Product Development

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Analytical services including methods' development

Accelerating your R&D process

Working in comliance with cGMP and GLP guidelines, Nextar provides analytical support and services for a wide variety of products. To make sure your product is well   characterized and continuously monitored, we involve our analytical team from the very begining of each project. Using an extensive range of state-of-the art fully qualified, and calibrated analytical equipment available as well as comprehensive stability chambers, we work closely with our clients to assist every analytical stage of the product development cycle. Nextar's analytical team may develop and validate methods for monitoring the product as well as its way in the human or animal body (Bio-analysis).

Method development:

Testing methods are developed in order to learn about the product characteristics and its stability:

  • Determination of the concentration of the active material and related substances
  • Stability Indicating Methods (SIM) including photo stability, sensitivity to acidic or basic conditions, UV radiation etc. using forced degradation studies
  • Detection of  Impurities and Degradation products (ID)
  • Characterization of the drug products (such as osmolality, particle size, pH etc.)
  • Dissolution and drug release profiling
  • Leachables and extractables  (study of potential materials resulting  from the  interaction between the drug product and its containers)
  • PharmacoKinetic (PK) bio-analyses in biological fluids and tissues
  • Compatibility studies between drug product and its device or package
  • Identification of intermediates and/ or degradation products

Method validation:

Nextar's analytical team will validate the analytical methods, as required by regulations. Method validation is gathering objective evidence that particular requirements are fulfilled for the intended use. Validation may include the study of the following method characteristics: accuracy, precision, specificity/ selectivity (including peak purity analysis), linearity and range, sensitivity, quantitation limit, detection limit, robustness. During the validation it may be necessary to study the specific standard and sample stability, to prove their integrity during the study.