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Indian Pharmacopoeia standards
Taj Pharma's fluconazole tablet IP 150mg is manufactured to exact Indian Pharmacopoeia standards with comprehensive quality control testing. Our WHO-GMP certified facility ensures compliance with all IP specifications for assay, dissolution, and quality parameters.
Exact Indian Pharmacopoeia specifications
International quality standards
Comprehensive quality parameters
Detailed technical specifications as per Indian Pharmacopoeia standards for fluconazole tablet IP 150mg manufacturing and quality control.
| Parameter | IP Specification | Taj Pharma Result | Test Method | Frequency |
|---|---|---|---|---|
| Identification | Conforms to IP standard | Conforms | IP Spectrophotometric | Every batch |
| Assay | 95.0% - 105.0% of labeled amount | 98.5% | IP HPLC Method | Every batch |
| Dissolution | Not less than 80% (Q) in 30 min | 92% | IP Apparatus 2, 50 rpm | Every batch |
| Content Uniformity | 85% - 115% of labeled amount | 96% - 104% | IP Individual Assay | Every batch |
| Hardness | 5-8 kg/cm² | 6.5 kg/cm² | Monsanto Hardness Tester | Every batch |
| Friability | Not more than 1.0% weight loss | 0.45% | Roche Friabilator | Every batch |
| Thickness | 3.0 - 4.0 mm | 3.5 mm | Vernier Caliper | Every batch |
| Weight Variation | As per IP limits | Within IP limits | Analytical Balance | Every batch |
| Microbial Limits | As per IP requirements | Within IP limits | IP Microbial Test | Every batch |
Comprehensive quality control testing procedures ensuring strict compliance with Indian Pharmacopoeia standards for fluconazole tablet IP 150mg.
Complete testing of fluconazole API and excipients as per IP specifications before manufacturing to ensure quality input materials.
Real-time monitoring of critical manufacturing parameters including granulation, compression, and coating processes.
Comprehensive testing of finished tablets as per IP specifications including assay, dissolution, and stability studies.
ICH-compliant stability studies confirming 24-36 months shelf life under various storage conditions as per IP guidelines.
Complete IP compliance documentation including test reports, certificates of analysis, and stability data for regulatory submissions.
Strict batch release procedures ensuring all IP parameters are met before product release to market.
State-of-the-art manufacturing process ensuring strict compliance with Indian Pharmacopoeia standards for fluconazole tablet IP 150mg production.
Comprehensive testing and qualification of all raw materials including fluconazole API and excipients as per Indian Pharmacopoeia monographs and specifications.
Advanced wet granulation technology ensuring uniform drug distribution and optimal tablet characteristics meeting IP specifications for content uniformity.
State-of-the-art tablet compression machines with real-time monitoring ensuring consistent hardness, thickness, and weight variation within IP limits.
Integrated quality assurance systems throughout manufacturing process ensuring IP compliance at every stage from raw material to finished product.
Contact us for fluconazole tablet IP 150mg manufactured to exact Indian Pharmacopoeia standards with comprehensive quality documentation and regulatory support.