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The Spark-Lab Laboratory conducts research and development work in cooperation with pharmaceutical and cosmetic production plants. The Laboratory offers the support provided by its qualified staff and modern apparatus at the initial stage of work on a generic medicinal product or a cosmetic product (pre-formulation).

 

As a result of this research, we obtain information on the qualitative and quantitative composition of the future finished product. At the same time, analytical methods are developed to determine the amount of the main substances and contaminants, with the use of such techniques as spectrophotometry as well as liquid and gas chromatographic analysis. The work on analytical methods is divided into four stages:

  • Designing and optimizing the method or modifying the already existing method in accordance with the existing Ph. Eur., ICH and USP guidelines;
  • Validating the analytical method;
  • Transferring the method into the Client’s laboratory;
  • Providing training for the employees in the implemented method;
MEDICAL DEVICES, MEDICINAL PRODUCTS AND BIOCIDES
MEDICAL DEVICES, MEDICINAL PRODUCTS AND BIOCIDES

Moreover, the pharmaceutical laboratory of Spark-Lab Sp. z o.o. conducts research projects and provides services within the area of:

  • Determining the chemical identity of raw materials (starting materials);
  • Analysing and determining the purity of raw materials (starting materials);
  • Determining the chemical identity of contaminants (identifying chemical compounds) in both raw materials and finished products;
  • Isolating the contaminants (with the use of chromatographic techniques) intended to be used as models;
  • Analysing the content of contaminants in raw materials and finished products;
  • A qualitative or quantitative analysis (the analysis of composition) of finished products;

 

The conducted research projects are subject to numerous procedures which are required by the Quality Management System ISO 9001:2015 that was introduced. At each stage of the work, the employees of the laboratory are in close contact with the Clients, informing them about the research progress. Being aware of the confidentiality of the data the Spark-Lab Laboratory has at its disposal when conducting projects, the management ensures high safety of information provided by the Clients by entering into confidentiality agreements.

CONTACT US

PHONE NUMBER
+48 58 698 23 56
+48 782 811 350

ADDRESS
Aleja Zwycięstwa 96/98
81-451 Gdynia

E-MAIL ADDRESSES
office@spark-lab.pl
zapytania@spark-lab.pl

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