Analytical

Analytical

Analytical method development plays a pivotal role in ensuring the quality, safety, and efficacy of therapeutic products. At APC, our Analytical Process Development services are tailored to deliver comprehensive analytical solutions that empower our clients to make informed decisions at every stage of the development process.

Advanced Analytical Capabilities

We boast a state-of-the-art analytical infrastructure equipped with advanced instrumentation and methodologies to tackle the most challenging analytical tasks. From chromatography and spectroscopy to mass spectrometry and microscopy, our suite of analytical techniques provides unparalleled insights into the chemical composition, structure, and behaviour of pharmaceutical compounds.

Method Development and Validation

Our experienced team of analytical scientists specializes in method development and validation across a wide range of analytical techniques. Whether it's developing new analytical methods or validating existing ones, we ensure robustness, accuracy, and compliance with regulatory standards, enabling reliable and reproducible analytical results.

Stability Studies and Characterization

Stability studies are critical for assessing the long-term stability and shelf-life of pharmaceutical products. We offer comprehensive stability testing services, including forced degradation studies, accelerated stability testing, and real-time stability monitoring, to evaluate the physical, chemical, and microbiological stability of drug substances and products.

Impurity Profiling and Quantification

Detecting and quantifying impurities is essential for ensuring the safety and quality of pharmaceutical products. Our analytical experts specialize in impurity profiling and quantification using advanced chromatographic and spectroscopic techniques, allowing for the accurate identification and quantification of impurities at trace levels.

Solid State Analysis

Solid-state analysis is crucial for optimizing specific unit operations (e.g. filtration, drying etc.) as well as medicine formulations to ensure product performance and stability. In this regard, our analytical capabilities encompass particle size analysis, rheological characterization, and dissolution profiling, providing valuable insights into formulation properties and behavior.

Regulatory Support and Compliance

We understand the importance of regulatory compliance in the pharmaceutical industry. Our Analytical Process Development team is well-versed in regulatory requirements and guidelines, including ICH, FDA, and EMA regulations. We provide comprehensive support for regulatory submissions, including preparation of analytical methods, validation reports, and regulatory documentation.

Collaborative Approach

At APC, we believe in a collaborative approach to Analytical Process Development, working closely with our clients to understand their unique analytical challenges and objectives. Whether it's routine testing, method development, or troubleshooting analytical issues, we strive to deliver tailored solutions that meet the specific needs of each project.