1. Allopurinol API Supplier & Manufacturer | GMP-Certified Bulk Pharmaceutical Grade Allopurinol Powder
AIHerba® is a professional Allopurinol API manufacturer and bulk supplier, providing pharmaceutical-grade Allopurinol powder for regulated industrial and formulation use. Produced under GMP-compliant manufacturing systems, our Allopurinol meets strict international quality standards including USP / EP specifications, making it suitable for pharmaceutical factories, formulation companies, contract manufacturers, and OEM/ODM partners worldwide.
With stable batch consistency, full COA documentation, and global shipping capabilities, AIHerba® supports long-term supply programs and project-based procurement. Our technical team assists buyers with specifications, regulatory compliance, and formulation compatibility, ensuring efficient sourcing and risk-controlled procurement.
✔ GMP-certified manufacturing facility
✔ Bulk & wholesale supply available
✔ Full COA, MSDS & technical documentation
✔ Dedicated B2B sales & technical support
Contact us today to request specifications, samples, and pricing.
2. What Is Allopurinol?
What is Allopurinol?
Allopurinol is a synthetic xanthine oxidase inhibitor widely used as an active pharmaceutical ingredient (API) in regulated pharmaceutical manufacturing. It is a white to off-white crystalline powder, characterized by high chemical stability and consistent molecular structure.
Benefits (Functional & Material Properties)
-
High purity and formulation stability
-
Suitable for solid dosage manufacturing
-
Consistent particle size distribution
-
Compatible with standard pharmaceutical excipients
Applications
-
Pharmaceutical API manufacturing
-
Research & analytical reference material
-
Regulated formulation development
Dosage / Specification
Dosage and usage depend on finished formulation design and regulatory approval. AIHerba® supplies raw material only, not finished dosage forms.
Safety
Allopurinol must be handled and formulated by qualified professionals in compliance with applicable pharmaceutical regulations.
Supplier / Manufacturer
AIHerba® operates as a GMP-certified API manufacturer and exporter, serving global B2B customers.
3. Detailed Technical Specifications
| Parameter | Specification |
|---|---|
| Ingredient Name | Allopurinol |
| CAS Number | 315-30-0 |
| Molecular Formula | C5H4N4O |
| Molecular Weight | 136.11 g/mol |
| Appearance | White to off-white powder |
| Typical Purity | ≥ 99.0% (HPLC) |
| Grade | Pharmaceutical Grade |
| Solubility | Slightly soluble in water |
| Loss on Drying | ≤ 0.5% |
4. Product Source & Raw Material Origin
Allopurinol supplied by AIHerba® is synthetically manufactured using validated chemical synthesis routes. Raw materials are sourced from qualified upstream suppliers with full traceability, ensuring consistent quality and regulatory compliance.
5. Mechanism of Action & Functional Properties
From a functional material perspective, Allopurinol acts as a xanthine oxidase interaction compound, making it suitable for controlled pharmaceutical formulations. This description is non-clinical and non-therapeutic, intended solely for industrial and formulation understanding.
6. Application-Relevant Benefits (Regulatory-Safe)
-
Enables precise dosage control in formulations
-
Supports standardized pharmaceutical manufacturing
-
Demonstrates stable chemical behavior during processing
-
Widely documented in pharmacopeial references
No medical or therapeutic claims are made.
7. Usage Guidelines & Formulation Recommendations
-
Intended for licensed pharmaceutical manufacturers only
-
Suitable for tablet and capsule formulations
-
Compatibility testing with excipients is recommended
-
Final formulation responsibility lies with the buyer
8. Traditional & Modern Industrial Applications
-
API production for regulated pharmaceutical products
-
Reference material in analytical laboratories
-
Process validation and formulation research
9. COA & Quality Control Specifications
Pesticide Residue Limits
| Item | Limit | Method |
|---|---|---|
| Organochlorine Pesticides | Not Detected | GC-MS |
| Organophosphates | Not Detected | GC-MS |
| Pyrethroids | Not Detected | GC-MS |
Heavy Metals
| Item | Limit | Method |
|---|---|---|
| Lead (Pb) | ≤ 3 ppm | ICP-MS |
| Arsenic (As) | ≤ 2 ppm | ICP-MS |
| Cadmium (Cd) | ≤ 1 ppm | ICP-MS |
| Mercury (Hg) | ≤ 0.1 ppm | ICP-MS |
Microbiological Control
| Item | Limit | Method |
|---|---|---|
| Total Plate Count | ≤ 1,000 CFU/g | USP <61> |
| Yeast & Mold | ≤ 100 CFU/g | USP <61> |
| E. coli | Negative | USP <62> |
| Salmonella | Negative | USP <62> |
10. Manufacturing Process & Production Flow
Raw Material Qualification → Controlled Chemical Synthesis → Crystallization → Purification → Drying → Milling → Quality Testing → Packaging → Batch Release
Each batch is fully traceable with documented production records.
11. Storage, Shelf Life & Packaging
-
Storage: Cool, dry, sealed environment
-
Shelf Life: 36 months (under recommended conditions)
-
Packaging: 1 kg / 5 kg / 25 kg fiber drums or custom packaging
12. MOQ, Sample Policy & Global Shipping
-
MOQ: Negotiable based on project volume
-
Samples: Available for qualified B2B buyers
-
Shipping: Air / Sea / Express
-
Export Markets: USA, EU, Asia, Middle East
13. Clinical Data & Scientific Research
Scientific and pharmacological data on Allopurinol are publicly available through peer-reviewed publications and regulatory databases. AIHerba® does not provide clinical claims or conclusions.
14. Applicable Industries
-
Pharmaceutical manufacturing
-
Contract manufacturing organizations (CMO)
-
Research institutions
-
Regulated formulation developers
15. Industry Application Scenarios
Scenario 1: Pharmaceutical factory sourcing API for long-term production planning
Scenario 2: Contract manufacturer developing regulated solid dosage forms
Scenario 3: R&D laboratory requiring high-purity reference material
16. Supplier Comparison & Procurement Guide
When selecting an Allopurinol supplier, buyers should evaluate:
-
GMP compliance
-
Batch consistency
-
Regulatory documentation
-
Supply stability
-
Technical support capability
AIHerba® offers transparent documentation and direct factory supply.
17. FAQ for B2B Buyers
Q1: Do you provide GMP certificates?
Yes, full GMP documentation is available.
Q2: Can you support OEM/ODM projects?
Yes, for qualified pharmaceutical partners.
Q3: What purity levels do you offer?
Standard ≥99.0% (HPLC), customizable upon request.
Q4: Do you provide samples?
Samples are available for evaluation.
Q5: What is the lead time?
Typically 2–4 weeks depending on order volume.
Q6: Do you support regulatory documentation?
Yes, COA, MSDS, and technical files are provided.
19. References & Regulatory Sources
-
PubChem
-
FDA Drug Database
-
USP–NF Monographs
-
NIH Scientific Publications
Manufacturer & Quality Assurance
Manufactured by AIHerba® (Shaanxi Zhonghong Investment Technology Co., Ltd.),
a GMP-certified manufacturer specializing in high-purity botanical extracts
for dietary supplements, cosmetics, and pharmaceutical applications.
✔ GMP-certified production facility
✔ Full COA & technical specifications available
✔ Batch traceability & strict quality control
✔ Bulk supply & OEM/ODM services for global B2B buyers
📧 sales@aiherba.com | info@aiherba.com | liaodaohai@gmail.com
🌐 www.aiherba.com
If you are looking for a bulk supplier / OEM manufacturer of Allopurinol, contact us for specifications, COA, and pricing.
Reviews
There are no reviews yet.