When is Analytical Method Development required ?

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

What does analytical methodology consist of ?

• Techniques
• Method
• Procedure
• Protocol

What does analytical methodology provide to an analyst ?

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

Creating SOP

• The required range of analysis
• 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 ?

• Assuring quality and achieving 3 a levels
• Achieving acceptance of products by the international agencies.
• Mandatory requirement purposes for accreditation as per ISO 17025 guidelines
• Mandatory requirement for registration of any pharmaceutical product or Pesticide formulation
• Validated methods are only acceptable for undertaking proficiency testing.

What are the various parameters studied for Method Validation ?

• For validation the developed method is subjected to following studies
• Precision / Reproducibility
• Accuracy
• Linearity
• Specificity / Selectivity
• Limit of detection
• 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.

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