хроматография chem.

[Paravoli]

Помогите, нет вариантов.

Речь идет о высокоэффективной жидкостной хроматографии (ВЭХЖ).
Есть таблица с результатами исследований по этой самой хроматографии. И в столбце с критериями, необходимыми для признания пригодности лекарства такая надпись:

95-105% of the label claim for each API

Далее в таблице идет строчка с процентным содержанием для каждой партии лекарства. Что это может быть?

[Доброжеватель]

95-105% заявленного содержания для каждого действующего вещества

См.:

"Label claim percentage (%LC) of each drug is calculated as ratio of the amount of drug that is found during analysis in each filtrate to the amount known (or claimed) to be present in the tested solution, and expressed as percentage. ... For the chosen well characterized pharmaceutical products, the value of the label claim percentage (%LC) is between 98-102% for the accurately carried testing procedure. Any additional handling of the samples (e.g. filtering or centrifugation) is a source of additional error or inaccuracy. Therefore, specifications for the filtered samples are set to meet wider 97-103% interval of acceptability. "
http://www.pall.com/34696_42059.asp

"For example if an active pharmaceutical ingredient (API) has a known moisture content of 5.0%, this means that its potency is 95% and this should be factored into the amount added to the batch to ensure that the formulation is 100% of the product label claim; therefore each 100 gms of the API used "as is" would provide potency equivalent to 95 gms of the active ingredient and the weight would have to be adjusted upward to compensate for the moisture, in this hypothetical case 105.26 gms for each "100 gms" of active ingredient required."
http://www.fda.gov/cder/hdn/cnotes37.htm

[Paravoli]

Доброжевателю большой THANKS!