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Allopurinol is a xanthine oxidase inhibitor widely used for the prevention and treatment of gout, hyperuricemia, and uric acid nephrolithiasis. It works by inhibiting the enzyme xanthine oxidase, reducing the production of uric acid in the body, thereby preventing urate crystal deposition in joints and tissues.
Bluepill Express manufactures high-purity Allopurinol API under WHO-GMP, ISO 9001:2015, and cGMP-certified facilities, ensuring consistent quality, stability, and compliance with global pharmacopoeial standards (IP, BP, USP, EP). This API is suitable for tablet and capsule formulations, catering to both domestic and international pharmaceutical markets.
Therapeutic Uses
- Gout Management: Prevents recurrent gout attacks
- Hyperuricemia Treatment: Lowers serum uric acid levels in metabolic disorders
- Kidney Stone Prevention: Reduces urate stone formation in the urinary tract
- Chemotherapy Support: Prevents tumor lysis syndrome-induced hyperuricemia
- Combination Therapy: Can be used with uricosuric agents for enhanced uric acid control
Mechanism of Action
Allopurinol inhibits xanthine oxidase, the enzyme responsible for converting hypoxanthine and xanthine into uric acid:
- Reduces uric acid production
- Prevents urate crystal deposition in joints and tissues
- Minimizes flare-ups and complications associated with gout
- Supports renal health by decreasing uric acid load
Pharmacological Information
- Chemical Name: 1H-Pyrazolo[3,4-d]pyrimidin-4-ol
- Molecular Formula: C5H4N4O
- Molecular Weight: 136.11 g/mol
- CAS Number: 315-30-0
- Therapeutic Class: Anti-gout / Uric acid-lowering agent
- Pharmacological Class: Xanthine Oxidase Inhibitor
- ATC Code: M04AA01
Physical & Chemical Properties
| Property | Description |
|---|---|
| Appearance | White to off-white crystalline powder |
| Solubility | Slightly soluble in water; soluble in sodium hydroxide solution |
| Melting Point | 390°C – 395°C (decomposes) |
| pH (1% aqueous solution) | 5.0 – 6.5 |
| Storage | Store below 25°C in a dry, ventilated area, protected from light and moisture |
Technical Specifications
| Parameter | Specification |
|---|---|
| Appearance | White to off-white crystalline powder |
| Identification | IR, UV, and HPLC positive |
| Assay (Purity) | ≥ 99.0% (HPLC) |
| Loss on Drying | ≤ 0.5% |
| Residue on Ignition | ≤ 0.1% |
| Heavy Metals | ≤ 10 ppm |
| Related Substances | ≤ 0.5% (individual impurity) |
| Bulk Density | 0.35 – 0.50 g/mL |
| Tapped Density | 0.50 – 0.65 g/mL |
Applications
Allopurinol API is used in:
- Tablet and capsule formulations for gout and hyperuricemia
- Combination therapy with uricosuric agents
- Bulk API supply for domestic and international pharmaceutical markets
Documentation Provided
- Certificate of Analysis (COA)
- Material Safety Data Sheet (MSDS)
- Technical Data Sheet (TDS)
- Method of Analysis (MOA)
- Stability Data (ICH-compliant)
- Regulatory Dossier / DMF (on request)
Packaging & Export Details
- Available Packs: 1 kg | 5 kg | 10 kg | 25 kg HDPE drums with double poly liners
- Labeling: Product name, batch number, manufacturing/expiry dates, storage instructions
- Shelf Life: 36 months under recommended storage conditions
- Export Markets: Africa, Asia, Latin America, Europe, Middle East
