Methods that can provide précised quantification of such drugs in the raw materials not in the final drug formulations.
Not likely! What does the USP or EU say in its monograph? You are bound by them! In addition chromatography in many cases is required to separate 'related substances (impurities)' from the API as required by ICH Q3 (international Committee of Harmonization).
Content Uniformity (all raw material containers) can be performed by NIR but you are not looking for the related substances. However, this method must be validated per ICH Q2.
You have 2 solutions:
1. Break down and buy an HPLC just to remain in this business. This also means you have to invest in people, consumables, and method validation (some methods out there are pretty bad!).
2. Perform a QA audit of an outside contract lab that can perform this analysis. In the long term this is the most expensive option (they are in this business to make money which is also known as profit).
Certainly. You have spectroscopic methods (such as IR, UV, etc); you have thin layer chromatography and flash column chromatography, and you have titrimetric determinations. When you're dealing with percent level concentrations, such as in the raw material, you'll find that USP likes old fashioned titrations and gravimetric determinations a lot.
Quantitative HPLC is, in USP terms, relatively new, so typically the USP will specify other methods for assay.
USP has many old methods without using HPLC as other mentioned. You might save the time and budget using no-HPLC method, but increase the risk. There is a balance. If it is inactive ingredient, then you can try it. If it is your API, you might need to stick with HPLC method to get enough information like related substances, purity.
Trouble with old methods is that the regulatory authorities require compliance with current methods in the compendia unless you are willing to validate the older method.
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