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Analytical Services

Method Development

Analytical chemistry is a science to know about the molecule, and a tool to establish the identity, purity, and potency of molecule or product is known as Analytical Method (AM). AM could be spectral, chromatographic, electrochemical, or many more.

Our expert analytical chemists span a variety of molecules and ensure that method will be “Fit for Purpose

Method Validation

The United States Pharmacopeia (USP) defines method validation as a process by which it is established, through laboratory studies, that the performance characteristics of a method meet the requirements for its intended analytical applications.

Our team has sound knowledge of method validation and evaluate the following parameter such as Accuracy, Precision, Specificity, Detection Limit, Quantification Limit, Linearity, Range and Robustness. Agnitio provides complete solutions for method validation.

Raw Material/Finished Product Analysis

Raw Material and Finished products should comply with the guidelines of different regulatory agencies. Agnitio provides a hands-on solution to design the specification, impurity profiling, control strategy to meet international standards and provides a certificate of analysis as per ICH Q7 & Q8 Guidelines.

Certificate of Analysis

Agnitio analyses key starting materials, reagent, active pharmaceutical ingredient, and dosage form as per Pharmacopeial and in-house requirement and provides a certificate of analysis accordingly to different regulatory bodies.