Technical Services

Methodological validation

OFFERED SERVICES

 
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Given the risks there might be to health from the intake of uncontrolled amounts of impurities in drugs, control protocols are continually being developed for established maximum intakes.

Currently being reviewed are the USP (United States Pharmacopeia) standards and European guidance ICH Q3D, which set limits allowed for both inorganic impurities in the active ingredients and the analytical methodologies used. These rules also state permitted daily exposure limits (PDE) for each of impurities.

Because of the need to meet regulatory requirements, it is a requirement to use in the analysis of these compounds techniques which are sensitive and validated in accordance with the requirements reflected in the USP 232, 233 USP and ICH Q3D guide standards. These standards require that the methods are able to analyze reliably impurities in the corresponding established limits, fulfilling criteria of Accuracy, Precision, Robustness, Specificity, Linearity and Detection Limit.

THE PROBLEM
THE PROBLEM

The need to meet regulatory requirements means customers must consider having validated methodologies, and setups that require the latest technology, which are not accessible to all laboratories.

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THE SOLUTION
SOLUTION

LABAQUA offers a consultancy service for:

  • The update and development of methodologies necessary for regulatory compliance using the latest technology
  • Validation of analytical procedures methodology provided by customers.

 

OUR ADDED VALUE
ADDED VALUE

The main added values of the solution provided by LABAQUA can be described in the following points:

  • Using the latest technologies such as ICP-MS, ICP-OES, Atomic Fluorescence (AFS)
  • MultiMatrix pretreatment of samples, allowing the preparation of different types of active ingredients in the one process, and therefore a greater sample throughput with reduced costs.
  • Multielement analysis of the samples, which offers a faster delivery of results and greater economy.
  • Versatility of the technology used, offering the use of methodologies more in line with customer requirements.

 

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