



Founded in 2006, Laboratorio Cifga S.A. is a chemical-pharmaceutical company devoted to develop certified reference material of marine biotoxins and reagents for research and new therapeutic drugs.
The marine toxins are a serious health and socio-economic problem for the shellfish industry. The need to protect consumers requires complying with European and international legislation, with complex monitoring systems many countries have implemented. European Comission has issued a regulation that requires the mousse bioassay (MBA) to be replaced by LC-MS, therefore marine toxins CRMs are necessary and reliable tools to achieve this monitoring task. We have become the first producer of certified reference material of marine biotoxins in Europe.
We have access to a full complement of state of the art biological, organic and analytical instrumentation. Our products have been produced under the supervision of highly qualified chemist and biologist using an extensive and thorough purification process. Identification and quantitation are carried out by NMR spectroscopy or liquid chromatography coupled to mass spectrometry. Therefore the quality and the reproducibility attained with our production method is a guarantee to all of our customers and an additional value of the products.
Since many of these toxins have unknown mechanism of action, they are actively seeked by scientist for research. Laboratorio CIFGA S.A. is aware of the importance to provide quality products, therefore our goal is to produce products for analysis and research.
Why you can trust on our CRMs?First of all, our CRMs products are attained according to ISO Guide 34. The certification of reference materials follows strict rules which are described in a special ISO Guide 35. And therefore they are:
Traceable: By the use of quantitative NMR as a relative primary method, traceability can be achieved between different organic compounds since the NMR signal intensity is in direct relation to the numbers of protons that contribute to the signal. We use NIST Standard Reference Materials (SRM and lot number specified on the certificate) for calibration and direct comparison.
Precise: We have detailed error budgets that define the errors used in determining the uncertainty, giving us a unique value for each lot of material.
Pure: We have the experience, skills and technology to deliver the highest level of purity products. On average, our products are 95 % pure at least. Purity is assured by using state-of-the-art analytical methods (UPLC, NMR, UV, FLD, MS) for the identification, characterization and quality control of our products. This ensures that our products meet the specific requirements in trace analyses. We perform purifications and chemical modifications as required to meet predefined quality specifications.
Accurate: Validated assay qNMR method developed on Innova 750 MHz spectrometer leads accurate quantitation. qNMR and UPLC-MS/MS conjuction allows us to perform a reliable products.
Homogeneity & Stability: We have conducted homogeneity and stability studies on all CRMs. Homogeneity and stability have been demonstrated and fully documented.
Documentation: Each CRM is accompanied by a certificate of analysis that follows ISO 34 and ILAC G12 guidelines.
EVENTS
Laboratorio CIFGA S.A. has participated in the following Trade Shows and Congresses:
- 8th International Conference on Molluscan Shellfish Safety: June 12-17, 2011. Prince Edward Island, Charlottetown, Canada.
- 125th AOAC Annual Meeting & Exposition: September 18-21, 2011. New Orleans, Louisiana, United States.
with grants from IGAPE and Consellería de Economía e Industria (Xunta de Galicia)
