Certificate PL-26-00214 · IGF-1 LR3 Nasal Spray · lot PL-2610-100
VerifyCertificate page
PrymaLab
PrymaLab
PrymaLab Analytical · In-house laboratory
3705 Music Branch Rd, Ashland, KY 41102 · +1 (606) 465-9063 · prymalab.net
Certificate no.
PL-26-00214
Verification key
GQXPFCAB
Scan or enter both at
prymalab.net/testing/verify
Certificate of Analysis · Lot release

IGF-1 LR3 Nasal Spray

Lot PL-2610-100 · Solution · Label claim 2 mg per bottle
Tested in-house by PrymaLab
In-house analytical result,
not an independent third-party test
Lot / batch number
PL-2610-100
Date made
2026-10-05
Date of analysis
2026-10-06
Date issued
2026-10-13
Retest / expiry
2028-10-05
Units in lot / sampled
385 / 2
Storage
—
Certificate type
Lot COA, 2 pages
Compound
IGF-1 LR3
Long R3 IGF-1; recombinant human IGF-1 analogue with a 13-residue N-terminal extension and Glu3→Arg
CAS number
946870-92-4
Molecular formula
C400H625N111O115S9 (reduced-chain calculation)
Theoretical mass (avg.)
9,111.60 Da
Structure
83-aa 3 disulfides folded
Purity · RP-HPLC, area %
99.31%
Specification ≥ 99.0% • main peak at 15.13 min
Identity · Observed Mass
9,111.46 Da
Theoretical 9,111.60 Da • −0.14 Da (15 ppm)
Overall conclusion
PASS
Meets every specification for the tests performed
TestMethodSpecificationResultConclusion
Identity (mass)LC-MS, ESI positiveTheoretical ± 1.0 Da9,111.46 DaPASS
PurityRP-HPLC, UV 214 nm, area%≥ 99.0%99.31%PASS
Largest impurityRP-HPLC, area%≤ 1.0%0.36% (RT 14.50)PASS
Assay (label claim)Assay vs label claim1.9–2.1 mg/bottle1.95 mg/bottlePASS
Bacterial endotoxinLAL, kinetic≤ 5.0 EU/mg0.134 EU/mgPASS
Aerobic count (TAMC)USP <61>< 10 CFU/mL< 10 CFU/mLPASS
Yeast & mold (TYMC)USP <61>< 10 CFU/mL< 10 CFU/mLPASS
E. coliUSP <62>AbsentAbsentPASS

1HPLC chromatogram

Data file: PL-2610-100-HPLC.raw · Column C18, 150 × 4.6 mm · UV 214 nm
0.01%0.1%1%10%100%12131415161718Retention time (min) · stick height = area % (log scale)99.31% · 15.13 min0.24% †0.36% †0.09% †
Peak plot drawn from the integrated peak table (area %, log scale); it is not the instrument trace, which is retained in PL-2610-100-HPLC.raw. † Nominal reference retention time for the assigned impurity; the main-peak RT is observed in this lot.
PrymaLab
PrymaLab
Certificate of Analysis · continued
IGF-1 LR3 Nasal Spray · Lot PL-2610-100 · Certificate PL-26-00214
Lot PL-2610-100
Method, peak table and approval

2HPLC method · PL-2610-100-HPLC.raw

Instrument
Waters Alliance e2695
Data System
Empower 3
Detector
UV absorbance
Detection Wavelength
214 nm
Column
C18, 150 × 4.6 mm, 3.5 µm
Mobile Phase A
0.1% TFA in water
Mobile Phase B
0.1% TFA in MeCN
Gradient
5–95% B over 25 min (linear)
Flow Rate
1.0 mL/min
Column Temperature
40 °C
Injection Volume
10 µL

3Gradient program

Time (min)% A% B
0.0955
25.0595

4Peak table

PeakRT (min)AreaArea %
113.70 †—0.24
214.50 †—0.36
315.13—99.31
416.80 †—0.09
Total—100.00
Peaks: 1 deamidation product; 2 isoaspartate (isoasp) variant; 3 main peak (IGF-1 LR3); 4 truncated sequence · Area % from the integrated peak table (absolute areas are not part of the lot-release export) · † nominal reference RT for the assigned impurity · Purity = main peak area ÷ total integrated area × 100, to two decimals; main peak shaded.

5Identity by mass spectrometry

Instrument
Waters SQD
Ionization / Mode
ESI, positive
Reference m/z (charge)
1823.33 (5+) · 1519.61 (6+)
Deconvoluted Mass
9,111.46 Da
Theoretical Mass
9,111.60 Da
Difference
−0.14 Da (15 ppm)
Data File
PL-2610-100-MS.d
Acceptance
Within ± 1.0 Da

6Additional tests

TestPerformed byDateReport / file
Assay vs label claimPrymaLab Analytical2026-10-06—
Endotoxin (LAL, kinetic)PrymaLab Analytical2026-10-06—
Microbial limits (USP <61>/<62>)PrymaLab Analytical2026-10-12—
A test with no row here was not performed on this lot. Outside-laboratory reports, when used, are attached and named below.

7Review and approval

D. Reynolds
Analyst · performed the testing
Date: 2026-10-13
S. Calloway
Reviewer · checked against raw data
Date: 2026-10-13
M. Phelps
Lab Director · approved for release
Date: 2026-10-13