Mikromol™ API reference standards

If no official standard from a pharmacopoeia exists for a given purpose, primary standards from other sources can be used. For such primary reference standards the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) and Food and Drug Administration (FDA) demand a reference standard of the highest possible purity and full characterisation. Mikromol™ is covering a new range of API reference standards that fulfill ICH, FDA and other regulatory bodies’ requirements for pharmaceutical quality control. Using Mikromol™‘s API reference standards ensures that you are well equipped and prepared for all audits or inspections. Our API reference standards are produced under ISO Guide 34, and are filled into vials under argon atmosphere to ensure stability of unopened containers.

The detailed certificate of analysis includes:

Comprehensive identity information

Nuclear magnetic resonance (NMR) spectrum

Infrared spectrum (IR)

Mass spectrometry data (MS)

Detailed purity/assay data

Assay information by accredited technique, qNMR whenever possible Confirmation by orthogonal method, e.g. mass balance For the full range of available substances, please view our primary standards brochure.

For further information or to place an order, please contact us.