AssayIndex

AX-2026-043608

CJC-1295 (no DAC) · 2 mg declared · WuXi TIDES (WuXi AppTec Testing Division) · lot WXT-2511-N4987

FAILVERIFIED
Report ID
AX-2026-043608
Compound
CJC-1295 (no DAC)
Compound class
Growth-hormone axis peptides
Supplier
WXT — WuXi TIDES (WuXi AppTec Testing Division)
Batch / lot
WXT-2511-N4987
Declared label claim
2mg
Laboratory
PeptideMeter
Assay date
08 Mar 2026
Submitted
10 Mar 2026
Quarter
2026-Q1
Submitter
lu.krastev
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, 28 min gradient, 214 nm97.65% area≥ 98.0FAIL
Total impuritiesRP-HPLC, sum of reported peaks2.35% area≤ 2.0FAIL
Largest single impurityRP-HPLC — native GRF (1-29) (−59 Da)1.00% area≤ 1.00PASS
Identity — theoretical monoisotopic masscalculated from molecular formula3365.7402DaNOT TESTED
Identity — observed monoisotopic massLC-MS, high resolution (ESI-TOF/QTOF)3365.7483DaNOT TESTED
Mass accuracyobserved vs theoretical+2.4ppm± 15PASS
Total peptide contentby difference from the gravimetric mass balance91.64%w/wNOT TESTED
Target-compound contenttotal peptide content × purity89.49%w/wNOT TESTED
Gross fill (as weighed)five-place balance, under nitrogen2.02mg2 mg declaredNOT TESTED
Recovered target peptidegross fill × target content1.808mg2 mg claimNOT TESTED
Recovery against label claimrecovered ÷ claim90.4%90.0 – 110.0PASS
Water contentKarl Fischer, coulometric, duplicate3.55%≤ 9.0PASS
Counter-ion (acetate)anion-exchange ion chromatography3.97%≤ 12.0PASS
Residual solvent + inorganic residueestimated — see /methods/residual-solvents-q3c/0.84%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 calibration5.222.5 – 8.0PASS
Retention time (observed)RP-HPLC, 28 min gradient11.97min12.07 ± 0.30 (normalised)PASS
Peak asymmetry (10 % height)Ph. Eur. 2.2.460.860.80 – 1.50PASS
Plate count, main peakN = 5.54 (t/w½)²82,354≥ 20,000PASS
Resolution to nearest impurityvs deamidated (+1 Da)1.31no 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.

028535705855811410 CJC-1295 (no DAC)11.97 min · 97.65 % 11.65 same trace · ×50 vertical expansion, baseline-corrected · main peak off-scale reporting threshold 0.05 % area 051015202530 Retention time (min) Response (mAU)
Figure 1. RP-HPLC trace, 28 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 82,354, and skew follows the reported asymmetry factor of 0.86. 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 1.00 % impurity against a 97.65 % 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 peak11.974,746,09397.65
2native GRF (1-29) (−59 Da)11.6548,6031.00-58.995
3acetyl adduct (+42 Da)12.3842,2850.87+42.011
4des-Tyr1 (−163 Da)11.479,7210.20-163.063
5deamidated (+1 Da)11.757,2900.15+0.984
6truncated (1-24)10.896,3180.13-570.291
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+1683.88 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 3365.7483 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+674.1553674.15690.00168.2
4+842.4423842.44440.002157.2
3+1122.92071122.92340.0027100.0
2+1683.87741683.88140.004055.6
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 Fischer3.55
Counter-ion (acetate)ion chromatography3.97
Residual solvent + inorganic residueestimated0.84
Total peptide contentby difference91.64
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)98.1497.65divergence +0.28 pp vs batch median
Total impurities (% area)1.862.35
Largest single impurity (% area)1.221.00
Water (%)2.73.55
Counter-ion (%)7.93.97
Peptide content (%w/w)88.891.64
Endotoxin (EU/mg)not statednot determined
Method stated on certificateNOno method section — the result cannot be reconciled against any other
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, 7 d) → laboratory (hand-carried, 10 d) → assay.
Assay date
08 Mar 2026
Submitted to the index
10 Mar 2026
Laboratory
PeptideMeter, Tallinn, Estonia
Method basis
28 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.

