API-Impurity Synthesis And Profiling
With our expertise in Development and Manufacturing of Active pharmaceutical Ingredients in the domain of High Potent APIs as well Bulk actives and intermediates, Scintel extends our service for synthesis and profiling of API Impurity Standards, In Process Impurities, Degradation Impurities and complex Nitrosamine impurity standards. Every Impurity comprises with COA, Purity by HPLC or GC, 1H- NMR,C13-NMR, Mass, FTIR, Ash content or Potency by TGA and MSDS.
Additional Data like Q-NMR,CHNS,UV and RRF can also be given based of requirement.
We also provide Technical justification Report for impurities which are hard to synthesis or non-feasible by chemical route of synthesis. The Technical project report comprises of supporting Analytical Data and Technical justification.
- API Impurities
- API Reference Standards
- Nitrosomines
- Metabolites
- API Impurity Standards (USP/EP/BP/IP/JP/IH)
- In Process Impurities (KSM/RM/Formulation)
- Degradation Impurities - Stability Studies
- Nitrosamine Impurity Standards
- NDSRI (Nitrosamine Drug Substance/Formulation Products)
- API Metabolites
- API Glucuronides
- API CRS-WRS
- Technical Project Report Writing for Non-Formation of Impurities

We deliver every product with comprehensive, fully interpreted data
- COA
- Purity of HPLC Or GC
- 1H-NMR
- 13C-NMR
- Mass
- FTIR
- Ash Content by TGA
- Volatile Content by TGA
- MSDS
Additional data can be provided based on requirement
- Q-NMR
- CHNS
- UV
- RRF


