Frequently Asked Questions-Spectro Analytical Labs

Questions related to Method Development

When is Analytical Method Development required ?

Analytical Method Development is required for :

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

What does analytical methodology consist of ?

An Analytical Methodology consists of the following

bullet Techniques
bullet Method
bullet Procedure
bullet Protocol

What does analytical methodology provide to an analyst ?

bullet The data for a given analytical problem
bullet The sensitivity
bullet The required accuracy.

Creating SOP

bullet The required range of analysis
bullet The 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 ?

Method Validation is required for the following reasons

bullet Assuring 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 ?

bullet For 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