Precision in Practice:
Our Analytical Expertise
Curapath’s Analytical
Expertise:
Our analytical experts offer a wide array of testing methods to guarantee optimal purity:
- Routine characterizations
- In-process and quality control
- Stability testing
- Identity, quantitative, and limit tests
- Impurity profiles
- Analysis according to current monographs (e.g., Ph. Eur., USP)
- Method development and validation
- Testing and release under GMP environment
- Comprehensive cGMP documentation and release certificates
Polymer & Lipid Excipients
Relevant polymer and lipid excipient characterization tests
Test
METHOD
Raw Material Identification
Nuclear Magnetic Resonance (NMR), Fourier-Transform Infrared Spectroscopy (FTIR) and Ultra-high performance liquid chromatography coupled with mass spectrometry, ultraviolet and refractive index detector (UHPLC-RI-UV-MS)
Lipid Identity and Purity
Ultra-High Performance Liquid Chromatography with Evaporative Light Scattering, Charged Aerosol and Mass Spectrometry (UHPLC-ELSD-CAD-MS)
Polymer purity, MW, PDI
Size exclusion chromatography coupled with refractive index detector and multi-angle static light scattering (SEC-RI-MALS)
MW and DP by End Group Analysis
Ultra-high performance liquid chromatography coupled with mass spectrometry and ultraviolet detector (UHPLC-MS-UV)
Residual Solvent Quantification
Head-space Gas Chromatography coupled with Flame Ionization detector (HS-GC-FID)
Water Content Quantification
Enantiomeric Excess Quantification
Ultra-high performance liquid chromatography coupled with mass spectrometry and ultraviolet detector (UHPLC-MS-UV)
Bacterial Endotoxins
Ph.Eur 2.6.14 (Chromogenic Kinetic Method)
Bioburden
Ph.Eur 2.6.2 (Inoculation and Enumeration)
Lipid & Polymer Nanoparticles
CHARACTERIZATION
METHOD
Particle Size, Distribution, Zeta Potential
Dynamic and Evaporative Light Scattering Detector (DLS and ELS)
API Identity and concentration
(qPCR) and Ultra-High Performance Liquid Chromatography with Evaporative Light Scattering Detector and Charged Aerosol Detector (UHPLC-ELSD-CAD)
API Encapsulation Efficiency
Fluorescent Dye Encapsulation Assay
API Ratio
Automated Electrophoresis
Total API (RNA) Purity
Fragment Analyzer
Lipid Identity and Concentration
Ultra-High Performance Liquid Chromatography with Evaporative Light Scattering, Charged Aerosol and Mass Spectrometry (UHPLC-ELSD-CAD-MS)
Appearance, Viscosity, Osmolality, pH, VIC
Endotoxin, Sterility, SVP
United States Pharmacopeia (USP)
Track Record of Analytics
Methods Developed
(ICH Q2)
Compliance Rate
Meet Analytical and Regulatory Requirements
Quality Commitment: Our facilities and quality processes guarantee that any product manufactured meets applicable quality standards. Curapath’s commitment to quality and extensive expertise ensure we are your reliable partner for GMP manufacturing.