• USP Purified Water Testing
USP <643> Total Organic Carbon
USP <645> Water Conductivity
USP <61> Microbial Limit Tests
• Dissolution
USP <711> apparatus 1 and 2
Extended Release - Rotating Bottle
• Disintegration
USP <701>
• USP Monograph Testing
Drug Substances
Drug Products
• CHN & CHNS Analysis
• Testing using HPLC Techniques
Isocratic Methods
Gradient Methods
UV/Vis; Variable Wavelength and Diode Array Detection
Electrochemical Detection
Fluorescence Detection
Refractive Index Detection
Size Exclusion/Gel Permeation HPLC
• Testing using GC Techniques
Capillary Methods
Split/Splitless Injection
FID Detection
Headspace Sampling
• USP <467> Organic Volatile Impurities (OVI's)
Methods I, IV (Headspace), V, VI
• USP <905> Uniformity of Dosage Units
• Moisture Determination
USP <731> Loss on Drying
USP <921> Water Determination
Karl Fischer Coulometric
Karl Fischer Volumetric
• Related Substances/Chromatographic Purity
HPLC
GC
Capillary Electrophoresis
TLC
• HPLC / Mass Spectrometry
• Method Development
o Potency
Purity
Impurities
Degradants
Stability-Indicating Assays
Drug Release/Dissolution
Identification
Cleaning Validations
Residual Solvents
Moisture
• Method Validation
ICH Guidelines
Precision
Linearity
Accuracy/Recovery
Specificity
Limit of Detection
Limit of Quantitation
Stability Indicating Studies
Stress Studies
Peak Purity
Peak Identification
Ruggedness/Robustness
Sample/Standard Stability of Analytical Samples
Filter Studies
• Testing by UV/Vis
• Testing by various wet chemical methods
• Stability Storage (continuously monitored with NIST traceable recorders)
Contact us for your specific storage requirements
Freeze/Thaw Suitability
ICH Q1B Photostability Studies Option 1
Reconstitution Studies
Compatibility Studies
• High Performance Capillary Electrophoresis
General Feasibility Studies/Method Development
Protein/Peptide/DNA
Chiral Separations Development
Indirect Detection/Ion Analysis
All modes of CE, including MEKC, IEF and gels
• Other services are available. Please call with your specific needs.
Analytical Services
