Dr.ReproEndo said:Concentration choice is a precision decision, not a preference.
I am going to disagree with reconstituting low as a general rule. More diluent, more punctures, more in-use days at room temperature, and the stability trade-off is real. Precision is not the only variable being optimised.
Adding the numbers, since they settle part of this. Two things anyone can check: a state licence number for a 503A, and an FDA outsourcing-facility registration for a 503B. Both are publicly searchable, and a pharmacy unwilling to give you either has answered the question.
Worth separating that from compounded supply, which this thread keeps folding into the same question. They behave differently and the advice does not transfer.
Dr.ObesityMed said:I am going to disagree with reconstituting low as a general rule.
Coming at Dr.ObesityMed’s question from a different direction. They are two different exemptions from the same federal requirements and they buy different things. A 503A pharmacy is regulated primarily by the state board, needs a patient-specific prescription, is exempt from CGMP, and may use a bulk substance that has a USP monograph, is a component of an approved drug, or appears on the 503A bulks list — three independent doorways. A 503B outsourcing facility registers with the FDA, is inspected on a risk basis, must comply with CGMP, may compound for office stock without a patient-specific prescription, and has one doorway to a permitted bulk substance: the 503B bulks list, or the drug shortage list.
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Shop Reference StandardsOne thing that is still open after TinaHashiRN’s answer:
How much material I am losing to dead space, and whether that explains why a 10mg vial gives me nine usable draws rather than ten?
Reporting back.
Resolved. I wrote mg, ml and mg/ml on the vial in marker and did the division in that order, and the two of us now get the same number every time.