Tier 1: Full Documentation Standard Recommended Criteria met: Third-party HPLC purity report above 98%, mass spectrometry confirmation of molecular weight matched to the stated salt or free acid form, named ISO-accredited testing lab, batch number traceable between COA and product, refrigerated shipping, clear labeling of salt form, disclosed excipients
doi: 10.1016/j.jddst.2024.106226 41
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