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SCIENTIST SPOTLIGHT: February 2018

ScientistSpotlight_Vishal.jpegName: Vishal Rana
Alcami Site: Edison, NJ

How long have you been with Alcami?

I have been with Alcami for five years.

What is your role? 
I am a Senior Chemistry Analyst / Lab Coordinator at the Edison, NJ site. My day-to-day activities include working on HPLC, GC, and Wet Chem projects, as well as assigning projects to analysts.

What is the most rewarding part of your job?
The most rewarding part of my job is being part of a team which provides direct or indirect support to the development and commercial release of drug products. It’s a great feeling knowing your contributions help treat a variety of diseases, assist those in pain, and potentially save millions of lives.

What are your team’s latest achievements?
Alcami Edison is now equipped with ICP-MS capabilities for the detection of elemental impurities. Many individuals contributed extra time and resources to ensure the program's successful deployment. Although other Alcami sites have existing ICP-MS programs, the addition of the instrument to the Edison site will expand the program, adding more support and value to our customers.

How do you see those accomplishments affecting the pharmaceutical industry?
Elemental impurities are traces of metals found in finished drug products which, before 2018, required a visual analysis of raw material route release. The FDA now requires a quantitative approach, which looks at individual elements depending upon the drug product's route of administration. Elemental impurities can be introduced by API catalysts, formulation ingredients, or the manufacturing operation, and can interfere with drug efficacy.  As USP <231> was a visual color-comparison method, it did not provide adequate sensitivity for some of the more toxic elements of interest. Utilizing the ICP-MS for trace metal analysis, we can better detect the individual element impurities, which further serve to protect our clients and their customers.

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