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Development and validation of stability indicating assays from SGS – monitor the degradation of pharmaceutical products upon storage to guarantee safety and quality.

Life Science

The stability indicating method (SIM) is critical for stability testing and pharmaceutical product evaluation. FDA recommends that assay procedures for stability should be stability indicating.

We offer a comprehensive range of services for the development and validation of stability indicating assays, helping you to monitor degradation of pharmaceutical products upon storage that will guarantee safety and quality.

Why choose development and validation of stability indicating assays from SGS?

Our stability indicating method can help you:

  • Monitor assay/impurities during stability studies
  • Gain crucial data for routine quality control
  • Identify out of trend (OOT) and out of specification (OOS) events

Expert development and validation of stability indicating assays from a trusted provider

As a world leader in certification, inspection, verification and testing services, we offer you unrivalled expertise in development and validation of stability indicating assays. Our dedicated scientists provide you with accurate, linear, precise, specific and robust analytical methods to evaluate assay and impurities/degradation products.

The stability indicating method will be validated for the following parameters:

  • System suitability
  • Linearity
  • LOQ (including LOD where applicable)
  • Accuracy
  • Precision (including intermediate precision)
  • Specificity (including forced degradation studies)
  • Robustness (including standard and sample solution stability)

To discuss your development and validation of stability indicating requirements, contact us today.