GMP Reference Substances

HFR offer services for manufacture of a high purity reference substance for assay (%w/w) determination and/or reference markers for identification in chromatographic work.

Reference substances are purified typically three times and fully characterized in order to determine purity in terms of weight. Material of this grade is required for assay (%w/w) determinations of analyte.

Reference marker samples are required to identify impurities in analyte chromatograms, these impurities may include starting materials, intermediates, process impurities, degradants and by-products.

In both cases a quality assured certificate of analysis will be supplied upon completion of work together with copies of analytical data and methods.