Analytical Services:
- Assay (HPLC, GC, UV-Vis)
- Compendial tests
- Conductivity
- Container closure integrity testing
- Content uniformity
- Disintegration
- Dissolution testing (UV & HPLC)
- Final product release testing
- Forced degradation studies
- FT-IR
- Full chemical USP/NF compendial testing
- Identification (TLC, HPLC, GC)
- Impurity and degradation product
identification
- Melting Point
- Heavy Metal limit testing
- Method transfer
- Method validation
- Moisture analysis
- Optical rotation
- Organic Volatile Impurity (OVI)
- Osmolality
- Partition coefficient
- pH
- pKa measurements
- Raw material testing
- Reference standard qualification
- Solubility
|
Stability studies
- Stability-indicating methods
- Titrations
- Total Organic Carbon (TOC)
- Trace Contamination Identity
- Viscosity
- Customized contract projects
Stability Chambers:
- Fully mapped (empty & full) for
both temperature (°C) and relative
humidity (% RH) to ensure
temperature and humidity
uniformity
- 25ºC / 60% RH
- 40ºC / 75% RH
- Continuously monitored
- UV-Vis - Spectrophotometer
Instrumentation Capabilities:
- Disintegration
- Dissolution
- Friability
- FT-IR
- GC
- Hardness
- HPLC with Diode Array detection
- Karl Fischer
- Potentiometric Titrations
|
