Be it the food we eat, the clothes we wear, the medicines we intake, or even the gadgets we use, every product that is tested and certified is considered as a credible and authentic product. Testing the products not only assures the consumers of their quality, but also increases the brand reputation. This is where Analytical Testing comes into picture. Analytical Testing can be defined as the process that involves using various techniques that are used to identify the chemical makeup or characteristics of a particular sample.

Major industries that opt for analytical services are pharmaceutical, healthcare F&B, electronics, and other industry materials, Among these, pharma/ healthcare and F&B businesses are the major users of analytical testing services. This can be attributed to the ongoing Covid pandemic that brought about a drastic shift in consumer behaviour. As per a study, the global analytical testing laboratories market which stood at $202.8 million in 2016, grew at a CAGR of 105.5 percent to reach 333.8 million in 2021.

iTrace Pharmaceutical Solutions is an end-to-end analytical testing services firm with specialization across diverse pharma testing verticals. “We have one of the most experienced team in Trace level analysis like genotoxic impurities, Nitrosamine analysis as well as Extract ables and leachables testing. We specialize in E&L study design as well as glass delamination studies. We cater to all routine and nonroutine testing needs of our clients. We have all the necessary instruments like LC-MS, GC-MS, HS-GC-FID, SEM, HPLC, ICP-MS and UV-V is Spectrophotometer. We work in GMP environment and we have necessary certifications (National FDA, ISO 9001 and USFDA FEI)”, says Dr. Atul Nalavade, Director, iTrace Pharmaceutical Solutions.

Despite release testing is a major requirement, there is growing demand for trace level analysis and non-routine testing. But there is limited availability and knowledge of interpretation of sophisticated instruments and lack of experienced manpower. This is where i-Trace assists its clients in their diverse queries.

iTrace offers a wide range of services that include routine testing related substances, assays, residual solvents, and elemental analysis in different dosage forms and drug substances. However, its flagship services in which the company specializes is in E&L studies for packaging systems & medical devices, nitrosamine testing as well genotoxic impurity testing in drug products and APIs. Other services include Glass delamination studies as per USP <1660>, Deformulation studies, Excipient analysis.

We have one of the most experienced team in Trace level analysis like genotoxic impurities, Nitrosamine analysis as well as Extractables and leachables testing

Standing-out Among the Crowd
On time delivery and most importantly after analysis support to the regulatory queries is our specialty. We have even been supporting the clients for the regulatory queries received in trace level analysis and E&L studies which were performed at other third-party testing laboratories. Aggressive timelines and reply to regulatory queries about study designs, conduct and conclusions of results are the situations where we have been very effective as solution providers. To support the aggressive timelines as well as regulatory queries, we have sufficient trained and experienced team so we are able to deliver the results as committed”, explains Dr. Atul Nalavade about his company.

The iTrace staff have vast experience of working in the analytical services vertical for the last 12 years, and are currently working on sample preparation techniques for Nitrosamine analysis in complex matrices and also sample preparation for E&L studies. Additionally, the company is working on an in-house MS library especially for E&L related compounds.

Clients – The Paramount
Keeping clients’ confidence as paramount, iTrace lays strict emphasis on transparency, communication and on-time delivery. In the past couple of years, the company has worked with major pharma and chemical companies both in India and abroad. “We have very good experience in various dosage forms like Inhalation products, Injectables, Large volume parenterals, Ophthalmic solutions as well as processing components and medical devices. We are planning to add specialized instruments like LCMS, GCMS to cater to a more clients. Also, we are evaluating the scope for adding few more services which we will be able to disclose in near future”, concludes Atul.