AssayIndex

AX-2025-018883

CJC-1295 (no DAC) · 2 mg declared · Thermo Fisher Scientific (China) Co., Ltd. · lot TFS-{CAT}-9097

MARGINALVERIFIED
Report ID
AX-2025-018883
Compound
CJC-1295 (no DAC)
Compound class
Growth-hormone axis peptides
Supplier
TFS — Thermo Fisher Scientific (China) Co., Ltd.
Batch / lot
TFS-{CAT}-9097
Declared label claim
2mg
Laboratory
VendorInvestigate
Assay date
22 Apr 2025
Submitted
10 May 2025
Quarter
2025-Q2
Submitter
b.ferreira
Sample provenance
Buyer-sourced
Section 1

Results

Measured against the index acceptance specification for the growth-hormone axis peptides class. A specification is a decision the index made; a result is a measurement. See where each threshold came from.

ParameterMethodResultUnitIndex spec
PurityRP-HPLC, 32 min gradient, 214 nm98.86% area≥ 98.0PASS
Total impuritiesRP-HPLC, sum of reported peaks1.14% area≤ 2.0PASS
Largest single impurityRP-HPLC — deamidated (+1 Da)0.71% area≤ 1.00PASS
Identity — theoretical monoisotopic masscalculated from molecular formula3365.7402Da—NOT TESTED
Identity — observed monoisotopic massLC-MS, high resolution (ESI-TOF/QTOF)3365.7271Da—NOT TESTED
Mass accuracyobserved vs theoretical-3.9ppm± 15PASS
Peptide contentnot ordered on this submissionnot determined—required to check label claimNOT TESTED
Water contentKarl Fischer, coulometric, duplicate4.19%≤ 9.0PASS
Counter-ion (acetate)anion-exchange ion chromatography3.80%≤ 12.0PASS
Residual solvent + inorganic residueestimated — see /methods/residual-solvents-q3c/0.88%—NOT TESTED
Endotoxinkinetic chromogenic LAL0.29EU/mg≤ 5.0PASS
Sterilitymembrane filtration, USP <71>, 14 dNo growth at 14 d—no growthPASS
Appearancevisual, diffuse light, black and white backgroundWhite lyophilised cake, intact—white to off-white intact cakePASS
Reconstitution clarityreconstituted per submitter procedureClear, colourless, no visible particulates—clear, no visible particulatesPASS
pH (reconstituted, 1 mg/mL)potentiometric, two-point calibration3.89—2.5 – 8.0PASS
Retention time (observed)RP-HPLC, 32 min gradient12.66min13.65 ± 0.30 (normalised)FAIL
Peak asymmetry (10 % height)Ph. Eur. 2.2.461.13—0.80 – 1.50PASS
Plate count, main peakN = 5.54 (t/w½)²70,632—≥ 20,000PASS
Resolution to nearest impurityvs deamidated (+1 Da)1.31—no index criterionREPORTED
Section 2

Chromatogram and peak integration

The figure is drawn from the table. It is not an independent illustration — if a number in the table changed, the trace would change with it.

02256451167679023 CJC-1295 (no DAC)12.66 min · 98.86 % 12.40 same trace · ×50 vertical expansion, baseline-corrected · main peak off-scale reporting threshold 0.05 % area 05101520253035 Retention time (min) Response (mAU)
Figure 1. RP-HPLC trace, 32 min gradient, 214 nm. Drawn from the peak-integration table below: peak positions are the reported retention times, peak areas are the reported area percentages, peak widths follow the reported plate count of 70,632, and skew follows the reported asymmetry factor of 1.13. Baseline noise is seeded from the report ID and is illustrative. The lower panel is the same trace at a stated vertical expansion with the slow gradient drift subtracted, because at full scale a 0.71 % impurity against a 98.86 % main peak is a line two pixels tall; the main peak runs off-scale there by design.
#PeakRTArea (µV·s)% areaΔ mass (Da)
1CJC-1295 (no DAC) — main peak12.664,804,90298.86—
2deamidated (+1 Da)12.4034,5080.71+0.984
3des-Tyr1 (−163 Da)12.088,7490.18-163.063
4acetyl adduct (+42 Da)13.138,2630.17+42.011
5native GRF (1-29) (−59 Da)12.301,9440.04-58.995
6truncated (1-24)11.421,9440.04-570.291
Closure check — purity + Σ impurities 100.00CLOSES

Reporting threshold 0.05 % area. Peaks below it are not reported and are therefore excluded from the total, which overstates purity by their sum — see peak integration.

Section 3

Mass spectrum and identity

Theoretical monoisotopic mass 3365.7402 Da, computed from C152H252N44O42. All ppm figures on this site are against monoisotopic values — see why that matters.

02550751005507751000122514501675 [M+3H]3+1122.92[M+4H]4+842.44[M+2H]2+1683.87 m/z Relative abundance (%)
Figure 2. ESI charge-state envelope, high-resolution instrument. Sticks are placed at m/z = (M + z × 1.007276)/z for the observed neutral mass of 3365.7271 Da. Sodium (+21.982/z) and potassium (+37.956/z) adducts are shown where the parent charge state exceeds 25 % relative abundance; they are adducts of the same molecule and are not impurities.
ChargeTheoretical m/zObserved m/zΔ m/zRel. abundance (%)
5+674.1553674.1527-0.00268.8
4+842.4423842.4391-0.003253.3
3+1122.92071122.9163-0.0044100.0
2+1683.87741683.8708-0.006652.5
Section 4

Gravimetric mass balance

Water, counter-ion, residual and total peptide content are exhaustive and mutually exclusive categories. They must account for 100 % of the cake mass. The index closes this to within 0.02 pp and the build asserts it.

