The short version: intact crimp, seated stopper, legible lot code, and a cake that looks like a cake.
Look for fibres, glass fragments and dark particulate in the cake. Glass is the one that matters and is usually a crimping or handling artefact rather than a synthesis one.
Dead space by syringe type
| Configuration | Dead volume | Loss at 5 mg/mL | Over 20 draws |
|---|
| Fixed-needle insulin syringe | 3–5 µL | 15–25 µg | 0.3–0.5 mg |
| Low-dead-space, detachable | <2 µL | <10 µg | <0.2 mg |
| Standard luer-lock + 30G | 35–60 µL | 175–300 µg | 3.5–6 mg |
| Luer-lock + 21G drawing needle | 70–100 µL | 350–500 µg | 7–10 mg |
After reconstitution, hold against a light and look for haze, floaters or a Tyndall effect. A clear solution that goes clear on contact is what a well-made preparation looks like.
Visual inspection for particulate matter is a pharmacopoeial requirement for parenteral products and the standard technique uses both light and dark backgrounds.
The caveat is that inspection cannot detect identity, purity, content or endotoxin, which are the things most likely to be wrong.
Inspect before reconstitution. Afterwards you cannot tell whose particle it is.
5Confirming: I did the wrong thing here once and got exactly the predicted result. – Dr_Nadia_Farsi 2 months ago add a comment