Drug testing supplies for research and clinical laboratories.

Reference standards where a NIST SRM exists are characterized against the SRM and shipped with documented traceability on the COA. Materials without a NIST equivalent are characterized against in-house primary references with documented purity by orthogonal methods (HPLC-UV, NMR, mass-balance). The COA states the reference chain explicitly so your method validation file shows traceability without ambiguity.

ASC retains representative samples of every lot beyond the labeled expiration, consistent with ICH Q1A stability retention guidance for reference standards. If your lab receives a regulatory query on a historical run, we can pull a retention sample and re-test against the original COA. Lot records (manufacturing, QC, ship destination) are retained indefinitely.

Multi-level QC controls ship with the certified concentration of each level. Linearity validation is your lab's method-development responsibility; the materials are formulated to bracket SAMHSA / Part 26 / your facility cutoffs at typical analytical ranges (typically 0.5x, 1x, and 1.5x the cutoff, with high-end at 5-10x for upper-LOQ characterization). Custom level configurations are available on contract.

Schedule II reference materials require a DEA Form 222 from a DEA-registered analytical laboratory. Ordering process: your lab submits your DEA registration and an executed Form 222, we verify against the DEA database, ship via registered courier with chain-of-custody. Schedule III-V materials require DEA registration but not Form 222. All controlled substance shipments are logged per 21 CFR 1304 recordkeeping requirements.

Yes. Our COA documentation, lot-retention program, and supplier qualification packet meet the test-article characterization expectations of 21 CFR Part 58 (GLP for nonclinical lab studies). For labs under 21 CFR Part 11 electronic recordkeeping, COAs ship as both signed PDF and structured data, digestible by your LIMS or eQMS without manual re-entry.

Reference standards are manufactured under a master batch record with the same starting materials, the same crystallization or formulation procedure, and the same release specifications across every lot. Each new lot is characterized against the prior lot in a bridging study before release. Your lab's subscription lock-in means you receive product from the same lot family across reorders until a documented changeover is required.

Reference standards requiring refrigerated (2-8°C) or frozen (-20°C / -80°C) storage ship in qualified shipping containers with temperature data loggers. The logger arrives with the shipment so your QA can verify the temperature profile from origin to receiving. For ambient-stable materials, standard ground shipping is the default; the COA explicitly states required storage conditions.