Accepted answer
The relevant principle is that anything you find before reconstitution is the supplier's, and anything you find after might be yours.
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 |
Confirm the lot code is physically on the vial and legible, and that it matches the certificate and the invoice. A code on the box only ties a certificate to a box.
Visual inspection for particulate matter is a pharmacopoeial requirement for parenteral products and the standard technique uses both light and dark backgrounds.
Inspect before reconstitution. Afterwards you cannot tell whose particle it is.
edited 31 Mar 2026 by kofi_mensah — reworded for clarity after a comment