No — 99.2 per cent purity and 6.1 mg content are answers to different questions and cannot contradict each other. Purity is a ratio: 99.2 of every 100 units of detected peak area, with 0.8 per cent belonging to something else. Content is a mass: 6.1 mg of peptide in the vial, measured against a standard. A vial can be 99.2 per cent pure and hold 6.1 mg because the things that make up the difference between gross fill and 6.1 mg — water, counter-ion, a short fill — are not impurity peaks and never appear in a purity figure. Against a nominal 10 mg label, 6.1 mg is 61 per cent of claim, and that is the number that changes your dosing arithmetic. The 99.2 per cent does not.
Put another way, what a useful certificate carries is debatable, but there are certain fields that almost no research-grade certificate includes despite their being standard in pharmaceutical work.
Writing the lot number on your vial in permanent marker is worth doing because it later proves that the certificate traces to your material.
Batch versus lot is a semantic distinction that determines whether one certificate applies to ten vials or to one, and checking this distinction is worth a minute.
Research-grade certificates carry no regulatory backing and no standing in quality systems, and that limitation is worth being explicit about.
Worth noting that none of this is medical advice, and a compound sold for research use carries no regulatory approval in any jurisdiction.
My working rule is that a document without a lot number, a method section and a test date is marketing.
5The system-suitability data is the part that tells you whether to believe the rest. – k_szabo 7 months ago add a comment