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KPV Pen certificate of analysis, lot PL-2610-117

Certificate PL-26-00231 reports the release tests for KPV Pen lot PL-2610-117: 99.59% purity by reverse-phase HPLC and identity confirmed by LC-MS, tested October 6, 2026. The lot number printed on each unit matches this certificate.

Certificate numberPL-26-00231
Lot numberPL-2610-117
CompoundKPV Pen 15 mg
SequenceH-KPV-OH (3 residues; free N- and C-termini)
Molecular formulaC16H30N4O4
CAS number67727-97-3
Purity (RP-HPLC)99.59%
Identity (LC-MS)Conforms (342.42 Da) · expected 342.43 Da, found 342.42 Da
MethodRP-HPLC (UV 214 nm) + LC-MS
TestedOctober 6, 2026
Retest byOctober 5, 2028
Tested byManufacturer’s in-house laboratory (not an independent third-party test)
ConclusionConforms

Tests run on this lot

TestMethodSpecificationResult
Identity (mass)LC-MS, ESI positiveTheoretical ± 1.0 Da342.42 Da (PASS)
PurityRP-HPLC, UV 214 nm, area%≥ 99.0%99.59% (PASS)
Largest impurityRP-HPLC, area%≤ 1.0%0.28% (RT 7.10) (PASS)
Assay (label claim)Assay vs label claim4.75–5.25 mg/mL4.88 mg/mL (PASS)
Bacterial endotoxinLAL, kinetic≤ 5.0 EU/mg0.465 EU/mg (PASS)
SterilityUSP <71>, 14-dayNo growthNo growth (PASS)

What these results mean

HPLC purity is the share of UV-detectable material that elutes as the target compound; it is not the same as net peptide content, which also accounts for water and counter-ions. Identity means the measured mass matched the mass calculated for the compound. A certificate reports only the tests run on this lot; endotoxin, sterility and contaminant panels are not part of standard lot release. How to read a certificate of analysis.

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