Intended Research Use

This Schedule III controlled substance is provided exclusively as an analytical reference standard for:

• Forensic toxicology (GC/MS, LC-MS/MS calibration)

• Pharmaceutical QA testing (dissolution profile studies)

• Metabolite research (in vitro hepatic models)

• Drug detection method development (HPLC method validation)

Legal Note: Only available to DEA-registered researchers under 21 CFR 1301.13.

Product Specifications

Quality Assurance

Each batch includes:

• Chromatographic Validation (HPLC-PDA against USP reference)

• Mass Spectrometry Confirmation (QTOF-MS/MS)

• Content Uniformity Testing (meets USP <905> standards)

• Stability Data (ICH Q1A accelerated degradation studies)

Compliance Requirements

Mandatory for Purchase

1. Valid DEA Researcher Registration (Form 225)

2. Institutional Controlled Substance Authorization (if applicable)

3. Signed End-Use Declaration (research purpose affidavit)

Shipping Protocol

• Domestic: DEA-approved carriers only (tracked signature required)

• International: Not available for export (Schedule III restrictions)

Why Choose USA CHEM X for Reference Materials?

✅ Direct Pharmaceutical Sourcing – Authentic products from licensed manufacturers
✅ DEA-Compliant Documentation – Complete chain of custody records
✅ Batch-Specific Certification – Full analytical data package included
✅ Regulatory Expertise – 21 CFR Part 11 compliant documentation

Legal Disclaimer

This product contains buprenorphine hydrochloride (DEA #9064), a Schedule III controlled substance per the Controlled Substances Act (21 U.S.C. § 812). Sale is restricted to qualified researchers with active DEA registrations. Misuse violates federal law (21 U.S.C. § 841) and may result in criminal prosecution.

Research FAQ

1. Can this be used for clinical studies?

No. This material is strictly for analytical method development – clinical trials require different regulatory approvals.

2. What documentation is provided?

Each shipment includes:

• Certificate of Analysis (USP methods)

• DEA 222 Form copy (for controlled substance tracking)

• Stability data sheet

3. How should samples be stored?

In original blister packaging at controlled room temperature (15-30°C) with ≤60% RH.

4. Is metabolite research allowed?

Only with approved IACUC protocol (animal studies) or institutional biosafety approval (in vitro).

5. What’s the minimum order quantity?

Authentic Subutex 8mg tablets for forensic/pharma research. DEA-regulated, HPLC-verified. Strictly for analytical applications by qualified researchers.