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Livagen Nasal Spray certificate of analysis, lot PL-2610-120

Certificate PL-26-00234 reports the release tests for Livagen Nasal Spray lot PL-2610-120: 99.71% 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-26-00234
Lot numberPL-2610-120
CompoundLivagen Nasal Spray 20 mg
Molecular formulaC18H31N5O9
CAS numberNot assigned
Purity (RP-HPLC)99.71%
Identity (LC-MS)Conforms (461.44 Da) · expected 461.47 Da, found 461.44 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 Da461.44 Da (PASS)
PurityRP-HPLC, UV 214 nm, area%≥ 99.0%99.71% (PASS)
Largest impurityRP-HPLC, area%≤ 1.0%0.13% (RT 10.60) (PASS)
Assay (label claim)Assay vs label claim19–21 mg/bottle19.98 mg/bottle (PASS)
Bacterial endotoxinLAL, kinetic≤ 5.0 EU/mg0.404 EU/mg (PASS)
Aerobic count (TAMC)USP <61>< 10 CFU/mL< 10 CFU/mL (PASS)
Yeast & mold (TYMC)USP <61>< 10 CFU/mL< 10 CFU/mL (PASS)
E. coliUSP <62>AbsentAbsent (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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