AssayIndex

AX-2024-004324

CJC-1295 (no DAC) · 5 mg declared · Qingdao Sigma Chemical Co., Ltd. · lot QSC-2410-L7328

PASSVERIFIED
Report ID
AX-2024-004324
Compound
CJC-1295 (no DAC)
Compound class
Growth-hormone axis peptides
Supplier
QSC — Qingdao Sigma Chemical Co., Ltd.
Batch / lot
QSC-2410-L7328
Declared label claim
5mg
Laboratory
Janoshik Analytical
Assay date
21 Oct 2024
Submitted
16 Nov 2024
Quarter
2024-Q4
Submitter
an.pereira
Sample provenance
Laboratory-retained
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 nm99.93% area≥ 98.0PASS
Total impuritiesRP-HPLC, sum of reported peaks0.07% area≤ 2.0PASS
Largest single impurityRP-HPLC — native GRF (1-29) (−59 Da)0.04% area≤ 1.00PASS
Identity — theoretical monoisotopic masscalculated from molecular formula3365.7402Da—NOT TESTED
Identity — observed monoisotopic massLC-MS, high resolution (ESI-TOF/QTOF)3365.7429Da—NOT TESTED
Mass accuracyobserved vs theoretical+0.8ppm± 15PASS
Total peptide contentby difference from the gravimetric mass balance88.86%w/w—NOT TESTED
Target-compound contenttotal peptide content × purity88.80%w/w—NOT TESTED
Gross fill (as weighed)five-place balance, under nitrogen5.31mg5 mg declaredNOT TESTED
Recovered target peptidegross fill × target content4.715mg5 mg claimNOT TESTED
Recovery against label claimrecovered ÷ claim94.3%90.0 – 110.0PASS
Water contentKarl Fischer, coulometric, duplicate6.67%≤ 9.0PASS
Counter-ion (acetate)anion-exchange ion chromatography4.13%≤ 12.0PASS
Residual solvent + inorganic residueestimated — see /methods/residual-solvents-q3c/0.34%—NOT TESTED
Endotoxinkinetic chromogenic LAL0.33EU/mg≤ 5.0PASS
Sterilitymembrane filtration, USP <71>, 14 dNo growth at 14 d—no growthPASS
Appearancevisual, diffuse light, black and white backgroundWhite powder, no defined cake (melt-back)—white to off-white intact cakeFAIL
Reconstitution clarityreconstituted per submitter procedureClear, colourless, no visible particulates—clear, no visible particulatesPASS
pH (reconstituted, 1 mg/mL)potentiometric, two-point calibration6.35—2.5 – 8.0PASS
Retention time (observed)RP-HPLC, 30 min gradient12.93min12.86 ± 0.30 (normalised)PASS
Peak asymmetry (10 % height)Ph. Eur. 2.2.461.27—0.80 – 1.50PASS
Plate count, main peakN = 5.54 (t/w½)²65,205—≥ 20,000PASS
Resolution to nearest impurityvs native GRF (1-29) (−59 Da)1.64—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.

02013402560388051 CJC-1295 (no DAC)12.93 min · 99.93 % 12.59 same trace · ×200 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 65,205, and skew follows the reported asymmetry factor of 1.27. 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 0.04 % impurity against a 99.93 % 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 peak12.934,856,90899.93—
2native GRF (1-29) (−59 Da)12.591,9440.04-58.995
3des-Tyr1 (−163 Da)12.391,4580.03-163.063
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 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+2H]2+1683.88[M+4H]4+842.44 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 3365.7429 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+674.1553674.15590.00069.2
4+842.4423842.44300.000761.0
3+1122.92071122.92160.0009100.0
2+1683.87741683.87870.001362.3
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 Fischer6.67
Counter-ion (acetate)ion chromatography4.13
Residual solvent + inorganic residueestimated0.34
Total peptide contentby difference88.86
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)99.9099.93divergence -0.03 pp vs batch median
Total impurities (% area)0.100.07
Largest single impurity (% area)0.060.04
Water (%)5.96.67
Counter-ion (%)8.34.13
Peptide content (%w/w)85.288.86
Endotoxin (EU/mg)not stated0.33
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
Laboratory-retained
Evidentiary weight
Provenance documented, selection uncontrolled.
Chain of custody
Laboratory retained sample (−20 °C, 26 d since original receipt) → re-assay.
Assay date
21 Oct 2024
Submitted to the index
16 Nov 2024
Laboratory
Janoshik Analytical, Ostrava, Czechia
Method basis
30 min gradient · high-resolution MS
Verification status
VERIFIED
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.

quarter_over_quarter
Single records do not establish trends. Where this supplier's quarterly medians are stable across four quarters, a result like this reads as the process rather than the draw — and the timeline page is where to check that.
lambda_214
Detection wavelength does not affect a mass determination but it does affect the purity figure sitting next to it. Both are stated on this record, which is the point.
units_pedant
Anhydrous salt-free content is the basis most laboratories default to and the basis fewest certificates state. Where it is stated, everything downstream becomes arithmetic.
Section 7

Related records

Same batch — lot QSC-2410-L7328 n=6

ReportLotLabQuarterPurity %Water %Recovery %ProvenanceFlagsResult
AX-2024-004325QSC-2410-L7328Janoshik2024-Q499.937.06104.4Buyer-sourced0PASS
AX-2024-004326QSC-2410-L7328Janoshik2024-Q499.936.55—Buyer-sourced0PASS
AX-2024-004327QSC-2410-L7328Kestrel2024-Q499.936.24—Buyer-sourced0PASS
AX-2024-004328QSC-2410-L7328Medutest2024-Q499.476.81—Buyer-sourced0PASS
AX-2024-004329QSC-2410-L7328PeptideMeter2024-Q499.886.28—Buyer-sourced0PASS

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 QSC records in the index.
ReportCompoundLotLabQuarterPurity %Water %Recovery %ProvenanceFlagsResult
AX-2026-041599CJC-1295 (no DAC)QSC-2606-V7416VendorInvestigate2026-Q397.963.52—Buyer-sourced1FAIL
AX-2026-041601CJC-1295 (no DAC)QSC-2606-V7416Kestrel2026-Q398.334.10—Buyer-sourced1MARGINAL
AX-2026-041602CJC-1295 (no DAC)QSC-2606-V7416VendorInvestigate2026-Q398.363.38101.8Buyer-sourced1MARGINAL
AX-2026-041477TriptorelinQSC-2607-C5749Nordanalyt2026-Q399.533.42—Buyer-sourced0PASS
AX-2026-041600CJC-1295 (no DAC)QSC-2606-V7416Nordanalyt2026-Q397.744.91100.9Buyer-sourced1FAIL
AX-2026-041603CJC-1295 (no DAC)QSC-2606-V7416PeptideMeter2026-Q398.434.20—Buyer-sourced1MARGINAL
AX-2026-041606CJC-1295 (no DAC)QSC-2606-V7416Janoshik2026-Q398.033.58—Buyer-sourced1MARGINAL
AX-2026-041585LiraglutideQSC-2605-W7381Medutest2026-Q399.595.0992.8Laboratory-retained0PASS