Marco Ricca
Internship at Pfizer @Pfizer
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WORK HISTORY
Internship at Pfizer @Pfizer
DEVELOPMENT AND VALIDATION OF A FAST HPLC METHOD FOR DETERMINATION OF RELATED IMPURITIES IN TYGACIL® 50mg Main benefits: 74% increase in sample throughput than compendial Usp method that means running more samples in less time Significant cost benefits due to reduced analysis time (-75%) and solvent consumption (-62%)(including subsequent disposal) Analysis was improved by using Core-Shell column technology achieving chromatographic performance equivalent to sub-2 µm particles column at lower operating pressures (<400 bar) that are compatible with conventional HPLC avoiding replacement of existing laboratory instrumentations and capital investment in more expensive UHPLC systems. The modifications are made according to the United States Pharmacopeia (USP chapter 621) guidelines on allowed deviations. All chromatographic system requirements were met. The developed method was validated as per ICH guideline and found to be specific, precise, sensitive and robust.
EDUCATION
Università degli Studi di Perugia
Master’s Degree, Pharmaceutical Chemistry and Technology (CTF)
SKILLS
ABOUT MARCO RICCA
Analytical development specialist at Pfizer. I developed a Fast Hplc method for determination of related impurities in TYGACIL® 50mg (Tigecycline for injection for intravenous use).My current interests include UHPLC/Fast HPLC technology, with a focus on reducing impact of system dispersion in currently available systems, increasing sample throughput and decreasing solvent consumption (including waste disposal).Main activities include: Method development and optimization, Specification setting Spectroscopic techniques-> MASS, FT-IR, UV-VIS Chromatographic techniques-> MPLC, HPLC, GC Elaboration of testing strategy to optimize, validate and transfer chemical methods Instrument and column characterization Transferring Compendial HPLC Methods to Core-Shell/UPLC Technology Faster time to market for routine analysis of drugs Decrease the overall operating expenses in development and quality control laboratories Release of batches produced in pilot plant Analyze finished products/raw materials/stability samples using various chemical and instrumental techniques in accordance with established compendial and in-house testing methods Recognizing out-of-specification or out-of-trend results and assisting in the completion of lab investigation Identifying and troubleshooting instrumental and analytical problems Improve technological approaches for pharmaceutical products GMP guidelines, ICH and Pharmacopeia applied to analytical development, technology transfer and Quality Control QC.Main instruments used: Hplc, Uhplc Gc/Fid Karl Fischer Subvisible particles Counter Colorimeter Spectrophotometer Glovebox (handling of photosensible and hygroscopic standards) Sofware: Empower (HPLC/GC) EasyMatch (Colorimeter) Labware Lims Full pack of Office ChemDraw e ChemSketch for molecular design Magistra for galenics management Working on the following o.s: Windows, Linux, Mac Adobe Photoshop
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