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

  This guideline provides a validation requirements and assessment for quantitative analytical methods and post-approval control and monitoring purposes. This can also be used for active substances. It also elaborate the parameters important for the validating a method and its acceptance criteria for different parameters. This framework includes a set of analytical steps to validate the method and response of test chemical on instrument.
  The following parameters are used for method development and validation.

  PARAMETERS	DEFINITION
  Linearity range	The proportionality of the measurement to the concentration of the analyte within a specified range
  Precision	Measure of the repeatability for multiple measurements on the same sample
  Specificity	Ability to assess the analyte in the presence of other components
  LOD	The lowest amount of analyte that can be detected accurately
  LOQ	The lowest amount of analyte that can be quantified accurately
  System suitability	To ensure the system performance before or during the analysis of unknowns.
  Extraction efficiency	The ratio of extracted analyte(s) and the total amount of analyte(s) in a certain sample.

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

  Purity analysis is performed to cover the identification of active ingredient by validated method on HPLC. It is one of the spectral analysis performed in the ESSEM test facility which is conducted by following the Principles of Good Laboratory Practices. The study is conducted in accordance with Standard operating procedures of test facility and mutually agreed study plans and amendments. Instruments and equipment is well equipped and calibrated according to the standard operating procedures. Internal as well as external calibration are performed at regular intervals. The purity analysis is carried out with the reference to SANCO/3030/99 (rev. 5).

  
  

  The SANCO guidance provides a framework for the use of chemical derivation, when the properties of the target analyte are not compatible with the analytical procedure. The guidance also specifies the criteria for the validation of methods for the analysis of technical active substances. This includes the determination of the active substance, impurities or additives/co-formulants. For technical active substances, confirmation of the identity of the analyte is required for a pre-registration application. The development and validation of a method is not part of GLP. However, when a method is used to generate data for safety purposes, for example when the active substance degrades into (eco)toxicologically active products, these studies should be carried out within the GLP framework.

• 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