Pharmaceutical analysis

Mikro Kemi provides services both for research and quality control. We perform analyses of raw materials, API's, intermediates, excipients, pharmaceutical substances and finished products. Pharmacopeia methods are performed according to the European Pharmacopoeia, the United States Pharmacopeia (USP) and the Japanese Pharmacopoeia. We also utilize customer specified and proprietary methods. We develop analytical methods and perform validations in accordance with ICH's guidelines (International Conference on Harmonisation).

• Quality control of raw materials
• Assay
• Purity
• Identity
• Stability studies
  
  

We perform nearly all chemical analyses ourselves. For microbiology and certain other analyses we use carefully selected partners. Our partner for microbiology analysis is PharmaControl MQL AB in Uppsala. We use ALS Scandinavia AB in Luleå for ICP-MS analysis.