Accepted answer
5 days is 0.18 times the twenty-eight days conventionally allowed for a preserved multi-dose vial once it has been entered. That convention assumes a preservative. Phosphate-buffered diluent has none, which makes it a single-entry preparation — its clock runs in hours after piercing, and 5 days is 120 of them. So the twenty-eight-day arithmetic never applied, and 0.18 times a figure that was never yours is not a reassurance. Growth at the densities that matter is not visible, so inspection is not the check people take it for. Date the vial at first entry and mark the punctures on the label; both cost nothing and both are the evidence you will want later.
The distinction that resolves most of these questions is understanding that bacteriostatic water is a preservative system for multi-withdrawal presentations, not a substitute for aseptic technique.
Benzyl alcohol concentration at 0.9 per cent is the approved level — lower concentrations do not provide the same suppression and higher concentrations are unnecessarily irritant.
Concentration and unit conversion at a glance
| Vial | Diluent | Concentration | 0.25 mg | 0.5 mg | 1 mg | 2.5 mg |
|---|
| 5 mg | 1 mL | 5 mg/mL | 5 u | 10 u | 20 u | 50 u |
| 5 mg | 2 mL | 2.5 mg/mL | 10 u | 20 u | 40 u | 100 u |
| 10 mg | 1 mL | 10 mg/mL | 2.5 u | 5 u | 10 u | 25 u |
| 10 mg | 2 mL | 5 mg/mL | 5 u | 10 u | 20 u | 50 u |
| 10 mg | 3 mL | 3.33 mg/mL | 7.5 u | 15 u | 30 u | 75 u |
Units are U-100 insulin units, where 1 unit = 0.01 mL. Divide dose by concentration for millilitres, then multiply by 100.
A vial that has been sitting out at room temperature is not sterile and bacteriostatic water does not make it so.
Published pharmacopeial standards specify the use and limits of benzyl alcohol in preserved presentations.
Worth noting that some people have reactions to benzyl alcohol, which is worth knowing if you are going to inject.
If you are doing single-withdrawal use, sterile water is the better choice.
3Reading the leading edge of the stopper rather than the shoulder is worth a sentence of its own. – Dr_Ilse_Vandenberg 9 months ago 4Thank you — this is the answer I was looking for. – charge_state_3 17 days ago add a comment