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TB-500 (Thymosin Beta-4) Pen certificate of analysis, lot PL-2610-201

Certificate PL-26-00314 reports the release tests for TB-500 (Thymosin Beta-4) Pen lot PL-2610-201: 99.50% purity by reverse-phase HPLC and identity confirmed by LC-MS, tested October 8, 2026. The lot number printed on each unit matches this certificate.

Certificate numberPL-26-00314
Lot numberPL-2610-201
CompoundTB-500 (Thymosin Beta-4) Pen 15 mg
SequenceAc-SDKPDMAEIEKFDKSKLKKTETQEKNPLPSKETIEQEKQAGES-OH (43 residues; N-acetyl; free C-terminus)
Molecular formulaC212H350N56O78S
CAS number77591-33-4
Purity (RP-HPLC)99.50%
Identity (LC-MS)Conforms (4,963.43 Da) · expected 4963.44 Da, found 4963.43 Da
MethodRP-HPLC (UV 214 nm) + LC-MS
TestedOctober 8, 2026
Retest byOctober 7, 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 Da4,963.43 Da (PASS)
PurityRP-HPLC, UV 214 nm, area%≥ 99.0%99.50% (PASS)
Largest impurityRP-HPLC, area%≤ 1.0%0.22% (RT 15.60) (PASS)
Assay (label claim)Assay vs label claim4.75–5.25 mg/mL4.95 mg/mL (PASS)
Bacterial endotoxinLAL, kinetic≤ 5.0 EU/mg0.158 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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