PHARMACEUTICAL ANALYSIS DEPARTMENT

Pharmaceutical Analysis Department performs routine analyses with a special emphasis on determination of excipients, such as:

  • Quantitative determination of sorbitol, glycerol, maltitol, mannitol in liquid forms based on our own method;
  • Quantitative determination of glucose in liquid forms based our own method;
  • Quantitative determination of edetate disodium in liquid forms based on our own method;
  • Quantitative determination of lactic acid in semisolid and solid forms based on our own method;
  • Quantitative determination of B vitamins in liquid forms based on our own method;

Moreover, Spark-Lab Ltd. accepts orders for determination tasks in accordance with detailed European Pharmakopoeia and the United States Pharmakopoeia monographies for pharmaceutical substances and resources. It is also possible to employ analytical methods provided by the Client to perform the determination task.

The Pharmaceutical Analyses Department of Spark-Lab conducts research and development work in cooperation with pharmaceutical and cosmetics manufacturing plants. The Laboratory provides services through its highly skilled personnel and state-of-the-art equipment at the initial phase of works on a generic medicinal or cosmetic product (pre-formulation).

The conducted research results in obtaining information on the qualitative and quantitative composition of a future final product. At the same time, the analytical methods for determination of the active pharmaceutical ingredients and impurities content in raw materials and final products are being developed through spectrophotometric techniques and liquid and gas chromatography. Works on analytical methods are divided into four stages:

  • Design and optimisation methods or modification of the existing method in line with Ph. Eur., ICH, USP guidelines;
  • Validation of the analytical method;
  • Transfer of the method to the Client’s laboratory;
  • Employee training on the implemented method;

Moreover, pharmaceutical laboratory of Spark-Lab Ltd. company conducts research and provides services in the areas of:

  • Identity analysis of raw materials;
  • Purity analysis of raw materials;
  • Identity analysis of impurities (identification of chemical compounds) in raw materials and final products;
  • Isolation identified impurities (chromatographic techniques) intended for use as standards;
  • Quantitative analysis of impurities in raw materials and final products;
  • Qualitative and quantitative analysis (composition analysis) of final products;

The conducted research projects are subject to numerous procedures enforced by the implemented Quality Management System ISO 9001:2008. At each phase of works, laboratory employees stay in contact with Clients and inform them about the progress in research. Being aware of the confidentiality of data held by the Spark-Lab Laboratory in the course of conducting projects, when concluding confidentiality agreements the management ensures high level of safety of Client’s information.