Analytical

Analytical

Preformulation Studies

The formulation development center at Ascent Offers a wide range of Analytical Support & Services, to support formulation & process development:

  • Physico-chemical characterization
  • Drugs Excipient Compatibility Study
  • Analytical Method Development

Our offerings include

Physico-Chemical Characterization
  • pH- solubility profile
  • Solubility in various aqueous and non-aqueous vehicles
  • pH- stability profile
  • Melting point
  • Hygroscopicity
  • Polymorph characterization studies
Powder Characteristics
  • Particle size distribution
  • Bulk and tap density determination
  • Flow properties
Drug Excipient Compatibility Study
  • Binary or ternary mixtures of API with excipients from various functional categories such as diluents, binders, glidants, disintegrants, lubricants etc.
  • Packaging material compatibility studies
  • Selection of excipients for formulation development is based on the results of this study

Analytical Method Development & Validation

Ascent offers complete analytical support for product development including analytical method development for drug formulations, method validation of the same as per global regulatory guidelines and analytical method transfer to Quality control laboratory of manufacturing site.

Quality control (QC) support for current good manufacturing practice (cGMP) activities such as validation, ICH stability
studies and release testing of clinical supplies.

Our Expertise include

Analytical Method Development
  • Assay, purity, dissolution testing
  • De-formulation Studies (Reverse Engineering Studies)
  • Forced degradation studies
  • Impurity identification and characterization
  • Cleaning verification
  • Stability testing and routine analysis
Analytical Method Validation
  • Specificity
  • Accuracy
  • Precision
  • Quantitation limit
  • Linearity
  • Solution stability
  • Detection limit
  • Range
  • Robustness
  • System suitability testing