AssayIndex

AX-2026-041600

CJC-1295 (no DAC) · 2 mg declared · Qingdao Sigma Chemical Co., Ltd. · lot QSC-2606-V7416

FAILPURITY ONLY
Report ID
AX-2026-041600
Compound
CJC-1295 (no DAC)
Compound class
Growth-hormone axis peptides
Supplier
QSC — Qingdao Sigma Chemical Co., Ltd.
Batch / lot
QSC-2606-V7416
Declared label claim
2mg
Laboratory
Nordanalyt Laboratories
Assay date
26 Aug 2026
Submitted
03 Sep 2026
Quarter
2026-Q3
Submitter
esi_tof
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, 35 min gradient, 214 nm97.74% area≥ 98.0FAIL
Total impuritiesRP-HPLC, sum of reported peaks2.26% area≤ 2.0FAIL
Largest single impurityRP-HPLC — des-Tyr1 (−163 Da)0.84% area≤ 1.00PASS
Identitynot ordered on this submissionnot determinedrequired for VERIFIED statusNOT TESTED
Total peptide contentby difference from the gravimetric mass balance90.90%w/wNOT TESTED
Target-compound contenttotal peptide content × purity88.85%w/wNOT TESTED
Gross fill (as weighed)five-place balance, under nitrogen2.27mg2 mg declaredNOT TESTED
Recovered target peptidegross fill × target content2.017mg2 mg claimNOT TESTED
Recovery against label claimrecovered ÷ claim100.9%90.0 – 110.0PASS
Water contentKarl Fischer, coulometric, duplicate4.91%≤ 9.0PASS
Counter-ion (acetate)anion-exchange ion chromatography3.46%≤ 12.0PASS
Residual solvent + inorganic residueestimated — see /methods/residual-solvents-q3c/0.73%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 cake, partially collapsedwhite to off-white intact cakeFAIL
Reconstitution clarityreconstituted per submitter procedureClear, colourless, no visible particulatesclear, no visible particulatesPASS
pH (reconstituted, 1 mg/mL)potentiometric, two-point calibration5.922.5 – 8.0PASS
Retention time (observed)RP-HPLC, 35 min gradient14.84min14.83 ± 0.30 (normalised)PASS
Peak asymmetry (10 % height)Ph. Eur. 2.2.461.110.80 – 1.50PASS
Plate count, main peakN = 5.54 (t/w½)²51,404≥ 20,000PASS
Resolution to nearest impurityvs deamidated (+1 Da)1.04no 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.

01638327749156554 CJC-1295 (no DAC)14.84 min · 97.74 % 14.21 same trace · ×50 vertical expansion, baseline-corrected · main peak off-scale reporting threshold 0.05 % area 0510152025303540 Retention time (min) Response (mAU)
Figure 1. RP-HPLC trace, 35 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 51,404, and skew follows the reported asymmetry factor of 1.11. 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 0.84 % impurity against a 97.74 % 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 peak14.844,750,46797.74
2des-Tyr1 (−163 Da)14.2140,8270.84-163.063
3native GRF (1-29) (−59 Da)14.4432,5640.67-58.995
4truncated (1-24)13.4922,3570.46-570.291
5acetyl adduct (+42 Da)15.357,2900.15+42.011
6deamidated (+1 Da)14.566,8040.14+0.984
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 Fischer4.91
Counter-ion (acetate)ion chromatography3.46
Residual solvent + inorganic residueestimated0.73
Total peptide contentby difference90.90
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)97.6097.74divergence -0.43 pp vs batch median
Total impurities (% area)not stated2.26
Largest single impurity (% area)not stated0.84
Water (%)not stated4.91
Counter-ion (%)not stated3.46
Peptide content (%w/w)not stated90.90
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
Buyer-sourced
Evidentiary weight
Strongest available evidence in this index.
Chain of custody
Retail purchase → third-party forwarder (29 d) → laboratory (courier, cold pack, 3 d) → assay.
Assay date
26 Aug 2026
Submitted to the index
03 Sep 2026
Laboratory
Nordanalyt Laboratories, Uppsala, Sweden
Method basis
35 min gradient · high-resolution MS
Verification status
PURITY ONLY
Section 6

Annotations 3

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.

