Business Need
- Topologically directed confocal Raman imaging (TD-CRI) can be successfully employed to reverse engineer RLD on following
- API/excipient particle size
- API/excipient polymorphism
- Compositional distribution of API and/or excipients
Approach
- CRI is time-consuming and laborious procedure
- Statistical methods to aid in obtaining sample representativeness and sample randomization is employed using
- Non-parametric population analysis
- Bootstrapping
- d-statistics attribute-based control charts
What was Demonstrated
- Topologically directed confocal Raman imaging (TD-CRI) can be successfully employed to reverse engineer RLD on following
- API/excipient particle size
- API/excipient polymorphism
- Compositional distribution of API and/or excipients
- Right First Time-Right Every Time (RFT-RET
Delivery Impact
Muthudoss et al., Topologically directed confocal Raman imaging (TD-CRI): Advanced Raman imaging towards compositional and micromeritic profiling of a commercial tablet components. Journal of Pharmaceutical and Biomedical Analysis. 2022 Feb 20;210:114581.