Quality
Quality control & analytical capabilities
Quality is integrated into every stage of manufacturing. Our Quality Control laboratory supports raw-material testing, in-process monitoring, finished-product analysis, product release, and batch-to-batch consistency.
Analytical instrumentation
Instruments behind every release
- Gas chromatographs (GC) — 2 units
- Agilent GC headspace system
- High-performance liquid chromatographs (HPLC) — 3 units
- Karl Fischer titrator
- Ultrasonic bath and melting-point apparatus
- Analytical balances, pH meter, and conductivity meter
- Muffle furnace, laboratory oven, and magnetic stirrers
Our robust quality systems ensure complete control over manufacturing process, documentation, testing and product release.
Microbiology laboratory
Microbial testing and environmental monitoring
Our dedicated microbiology laboratory supports microbial testing and environmental monitoring as required by product and quality-system needs.
- Controlled-temperature incubators
- Hot-air oven
- Biosafety cabinet
- Autoclaves, including a decontamination autoclave
- Microscope and colony counter
- Analytical balance and pH meter
Stability testing
Studies aligned to ICH guidelines
Dedicated stability chambers support long-term and accelerated stability studies in accordance with applicable ICH guidelines.
| Long-term | 25°C ± 2°C / 60% RH ± 5% RH |
|---|---|
| Intermediate | 30°C ± 2°C / 65% RH ± 5% RH |
| Accelerated | 40°C ± 2°C / 75% RH ± 5% RH |
These facilities support product development, validation, regulatory submissions, stability monitoring, and lifecycle management.
