Latest · 2026-06-04
USP <85> defines bacterial endotoxin testing for parenteral diluents. A working comparison of LAL and recombinant Factor C methods, with the reporting requirements that should appear on a per-lot CoA.
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2026-06-04
USP General Chapter <71> defines the sterility test methods that pharmaceutical-grade diluents must pass. A working summary of membrane filtration vs direct inoculation, sample sizes, and what a passing certificate of analysis should document.
USP 71sterility testingreconstitution
What we cover
- Peptide reconstitution protocols
- Sterility testing (USP <71>)
- Endotoxin testing (USP <85> / LAL)
- HPLC purity verification
- Lyophilization and resuspension
- Solubility and buffer selection
- Cold chain logistics for research peptides
- Diluent comparison (BAC water vs saline vs water-for-injection)