When is Analytical Method Development required ?

  • bullet New process and reactions
  • bullet Active ingredients (Macro analysis)
  • bullet Residues (Microanalysis)
  • bullet Impurity Profiling

What does analytical methodology consist of ?

  • bulletTechniques
  • bulletMethod
  • bulletProcedure
  • bulletProtocol

What does analytical methodology provide to an analyst ?

  • bulletThe data for a given analytical problem
  • bulletThe sensitivity
  • bulletThe required accuracy.

Creating SOP

  • bulletThe required range of analysis
  • bulletThe required precision

i.e. the minimum requirements which essentially are the specifications of the method for the intended purpose: To be able to analyze the desired analyte in different matrices with surety and certainty.

What are the capabilities of SPECTRO in method development ?

SPECTRO has the expertise and all the state-of-the-art-facilities required for developing new methods of analysis for all kinds of components in different complex matrices. The methods developed by SPECTRO can be used by other laboratories.

What is Method Validation / Evaluation ?

Method validation is the process of documenting or proving that: Analytical Method provides analytical data for the intended use as per standard protocol.

Why is analytical method validation required ?
  • bulletAssuring quality and achieving 3 a levels
  • bullet Achieving acceptance of products by the international agencies.
  • bullet Mandatory requirement purposes for accreditation as per ISO 17025 guidelines
  • bullet Mandatory requirement for registration of any pharmaceutical product or Pesticide formulation
  • bullet Validated methods are only acceptable for undertaking proficiency testing.
What are the various parameters studied for Method Validation ?
  • bulletFor validation the developed method is subjected to following studies
  • bullet Precision / Reproducibility
  • bullet Accuracy
  • bullet Linearity
  • bullet Specificity / Selectivity
  • bullet Limit of detection
  • bullet Limit of quantization
General Process of Validation / Evaluation of Methodology

At SPECTRO besides the Method Development, the Method Validation Studies for the developed methods for various parameters as per the following protocols and guide lines are being regularly undertaken.

  • bullet EN 45 000 series of standards
  • bullet ISO / IEC Guide 25
  • bullet International Conference on Harmonization (ICH)
  • bullet US EPA