Auriga Fprovides research and development services, technical problem solving and contract analytical services to industry, government and academia and is an ISO9001:2000 registered company. Arbro specialises in spectroscopy, microscopy, chemical analysis and instrumentation development to provide tailored innovative solutions to client requirements.
Characterization cover the generation of complete specifications of any product like – Assay, Impurity/Related substances, Identification, Dissolution, Uniformity of content etc. The basic components of this exercise are for characterization is
- Review of literature
- Selection of analytical technique
- Analytical method validation
Method validation is one of the most crucial components in any regulatory submission. We can conduct method validations for various analytical methods; from simple UV based assays to complex chromatographic methods for impurities and related substances. Our validation protocols and reports are based on globally acceptable guidelines like ICH/FDA/USP guidelines and cover various parameters like
- Limit of detection
- Limit of quantification
4. Characterization of Drug Substance
- Mass spectra
- FTIR spectra
- DSC Thermograms
Client is provided comprehensive reports and raw data (including chromatograms) for all of the above studies and we will support you in answering any queries from the regulatory bodies after submission of the data. We are open to being audited by members of your organization at any time to further enhance your confidence in our systems and procedures.