PrymaLab

PrymaLab Analytical · In-house laboratory

3705 Music Branch Rd, Ashland, KY 41102 · +1 (606) 465-9063 · prymalab.net

Certificate no.

PL-26-00215

Verification key

VLC8YLQH

Scan or enter both at
prymalab.net/testing/verify

Certificate of Analysis · Lot release

IGF-1 LR3 1 mg/mL Pen

Lot PL-2610-101 · Solution · Label claim 1 mg/mL

Tested in-house by PrymaLab

In-house analytical result,
not an independent third-party test

Lot / batch number

PL-2610-101

Date made

2026-10-05

Date of analysis

2026-10-06

Date issued

2026-10-20

Retest / expiry

2028-10-05

Units in lot / sampled

183 / 3

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 %

99.16%

Specification ≥ 99.0% • main peak at 15.13 min

Identity · Observed Mass

9,111.79 Da

Theoretical 9,111.60 Da • +0.19 Da (21 ppm)

Overall conclusion

PASS

Meets every specification for the tests performed

Test	Method	Specification	Result	Conclusion
Identity (mass)	LC-MS, ESI positive	Theoretical ± 1.0 Da	9,111.79 Da	PASS
Purity	RP-HPLC, UV 214 nm, area%	≥ 99.0%	99.16%	PASS
Largest impurity	RP-HPLC, area%	≤ 1.0%	0.43% (RT 16.80)	PASS
Assay (label claim)	Assay vs label claim	0.95–1.05 mg/mL	1.02 mg/mL	PASS
Bacterial endotoxin	LAL, kinetic	≤ 5.0 EU/mg	0.187 EU/mg	PASS
Sterility	USP <71>, 14-day	No growth	No growth	PASS

1HPLC chromatogram

Data file: PL-2610-101-HPLC.raw · Column C18, 150 × 4.6 mm · UV 214 nm

Peak plot drawn from the integrated peak table (area %, log scale); it is not the instrument trace, which is retained in PL-2610-101-HPLC.raw. † Nominal reference retention time for the assigned impurity; the main-peak RT is observed in this lot.

PrymaLab

Certificate of Analysis · continued

IGF-1 LR3 1 mg/mL Pen · Lot PL-2610-101 · Certificate PL-26-00215

Lot PL-2610-101

Method, peak table and approval

2HPLC method · PL-2610-101-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
0.0	95	5
25.0	5	95

4Peak table

Peak	RT (min)	Area	Area %
1	13.70 †	—	0.34
2	14.50 †	—	0.07
3	15.13	—	99.16
4	16.80 †	—	0.43
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

9,111.79 Da

Theoretical Mass

9,111.60 Da

Difference

+0.19 Da (21 ppm)

Data File

PL-2610-101-MS.d

Acceptance

Within ± 1.0 Da

6Additional tests

Test	Performed by	Date	Report / file
Assay vs label claim	PrymaLab Analytical	2026-10-06	—
Endotoxin (LAL, kinetic)	PrymaLab Analytical	2026-10-06	—
Sterility (USP <71>, day-14 read-out)	PrymaLab Analytical	2026-10-20	—

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: 2026-10-20

S. Calloway
Reviewer · checked against raw data
Date: 2026-10-20

M. Phelps
Lab Director · approved for release
Date: 2026-10-20