Analytical Development & Validation

Our highly skilled professionals are equipped to proficiently handle challenges during method development. With extensive knowledge of regulatory requirements and a wealth of scientific and technical expertise, our experienced teams are well-prepared to find solutions for development needs. We embrace unconventional and challenging tasks.

Meticulously analyzing the complexities of drug development and identifying impurities is our driving force and source of motivation in dedication to our projects. As your trusted partner, we offer an array of analytical capabilities in our state-of-the-art facilities, utilizing advanced instrumentation to guarantee accurate and consistent results.

At Neuland analytical teams have considerable expertise in the development and validation of analytical methods including:

• HPLC/UPLC stability-indicating methods for identification, assays, and impurities 
• Chiral HPLC methods for enantiomeric purity 
• GC-FID methods for residual solvents 
• GC-MS and LC-MS methods for potential genotoxic/mutagenic impurities  
• High-resolution LC-MS methods for impurity identification/quantitation 
• ICP-MS methods for elemental impurities 
• NMR methods for identification 
• Particle size determination 
• X ray Diffraction, DSC and TGA for solid state properties 
• HPLC with different detectors including ELSD and CAD detectors

Neuland also provides method transfer and method optimization solutions. We adhere to good laboratory practice (GLP) and current good manufacturing practice (cGMP) guidelines, ensuring that all methods and processes are compliant with regulatory requirements. Our team of experts designs and optimizes the analytical method, considering factors such as sensitivity, selectivity, reproducibility, and robustness. The method is then validated according to the International Council for Harmonization (ICH) guidelines, ensuring that it meets the required standards for accuracy, linearity, precision, and specificity. This thorough validation process ensures that products are being tested accurately and reliably. 

Neuland has a team of experienced scientists who specialize in detecting impurities in drug substances, even at low levels. Our comprehensive services include residual solvent analysis, evaluation of process-related impurities, forced degradation and stability studies, and assessment of genotoxic impurity levels in API.  

Neuland provides extensive assistance with the identification and characterization of impurities found in drug substances. This includes conducting stability tests and developing and validating methods for accurately quantifying impurities including nitrosamine Impurities, genotoxic impurities, residual solvents, and elemental impurities.  Genotoxic impurity assessment with DERIC software and CASE software enables the team to focus on impurity controls right from the process optimization phase itself.   

We utilize advanced analytical techniques, such as high-performance liquid chromatography (HPLC), gas chromatography (GC), and LC mass spectrometry (LCMS), and nuclear magnetic resonance (NMR), to identify and quantify impurities in drug substances and products. These techniques provide accurate and sensitive results, ensuring the reliability of the data. 

Neuland has significant expertise in conducting stability studies throughout the entire lifespan of a product.  Stability storage and testing are essential in determining changes in the quality of drug substances and products over time, when subjected to environmental elements like temperature, humidity, and light. These tests determine the shelf life and storage conditions of a product, ensuring its safety and efficacy.  

Our stability testing for API synthesis allows us to closely monitor the quality of APIs under different conditions and time periods. By analyzing the data and purity over time, we can assess the stability of the product.  

In cases where there are no reference standards, Neuland offers a range of analytical tests to identify and characterize the new material. These tests can detect impurities and their quantities, as well as the presence of atmospheric water or residual solvents from the manufacturing process. Our in-house stability and analytical chemistry team can conduct comprehensive characterization.