AssayIndex

AX-2026-042662

CJC-1295 (no DAC) · 10 mg declared · Nantong Guangyuan Chemical Co., Ltd. · lot GGPE-2606-E8495

FAILPURITY ONLY
Report ID
AX-2026-042662
Compound
CJC-1295 (no DAC)
Compound class
Growth-hormone axis peptides
Supplier
GGPeps — Nantong Guangyuan Chemical Co., Ltd.
Batch / lot
GGPE-2606-E8495
Declared label claim
10mg
Laboratory
Janoshik Analytical
Assay date
21 Sep 2026
Submitted
22 Sep 2026
Quarter
2026-Q3
Submitter
k.chowdhury
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 nm97.89% area≥ 98.0FAIL
Total impuritiesRP-HPLC, sum of reported peaks2.11% area≤ 2.0FAIL
Largest single impurityRP-HPLC — deamidated (+1 Da)1.24% area≤ 1.00FAIL
Identitynot ordered on this submissionnot determinedrequired for VERIFIED statusNOT TESTED
Total peptide contentby difference from the gravimetric mass balance92.04%w/wNOT TESTED
Target-compound contenttotal peptide content × purity90.10%w/wNOT TESTED
Gross fill (as weighed)five-place balance, under nitrogen10.55mg10 mg declaredNOT TESTED
Recovered target peptidegross fill × target content9.506mg10 mg claimNOT TESTED
Recovery against label claimrecovered ÷ claim95.1%90.0 – 110.0PASS
Water contentKarl Fischer, coulometric, duplicate4.11%≤ 9.0PASS
Counter-ion (acetate)anion-exchange ion chromatography3.61%≤ 12.0PASS
Residual solvent + inorganic residueestimated — see /methods/residual-solvents-q3c/0.24%NOT TESTED
Endotoxinnot ordered on this submissionnot determined≤ 5.0NOT TESTED
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 with a single visible fibreclear, no visible particulatesFAIL
pH (reconstituted, 1 mg/mL)potentiometric, two-point calibration5.652.5 – 8.0PASS
Retention time (observed)RP-HPLC, 30 min gradient12.80min12.86 ± 0.30 (normalised)PASS
Peak asymmetry (10 % height)Ph. Eur. 2.2.461.000.80 – 1.50PASS
Plate count, main peakN = 5.54 (t/w½)²82,967≥ 20,000PASS
Resolution to nearest impurityvs deamidated (+1 Da)1.32no 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.

025505100765010200 CJC-1295 (no DAC)12.80 min · 97.89 % 12.56 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 82,967, and skew follows the reported asymmetry factor of 1.00. 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 1.24 % impurity against a 97.89 % 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 peak12.804,757,75797.89
2deamidated (+1 Da)12.5660,2681.24+0.984
3truncated (1-24)11.6425,7600.53-570.291
4native GRF (1-29) (−59 Da)12.4610,2070.21-58.995
5acetyl adduct (+42 Da)13.243,8880.08+42.011
6des-Tyr1 (−163 Da)12.262,4300.05-163.063
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.

ComponentDetermination%w/w of cake
WaterKarl Fischer4.11
Counter-ion (acetate)ion chromatography3.61
Residual solvent + inorganic residueestimated0.24
Total peptide contentby difference92.04
Total100.00 CLOSES

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)98.3897.89divergence +0.31 pp vs batch median
Total impurities (% area)1.622.11
Largest single impurity (% area)0.691.24
Water (%)2.74.11
Counter-ion (%)6.23.61
Peptide content (%w/w)90.592.04
Endotoxin (EU/mg)not statednot determined
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, 7 d) → assay. Submitter did not handle the vial.
Assay date
21 Sep 2026
Submitted to the index
22 Sep 2026
Laboratory
Janoshik Analytical, Ostrava, Czechia
Method basis
30 min gradient · high-resolution MS
Verification status
PURITY ONLY
Section 6

Annotations

No annotations on this record. Annotations are short signed technical comments from index contributors; see how to contribute.

Section 7

Related records

Same batch — lot GGPE-2606-E8495 n=12

ReportLotLabQuarterPurity %Water %Recovery %ProvenanceFlagsResult
AX-2026-042659GGPE-2606-E8495Janoshik2026-Q398.563.7495.8Supplier-supplied1MARGINAL
AX-2026-042660GGPE-2606-E8495PeptideMeter2026-Q397.883.38Supplier-supplied1FAIL
AX-2026-042661GGPE-2606-E8495Nordanalyt2026-Q398.244.09Supplier-supplied0PASS
AX-2026-042663GGPE-2606-E8495Medutest2026-Q397.964.1490.0Laboratory-retained2FAIL
AX-2026-042664GGPE-2606-E8495Nordanalyt2026-Q397.753.84Buyer-sourced1FAIL
AX-2026-042665GGPE-2606-E8495Janoshik2026-Q398.444.0093.2Supplier-supplied1MARGINAL
AX-2026-042666GGPE-2606-E8495Janoshik2026-Q397.873.7494.3Buyer-sourced2FAIL
AX-2026-042667GGPE-2606-E8495Janoshik2026-Q398.134.22106.1Supplier-supplied1MARGINAL
AX-2026-042668GGPE-2606-E8495Nordanalyt2026-Q398.024.53103.9Supplier-supplied1MARGINAL
AX-2026-042669GGPE-2606-E8495Medutest2026-Q398.614.0695.5Supplier-supplied0PASS
AX-2026-042670GGPE-2606-E8495Janoshik2026-Q398.324.96Supplier-supplied1MARGINAL
Other recent CJC-1295 (no DAC) records in the index.
ReportSupplierLotLabQuarterPurity %Water %Recovery %ProvenanceFlagsResult
AX-2026-041683QSCQSC-2606-V8637Janoshik2026-Q399.933.6397.1Supplier-supplied1FAIL
AX-2026-042669GGPepsGGPE-2606-E8495Medutest2026-Q398.614.0695.5Supplier-supplied0PASS
AX-2026-042665GGPepsGGPE-2606-E8495Janoshik2026-Q398.444.0093.2Supplier-supplied1MARGINAL
AX-2026-042663GGPepsGGPE-2606-E8495Medutest2026-Q397.964.1490.0Laboratory-retained2FAIL
AX-2026-041686QSCQSC-2606-V8637Janoshik2026-Q399.934.04Supplier-supplied0PASS
AX-2026-042666GGPepsGGPE-2606-E8495Janoshik2026-Q397.873.7494.3Buyer-sourced2FAIL
AX-2026-042668GGPepsGGPE-2606-E8495Nordanalyt2026-Q398.024.53103.9Supplier-supplied1MARGINAL
AX-2026-041685QSCQSC-2606-V8637Medutest2026-Q399.933.62Supplier-supplied1FAIL
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