Services
Our Services
Analytical Services
- Analytical method development, Validation/Verification and Method transfer
- Raw materials, Excipients and Finished Product analysis as per IP, USP, BP, EP and JP monographs
- Stability study as per ICH and regulatory requirements
- Photo stability, Thermal Cycling studies
- Pre-Formulation and excipients compatibility study
- Dilution, Reconstitution and In-Use study
- Dissolution study
- In vitro binding study
- Element impurities testing and risk assessment report preparation as per ICH Q3D
- Genotoxic impurities testing and risk assessment as per ICH M7
- Nitrosamine and NDSRI testing and risk assessment report preparation
- Nitrate and nitrite impurities analysis in Raw materials, Excipients and Drug products
- Extractable and Leachable studies
- Peptide and peptide impurities characterization
- Working standard and reference standard preparation, characterization and supply
- Impurities isolation, Identification, synthesis, characterization and supply
- RLD characterization and comparative study between RLD and test products
- Cleaning validation method development, validation and transfer
- Onsite calibration of lab instruments
Analytical Services
Analytical devices in a laboratory are essential for measuring, analyzing, and characterizing materials and substances. Here’s an overview of some common types:
Spectroscopy
Nuclear Magnetic Resonance (NMR) Spectroscopy: Provides information about the structure of organic compounds. Analyzes molecular vibrations and functional groups.
Chromatography
High-Performance Liquid Chromatography (HPLC): Used for separating, identifying, and quantifying components in a liquid mixture.
Mass Spectrometry (MS)
Analyzes the mass-to-charge ratio of ions to identify compounds and determine molecular weights.
Electrochemical Analyzers
Voltammetry: Studies the current response of an electrochemical system to changes in potential.