About Us
Our Story
RKapsilan Research lab
RKAPSILAN Research lab incorporated to establish state-of the art facility to cater to the needs of Nitrosamine impurities testing, Leachable and Extractable studies, Impurity Characterization.
The facility supports testing requirements for small molecule APIs, key sourcing materials (KSM), and intermediates. The lab shall be established to get Internationally accreditation by implementation
of strong complains and highly skilled Scientists.
Current regulatory guidelines are more stringent towards Genotoxic impurities, Nitrosamine impurities, Azido impurities, Leachable and extractables. Small scale and some of the large-scale industries depending on third party testing laboratories to full fill the regulatory requirements.
RK research lab continuously strive to address the unmet testing need of the pharmaceutical industries, Foods and Drugs, Argo, Polymer and Petrochemicals to deliver their needs with respect to regulatory requirements.
We are committed to enhancing testing capabilities by using advanced analytical techniques and well-being by providing services with affordable prices. The company Strengths are diverses experience in risk assessment, Method development, method validation and testing of Nitrosamine impurities in drug products, Drug substances, KSM and intermediates. Develop and validate according to USP and other regulatory requirements. Availability of technically skilled peoples and having hands on experience in Nitrosamine impurities, Leachable & Extractables and Characterization of impurities. Lab shall be established as per cGMP and meets the requirements of multiple regulatory agencies.
Our Capabilities are Dedicated area for Nitrosamine impurities and Azido impurities, Dedicated area for Leachable & extractables studies and Characterization, all methods are established as per the regulatory requirements, Risk assessment reports based on the technical data and root of synthesis. Faster turnaround on method development and validations analysis and Providing competitive prices as per the current market.