At APSL, we have a well-experienced team that is skilled with global quality and regulatory guidelines to complement your projects with the right set of analytical activities. We have a state-of-the-art analytical lab through which we can develop a variety of analytical methods. We plan the analytical strategy based on the project lifecycle and customer needs. We have capabilities across method verification, development, validation and impurity profiling that includes isolation, identification & characterization and assessment of nitrosamine or other genotoxic impurities. We also conduct stability studies as per ICH guidelines.
Mass spectrometer (LC-MS and HR-MS)
For early phase projects, we develop analytical methods in hand-in-hand with the process development program. For critical quality attributes of the final product such as assay, related substances, and residual solvents analytical methods are verified. Our standard analytical method verification procedures check LOD, LOQ, linearity, precision, specificity, accuracy, robustness, solution stability, and mobile phase stability. Along with these verifications, fit-for-purpose analytical methods for testing raw materials, in-process controls, and intermediate analysis are developed. Post mapping of equipment at the manufacturing facility, an appropriate residue method is also developed and validated. We generate and qualify the appropriate quantity of reference standards to support the analysis and method transfers.
We perform method validation as per the internal SOP of APSL against the predefined specification. The method will be validated as per ICH guidelines for parameters like LOD, LOQ, linearity, repeatability, recovery, solution stability, specificity, precision, accuracy, robustness, and mobile phase stability. Analytical activities also depend on whether we are working on intermediates, RSM, or the final API.
We perform analytical validation in compliance with the Pharmacopoeia, current Good Manufacturing Practices (cGMP) & ICH requirements as per customer needs. Following are the salient features of our method validation activities:
We perform stability studies for developmental APIs, intermediates, RSMs and drug products.
We have the stability chambers, refrigerator and deep fridge storage suiting to requirements of different climatic zone.
Expertise in global quality & regulatory guidelines
Phase appropriate standard operating procedures
Dedicated infrastructure
Breadth of analytical services
Expertise in the niche analytical requirements for various technology classes
We understand that clear communication is essential to successful collaborations, and that's why we have a dedicated team that is always ready to help you. Whether you have questions about our services, want to discuss a potential partnership, or simply want to learn more about our company, we're here to help.
Our team of experts is dedicated to providing personalised solutions tailored to your unique needs. So, please don't hesitate to reach out to us. We look forward to hearing from you and helping you achieve your business goals.
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October 24th-26th, 2023 | Barcelona, Spain
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