Dosage
Analytical Services
ANALYTICAL DEVELOPMENT & TESTING SERVICES
We provide comprehensive analytical support for formulation development, clinical trial supply, scale up and commercial manufacturing. Our labs boast of high end analytical equipment. Additionally we have a dedicated analytical lab for high potency molecules.
The team works in a highly coordinated manner with product development, project management and quality assurance teams to ensure effective and accelerated product development.
We offer the following services
Analytical services on standalone basis or in support of product development
- API Characterization
- Method Development and Validation (Assays, Related Substances, In-Process Testing, Stability Indicating, Chiral, Dissolution, Preservative, Cleaning, Residual Solvents & Microbial)
- Method Evaluation and Revalidation
- Phase Specific Method Validation
- Forced Degradation Studies
- Method Transfer
- Dissolution Testing and Drug Release Profiling
- Stability Studies (per ICH)
- Isolation and Identification of Impurities
- Heavy Metal/Trace Metal Analysis
- Thermal Analysis
- Particle Characterization
- Surface Area and Porosity Determination
- Polymorph Characterization & Stability
- Compendial Testing (per Current USP/NF, PhEur/PharmEuropa, JP/JPE for Registration and Commercial Manufacturing)
- Specifications Development
- QC Testing (for cGMP Manufacturing)
Microbiology testing and validation services in support of product development
- USP/EP/JP Microbial Testing
- Microbial Limit Test
- Antimicrobial (Preservative) Efficacy Test
- Bacterial Endotoxin Test (by Gel Clot Method)
- Sterility Testing
- Particulate Matter Testing (by Light Obscuration and Microscopy)
- Microbial Identification (by Automated Biochemical Procedures)
- Total Viable Spore Count of Biological Indicators
- Container/Closure Integrity by Microbial Ingress
- Total Organic Carbon Analysis
- Water Activity Testing
CPS' in-house analytical development laboratories utilize some of the most advanced scientific equipment available, which aids our scientists in formulating shelf stable and scalable dosage forms. Having this advanced capability in-house results in fast, scientifically sound results.
View Equipment List
- HPLCs with UV-Vis, Photodiode Array (PDA), RI, Fluorescence, and ELS Detectors
- UPLCs with UV-Vis & PDA Detectors
- GCs with FID, TCD, and ECD Detectors, and Head Space Analyzers
- Mass Spectrometry (GC-MS, LC-MS, Tandem MS-MS & High Resolution MS)
- Ion Chromatography
- Flash Chromatography
- Preparatory LCs
- Dissolution Testers (USP types I, II, III & IV & Intrinsic Dissolution)
- FT-IR & UV-Vis Spectrophotometers
- Nuclear Magnetic Resonance Spectrophotometers (400 & 500 MHz)
- X-Ray Diffraction (pXRD)
- Thermal Analysis (DSC & TGA)
- Atomic Absorption Spectroscopy (AAS)
- Inductively Coupled Plasma-Optical Emission Spectrometer (ICP-OES)
- Dynamic Vapor Sorption Analyzer
- Particle Size Analyzer (by Laser Diffraction)
- Surface Area Analyzer (BET)
- Capillary Electrophoresis
- Autotitrators
- Microbial Identification System
- TOC Analyzer
- Liquid Borne Particle Counter
- Water Activity Tester