you support small-batch custom concentrations?

A: Our R&D facility accommodates minimum order quantities starting from 100kg for specialized assay requirements.

Contact Us

Ready to secure your pharmaceutical-grade antibiotic supply Amoxicillin Powder? Contact our technical sales team at duke@hongdaherb.com for detailed quotations, sample requests, and regulatory documentation support.