AssayIndex

AX-2026-042844

CJC-1295 with DAC · 10 mg declared · Nantong Guangyuan Chemical Co., Ltd. · lot GGPE-2510-T1661

FAILPURITY ONLY
Report ID
AX-2026-042844
Compound
CJC-1295 with DAC
Compound class
Growth-hormone axis peptides
Supplier
GGPeps — Nantong Guangyuan Chemical Co., Ltd.
Batch / lot
GGPE-2510-T1661
Declared label claim
10mg
Laboratory
Janoshik Analytical
Assay date
03 Mar 2026
Submitted
16 Mar 2026
Quarter
2026-Q1
Submitter
endotoxin_limit
Sample provenance
Supplier-supplied
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, 30 min gradient, 214 nm98.20% area≥ 97.5PASS
Total impuritiesRP-HPLC, sum of reported peaks1.80% area≤ 2.5PASS
Largest single impurityRP-HPLC — hydrolysed maleimide (+18 Da)1.20% area≤ 1.00FAIL
Identitynot ordered on this submissionnot determinedrequired for VERIFIED statusNOT TESTED
Peptide contentnot ordered on this submissionnot determinedrequired to check label claimNOT TESTED
Water contentKarl Fischer, coulometric, duplicate6.34%≤ 9.0PASS
Counter-ion (acetate)anion-exchange ion chromatography3.73%≤ 12.0PASS
Residual solvent + inorganic residueestimated — see /methods/residual-solvents-q3c/0.74%NOT TESTED
Endotoxinkinetic chromogenic LAL5.54EU/mg≤ 5.0FAIL
Sterilitynot ordered on this submissionnot determinedno growthNOT TESTED
Appearancevisual, diffuse light, black and white backgroundWhite lyophilised cake, intactwhite to off-white intact cakePASS
Reconstitution clarityreconstituted per submitter procedureClear, colourless, no visible particulatesclear, no visible particulatesPASS
pH (reconstituted, 1 mg/mL)potentiometric, two-point calibration5.452.5 – 8.0PASS
Retention time (observed)RP-HPLC, 30 min gradient14.61min14.62 ± 0.35 (normalised)PASS
Peak asymmetry (10 % height)Ph. Eur. 2.2.461.030.80 – 1.50PASS
Plate count, main peakN = 5.54 (t/w½)²78,806≥ 20,000PASS
Resolution to nearest impurityvs deamidated (+1 Da)1.22no 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.

02152430464568608 CJC-1295 with DAC14.61 min · 98.20 % 13.9917.03 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, 30 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 78,806, and skew follows the reported asymmetry factor of 1.03. 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 1.20 % impurity against a 98.20 % 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 with DAC — main peak14.614,772,82498.20
2hydrolysed maleimide (+18 Da)13.9958,3241.20+18.011
3mod-GRF (1-29) (−279 Da)12.8514,0950.29-279.235
4deamidated (+1 Da)14.3510,2070.21+0.984
5maleimide dimer17.034,8600.10+3644.975
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 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)98.5798.20divergence +0.56 pp vs batch median
Total impurities (% area)not stated1.80
Largest single impurity (% area)not stated1.20
Water (%)4.06.34
Counter-ion (%)7.73.73
Peptide content (%w/w)87.7not determined
Endotoxin (EU/mg)not stated5.54
Method stated on certificateYEScolumn, 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
Supplier-supplied
Evidentiary weight
Weaker evidence. Read with the caveat below.
Chain of custody
Supplier despatch → laboratory direct (courier, cold pack, 10 d) → assay. Submitter did not handle the vial.
Assay date
03 Mar 2026
Submitted to the index
16 Mar 2026
Laboratory
Janoshik Analytical, Ostrava, Czechia
Method basis
30 min gradient · high-resolution MS
Verification status
PURITY ONLY
Section 6

Annotations 4

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.

lal_assay
5.54 EU/mg is above the index screening threshold of 5.0. Two things to keep separate: the index threshold is a screening figure, and a real limit is dose-dependent. The endotoxin dose-limit calculator does that arithmetic. What this record establishes is that the burden is measurable and high relative to the rest of the dataset.
one_directional
Endotoxin determined but the LAL method is not stated. Kinetic chromogenic and gel-clot give different results and different sensitivity. The value cannot be interpreted without knowing which.
5.54 EU/mg is elevated relative to the index median and the record shows no depyrogenation step. If this material will be reconstituted in aqueous buffer for any downstream use, that endotoxin load is a risk.
prep_hplc_cut
5.54 EU/mg is at the sensitivity limit of Janoshik's LAL method. The true value is unspecified; treating this as a point estimate is overstating precision.
Section 7

