Drug Assay or Impurity Method Development (GLP and Non-GLP)

  • Research and Development Analytical Support
  • CMC Analytical Support
  • cGMP Release Testing
  • Excipients Analysis (Medical Devices and Pharma)
  • Content Uniformity Testing

Forced Degradation Assays

  • Following ICH Guidelines
  • Stability Indicating Assay
  • Acid, Base, Free Radical, Temperature

Extractables and Leechables

  • Non-Polar, Polar Solvents
  • ICP/MS (Metals Extractables), GC/MS
  • HPLC/MS Testing

Photostability Testing

  • Following ICH Guidelines (Q1B)
  • Quinine Actinometry Monitoring
  • Visible and UV Light

Drug Solubility Testing

Cleaning Method Development/Validation

Drug Release Assay Method Development and Testing

  • Controlled Temperature Waterbath with Shaking
  • Mass Balance

Dissolution Testing USPI/II

  • Paddles or Baskets
  • 1L, 500mL, 250mL, 100mL vessel(s)

Residual Solvents Analysis

  • Headspace GC-FID/MS
  • Analysis of OVI (Organic Volatiles Impurities) or VOC’s
  • USP <467>
  • API or Drug Product
  • Class I, II, III Solvents

Impurity Identification (LC-MS)(GC-MS)

  • Library Search for Structural I.D.

ICP-MS Heavy Metals

  • Elemental Impurities Limits USP <232>, <233>
  • V, Co, As, Cd, Hg, Pd, Ni, Pb, K, Tl- Oral Dose Forms
  • Customized Metals Analysis

FTIR, UV/VIS, KF Testing

  • Measured by ATR (Attenuated Total Reflectance)
  • Identity Testing
  • % Water

Stability Testing

  • Real time Monitoring for Clinical Studies

Chiral Analysis

  • HPLC Chiral Columns
  • Research and Development Testing

Counterfeit Drug Analysis

  • Determination of API in dose form and Impurities by GC/MS, LC/MS, ICP/MS
  • Dissolution Screening
  • Organic Volatiles Analysis by GC/MS
  • Hygroscopicity/FT-IR