|
Product Quality Control &
Release Testing...
Quantex Laboratories offers comprehensive QC and release testing for Active Pharmaceutical Ingredients (APIs), pharmaceutical intermediates, excipients and finished products. Our analytical laboratories provide release testing of in-process materials as well as finished products. Whether you need results overnight or next week, we have the capabilities to meet your most demanding turnaround time requirements.
QC and Release Testing Capabilities Include:
- Stability Studies (Shelf life 2 years, 3 years)
- Arsenic, Heavy metal and Mercury limits
- Cleaning validation and contamination studies on production equipment
- Compendial testing on raw material and finished product per monograph
- Dissolution testing for drugs, including convention, and extended released for capsule, tablet and sublingual
- FTIR identification and quantitation
- GC for assay and chromatographic purity/impurities
- Headspace gas chromatographic for residual solvent analysis
- Hydroxypropyl assay
- HPLC for Assay and Identification Tests - General
- Karl Fischer moisture analysis
- Loss on drying, residue on ignition
- Method development and method validation
- Microbial limits testing
- Residual solvents (organic volatile impurities)
- Particle size
- Performance characteristics for colony counting methods in microbiology
- Potentiometric titration
- Preservative efficacy testing (Microbial Challenge)
- Qualitative Analysis for Pharmaceutical substances and Medicaments per USP
- Refractive index, specific gravity and specific rotation
- TLC Identification Test
- High Performance TLC for Impurities Analysis
- Total Organic Carbon
- UV identification and assay
- Viscosity
Click here to learn more
|
Quality Control &
Release Testing... |
 |
Testing of APIs and intermediates |
|
Testing of excipients |
|
Finished product release testing |
|
Finished product stability testing |
|
Container-closure testing
|
|
Microbial limits |
| |
| Methods... |
|
Client/customer methods |
|
Vendor supplied methods |
|
In-house developed and validated procedures |
|
USP methods |
|
PhEur methods
|
|
JP/JPE methods |
|
BP methods |
|
ACS monographs |
|
AOAC testing |
|
FCC testing procedures |
|