spec_vs_result
The index specification is a threshold the index chose. A result below it is a measurement below a decision, not a regulatory status and not a safety statement. What it does establish is that this vial is not what the class specification describes.
diode_array
Spectral homogeneity across the main peak would complete this record. Mass confirms what eluted; the spectrum confirms that only one thing did.
Section 7

Related records

Same batch — lot WXT-2511-N4987 n=10

ReportLotLabQuarterPurity %Water %Recovery %ProvenanceFlagsResult
AX-2026-043602WXT-2511-N4987Janoshik2026-Q197.973.7788.4Supplier-supplied1FAIL
AX-2026-043603WXT-2511-N4987Janoshik2026-Q197.944.23Buyer-sourced0FAIL
AX-2026-043604WXT-2511-N4987Janoshik2026-Q197.723.8797.9Buyer-sourced0FAIL
AX-2026-043605WXT-2511-N4987PeptideMeter2026-Q197.603.0995.2Buyer-sourced0FAIL
AX-2026-043606WXT-2511-N4987Kestrel2026-Q198.003.7397.9Buyer-sourced0PASS
AX-2026-043607WXT-2511-N4987Janoshik2026-Q198.113.44Buyer-sourced0PASS
AX-2026-043609WXT-2511-N4987Janoshik2026-Q197.784.2192.9Buyer-sourced0FAIL
AX-2026-043610WXT-2511-N4987Kestrel2026-Q198.024.26Buyer-sourced0PASS
AX-2026-043611WXT-2511-N4987Janoshik2026-Q197.673.80105.9Buyer-sourced0FAIL
Other recent CJC-1295 (no DAC) records in the index.
ReportSupplierLotLabQuarterPurity %Water %Recovery %ProvenanceFlagsResult
AX-2026-043077MKMMKM-2603-V3568Janoshik2026-Q399.093.85Buyer-sourced0PASS
AX-2026-042848GGPepsGGPE-2606-E9938Janoshik2026-Q397.994.5590.0Supplier-supplied0FAIL
AX-2026-043078MKMMKM-2603-V3568Janoshik2026-Q399.063.3194.0Buyer-sourced0PASS
AX-2026-042851GGPepsGGPE-2606-E9938Nordanalyt2026-Q397.884.58Buyer-sourced0FAIL
AX-2026-041707QSCQSC-2606-V8267Janoshik2026-Q399.933.74100.2Buyer-sourced0PASS
AX-2026-042852GGPepsGGPE-2606-E9938Nordanalyt2026-Q398.234.22Supplier-supplied0PASS
AX-2026-041706QSCQSC-2606-V8267Janoshik2026-Q399.933.8092.1Buyer-sourced0PASS
AX-2026-042849GGPepsGGPE-2606-E9938Janoshik2026-Q398.034.0599.2Buyer-sourced0PASS
Other recent WXT records in the index.
ReportCompoundLotLabQuarterPurity %Water %Recovery %ProvenanceFlagsResult
AX-2026-043651PramlintideWXT-2603-D6459PeptideMeter2026-Q398.214.97101.6Buyer-sourced1MARGINAL
AX-2026-043531LeuprolideWXT-2604-K4483Medutest2026-Q399.005.03Buyer-sourced0PASS
AX-2026-043561SemaglutideWXT-2604-C5135Janoshik2026-Q396.964.2291.3Buyer-sourced0FAIL
AX-2026-043627L-Glutathione (reduced)WXT-2605-B5720Janoshik2026-Q397.966.0892.3Buyer-sourced1FAIL
AX-2026-043564SemaglutideWXT-2604-C5135Janoshik2026-Q397.154.44104.7Buyer-sourced0PASS
AX-2026-043533LeuprolideWXT-2604-K4483PeptideMeter2026-Q399.894.94Supplier-supplied0PASS
AX-2026-043624L-Glutathione (reduced)WXT-2605-B5720Nordanalyt2026-Q398.186.95105.3Buyer-sourced2FAIL
AX-2026-043556SemaglutideWXT-2604-C5135PeptideMeter2026-Q397.564.3589.6Buyer-sourced1MARGINAL