Jul . 29, 2025 12:40 Back to list

High Quality Amoxicillin Trihydrate Powder for Pharmaceutical Use

Amoxicillin Trihydrate stands as a cornerstone in beta-lactam antibiotic production worldwide. With evolving regulatory standards, advanced manufacturing technologies, and global scale-up in demand, understanding its technical specifications, process flow, and competitive positioning is crucial for pharmaceutical and active pharmaceutical ingredient (API) sectors. This guide covers the latest industry trends, in-depth product data, production flowcharts, application cases, and expert FAQs—empowering technical professionals and procurement specialists alike.

I. Amoxicillin Trihydrate: Industry Overview & Market Dynamics

Global production exceeded 45,000+ tons in 2023 (source: API Manufacturers Association Report 2023).
Regulatory shift towards US FDA DMF, EU CEP dossiers for API export/registration.
Focus on green chemistry, waste minimization, and compliance with ISO 14001.
Growing applications not only in pharmaceuticals but also in veterinary medicine and biotech research.

High Quality Amoxicillin Trihydrate Powder for Pharmaceutical Use

“Demand for high-purity Amoxicillin Trihydrate is projected to increase by 6.2% CAGR up to 2028.” – Pharmacompass Industry Monitor

II. Amoxicillin Trihydrate Key Technical Specifications

Parameter	Specification	Industry Standard	Testing Method
CAS Number	61336-70-7	Ph.Eur, USP, BP, JP	N/A
Appearance	White to off-white crystalline powder	USP 39	Visual Inspection
Assay (% dry basis)	≥95.0	Ph. Eur. 9.0	HPLC
Moisture Content (%)	11.5~14.5	USP 41	KF Titration
Residue on Ignition (%)	≤0.1	USP 41	Gravimetric
Heavy Metals (ppm)	≤10	USP 41	ICP-MS
pH (5% Suspension)	4.0~6.0	USP 41	pH Meter

Each batch of Amoxicillin Trihydrate is strictly tested and certified according to ISO 9001:2015 and FDA cGMP standards, ensuring product reproducibility, safety, and regulatory conformity.

III. Visualizing Amoxicillin Trihydrate Technical Parameters and Market Trends

Assay (%) consistency, above global pharmacopoeia minimums, ensures high efficacy.
China, India, and the EU represent the bulk of global production and consumption in the past 5 years.
Technical parameter uniformity results in superior batch-to-batch pharmacological performance and compliance.

IV. Amoxicillin Trihydrate Manufacturing Process Flow

Sourcing & Pre-processing of Raw Materials (Penicillium chrysogenum, solvents, base chemicals)
Side Chain Synthesis & Amidation under controlled temperature/pressure
Crystallization of Amoxicillin Trihydrate in aqueous-organic media
Filtration & Purification (removal of impurities, advanced nanofiltration technologies)
Drying & Milling (precision control for particle size uniformity, water content)
Quality Control (QC) & Final Packaging, including rigorous HPLC and microbiological testing

The Amoxicillin Trihydrate process integrates CNC mixing vessels for precision dosing, and adheres to ISO 14644-1 cleanroom standards for contaminant control. Each critical step is validated per ICH Q7 good manufacturing practices (GMP).

Process flow schematic for Amoxicillin Trihydrate production

V. Competitive Analysis: Supplier Comparison & Customization

Parameter	DSBio Chemical (Amoxicillin Trihydrate)	Major Competitor A	Generic Products (Global Avg.)
Purity (Assay %)	≥96.2	95.6	95.3
Particle Size D50 (μm)	≤10	15~18	~20
Endotoxin Level (IU/mg)	<0.10	≤0.16	≤0.25
Stability / Shelf Life	36 months	24 months	18-24 months
Certification & Traceability	US FDA, ISO 9001, CEP	ISO 9001, WHO-GMP	Basic GMP or none
Custom Packaging	1kg~50kg, medical double PE, drum or foil bag	Bulk only	Bulk only

DSBio Chemical’s Amoxicillin Trihydrate is GMP v.2016 certified, offers customizable micronization, and meets both FDA and CEP requirements, giving your finished dosage formulations an advantage in regulatory submission and market entry speed.