Related records

Same batch — lot GGPE-2510-T1661 n=12

ReportLotLabQuarterPurity %Water %Recovery %ProvenanceFlagsResult
AX-2026-042836GGPE-2510-T1661Janoshik2026-Q198.015.90Supplier-supplied3MARGINAL
AX-2026-042837GGPE-2510-T1661Janoshik2026-Q198.065.7193.9Supplier-supplied1MARGINAL
AX-2026-042838GGPE-2510-T1661Medutest2026-Q197.965.62Supplier-supplied3FAIL
AX-2026-042839GGPE-2510-T1661VendorInvestigate2026-Q197.145.81Buyer-sourced1FAIL
AX-2026-042840GGPE-2510-T1661Nordanalyt2026-Q198.456.19Supplier-supplied2MARGINAL
AX-2026-042841GGPE-2510-T1661Janoshik2026-Q197.786.34Laboratory-retained2FAIL
AX-2026-042842GGPE-2510-T1661Medutest2026-Q197.525.79Supplier-supplied2MARGINAL
AX-2026-042843GGPE-2510-T1661Janoshik2026-Q198.215.49Supplier-supplied3FAIL
AX-2026-042845GGPE-2510-T1661VendorInvestigate2026-Q196.886.28Buyer-sourced1FAIL
AX-2026-042846GGPE-2510-T1661Medutest2026-Q198.006.16Supplier-supplied3FAIL
AX-2026-042847GGPE-2510-T1661Janoshik2026-Q198.616.04102.7Supplier-supplied2MARGINAL
Other recent CJC-1295 with DAC records in the index.
ReportSupplierLotLabQuarterPurity %Water %Recovery %ProvenanceFlagsResult
AX-2026-041727QSCQSC-2602-E9474Janoshik2026-Q398.886.62105.3Supplier-supplied1MARGINAL
AX-2026-041728QSCQSC-2602-E9474VendorInvestigate2026-Q398.427.04Buyer-sourced1MARGINAL
AX-2026-041734QSCQSC-2602-E9474Medutest2026-Q399.437.17105.5Supplier-supplied2FAIL
AX-2026-043539BCHBCH-2607-H7307Janoshik2026-Q398.125.78100.6Supplier-supplied1MARGINAL
AX-2026-041730QSCQSC-2602-E9474PeptideMeter2026-Q398.796.9395.4Supplier-supplied1MARGINAL
AX-2026-041731QSCQSC-2602-E9474VendorInvestigate2026-Q399.077.1899.6Buyer-sourced1MARGINAL
AX-2026-041725QSCQSC-2602-E9474Medutest2026-Q399.067.04107.3Supplier-supplied2FAIL
AX-2026-043537BCHBCH-2607-H7307Janoshik2026-Q398.455.49103.1Supplier-supplied1MARGINAL
Other recent GGPeps records in the index.
ReportCompoundLotLabQuarterPurity %Water %Recovery %ProvenanceFlagsResult
AX-2026-042737SelankGGPE-2603-J9708Janoshik2026-Q398.409.1497.4Buyer-sourced0FAIL
AX-2026-042804SelankGGPE-2602-G2056Janoshik2026-Q398.507.97Supplier-supplied0FAIL
AX-2026-042803SelankGGPE-2602-G2056Janoshik2026-Q398.488.01Laboratory-retained1FAIL
AX-2026-042802SelankGGPE-2602-G2056Janoshik2026-Q398.747.0996.0Supplier-supplied0FAIL
AX-2026-042796SelankGGPE-2602-G2056Janoshik2026-Q398.267.5697.5Buyer-sourced0FAIL
AX-2026-042648Melanotan IIGGPE-2603-P8735Janoshik2026-Q399.106.97Supplier-supplied4MARGINAL
AX-2026-042797SelankGGPE-2602-G2056Medutest2026-Q398.467.92Buyer-sourced0FAIL
AX-2026-042669CJC-1295 (no DAC)GGPE-2606-E8495Medutest2026-Q398.614.0695.5Supplier-supplied0PASS