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QC Procedures

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WHO-GMP Quality Control

Comprehensive QC Procedures for Fluconazole

Rigorous quality control protocols ensuring fluconazole API and finished dosage forms meet international pharmacopeial standards. Our QC laboratory follows WHO-GMP guidelines with validated analytical methods and comprehensive testing procedures.

50+ Test Methods
100% Batch Testing
ISO 17025 Lab Accreditation
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Fluconazole QC Laboratory

QC Excellence

  • Validated Analytical Methods
  • Stability Testing Programs
  • Microbial Limit Testing
  • Dissolution Profile Testing
Quality Control Framework

Comprehensive QC Testing Procedures

Our quality control procedures encompass complete testing of fluconazole from raw materials to finished products, ensuring compliance with USP, EP, JP, and WHO standards.

Raw Material Testing

Comprehensive testing of fluconazole API and excipients including identification, assay, impurity profile, and physical characteristics.

  • API Identification
  • Assay by HPLC
  • Related Compounds
  • Residual Solvents

In-Process Controls

Real-time monitoring during manufacturing including blend uniformity, compression parameters, and intermediate product testing.

  • Blend Uniformity
  • Hardness Testing
  • Friability Testing
  • Weight Variation

Finished Product Testing

Complete evaluation of finished fluconazole tablets and IV solutions including all pharmacopeial specifications.

  • Assay & Content Uniformity
  • Dissolution Testing
  • Microbial Limits
  • Stability Studies
Analytical Methods

Validated Testing Procedures

State-of-the-art analytical methods validated according to ICH guidelines for accurate and reproducible results.

Chromatographic Methods

Advanced HPLC and GC methods for quantitative and qualitative analysis of fluconazole and related substances.

HPLC Assay Method

Validated

System: RP-HPLC with UV detection at 260nm

Column: C18, 250mm × 4.6mm, 5μm

Mobile Phase: Phosphate buffer pH 3.0:Acetonitrile (75:25)

Flow Rate: 1.0 mL/min

Range: 80-120% of label claim

Related Compounds

Validated

LOD: 0.05% for each impurity

LOQ: 0.15% for each impurity

Accuracy: 98-102% recovery

Precision: RSD < 2.0%

HPLC Equipment for Fluconazole Testing

Method Validation Parameters

  • Specificity
  • Linearity
  • Accuracy
  • Precision
  • Robustness
  • System Suitability
Quality Specifications

Fluconazole Test Specifications

Comprehensive specifications meeting USP, EP, JP, and WHO pharmacopeial requirements.

Fluconazole API Specifications

Test Parameter Specification Method
Identification Conforms to reference IR, UV, HPLC
Assay 98.0% - 102.0% HPLC
Related Compounds NMT 0.5% HPLC
Residual Solvents As per ICH Q3C GC
Heavy Metals NMT 10 ppm AAS
Loss on Drying NMT 0.5% Gravimetric

Fluconazole Tablets Specifications

Test Parameter Specification Method
Description White to off-white Visual
Identification Conforms to reference UV, HPLC
Assay 90.0% - 110.0% HPLC
Content Uniformity 85.0% - 115.0% HPLC
Dissolution NLT 80% in 30min USP Apparatus 2
Hardness 5-10 kp Monsanto
Stability Programs

Comprehensive Stability Testing

Long-term and accelerated stability studies conducted according to ICH guidelines to establish shelf life and storage conditions.

Long-Term Stability

Conditions: 25°C ± 2°C / 60% RH ± 5%

Duration: 36 months

Testing: Quarterly for first year, semi-annually thereafter

  • Assay
  • Degradation Products
  • Dissolution
  • Physical Appearance

Accelerated Stability

Conditions: 40°C ± 2°C / 75% RH ± 5%

Duration: 6 months

Testing: Monthly intervals

  • Assay
  • Degradation Products
  • Dissolution
  • Physical Changes

Intermediate Stability

Conditions: 30°C ± 2°C / 65% RH ± 5%

Duration: 12 months

Testing: Quarterly intervals

  • Assay
  • Related Compounds
  • Dissolution
  • Container Integrity
QC Laboratory Equipment

State-of-the-Art Analytical Instruments

Modern, calibrated equipment ensuring accurate and reliable test results for all quality control procedures.

HPLC System

HPLC Systems

Waters Agilent systems with UV/PDA detectors for assay and impurity profiling

GC System

Gas Chromatography

GC-FID for residual solvent analysis and volatile impurity testing

Dissolution Apparatus

Dissolution Apparatus

USP Type I & II apparatus for dissolution testing of all dosage forms

FTIR Spectrometer

FTIR Spectrometer

For identification testing and polymorph analysis of fluconazole API

Quality Documentation

Comprehensive QC Documentation

Detailed documentation maintaining traceability and compliance with regulatory requirements.

Documentation System

Our quality documentation system ensures complete traceability and compliance with WHO-GMP requirements.

Batch Manufacturing Records

Complete documentation of each batch with in-process controls and testing results

Certificate of Analysis

Detailed COA for each batch with complete specification compliance

Stability Reports

Comprehensive stability data supporting shelf life claims

Validation Protocols

Method validation and equipment qualification documentation

QC Documentation System

Document Control

  • SOP Management
  • Version Control
  • Change Control
  • Training Records
  • Audit Trail

Request Our QC Procedures Manual

Get detailed information about our quality control procedures, testing methods, and specifications for fluconazole products.

Download QC Manual Quality Assurance