Supplier certificate, as declared

The supplier's own figures for this lot, beside the independent measurement. Divergence is assessed against the batch median, not against this single report — see rule AX-R05.

FigureSupplier COAThis reportIndex note
Purity (% area)98.5798.86divergence -0.37 pp vs batch median
Total impurities (% area)1.431.14
Largest single impurity (% area)1.000.71
Water (%)2.14.19
Counter-ion (%)9.23.80
Peptide content (%w/w)88.1not determined
Endotoxin (EU/mg)not stated0.29
Method stated on certificateYES—column, gradient and wavelength given
Section 5

Provenance and caveats

Where a sample came from changes the weight of the evidence. The index treats it as a first-class field.

Sample provenance
Buyer-sourced
Evidentiary weight
Strongest available evidence in this index.
Chain of custody
Retail purchase → submitter (ambient, 6 d) → laboratory (courier, cold pack, 9 d) → assay.
Assay date
22 Apr 2025
Submitted to the index
10 May 2025
Laboratory
VendorInvestigate, Riga, Latvia
Method basis
32 min gradient · high-resolution MS
Verification status
VERIFIED
Section 6

Annotations 2

Signed technical comments from index contributors. Not a discussion forum — annotations question or contextualise the result, and the data team replies where a reply is warranted.

shipping_temp
The custody block above records the shipping conditions this vial actually experienced, which is the condition an ordinary buyer's vial experiences too. That representativeness is the point.
label_claim
A retail vial is also a test of the label. Declared claim 2 mg against what the gravimetry recovers is a question only a purchased vial can answer honestly.
Section 7

Related records

Same batch — lot TFS-{CAT}-9097 n=10

ReportLotLabQuarterPurity %Water %Recovery %ProvenanceFlagsResult
AX-2025-018880TFS-{CAT}-9097PeptideMeter2025-Q298.963.59103.9Buyer-sourced1MARGINAL
AX-2025-018881TFS-{CAT}-9097Janoshik2025-Q299.083.64—Buyer-sourced0PASS
AX-2025-018882TFS-{CAT}-9097Medutest2025-Q299.444.05102.6Buyer-sourced0PASS
AX-2025-018884TFS-{CAT}-9097Medutest2025-Q299.374.15100.6Buyer-sourced0PASS
AX-2025-018885TFS-{CAT}-9097VendorInvestigate2025-Q298.863.65—Buyer-sourced0PASS
AX-2025-018886TFS-{CAT}-9097Medutest2025-Q298.923.13—Buyer-sourced1FAIL
AX-2025-018887TFS-{CAT}-9097Janoshik2025-Q298.753.51—Buyer-sourced0PASS
AX-2025-018888TFS-{CAT}-9097Medutest2025-Q299.124.20—Buyer-sourced0PASS
AX-2025-018889TFS-{CAT}-9097VendorInvestigate2025-Q298.894.7488.7Buyer-sourced1MARGINAL

Cross-sections

Other recent CJC-1295 (no DAC) records in the index.
ReportSupplierLotLabQuarterPurity %Water %Recovery %ProvenanceFlagsResult
AX-2026-042942MKMMKM-2603-V3346Janoshik2026-Q399.523.43—Supplier-supplied0PASS
AX-2026-041599QSCQSC-2606-V7416VendorInvestigate2026-Q397.963.52—Buyer-sourced1FAIL
AX-2026-042784GGPepsGGPE-2606-E1234Medutest2026-Q398.274.55—Buyer-sourced0PASS
AX-2026-042939MKMMKM-2603-V3346PeptideMeter2026-Q399.443.39—Buyer-sourced0PASS
AX-2026-041601QSCQSC-2606-V7416Kestrel2026-Q398.334.10—Buyer-sourced1MARGINAL
AX-2026-042945MKMMKM-2603-V3346PeptideMeter2026-Q399.393.54—Laboratory-retained0PASS
AX-2026-042786GGPepsGGPE-2606-E1234Janoshik2026-Q398.223.77—Buyer-sourced0PASS
AX-2026-041602QSCQSC-2606-V7416VendorInvestigate2026-Q398.363.38101.8Buyer-sourced1MARGINAL
Other recent TFS records in the index.
ReportCompoundLotLabQuarterPurity %Water %Recovery %ProvenanceFlagsResult
AX-2026-041681CJC-1295 with DACTFS-{CAT}-9675PeptideMeter2026-Q398.823.67—Buyer-sourced0PASS
AX-2026-041766BPC-157TFS-{CAT}-1156Janoshik2026-Q399.546.34—Buyer-sourced1MARGINAL
AX-2026-041682CJC-1295 with DACTFS-{CAT}-9675Nordanalyt2026-Q398.943.24—Buyer-sourced0PASS
AX-2026-041683CJC-1295 with DACTFS-{CAT}-9675Medutest2026-Q398.683.4697.0Buyer-sourced0PASS
AX-2026-041765BPC-157TFS-{CAT}-1156Janoshik2026-Q399.796.01—Buyer-sourced0PASS
AX-2026-041680CJC-1295 with DACTFS-{CAT}-9675Medutest2026-Q399.182.85100.4Buyer-sourced0PASS
AX-2026-041691SemaglutideTFS-{CAT}-9744Janoshik2026-Q298.316.0791.4Buyer-sourced0PASS
AX-2026-041700SS-31 (Elamipretide)TFS-{CAT}-1142Medutest2026-Q299.752.2796.3Buyer-sourced0PASS