Our APIs standards are characterized material suitable to test the strength, identification, quality, and purity of substances for pharmaceutical uses and medicinal products.
We offer from an API Research Material to “qualitative" purposes in our "Elemental Range" to an API primary characterized standards that meets ICH’s, FDA’s and other regulatory bodies’ requirements worldwilde for different laboratory applications, within our "Dynamic" and "Beyond" ranges.
Klivon has designed a range of primary API standards manufactured according international regulations and come with the most extensive Certificate of Analysis which includes Identity checks by several techniques. Assay information is also provided by Mass Balance and confirmed by a second independent method (qNMR or Carbon Titration) ensuring the reliability of your analysis regardless of your method
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select productsDeveloped for use in early-stage development, drug discovery, R&D, academia specially for qualitative purposes. A default set of analytical techniques to confirm the Identity was settled to secured the chemical structure of the Impurity plus a Purity test.
Research Chemicals / Analytical Standards
With Klivon Dynamic range you can count on carefully determined ASSAY values. Best cost-benefit ratio for varied non-compendial applications in compliance with ICH, FDA and WHO guidelines. A final remark (conclusion) bellow of each spectra is added.
Characterized Reference Standards
Our premium range of High Purity Reference Standards designed to meet the most demanding pharmaceutical laboratories and highly critical research, Klivon Beyond is accompanied by a comprehensive certificate of analysis (CoA), also comes with a complete spectrum elucidation report. A final remark (conclusion) or Spectra Interpretation bellow of each spectra is added.
Full Characterized Reference Standards
Our Impurity Characterized Standards portfolio comprises more than 5,000 compounds accompanied by a comprehensive CoA which can be found in 3 product categories that include a set of different analytical techniques for determining Identity and Purity.
We have designed a range of primary API standards manufactured according to international regulations that come with the most extensive Certificate of Analysis which includes Identity checks by several techniques.
Excipients standards comes with a detailed Certificate of Analysis with Identity, Purity and Assay data. They are also suitable for use with non-compendial analytical methods.
We offer tailor-made synthesis services of up to gram-quantities of materials for a wide range of pharmaceutical customers. The customer can order a specific molecule that is only synthesized on your request on the scale, with the purity and with the specification or methods you require.
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