ANALYTICAL R&D LABORATORY

Development of analytical methods, impurity studies, degradation studies, and more. Thanks to our analytical expertise and state-of-the-art equipment, we support our clients in the drug development and registration phases by following the latest trends in analytical chemistry.

Method Development and Validation

Product-specific analytical methods are developed using international guidelines (Turkish Pharmacopoeia, European Pharmacopoeia, American Pharmacopoeia, and British Pharmacopoeia, etc.) and validated in terms of accuracy, precision, selectivity, recovery, and robustness parameters.

Stability Studies

Studies are conducted in accordance with ICH stability guidelines to determine the shelf life and storage conditions of the products.

Impurity Analysis

Analyses are performed to identify potential organic impurities and degradation products that may be present in the products.

Raw Material and Finished Product Control

Raw materials and finished products are analyzed for compliance with defined specifications.

Analytical Consulting

We provide support for analytical strategy, method selection, and technical reporting for R&D and licensing processes.

Instrument Infrastructure

  • LC-MS/MS : WATERS Xevo G2-XS and APGC w/H-CLASS UPLC
  • AAS: SHIMADZU AA-7000
  • HPLC: SHIMADZU LC-2050C
  • WATERS: ANDREW + The Pipetting Robot
Address

Novagenix Biyoanalitik İlaç Ar-Ge Merk. San. Tic. A.Ş.
Balıkhisar Mah. Özal Bul. Novagenix Blok No: 395 06750 Akyurt / Ankara TÜRKİYE

Contact

Phone: +90 (312) 398 10 81 
Fax: +90 (312) 398 07 18

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