Accepted answer
To be exact about it, quantified content is how many milligrams of peptide are actually in the vial, measured against a calibrated reference standard, and it is the only measurement that directly answers that question.
System suitability for a quantitative method is stricter than for purity because a small systematic error in the standard directly translates into an error in the sample result.
Reconciling gross mass to label claim
| Component | Typical share | Counted in purity? | Counted in content? |
|---|
| Target peptide | 88–94 % | Yes, as main peak | Yes |
| Related impurities | 1–3 % | Yes, as other peaks | No |
| Counter-ion (TFA or acetate) | 2–8 % | No | No |
| Residual water | 2–6 % | No | No |
| Bulking agent, if present | 0–40 % | No | No |
Mechanically, water content and counter-ion content are part of the gross mass but not part of the content assay result, which is why the two do not sum to label claim.
The relative standard deviation on replicate quantitations of a homogeneous sample should be below two per cent when the method is under control.
Ask for both the purity and the content, and do not accept purity alone.
6The arithmetic checks out. I ran the same numbers and got the same result. – RP_C18 8 months ago add a comment