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;
– solubility;
– 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.

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