Can we use "pharmaceutical secondary standard" doxorubicin for loading/release from nanoparticle study?
And for other biological test like MTT assay etc.
I suggest you using an accessible BPCRS:
https://www.pharmacopoeia.com/Catalogue/ProductDetails?productid=1000015025&page=1&pageSize=20&searchText=doxorubicin&startsWith=
or EPCRS:
https://crs.edqm.eu/db/4DCGI/View=D2975000
The above, thinking on traceability. For purity tests; there are usually few impurities with the exact grade required for all USP BP/ Eur Ph. tests, so a secondary traced standard -when available- is advised... but on some cases ONLY a secondary standard without traced purity is available, and one may think at least inspecting chromatographic purity when needed. But yours: doxorubicin is API; so traceability concerns must be considered, then if you only want to start the information acquisition; then TRY YOUR TESTS with secondary std to see how they behave, then and next step for compliance (following pharmacopeial standards) you'll need a well known purity standard for your tests(meaning if you want to use it as internal information for previous design, then go untraced; but once you need to document and register the information for compliance, then you need go using traced standard, in some environments even the previous R&D NEED to be traced for obvious $ reasons and even for compliance). Another option is to use from the beginning your secondary standard traced by yourself: get EPCRS or BPCRS and run the normal assay for Injection, Tablets, API of your required pharmacopeia for your secondary untraced standard AND AGAINST THE CRS, I suggest API assay. Your traced secondary standard now charges your own analysis as if it were designed for testing THEN RUN YOUR TESTS using the secondary but traced std. The last is the best option for compliance of required traceability. I don't suggest using an indirect API ASSAY without ADDITIONAL & special purity testing!!
Other option is to take into consideration the very accessible PHR sigma aldrich with 1gram quantities http://www.sigmaaldrich.com/catalog/product/sial/phr1789?lang=en®ion=US sadly this time its tiny: 200mg but THE WORK IS DONE for this option by sigmaaldrich and traced at multi pharmacopeias!
Sometimes the use of a certified standard are optional: for example when indirect measurement is required in the API MONOGRAPHY, like using KHP or another primary and indirect standard, in such cases I suggest using the dosage form chromatographic assay in conjunction with the CRS and as an option an impurities test to be sure!. Common Sense from analytical chemistry.
trying to understand the question: what are the targets of the biological study, MTT or other tests, product and book reference? My previous answer are useful for a USP product needing compliance in a regulatory local office like FDA and expecting USP grade tests.
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