Drug Product Analysis
HPLC & Dissolution Testing
QCL’s Pharmaceutical Analysis Group provides comprehensive analytical services to the Pharmaceutical Industry in a GMP compliant environment. QCL offers HPLC analysis of pharmaceutical articles ranging from drug substance APIs and intermediates to drug product excipients and finished dosage forms. The extensive experience of our staff allows quick development and validation of analytical methods, including forced degradation studies and identification of resulting degradation products.
QCL’s Pharmaceutical Analysis Group provides comprehensive analytical services to the Pharmaceutical Industry in a GMP compliant environment. QCL offers HPLC analysis of pharmaceutical articles ranging from drug substance APIs and intermediates to drug product excipients and finished dosage forms. The extensive experience of our staff allows quick development and validation of analytical methods, including forced degradation studies and identification of resulting degradation products.
QCL can meet the testing needs of your entire product lifecycle:
- Analytical method development and validation
- Forced degradation studies
- Identification of degradation products
- Method transfers as well as qualifications/verifications
- Method remediations
- Support of formulation development and process validation
- Clinical trial material release
- Drug product release
- Stability studies
- Comparator studies
- Stability storage serices: Stability studies are conducted in well qualified chambers on site, including 12,000 cubic feet in walk-in chambers and several reach-in chambers at all ICH and some custom storage conditions
- Cleaning agent analysis (method development & validation)
- Full compendial testing
QCL also specializes in isolation and characterization of degradation products and process impurities. By coupling our vast knowledge in synthetic chemistry with our LC/MS capability, QCL has established a long and proven track record in identifying expected, as well as unexpected, impurities / degradation products.
HPLC Equipment
Our equipment includes 82 Agilent 1290/1260/1200 and 1100 HPLC systems with a variety of detection modes including:
- VWD (Variable Wavelength Detector)
- RI (Refractive Index)
- PDA (Photodiode Array)
- ECD (Electrochemical Detection)
- FL (Fluorescence)
- ELSD (Evaporative Light Scattering Device)
- CAD (Charged Aerosol Detection)
- MS (Mass Spectrometry)
- Ion Chromatography with Conductivity and PAD (Pulsed Amplitutde Detection)
- Column switching valves, thermostated autosamplers, fraction collection, semi-preparative LC are also available.
QCL offers state of the art in HPLC analysis with the Agilent 1290 Rapid Resolution UPLC for high throughput methods and method development screening. This technology allows for the use of sub 2 micron packing and operating pressures in excess of 400-bar thereby providing superior analytical speed and quality chromatography.
QCL employs Waters Empower 3 data acquisition system for efficient chromatography processing and calculations.
Dissolution Capabilities and Equipment
Our Dissolution Testing capabilities include, but are not limited to:
- IR (Immediate Release), DR (Delayed Release), & ER (Extended Release) Dosage Form Studies (including profiles over a 24 hour period)
- 26 – Agilent 708 DS with 280 DS Mechanical Qualificaton Systems; 4 – 8000 Dissolution Sampling Stations
- 2 – Hanson SR-8 Dissolution Test Stations
- USP Method 1 and 2 dissolution studies
- In Vitro Release Test (IVRT) method development and validation utilizing Agilent Enhancer Cells
- Intrinsic Dissolution Studies
Our Scientists, drawing from their experienced backgrounds, offer a solution-oriented approach to solving the most challenging projects. Our clients have grown to appreciate the timely resolution to their pharmaceutical analysis needs. Your success is our success.
Stability Services
QCL offers stability storage and testing as part of our stability management services for drugs substances and drug products from development to market.
Our experienced team of chemists allows us to offer development/validation of stability indicating methods, forced degradation studies, impurity/degradant characterization, in addition to routine analytical and microbiological testing.
QCL can completely manage your study from start to finish beginning with protocol creation and management and ending with data evaluation including stability summary tables (FDA format or custom), data trending, and expiration date prediction. With our recent expansion QCL has all of the typical ICH storage conditions available (25°C/60%RH, 30°C/65%RH, 40°C/75%RH, 5°C, -20°C, Photostability (Option 2). Ask about our other capabilities including: climatic zones III and IV storage, 25°C/40%RH for semi-permeable containers, thermal cycling, and freeze/thaw studies. All conditions are continuously monitored by the Veriteq Viewlinc Environmental Monitoring, Alarm Notification and Reporting System and is equipped with generators for power backup.
