Our services in melamine analysis
We offer selective determination of melamine and melamine metabolites in raw materials and auxiliaries of medicinal products under GMP conditions.
This means you get a statement about melamine, ammeline, ammelide and cyanuric acid in your samples by an effective sample extraction and subsequent quantification. You can trust on our support for your quality assurance.
Your advantage, reliability with the strict quality and safety requirements for your drug production. We have already supported other customers with quality assurance and the reduction of costs.
How can we support you?
HPLC-MS/MS and sample preparation (extractions)
Raw materials with risk of melamine contamination (e.g. lactose, povidone, glucagon...)
Melamine is used as a raw material for production of adhesives, wood glues and melamine resins, which are also used for production of camping and children's tableware.
In 2008, Chinese milk products for infants were spiked with melamine to simulate a high protein content in the products (known as "melamine scandal"). In combination of the melamine metabolite cyanuric acid, this led to kidney failure of several infants.
The Food and Drug Administration (FDA) recommends testing of all drug raw materials and auxiliaries that have an increased risk of contamination with melamine.
We offer product-specific validations and subsequent measurements of your raw materials and auxiliaries according to ICH Q2 guidelines. In addition to melamine, we also quantify its metabolites, ammeline, ammelide and cyanuric acid in the concentration ranges required by regulations.
Your benefit from our melamine determination
Thanks to CURRENTA melamine analysis, you comply with the official quality and safety requirements for your raw materials and auxiliaries of your drug products.
Other customers benefit from the quantification and limit test of melamine and melamine metabolites in accordance with ICH Q2 (R1) guidelines in various matrices.