Phone: +91712 2559950 | Mobile: +91844 6013555/+91932 2961056


Analytical Chemistry studies

The studies are offered in full compliance with global guidelines, viz., ASTM, FDA, ICH, OECD, OPPTS, SANCO, SANTE and others. The ESSEM facilities are well equipped with state-of-the-art instrumentation providing sensitive and low-level detection/quantitation capabilities. We have conducted more than 1500 spectral studies and it include

  • Method development, Method validation and Dose Concentration Verification

    Analytical methods are developed and validated in the test facility to ensure effective component identification and quantification. In validation, properly equipped and calibrated instruments for the study. The management of the test facility shall ensure that a properly developed and documented test method is used for the test. ESSEM has the standard operating procedures for method development and validation parameters with the reference to the SANTE/2020/12830 rev. 1. QA team ensures full GLP compliance of the protocol, corresponding operating SOP and the developed method. The following parameters are performed in the test: linearity, system adequacy test, specificity, detection limit, quantification limit, precision, extraction efficiency.

    SANTE/2020/12830 rev. 1 - Method Validation and Dose Concentration Verification

    SANCO/3030/99 rev.5 - CoA Generation/ Purity Analysis

  • Determination of ultraviolet-visible spectroscopy (UV spectra)
  • Fourier-transform infrared spectroscopy (FTIR) used to obtain an infrared spectrum of absorption or emission of solid, liquid
  • Qualitative and Quantitative analysis by High Pressure Liquid Chromatography- mass spectrometry/Gas chromatography-mass spectrometry (GC-MS)
  • Elemental analysis by Inductively coupled plasma-optical emission spectrometry (ICP-OES), Atomic absorption spectroscopy (AAS),
  • X-ray diffraction (XRD), XRF
  • Gel permeation chromatography (GPC)
  • Nuclear magnetic resonance (NMR)
  • Particle Size Distribution/ Hydrodynamic diameter