Quality Excellence

Comprehensive Fluconazole Certificate of Analysis

Detailed Certificate of Analysis with complete Taj Pharma QC activities. Each fluconazole batch undergoes rigorous testing with comprehensive quality parameters ensuring compliance with USP, EP, BP, and JP pharmacopeial standards.

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Ms. Anjali Patel

QC Director

QC Excellence

Taj Pharma Quality Control Activities

Taj Pharma's comprehensive QC activities encompass every stage of fluconazole manufacturing, from raw material verification to finished product release. Our quality control systems ensure consistent product quality, safety, and efficacy through systematic testing and validation procedures.

Multi-Stage Testing

Comprehensive testing at raw material, in-process, and finished product stages

Regulatory Compliance

Full compliance with USP, EP, BP, and JP pharmacopeial standards

Complete Traceability

Full batch traceability with detailed manufacturing and testing records

QC Procedures Quality Consultation

QC Activities

Comprehensive Quality Control Procedures

Detailed QC activities ensuring fluconazole product quality and regulatory compliance.

Raw Material QC

Activities: Complete verification of all incoming raw materials

Identity testing (IR, UV, NMR)
Potency assay by HPLC
Impurity profile analysis
Heavy metals testing (ICP-MS)
Microbial limits testing
Physical parameters (particle size, bulk density)
Supplier qualification audits

In-Process QC

Activities: Real-time monitoring during manufacturing

Blend uniformity testing
Granulation parameter monitoring
Compression force verification
Weight variation control
Hardness and friability testing
Environmental monitoring
Process validation studies

Finished Product QC

Activities: Comprehensive testing of final fluconazole products

Assay (98-102% by HPLC)
Related substances (≤0.5%)
Dissolution testing (>85% in 30min)
Content uniformity (85-115%)
Physical appearance verification
Container closure integrity
Package integrity testing

Microbiological QC

Activities: Comprehensive microbiological testing

Total aerobic count (≤10³ CFU/g)
Yeast and mold count (≤10² CFU/g)
Pathogen screening (E. coli, S. aureus, etc.)
Bacterial endotoxin testing (IV products)
Sterility testing (IV formulations)
Preservative efficacy testing
Environmental monitoring

COA Parameters

Certificate of Analysis Quality Parameters

Comprehensive quality parameters included in each fluconazole Certificate of Analysis.

Identification Tests

IR spectroscopy matching
UV-Vis absorption spectrum
Chemical reaction tests
Chromatographic retention time

Assay & Purity

Potency: 98.0% - 102.0%
Related substances: ≤0.5%
Individual impurities: ≤0.2%
Residual solvents: USP limits

Dissolution Profile

Q30min: ≥85% (USP)
Q15min: ≥80% (BP)
Uniformity of dosage units
Disintegration time: ≤15min

QC Equipment

Advanced Quality Control Equipment

State-of-the-art analytical equipment ensuring accurate and reliable testing results.

HPLC Systems

Waters Agilent HPLC with PDA detection for assay and impurity profiling

GC-MS

Gas chromatography-mass spectrometry for residual solvent analysis

FT-IR Spectrometer

Fourier-transform infrared for identification and structural analysis

Dissolution Apparatus

USP Type II dissolution apparatus with automated sampling

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Daily QC Tests

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Batch Release Compliance

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QC Instruments

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QC Professionals