Method Development & Validation

For all your pharmaceutical development activities a reliable analytical data is very vital. To achieve this, an Analytical method development and validation is very critical. Across the industry Method development and validation are costly and labour intensive. At TNTH we combine knowledge and experience along with advanced instrumentation, to develop efficient, accurate, reliable and robust analytical methods at affordable cost.

Analytical method development and validation as per ICH guidelines
Development of Stability-indicating methods
Impurity identification and quantification
Method Development and Validation for Heavy metal estimation by ICP OES/MS
Cleaning validations
Dissolution studies
Extractable and Leachable studies
Stability studies as per ICH guidelines

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Method development:

Our scientists are highly skilled and have acquired years of experience across many verticals, products, methods and analytical technologies to ensure that the method will be ‘fit for purpose’. Our expertise spans over a variety of molecules and formulations that includes small molecules, biologics, nano-particles, solids, patches, gels, ointments, liquids and inhaled products. Tamilnadu Test House is equipped with the state-of-art analytical technologies which includes chromatography, mass spectrometry, elemental analysis and spectroscopy. Our team is experienced in sample preparation techniques which include procedures for trace levels of analysis and approaches suitable to the physical and chemical properties of the matrix and the dosage form.

Method validation:

TNTH is not just a testing company offering testing services. We work with clients as a partner enabling their business with our strong experience in method validation requirements. To meet all regulatory compliance we follow relevant ICH guidelines such as ICH Q2(R1) or compendia guidance in combination with client-specific protocols.

Analytical method development and validation services offered are ICH guideline compliant. The dedicated validation group is equipped with the following analytical techniques: