- Analysis of Active and Inactive pharmaceutical ingredients, chemical intermediates and finished products
- Method Developments & Validation of analytical method for assay of active ingredients, impurity profiling, residual solvents, organic volatile impurities etc.
- Force degradation studies
- Tec-Mar Studies
- Analysis of elemental impurities and assay using AAS and IC instruments
- Polymorphic evaluation using XRD, DCS etc.
- Characterizations of Molecule using FTIR, XRD, DSC, UV and GC-MS
Expertise and experience in development, validation and execution of very sensitive bioanalytical methods for assay of various types of drugs and their active metabolites. Most sensitive assays have LLOQ concentrations ranging from 0.4 to 1.0 pg/ml.
Developed, validated and executed assay methods
- For endogenous compounds like Estradiol and Cortisol.
- For compounds usually observed in body fluids from food chain like Nicotine and Salicylic acid.
- For chiral compounds like Bicalutamide (chiral assay).
- For light sensitive compounds like Amlodipine, Felodipine, Artesunate etc.
- For several corticosteroids, harmones, β-androgenic agents, quaternary ammonium compounds for PK studies of inhalers and nasal sprays.
Developed and validated more than 120 bioanalytical methods.
- Pilot / Pivotal Bioavailability & Bioequivalence studies from 6 to 140 volunteers compliance to international regulatory authority
- Conducting studies in specialize population
- Food effect studies
- Solid Oral Formulations – Tablets, Capsules, Sprinkles, Immediate Release, Extended Release, Orally Dispersible Formulations
- Liquid Formulations – Suspensions & Syrups
- Experience in conducting studies for specialized formulations like Nasal Sprays, MDIs (Metered Dose Inhalers), DPIs (Dose Powder Inhalers), IVs (Intra Venous), Dermatological Patches etc.