How research peptides are made: Kylo's full methodology on sourcing, synthesis, testing, and shipping
Every vial goes through eight defined stages. This is research-grade chemistry under written SOPs with per-batch third-party verification, not cGMP, and not for human or veterinary use. USP and ICH methods are used where applicable.
Raw material sourcing
Fmoc-protected amino acids (≥99% HPLC), solid-phase resin (Wang / Rink amide / 2-chlorotrityl), coupling reagents (HATU, HBTU, DIC, Oxyma, DIPEA), and HPLC-grade+ solvents. Every incoming lot is logged against its supplier COA and retained for chain-of-custody.
Solid-phase peptide synthesis (SPPS)
Fmoc/tBu strategy on automated synthesizers under written SOPs, iterative deprotection (piperidine/DMF) and coupling cycles, with in-process Kaiser/chloranil monitoring and DMF wash steps. Hard sequences get double-coupling, pseudoproline dipeptides, or microwave assistance.
Cleavage and deprotection
TFA-based cleavage cocktail with scavengers (TIS, water, EDT for Cys/Met), then precipitation into cold diethyl ether.Crude purity typically 60–85% by HPLC
Preparative HPLC purification
C18 stationary phase, water/acetonitrile gradient with 0.1% TFA, UV detection at 214 nm; each fraction analyzed by HPLC + MS before pooling.70–90% target recovery on well-behaved sequences
Counter-ion handling
TFA salt can be 10–25% of dry mass before exchange. TFA-to-acetate (repeated lyophilization from dilute acetic acid) or TFA-to-chloride (ion exchange) where required. The counter-ion form is documented on every COA.
Lyophilization and vialing
Freeze-dried to a stable dry powder, filled at specified weight (typically 5 mg or 10 mg per vial), sealed, crimped, and labeled with product name, sequence, lot number, fill weight, storage, and the Research Use Only statement.
Analytical QC by FreedomDiagnostics
Every batch is sampled and submitted: identity (ESI-MS), purity (analytical HPLC), net content (UV 205/280), endotoxin (USP <85>, EU/mg), residual solvents (GC), and heavy metals (ICP-MS). Results issue under FreedomDiagnostics' letterhead with a unique verification ID and publish to the COA Library.
Packaging and shipment
Lyophilized peptides are stable at ambient for standard transit; long-distance, international, and warm-route orders get thermal packaging at no charge. International shipments include customs documentation and a research-use declaration.
Documentation every buyer can pull
- The batch-specific COA tied to the lot ID printed on the vial.
- The HPLC chromatogram (conditions, retention, integration, area %).
- The mass spectrum (observed vs theoretical monoisotopic mass).
- The endotoxin result (USP <85>, EU/mg) and method.
- The FreedomDiagnostics verification ID.
- Net peptide content (separate from purity), counter-ion form, and residual solvent / heavy-metal data where applicable.
What Kylo does not do
- Compounding, not a compounding pharmacy under 503A/503B; no patient-specific formulations.
- cGMP scope, not a cGMP manufacturer; no validated/clinical-grade analytics or ICH stability data.
- Sterility, not tested or certified under USP <71>; not represented as sterile.
- Biologic contaminants, no viral clearance / mycoplasma testing.
- Intended use, not for human or veterinary use. Research Use Only.
