Source comparison
TB-500 Pre-Research Checklist: Compliance Comparison
Supplier 503B Registration Cross-reference FDA 503B registry database Copy of current 503B certificate FDA Part 207 registration Non-negotiable for institutional research. Unregistered suppliers create liability Batch-Specific CoA HPLC purity ≥98%, mass spec c
This comparison does not assign a generated winner or score.
- Supplier 503B Registration
- Cross-reference FDA 503B registry database
- Copy of current 503B certificate
- FDA Part 207 registration
- Non-negotiable for institutional research. Unregistered suppliers create liability
- Batch-Specific CoA
- HPLC purity ≥98%, mass spec confirmation, endotoxin <1.0 EU/mg
- CoA issued within 90 days of synthesis
- ISO/IEC 17025 accredited testing
- Generic CoAs are red flags. Demand batch numbers matching your vial
- Third-Party Verification
- Independent lab re-test of peptide purity and identity
- Test report from unaffiliated analytical lab
- No formal standard but increasingly expected by IRBs
- Costs $120–$300 per batch but eliminates 90% of fraud risk
- Temperature Logging
- NIST-traceable digital thermometer with 15-min interval recording
- Continuous log for duration of peptide storage
- NIST traceability per 21 CFR Part 11
- Manual logs are insufficient. Digital with alarm thresholds required
- Sterile Technique Certification
- Lab personnel complete aseptic technique training
- Training certificate renewed annually
- Institutional biosafety protocol
- Lack of certification delays IRB approval by 4–8 weeks on average
- Disposal Compliance
- Autoclave sharps, classify peptide waste as chemical not biohazard
- Waste manifest and autoclave cycle log
- State-specific chemical waste regulations
- Improper disposal triggers institutional audit and potential EPA violation