The principle
Quarantine means incoming material is physically and administratively segregated, labeled as not yet released, and not sold or used until defined acceptance criteria are met. It is a long-standing principle in regulated manufacturing and a sensible one for any supplier of research chemicals.
A typical flow
- Receipt: verify paperwork, container condition and lot identity against the order.
- Quarantine: store under proper conditions in a segregated, labeled location. Status: Not released.
- Sampling: draw representative samples with chain of custody and send for independent testing.
- Testing: identity, purity, quantity, endotoxin, sterility and heavy metals, each against a written specification.
- Review: compare every result with specification; investigate any out-of-spec result.
- Disposition: pass lots are released; failing lots are destroyed or returned to the vendor.
Why independent testing
A supplier's own certificate reflects the supplier's own testing. Independent analysis by a separate laboratory gives a second, unbiased data point, which is particularly valuable when the material originates from outside the buyer's own facility.
What gets tested
| Attribute | Method |
|---|---|
| Purity | HPLC |
| Identity | Mass spectrometry |
| Quantity per vial | Verified content assay |
| Endotoxin | LAL |
| Sterility | Culture-based (about 14 days) or rapid nucleic-acid method (hours); method stated on report |
| Heavy metals | ICP-MS |
Handling failures
A failed lot is never "blended away" or sold at a discount. It is either destroyed or returned to the vendor, with the decision and reason recorded. That record is what makes the pass decisions credible.
How we do it
Every lot at DC ChemTech LLC is quarantined on arrival and stays that way until it passes testing. Read the full program on our Quality page.