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.
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.
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
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
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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