Infrastructure Service offerings Our expertise Key Methods Validated Methods  


The bio-analytical laboratory at Reliance is equipped with state-of-the-art instrumentation and automation equipment for performing a diverse range of analyses on biological samples. Our SOPs comply with Good Laboratory Practices and continuously evolve to keep pace with the requirements of international regulatory agencies and the pharmaceutical industry. Reliance’s bio-analytical team is highly experienced and has good understanding of GLP and Regulatory guidelines.

Infrastructure:
  • LCMS/MS – Sciex API-2000, API-3000, API-3200 Q-Trap, API-4000 (latest versions)
  • LCMS/MS –Thermo Discovery Max (latest versions)
  • Automated HPLC – Dionex, Shimadzu (latest versions)
  • Different detectors e.g. UV, PDA, Fluorescence, ECD etc
  • Enzyme-Linked Immuno-Sorbent Assay (ELISA)
  • High speed refrigerated centrifuges
  • Solid phase extraction system, both manifold and positive pressure
  • Different extraction technique like Liquid-Liquid Extraction, Solid Phase Extraction, Protein Precipitation and Ultra kit Filtration technique
  • Walk-in cold rooms for -200 C
  • Deep freezers -70°C and -20°C (temperature is constantly monitored through wireless data logger with a security alarm system)
  • 21 CFR part 11 compliant chromatographic software
  • Complete GLP laboratory

Our service offerings include:
Pre-clinical:

  • Bioavailability/ screening, Mass balance studies
  • Protein binding studies
  • Metabolism (mass balance, identification and quantitation)
  • Toxicokinetic studies
  • Formulation analysis & evaluation of stability studies

BA/BE & Phase I - IV:
  • Drug interaction studies
  • Studies on Schedule X drugs (Narcotics and Psychotropic drugs)
  • TQTc studies
Our expertise:
  • Rapid development and validation of new analytical methods
  • Execution of most complex analytical projects
  • Method development of Large molecules using (ELISA and LC/MS-MS techniques)
  • Adaptation and revalidation of sponsor’s assay methods
  • Bio-analysis of drugs for pre-clinical and clinical studies
  • Sample analysis of Proteins, Peptides, Olegoneucleotide and mAbs.
Some of our Key Methods:

Small molecules:

  • Quantitative estimation of Alendronate (by diazomethane derivatization) from human urine samples using LC-MS/MS technique
  • Simultaneous quantitative estimation of UDCA, and its conjugates GDCA, and TDCA from human plasma samples using LC-MS/MS technique
  • Simultaneous quantitative estimation of Metfromin, Glimepiride, Pioglitazone and Hydroxy metabolite of Pioglitazone from human plasma samples using LC-MS/MS technique
  • Quantitative estimation of Tetrahydrobiopterin or BH4 (Sapropterin) from human plasma samples using LC-MS/MS technique
  • Simultaneous quantitative estimation of Selegiline and its metabolites N-Desmethylselegiline, Methamphetamine and Amphetamine from human plasma samples using LC-MS/MS technique
  • Quantitative estimation of Lithium from human serum and plasma samples using LC-MS/MS technique
  • Quantitative estimation of Zopiclone S and R enantiomers from human plasma samples using LC/MS-MS technique

Large molecules:

  • Quantitative estimation of Erythropoietin from human serum samples using advanced Automated ELISA system
  • Quantitative estimation of Bevacizumab from human serum samples using ELISA technique
  • Quantitative estimation of PEG GCSF from human serum samples using ELISA technique
  • Quantitative estimation of Trastuzumab from human serum samples using LC/MS-MS technique
To review Summary of some of our key methods, click here

Validated Methods:

We have more than 190 validated bio-analytical methods for quantitative estimation of drugs and metabolites from various biological fluids. To download the list of validated Bioanalytical methods available with us, click here.