Analytical development

Development and validation of analytical methods play important roles in the discovery, development and manufacturing of pharmaceuticals. Method development is the process of proving that an analytical method is acceptable for use, to measure the concentration of an API in a specific compounded dosage form which allows simplified procedures to be employed to verify that an analysis procedure, accurately and consistently will deliver a reliable measurement of an active ingredient in a compounded preparation. The analytical method validation is essential for analytical method development and tested extensively for specificity, linearity, accuracy, precision, range, detection limit, quantization limit, and robustness. In summary, analytical method development and validation allows to confirm that an accurate and reliable potency measurement of a pharmaceutical preparation can be performed.

Compliance with both GLP and cGMP regulations enables the company to support all stages of pharmaceutical development in accordance with client-specific protocols, internal SOPs and FDA and ICH guidelines.

1. Analytical method development and validation for

  • Impurity detection
  • Genotoxic impurity detection
  • Elemental impurity by ICP-MS
  • Assay
  • Dissolution study

2. Stability study for Drug products and Drug substances as per ICH guidelines.

3. Microbial testing

  • Sterility testing
  • Particulate matter test by LPC (Liquid Particle Count)
  • BET
  • MLT testing