Ultra Fast Mass Spectrometer: GCMS-TQ8030

Our main activities are related to research and development. Mainly we check quality of raw materials which are used in the process. Apart from this we extensively use the instrumentation for Organic Volatile Impurities analysis, Genotoxic impurity analysis and residual solvent analysis as per USP467 for APIs. I am heading all the activities in the lab so I am directly or indirectly involved in most of the activities. We have group of managers handling day to day activities and if they have problems or need guidance, they take my suggestions.

Once we find the impurities in the in-process or API, we characterize them with respect to molecular weight, structure and other parameters. For confirmation of these impurities, we isolate or synthesize them in lab. We carry out Ames test to check toxicity of impurity. Then as per QSRM (Quantitative Security Risk Management) , depending on daily intake permissible limits, we decide the detection and quantitation limits for these compounds. So in whole process HS-20 and GCMS-TQ8030 serves great purpose. Especially when we have to go for sub-ppm level detection, we require highly sensitive instrument and we use HS-20 with GCMS-TQ8030 or GCMS-TQ8030 alone.

When we were selecting the system we gave importance to mainly three parameters. First was performance with respect to sensitivity and ruggedness. For which we did actual evaluations in vendor’s facilities. Secondly we were looking for good service support background and last but not least we wanted to have user friendly software with minimal complications. We found Shimadzu up to the mark for all parameters.

In my opinion Shimadzu has come up with good technological improvement. This instrument is giving very much satisfactory results but still I cannot say as number one in market because we don’t have fair comparison of results. But I can say that for whatever analysis we are doing in lab pertaining to head space, HS-20 is preferred instrument of choice.

As per my experience with Shimadzu, we are very much satisfied with all type of support. Especially service support is very good and cannot be compared with any other vendor’s support. Most of the time support is proactive or anticipatory with our expectations and we don’t have to wait for it. All the Shimadzu’s instruments we have in lab are performing well and are rugged, as we expected. Technology wise Shimadzu has very good technology but still has good scope for development in polymorphism area and other technologies like FT Raman and software.

During the last decade, keeping in view the growing demands for high end technologies in Pharmaceutical Industries, Shimadzu has come up with many new instruments right from Ultra Fast LCs like Nexera to high end Ultra Fast Mass Spectrometers. The growing concern of lower detection levels of impurities in APIs(especially when genotoxic) and high throughput for fast release of production batch is addressed by Shimadzu by providing best in class hyphenated technique, HS-20 headspace and GCMS-TQ8030 triple quad.

At the end of the interview, we are very happy to know that the skilled and highly experienced staff of top pharmaceutical company like Lupin, is very much satisfied and happy with not only the technology we provided but also the support. Our happiness lies in users’ success and satisfaction. We herewith thank Dr. Upadhyay and his staff for spending time with us and extended cooperation during our visit.