The T&E Analytical Center, has great expertise in cancer products. For this he specialized in pharmaceutical forms as:
· Freeze-dried powders;
· Injectable solutions and suspensions;
· Tablets and capsules;
· Transdermal Adhesives;
By regulation of ANVISA, it is necessary that the Center has a separate environment from the other areas. It consists of a closed room, with a biological security booth, scale, exhaust hood and the employees use specific PPE, guaranteeing their safety..
For the analysis of CYTOTOXICS it is necessary knowledge and a lot of interaction with the manufacturer, from the raw material to the intermediate product as the final product.
COST AND QUANTITIES
They are products of high cost and price (if the study requires product Market Reference).
The quantity of samples should be fair and meet ANVISA for retest and retention.
Identification and Quantification:
The most used analytical techniques for Clean Validation are in function of the molecule and the analytical resources employed, among the techniques most used are:
· Gas-phase Chromatography (GC-FID-ECD-TCD-MS-Head Space);
· Liquid phase chromatography (UPLC or HPLC-UV / Vis; Fluorescence; ELSD);
· LC-MS / MS: Mass Spectrometry coupled to HPLC or UPLC;
· ICP-OES (Induced-Simultaneous and Sequential Plasma); AA - (Atomic Absorption) and FC (photometry of flame).
· Determination of peak purity using DAD.
Other solutions may occur during the technical exchange and thus solve the problem of your company.