Elemental Analysis

Focus on Impurity Profiling Elemental to Organic

Facility : Received EIR report from USFDA. Maharashtra FDA Approved

Instruments : LC-MS/MS with PDA Detector with chromeleon Software ICP-MS.

Analytical Services

Genotoxic Impurities as per ICH M7 Method Development, Method Validation & Sample Analysis Mass Identification By Direct Infusion & BY LCMSMS

Elemental Analysis Elemental Impurities as per USP<232>/<233> & ICH Q3D guidelines

Extractables & Leachables

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Elemental Analysis in India

Elemental Analysis

Nalanda Research Laboratories, fully focused on Elemental Analysis is performed via Inductively Coupled Plasma Mass Spectrometry (ICP-MS). Used to analyze Excipients, Raw Materials, Drug Products or Finished Products, our analyses are screened incompliance with Elemental Impurity Methods USP <232> – Limits and USP <233> – Procedures.

We currently offer the following Services for Pharmaceutical Industry:

  • Scanning of Excipients, API (Drug Substances), Drug products or Finished products for Elemental Impurities
  • Analytical Method Development on Elemental Impurities by ICP-MS
  • Analytical Method Validation on Elemental Impurities by ICP-MS
  • Elemental Impurities Testing as per USP<232>/<233> & ICH Q3D guideline
  • Heavy Metals Testing

ICP-MS combines a high-temperature ICP source with a mass spectrometer. The ICP source converts the atoms of the elements in the sample to ions. These ions are then separated and detected by the mass spectrometer, detecting the metals and non-metals at very low concentrations.

ICP-MS has many advantages over other elemental analysis techniques such as optical emission spectrometry (ICP-OES), including:

  • Superior sensitivity advantages over ICP-OES.
  • Detection & Quantitation limits for most elements are 5 to 10 times better than ICP-OES.
  • Higher throughput.
  • Scanning for all the elemental impurities can be done with & without standard.
  • Low sample quantity required than ICP-OES.
  • The ability to handle both simple and complex matrices with a minimum of interferences due to the high-temperature source & the separation technique.
  • Separation take place on Mass analyzer as per their mass to charge ratio.
  • The ability to obtain isotopic information
  • Identification in both qualitative (determining what elements are present), and quantitative (determining how much of each are present) form.