Analytics



R&D Analytical Chemistry Department,  Quality Control Department and Drug Form Analytical Department  perform analytical studies in accordance with the requirements of international organizations ICH and EMA, as well as the National Office for the Registration of Medicinal Products , Medical Devices and Biocides . Additional analytical services are presented on the Structural Research Laboratory  website.

Range of services offered by

R&D Analytical Chemistry Department:

Development of analytical methods for chemical and pharmaceutical substances.

Instrumental validation of analytical methods in accordance with the current ICH guidelines .

Full impurity profile determination.

Particle size and shape distribution profile determination.

Comprehensive stability studies under accelerated and long-term  conditions.

Chemical compound structure determination.

Analytical polymorphic evaluation .

Analytical documentation development in the form of Analytical Manuals , Specifications and Standards .

Analytical registration dossier preparation in a CTD format , Module 3

 

Analytical polymorphic evaluation performed in the R&D Analytical Chemistry Department:

Structural and thermal characteristics of polymorphic forms .

Quantitative analysis of polymorphic purity of pharmaceutical substances .

Identification of polymorphic forms of the active substance in a medicinal product .

Stability studies of pharmaceutical polymorphic forms .

 

Range of services offered by the Quality Control Department :

Certification of chemical and pharmaceutical substances, excipients and medicinal products.

Analysis of optically active compounds by HPLC and UPLC .

Impurity profile testing.

Analytical method validation in accordance with current ICH guidelines .

Development and validation of analytical methods applied in the process of cleaning the equipment used for manufacturing pharmaceutical substances and medicinal products.

Determination of residual solvents in pharmaceutical substances by classical and Head Space method.

Stability studies of pharmaceutical substances and medicinal products conducted in validated climatic chambers under normal (25 ° C/60 % RH) , intermediate (30 ° C/65  % RH) and  accelerated conditions (40 ° C/75 % RH) and in a refrigerator at 5 ± 3 ° C or freezer  at- 20 ± 5 ° C.

Pharmaceutical availability testing ( drug dissolution profiles ) .

Performing analyses on demand.

 


 R&D Analytical Chemistry Department
 Head of Department:

 Joanna Zagrodzka, M.Sc.
 Land line: (+48 22) 456 39 05
 Mobile.: (+48) 601 333 919
 Fax: (+48 22) 456 38 38
 E-mail:  j.zagrodzka@ifarm.eu

Quality Control Department    
 Acting Head of Department:

 Ewa Chojecka-Koryn, Ph.D.
 Land line: (+48 22) 456 39 02
 Fax: (+48 22) 456 38 38
 E-mail:  a.ignaciuk@ifarm.eu

 

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