Sterility

Compendial sterility test for injectables. Included in Gold and Elite; $150 added to Silver.

At a glance

Turnaround

14-day incubation; about 15 days to report.

Price

$150 added to Silver. Included in Gold $550 and Elite $700.

Sample

1 unopened vial. Counted within the 3 or 4 vials of Gold and Elite.

Accreditation

ISO 17025 quality system, scope extension in progress

Scope

Presence or absence of viable microorganisms after 14 days of incubation.

Method

USP 71 membrane filtration. 14-day incubation.
Culture method. Rapid or PCR screens are not substituted.

Reported as

No growth or growth at 14 days.
Preliminary COA issued with sterility pending; the same QR code opens the final COA.

Sample

1 unopened vial. Counted within the 3 or 4 vials of Gold and Elite.
Injectables only. Non-injectable forms receive bioburden (USP 61).

Accreditation

Performed under the laboratory’s ISO/IEC 17025:2017 quality system. A2LA scope extension (certificate 6377.01) in progress.

Questions

Can I get the other results before sterility is done?

Yes. A preliminary COA is issued with sterility marked pending.

Order

Start an order online, or send the compound name and the tests you need for a quote.

All peptide testing