-
- Posts: 3
- Joined: Tue May 07, 2019 5:47 pm
Currently I am working on a injectable product having 1 API label claim 0.2 mg/mL and other API has label claim 9mg/mL. in RS analysis both have same wavelength..and due to low label claim sample injeted as such(as per monograph assay method)....I have prepared Spiked sample in placebo sample during method development....
I have 2 label claim for unknown of both,so both placebo injection is required to confirm unknown for specific analyte.
If I Spike i impurity in sample then my sample concentration will change due to as such sample injection in method.
I want to know that, is there any other method to prepare Spike sample for method precision?
Thanks & Regards
Pratik