Products and Services. Chemical Analysis of Medicinal Products

The Chemical Analysis Department (ZACh) provides the services in respect of analytical examinations of medicinal products, active substances and pharmaceutical raw materials.

The ZACh has a quality management system compliant with ISO 9001:2000 in place for “chemical analysis and analytical examinations”. This is endorsed by the DNV Certificate (no. 45888-2009-AQ-POL-FINAS). Moreover, the ZACh follows Good Laboratory Practice as determined in the documents issued by the Organization for Economic Cooperation and Development (OECD).

The Department follows the GMP guidelines and holds a drug manufacturing license that covers research and quality control during the manufacturing process, issued by the Chief Pharmaceutical Inspector (GIF). This license also covers products for clinical trials.

Analytical examinations and tests conducted in the Chemical Analysis Department include:

• identification and determination of substance content by high-performance liquid chromatography (HPLC),
• determination of contamination content by HPLC,
• identification and determination of contamination by thin-layer chromatography (TLC),
• identification and determination of solvent content by gas chromatography (GC),
• determination of active substance content in serum, plasma or full blood by HPLC,
• stability of an active substance and medicinal products,
• determination of water content by Karl Fischer titration,
• determination of element content by flame atomic absorption spectroscopy (F-AAS),
• determination of element content by graphite furnace atomic absorption spectrometry (GF-AAS),
• measurement of optical rotation,
• measurement of UV-visible absorption,
• determination of substance content by UV method,
• determination of substance content by titration (potentiometric titration, traditional titration),
• microscopic examinations,
• measurement of IR, NIR absorption,
• determination of loss on drying,
• determination of sulfated ash,
• determination of heavy metal content,
• melting point measurement,
• identification and determination of ion content,
• identification and determination of insolubles content (contaminations) in injection solutions by HIAC,
• assessment of tablet disintegration time,
• assessment of the medicinal substance release from various forms of drugs (tablets, capsules, granulated mass, suspensions, other),
• evaluation of medicinal products pharmaceutical availability (release profiles),
• assessment of mechanical resistance of a tablet to abrasion,
• measurement of tablet hardness,
• pH measurement,
• osmolarity measurement,
• density measurement,
• viscosity measurement,
• particle size measurement by laser diffraction.

Analytical services provided by the ZACh include:

• analyses of medicinal products, active substances and chemical raw materials in accordance with the Company Standards of the customer, suitable pharmacopoeias or in-house methods.
• development of evaluation methods for chemical substances, pharmaceutical formulations and medicinal products.
• identification and determination of therapeutically active proteins obtained by DNA recombination method,
• identification and determination of related-proteins being by-products created in the technological process.
• development of new methods of determination of non-protein contaminations in substances and medicinal products of biotechnological origin.
• analytical method validation.
• studies and assessments in respect of technology process analytical control (validation of washing processes, contamination profiles).
• analytical examinations at the phase of drug and manufacturing technology development.
• evaluations of active substances and medicinal product stability.
• evaluations of the pharmaceutical availability of drugs.

 

For any of these services please contact:

Head of the Chemical Analysis Department
Bożena Tejchman-Małecka, M.Sc.
phone: +48 (22) 37 86 140
mail: tejchmanb@iba.waw.pl

Deputy Head of the Chemical Analysis Department
Grażyna Tronczyńska-Lubowicz, M.Sc.
phone: +48 (22) 37 86 141
mail: lubowiczg@iba.waw.pl