Pharma Testing Lab – CDSCO Approved Testing Lab

1. Stability Studies
——————–
Tamilnadu test House conducts Stability studies to determine how the quality of a drug substance or drug product varies over time under the influence of environmental factors such as temperature, humidity, and light. The International Council for Harmonisation (ICH) has provided detailed guidelines on stability testing to ensure the safety, efficacy, and quality of pharmaceutical products throughout their shelf life.

2. Analytical method Development and Validation
——————————————————–
Pharmaceutical method development and validation are critical processes in ensuring the accuracy, reliability, and consistency of analytical methods used for drug testing. Method development involves selecting appropriate analytical techniques, such as chromatography (HPLC, GC) or spectroscopy (UV, IR), to effectively separate, identify, and quantify drug substances and their impurities. Validation, as per ICH Q2(R1) guidelines, confirms that the developed method meets predefined criteria for accuracy, precision, specificity, linearity, range, robustness, and detection limits. A validated method ensures regulatory compliance and guarantees the quality, safety, and efficacy of pharmaceutical products throughout their lifecycle.

3. Pharmaceutical API Characterization
——————————————-
Active Pharmaceutical Ingredient (API) characterization is a crucial step in drug development, ensuring the identity, purity, potency, and stability of the active component in a pharmaceutical formulation.

TNTH provide the Key characterization parameters include physicochemical properties (appearance, solubility, melting point, hygroscopicity, pKa), solid-state properties (polymorphism, Crystallinity, particle size), and chemical properties (assay, impurity profiling, degradation pathways). Analytical techniques such as HPLC, GC, NMR, FTIR, DSC, XRD, and mass spectrometry are commonly used.