Accepted answer
Keep the paperwork with the material, or the material becomes anonymous.
Lyophilised powder: refrigerated at two to eight degrees for months, frozen at minus twenty for longer. The gain from minus eighty over minus twenty is small for a dry solid and is not usually worth the arrangement.
Degradation pathway by condition
| Pathway | Dominant when | Detected by |
|---|
| Deamidation | Solution, neutral to alkaline pH | RP-HPLC, +1 Da on MS |
| Oxidation | Light, trace metals, peroxides | RP-HPLC, +16 Da on MS |
| Hydrolysis | Solution, extremes of pH | RP-HPLC, fragment masses |
| Aggregation | Agitation, interfaces, high concentration | SEC, visual haze; often invisible on RP-HPLC |
| Freeze-concentration damage | Freeze-thaw of buffered solution | SEC, loss of recovered content |
In practice, reconstituted with a preservative-containing diluent: refrigerated, conventionally treated as usable for about 28 days from first entry. Without a preservative, single use and discard.
The 28-day in-use period for preservative-containing multi-dose preparations is printed on the diluent labelling and is a long-standing pharmacy convention.
The caveat is that storage conditions preserve what you have and cannot improve it.
Dry, cold, dark, still. Four words and you have the answer.
5Adding for future readers: the domestic leg after delivery is the part you control. – meniscus_film 8 months ago add a comment