VI. Customization & Value-Added Services

Customized Particle Size Distribution to match oral solid/IV/injectable formulations.
Enhanced Stability & Moisture Barrier Packaging for export or tropical logistics.
Batch-specific Documentation: COA, MSDS, TSE/BSE statements, impurity profiles, per ISO 10993.
Regulatory Dossier Support (US DMF, EU CEP), including stability data, process validation, and impurity fate studies.
Real-Time Supply Chain Traceability: Digital batch tracking via blockchain-enabled ERP.

DSBio offers Amoxicillin Trihydrate in customized grades for oral suspension, tablet compression, and parenteral APIs. Global clients benefit from localized support, rapid response to regulatory queries, and a validated chain of custody.

VII. Application Scenarios & Field Case Studies

Hospital Formulations: Used in >70% of WHO-recommended essential antibiotic lists for pediatrics and adults.
Veterinary Premix: Particle customization reduces caking and improves flow in automated feed mills (Used by Top 10 EU veterinary medicine producers).
Biopharma R&D: Reference standard in biosimilar and extended-release platform validation (2022 data: >1,200 documented global research projects).
Resource-Limited Regions: Shelf-stable at up to 35°C, reducing loss rates during shipment in African and South Asian deployments.
COVID-19 Era Logistics: “Fast-ship” 250kg lots airfreighted to Latin America during acute antibacterial shortages (Client case: Brazilian generic manufacturer 2021).
Green API Manufacturing Plants: Process water recycling at over 42% (internal benchmark vs. global avg. 23%).

Client Testimonial: “DSBio’s Amoxicillin Trihydrate enabled us to halve process deviations in our GMP line. Technical support was instrumental in passing a PIC/S inspection.” – Head of QA, South Asia API Producer, 2023

VIII. Amoxicillin Trihydrate – Technical FAQs

1. What is the main material specification of Amoxicillin Trihydrate?: The API is supplied as a white to off-white, crystalline trihydrate with purity typically ≥96.2%, particle size ≤10 μm (D50), and low endotoxin (
2. Which international certifications does your Amoxicillin Trihydrate plant hold?: It is GMP (ICH Q7), US FDA, ISO 9001:2015, ISO 14001:2015, EU CEP, and WHO PQ certified. Cleanroom environments comply with ISO 14644-1 Class 8 or better.
3. What are the typical packaging specifications?: Available as 1kg, 5kg, 10kg, 25kg, and 50kg double PE bags enclosed in fiber drums or aluminum-foil bags; custom packaging available for enhanced moisture or UV protection.
4. What analytical methods are employed to verify quality?: HPLC for assay & impurities (per EP/USP), Karl Fischer titration for moisture, ICP-MS for heavy metals, and microbiological methods for sterility/endotoxins.
5. How does your product performance impact formulation?: Superior particle size control and ultra-low heavy metals enhance compressibility, minimize API agglomeration, and aid in achieving rapid dissolution in oral/IV dosage forms.
6. What is your lead time and support process?: Standard delivery is 2–4 weeks (ex-factory), with regulatory documentation provided within 24–48h. 24/7 regulatory and technical support is available globally.
7. Are reference standards and impurity markers available?: Authenticated reference standards (including impurity markers per Ph. Eur. and USP) are supplied on request, useful in QC, process validation, and R&D labs.

Order Fulfillment, Warranty, and Customer Assurance

Typical Delivery Cycle: 2–4 weeks EXW or DAP incoterms. Airfreight and Express shipping available for emergency orders.
Product Warranty: 36-month stability guarantee under original packaging and controlled temperature (as per COA).
Customer Support: Dedicated after-sales and regulatory support, with 24h response time globally.
Document Access: e-COA, MSDS, TSE/BSE, Process Validation batches available via secure company portal.
Recall Protocol: Zero recall record in past five years; annual mock recall audits performed per ISO 22000.

All Amoxicillin Trihydrate orders are accompanied by anti-counterfeit labels and full digital batch traceability—your assurance of authenticity and compliance.