044 26493005 | +91 75500 53005 | 7550053001 info@tn-th.com

Method Development & Validation

Method Development and Validation
  • 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
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.
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:

HPLC with UV-visible/ Fluorescence/ PDA/ RI Detectors

GC and HSGC with FID/TCD/MS detectors

LC/MS-MS

Ion Chromatography

Atomic Absorption Spectra

Method development is undertaken for:

Assay

Dissolution

Impurities

Trace metals

Residual solvents

Physico-chemical tests

We also offer complete impurity profiling of pharmaceuticals.