QUALITY CONTROL

Our Certificate of Analysis covers a wide range of categories, including but not limited to:

Physical parameters, chemical parameters, chromatographic fingerprinting, quantified active compounds, impurity profile, microbial profile, residual solvents, residual pesticides, heavy metals profile, aflatoxins and organoleptic properties.

The stability of every ingredient is periodically monitored throughout the product’s lifetime and elaborate documentation is maintained to ensure traceability at all levels.

 

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 QUALITY ASSURANCE

All Karallief® products are manufactured at Green Chem® in their ISO 22000 and GMP certified facilities. Specific HACCP (Hazard Analysis and Critical Control Points) procedures and HARPC (Hazard Analysis and Risk-Based Preventative Control) procedures consisting of Prerequisite Programs (PRPs) and Operational Prerequisite Program (OPRPs) are followed to analyze each step in the production process. 

The detailed procedures followed enables us to assess the risk of any potential biological, chemical or physical hazards and contamination, and if a hazard or contamination potential is identified, we work with Green Chem to implement specific control measures to address the issue and to ensure that the product is manufactured safely, free from hazards and free from cross-contamination.

 

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 CONTROL SAMPLES & STABILITY TESTING

Control samples for every single batch of Karallief products are maintained at Green Chem to facilitate traceability and ensure all products consistently meet our high-quality standards. Stability testing of the product, including real-time and accelerated stability testing, is also performed at specified time intervals. This helps us determine the shelf life of the product and also allows us to monitor the characteristics of the product over time.

High-end Testing Equipment

All Karallief products are thoroughly and methodically tested at Green Chem’s labs.

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Gas Chromatography - Tandem Mass Spectrometry [GC-MS/MS]

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Inductively coupled plasma mass spectrometry [ICP-MS]

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Atomic absorption spectroscopy [AAS]

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High Performance Liquid Chromatography [HPLC]

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Gas Chromatography [GC]

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Liquid Chromatography with tandem mass spectrometry [LCMS-MS]

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Ultraviolet [UV]

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High-performance thin-layer chromatography [HPTLC]

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Prep.HPLC