OSD
Adapting analytical testing to increasing development complexity
As pipelines diversify and regulatory expectations rise, analytical testing plays a central role in ensuring product quality and programme continuity. Teams are required to manage complex impurity profiles, advanced characterisation, stability commitments and emerging areas such as nitrosamines and extractables and leachables, all while generating data suitable for global submissions. Maintaining this breadth of capability internally can place significant pressure on resources and timelines.
Analytical support across characterisation, method development, stability, release testing and specialised areas such as IVPT/IVRT, nitrosamines and E&L enables programmes to progress with greater predictability. Dedicated analytical centres combine scientific expertise, appropriate instrumentation and regulatory alignment to generate reliable data packages for each development stage.
Stability testing spans real time or room temperature storage, accelerated and intermediate conditions, freeze–thaw assessments, photostability, bulk hold studies and Period-After-Opening (PAO) evaluations. Reproducible outcomes depend on controlled environments, defined study designs and consistent data-handling practices.
Nitrosamine assessment remains a priority as requirements evolve. Current analytical approaches support the detection of both known and previously unidentified N-nitrosamine compounds across APIs, finished products, excipients, container-closure systems and select process materials, supported by orthogonal confirmation techniques and structured reporting.
IVPT & IVRT method development
In vitro permeation and release testing present challenges due to formulation variability, biological differences in skin samples and the complexity of diffusion cell systems. Standardised protocols, qualified equipment, clear system-suitability criteria and harmonised practices for skin sourcing and preparation help improve reproducibility and regulatory readiness.
Extractables and leachables
E&L assessments require thorough evaluation of packaging and device components, as extractable substances may interact with products under specific conditions. Structured risk assessments, early gathering of material-of-construction information and the combined use of targeted and untargeted analytical techniques help identify potential leachables and characterise their safety relevance in line with regulatory expectations.
As analytical complexity continues to grow, consistent data, appropriate technologies and experienced scientific input remain essential. Structured analytical services help reduce uncertainty, support regulatory compliance and enable programmes to move more efficiently from development to commercialisation.
Read the full article in Pharma Outlook India, where Dr. Ramesh Jagadeesan explores the analytical considerations shaping today’s analytical development.
In its November Special 2025, India Pharma Outlook highlights Recipharm as a leading company offering high quality pharmaceutical products and services backed by extensive experience and expertise. Access the full list here.
Fact sheet
Fact sheet
