SCALE Performance

PT-141 Nasal Spray certificate of analysis, lot PL-2610-162

Certificate PL-26-00275 reports the release tests for PT-141 Nasal Spray lot PL-2610-162: 99.58% purity by reverse-phase HPLC and identity confirmed by LC-MS, tested October 7, 2026. The lot number printed on each unit matches this certificate.

Certificate numberPL-26-00275
Lot numberPL-2610-162
CompoundPT-141 Nasal Spray 10 mg
SequenceAc-Nle-cyclo[D-H-[D-Phe]-R-W-K]-OH (7 residues; Asp–Lys side-chain lactam; N-acetyl; free C-terminal acid)
Molecular formulaC50H68N14O10
CAS number189691-06-3
Purity (RP-HPLC)99.58%
Identity (LC-MS)Conforms (1,025.14 Da) · expected 1025.18 Da, found 1025.14 Da
MethodRP-HPLC (UV 214 nm) + LC-MS
TestedOctober 7, 2026
Retest byOctober 6, 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 Da1,025.14 Da (PASS)
PurityRP-HPLC, UV 214 nm, area%≥ 99.0%99.58% (PASS)
Largest impurityRP-HPLC, area%≤ 1.0%0.21% (RT 11.90) (PASS)
Assay (label claim)Assay vs label claim9.5–10.5 mg/bottle9.75 mg/bottle (PASS)
Bacterial endotoxinLAL, kinetic≤ 5.0 EU/mg0.093 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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