Confarma

Quality Control Services

Solvias has a proven track record in the timely delivery of identity, strength, quality, purity, safety and potency information. This is the cornerstone of quality control and release testing.

We routinely perform QC analysis according to ISO or GMP quality standards for:

  • Starting materials
  • Excipients
  • Intermediates
  • Drug substances and products: small molecules in various galenical forms (solids, semi-solids, liquids and injectables)

according to either compendial method (USP, Ph.Eur. and JP), Solvias proprietary method or your method. We can transfer validated analytical methods to or from your site, according to the formal process of the ICH guidelines. Alternatively, the methods can be developed and validated at Solvias or are routine methods already in place at Solvias or requiring verification only.

Analytical Packages or Single Methods

For full CGMP compliance, many clients choose to outsource their entire Quality Control product testing program to us. You simply send us a sample of your product, and we deliver the results in a Certificate of Analysis or an Analytical Report that can be used to immediately release the product. We can also perform selected methods of your monograph, if this option suits your needs better.

Whatever your needs, we can handle any combination of development, validation and QC release testing for individual methods or complete release packages.

Release testing parameters typically address:

  • Identity: identifications of ions and functional groups, chromatographic methods: HPLC, TLC and GC, spectroscopic methods: IR, UV
  • Strength and purity: chromatographic methods: HPLC, UHPLC, HPTLC and GC, titration
  • Quality: physico-chemical properties, water content, aerodynamic particle sizing (e.g. NGI for inhalers), galenical tests for all dosage forms, hydrolytic resistance of glass
  • Safety: limit tests of heavy metals and ions, residual solvents by GC
  • Potency: enzymatic activities