Analytical Method Development and Validation Services.
Method validations are performed to meet current ICH (International Conference on Harmonization) guidelines. We can develop and write the protocol for method validations and protocols are developed and experiments are executed to FDA/ICH guidelines for method validation.
Analytical problem solving activities
We followed Standard operating procedures (pharmacopoeial known method) are prepared and methods transferred to client laboratories, in case method is unknown we developed in-house method which relates with parent molecule by literature search or on the basis of customer method (Vendor qualification on MOU basis).
Analytical problem solving activities include identification of unknown peaks, evaluation of methods with excipients products or processes and investigation of more expeditious and simpler analytical alternatives. The same implements are frequently used to troubleshoot processes, development and manufacturing a Compliance Analytical Lab.
CERTIFICATE OF ANALYSIS (COA)
All products offered are thoroughly characterization and supply to our valuable customer with certified Certificate Of Analysis (COA) and supported by comprehensive analytical data like IR, HPLC purity, Mass and NMR.
All data are looking closely reviewed and each project undergoes a R&D Head and technical QC review before releasing to our valuable clients. Our COA includes FT-IR , HPLC Purity/ GC Purity, HNMR & MS (Mass Spectroscopy)
Apart from this, the customized reports with any of the following analysis are withal available on request
Chiral Purity
LC-MS
Potency
Thermo Gravimetric Analysis (TGA)
Loss on Drying (LOD), Moisture Content
CMR (Carbon-13 nuclear magnetic resonance), COSY(Correlation Spectroscopy)
