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Analysis of API and excipients

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Central Laboratory offers an analytical testing of pharmaceutical substances (APIs)  and inactive ingredients according to the leading Pharmacopoeias of the world (Ph.Eur., BP, USP, Ph.Int., JP). Also, the analysis can be carried out according to the manufacturer’s methods. Our services include:

  • Testing according to pharmacopoeial monographs
  • Residual solvents
  • Analyses by HPLC and GC methods
  • Spectrophotometric methods (FTIR, UV / VIS)
  • Metal Content Analysis (by AAS)
  • Ethylene oxide and 1,4-dioxane content
  • Control of containers and materials for the packaging of pharmaceutical products (Ukrainian Pharmacopoeia/Ph.Eur., 3, USP <661>, <671> Container Testing)
  • Analysis of purified and sterile water for injection (Ukrainian Pharmacopoeia/ Ph.Eur., USP – Purified Water, Sterile Water for Injections)
  • Determination of water by the Karl Fischer method
  • Quality Control for Ethyl Alcohol (Ukrainian Pharmacopoeia/ Ph.Eur.)
  • Oil components composition
  • Methods of “wet” chemistry (identification, limit tests), etc.
  • Sterility
  • Microbiological purity
  • Bacterial endotoxins and others.

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