Analytical Method Development

Analytical Method Development

Analytical research and development (AR&D) offers standalone services and supports our formulation development activities. The AR&D teams are integrated with preformulation, product development and quality assurance teams to ensure effective and accelerated product development. Our experience in developing methods for highly complex and unstable drug products compliments our formulation capabilities.

Method Development

We offer a wide range of compendial and non-compendial testing services. Our analytical laboratories are based on philosophy of cGLP and designed to facilitate in-house development of API as well as drug product methods like assay, dissolution, residual solvent, related substances etc.

Stability Testing

Cuckos offers GLP compliant ICH stability testing services. We have dedicated stability chambers for informal (R&D) and registration (cGMP) stability. All our walk-in stability chambers are continuously monitored. We use 21 CFR Part 11 compliant software. An alert system, back up chamber and electricity back-up assures sample integrity. The following climatic zones are available:

  • 5°C

  • 25°C/60% RH

  • 30°C/65% RH

  • 30°C/35% RH

  • 40°C/75% RH

  • Photo stability chamber

  • Customer specific conditions

Our extensive analytical development services and capabilities include

  • API Characterization

  • Method development, validation and transfer

  • Stability studies

  • Photo stability studies

  • Analytical methods for cleaning verification and validation

  • Dissolution and drug release profiling

  • Forced degradation studies and stability indicating method development

  • Specifications development

  • Regulatory support

Equipment* and Capabilities :

  • HPLCs with photodiode array detectors

  • Head space GC analyzer

  • FT-IR (A Fourier Transform Infrared) spectrometer

  • NMR (Nuclear Magnetic Resonance)

  • PXRD (X-Ray Diffraction)

  • Thermal analysis: DSC (Differential Scanning Calorimetry), TGA (Thermogravimetric Analyzer)

  • Dynamic vapor sorption/desorption

  • Capillary electrophoresis

  • SEM (Scanning Electron Microscopy) and TEM (Transmission Electron Microscope)

  • Potentiometer

  • Laser light diffraction particle size analyzer

  • Intrinsic dissolution

  • * Few of the specialty testing are done at USFDA approved lab.

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