mass_defect
Before assigning des-Tyr1 (−163 Da) from retention alone, check the mass defect on the impurity peak. Plausible and implausible assignments separate cleanly and the check costs nothing.
aaa_hydrolysis
Content by hydrolysis assumes complete recovery of every residue. Where it disagrees with the balance by a percent or two, the hydrolysis is the more likely culprit.
schema_v2
All four balance components are separate fields in the published dataset, so the closure can be re-derived from the CSV rather than taken on trust. That is the intent.
Section 7

Related records

Same batch — lot QSC-2606-V7416 n=9

ReportLotLabQuarterPurity %Water %Recovery %ProvenanceFlagsResult
AX-2026-041598QSC-2606-V7416Janoshik2026-Q398.163.76Buyer-sourced1MARGINAL
AX-2026-041599QSC-2606-V7416VendorInvestigate2026-Q397.963.52Buyer-sourced1FAIL
AX-2026-041601QSC-2606-V7416Kestrel2026-Q398.334.10Buyer-sourced1MARGINAL
AX-2026-041602QSC-2606-V7416VendorInvestigate2026-Q398.363.38101.8Buyer-sourced1MARGINAL
AX-2026-041603QSC-2606-V7416PeptideMeter2026-Q398.434.20Buyer-sourced1MARGINAL
AX-2026-041604QSC-2606-V7416VendorInvestigate2026-Q397.893.6095.0Buyer-sourced1FAIL
AX-2026-041605QSC-2606-V7416PeptideMeter2026-Q397.963.59102.5Laboratory-retained1FAIL
AX-2026-041606QSC-2606-V7416Janoshik2026-Q398.033.58Buyer-sourced1MARGINAL
Other recent CJC-1295 (no DAC) records in the index.
ReportSupplierLotLabQuarterPurity %Water %Recovery %ProvenanceFlagsResult
AX-2026-042942MKMMKM-2603-V3346Janoshik2026-Q399.523.43Supplier-supplied0PASS
AX-2026-041599QSCQSC-2606-V7416VendorInvestigate2026-Q397.963.52Buyer-sourced1FAIL
AX-2026-042784GGPepsGGPE-2606-E1234Medutest2026-Q398.274.55Buyer-sourced0PASS
AX-2026-042939MKMMKM-2603-V3346PeptideMeter2026-Q399.443.39Buyer-sourced0PASS
AX-2026-041601QSCQSC-2606-V7416Kestrel2026-Q398.334.10Buyer-sourced1MARGINAL
AX-2026-042945MKMMKM-2603-V3346PeptideMeter2026-Q399.393.54Laboratory-retained0PASS
AX-2026-042786GGPepsGGPE-2606-E1234Janoshik2026-Q398.223.77Buyer-sourced0PASS
AX-2026-041602QSCQSC-2606-V7416VendorInvestigate2026-Q398.363.38101.8Buyer-sourced1MARGINAL
Other recent QSC records in the index.
ReportCompoundLotLabQuarterPurity %Water %Recovery %ProvenanceFlagsResult
AX-2026-041599CJC-1295 (no DAC)QSC-2606-V7416VendorInvestigate2026-Q397.963.52Buyer-sourced1FAIL
AX-2026-041601CJC-1295 (no DAC)QSC-2606-V7416Kestrel2026-Q398.334.10Buyer-sourced1MARGINAL
AX-2026-041602CJC-1295 (no DAC)QSC-2606-V7416VendorInvestigate2026-Q398.363.38101.8Buyer-sourced1MARGINAL
AX-2026-041477TriptorelinQSC-2607-C5749Nordanalyt2026-Q399.533.42Buyer-sourced0PASS
AX-2026-041603CJC-1295 (no DAC)QSC-2606-V7416PeptideMeter2026-Q398.434.20Buyer-sourced1MARGINAL
AX-2026-041606CJC-1295 (no DAC)QSC-2606-V7416Janoshik2026-Q398.033.58Buyer-sourced1MARGINAL
AX-2026-041585LiraglutideQSC-2605-W7381Medutest2026-Q399.595.0992.8Laboratory-retained0PASS
AX-2026-041586LiraglutideQSC-2605-W7381Janoshik2026-Q398.856.0090.7Buyer-sourced0PASS