5-batch studies

Since 2003, Agrifor Scientific has completed over 850 projects on over 250 active substances. Our understanding of impurity profiles and whether those profiles will meet International regulatory requirements is World Class. We offer both GLP and Non-GLP reports depending on country requirements.

 

Agrifor uses modern analytical techniques (LC-MS-MS, GC-MS, GC-FID, NMR) to characterise the technical active ingredient including purity, significant and toxic impurities in accordance with FAO / WHO, EPA, EU and APVMA requirements and specifications relevant in individual countries.

 

Agrifor actively develops and validates new methods for the quantitative determination and identification of active substances and impurities including toxicologically relevant impurities in both technical grade and formulated products.

 

As an initial step, Agrifor offers a screening service for the elucidation and identification of impurities in the active substance. The impurity structures are accurately described and confirmed through NMR analysis. All impurities at > 0.05% are determined. Screening provides an understanding of the impurity profile of the active substance and the impurity standards that may be required to complete the main study.

 

The Comprehensive GLP 5-Batch analysis will include use of impurity standards, full method validation, NMR confirmation of active and impurity identification, 3D chromatograms, all raw data and calculations required in many jurisdictions today.

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