Secure your Pharma QC-reference standards

By EP News Bureau On Oct 1, 2025

Dr Markus Obkircher, Director, Head of Customer Solutions R&D, Chemistry, Merck KgaA

The Bengaluru Pharma Event 2025 also featured a detailed session by Dr Markus Obkircher, Director, Head of Customer Solutions R&D, Chemistry, Merck KgaA. He presented on the theme “Secure Your Pharma QC – Reference Standards.”

Dr Obkircher began by explaining the critical role of reference standards in drug discovery, development, and quality testing. He distinguished between primary standards and secondary standards, which serve as cost-effective, traceable alternatives for routine QC applications.

Merck introduced its portfolio of Pharma Secondary Certified Reference Materials (CRMs), which are fully traceable to both national metrology institutes (such as NIST and PTB) and compendial standards. These materials provide laboratories with reliable, ready-to-use solutions, reducing the significant time and resources often spent on developing in-house working standards.

Highlighting the regulatory framework, Dr Obkircher noted that both the US FDA and Pharmacopoeias allow the use of secondary standards as long as they are qualified against primary standards. This, he emphasised, makes Merck’s offering unique, as it combines dual traceability with global availability across a wide range of APIs and impurities.

He informed that Merck’s product portfolio spans over 2,500 catalog items, including APIs such as ibuprofen, acetaminophen, metformin, amlodipine, and amoxicillin. Each product is developed with metrological traceability through advanced methods like quantitative NMR (qNMR) and mass balance characterisation, ensuring accuracy and comparability across labs worldwide.

The session also introduced ChemisTwin, Merck’s digital innovation for QC laboratories. This online platform enables automated analytical spectra interpretation using a comprehensive database of digital reference materials (dRMs).

According to Dr Obkircher, the adoption of secondary standards and digital tools can help scientists focus more on innovation rather than administrative and compliance burdens. He stressed that as regulatory scrutiny increases globally, metrological traceability and digitalisation will become essential for maintaining quality and competitiveness in pharma manufacturing.