Analytical Testing

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A well-developed method serves as a solid foundation for the life cycle of an analytical method. We develop methods that are both cost-effective and fit-to-the purpose. 

We adhere to the most recent ICH recommendations on analytical method validations. We are also able to provide validations that are customized to each market need. 

Dissolution studies provide critical in vitro drug release information. We offer various kinds of dissolution studies for both quality control and drug product development purpose.

Elemental impurities should be controlled within acceptable limits (ICHQ3D). With the help of high-sentivie ICPMS, we offer testing, validation, and risk-assessment solutions.

Residual Solvents are organic volatile impurities that need to be controlled (ICHQ3C). We offer testing, validation, and risk-assessment solutions.

We offer testing, validation, and risk-assessment solutions for trace-level volatile impurities (ex. some genotoxic impurities)using highly sensitive GCMS.

We offer testing, validation, and risk-assessment solutions for trace-level analytes using highly sensitive instruments.

  Nitrosamines are cancer-causing impurities that may potentially be present in some pharmaceutical products. We provide a total solution including a control strategy and risk-assessment

Reverse engineering of reference formulation key is setting the direction of successful development of a generic drug product developemt.