July 27th, 2015
SARA Pharm Solutions was approved by the National Agency for Medicine and Medical Devices for physico-chemical testing, stability testing,
method validation and development on API and final products, obtaining Good Manufacturing Practice (GMP) certification.
Approved testing activities:
1. Physicochemical testing:
– XRPD – X-Ray Powder Diffraction;
– DSC – Differential Scanning Calorimetry;
– TGA – Thermogravimetric analysis;
– HPLC – High- Performance Liquid Chromatography;
– melting point;
– freezing point;
– aspect and coloration of solutions;
– loss on drying;
– pH determination;
– water determination;
– potentiometric titration.
2. Stability testing: accelerated and long term conditions.
3. Development and validation of analytical methods.
You can view the authorization here.