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- Physico -
chemical and microbiological analysis of raw materials and finished
products.
- Analytical Transfer
- Validation of analytical methods according to ICH guidelines (Q2A
& Q2B)
Analytical Development :
- Optimization of existing analytical methods, Troubleshooting
- Development of new analytical methods on finished products ( assay,
impurities,
- Preservatives, in vitro dissolution tests)
Stability Studies ICH :
- Led of stability studies according to ICH guidelines (Q1A R2 à
Q1F)
Storage and analysis on site in various conditions :
25±2°C/60±5% HR
30±2°C/65±5% HR
40±2°C/75±5% HR
- Storage under other possible specific climatic conditions.
Well equipped platform :
- High performance liquid chromatography (UV, Refractometer)
- Gas chromatography (Head space)
- Spectrophotometry (UV - Visible, IR)
- Pharmaco technical analysis
- In vitro dissolution equipment
- Sprays testing device of MDI (Metered Dose Inhalers)
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