AssayIndex

AX-2025-019319

CJC-1295 (no DAC) · 5 mg declared · AmbioPharm, Inc. · lot AMB-2506-G6519

PASSIDENTITY CONSISTENT
Report ID
AX-2025-019319
Compound
CJC-1295 (no DAC)
Compound class
Growth-hormone axis peptides
Supplier
AMB — AmbioPharm, Inc.
Batch / lot
AMB-2506-G6519
Declared label claim
5mg
Laboratory
Medutest
Assay date
09 Nov 2025
Submitted
18 Nov 2025
Quarter
2025-Q4
Submitter
a.castellanos
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, 25 min gradient, 214 nm99.04% area≥ 98.0PASS
Total impuritiesRP-HPLC, sum of reported peaks0.96% area≤ 2.0PASS
Largest single impurityRP-HPLC — native GRF (1-29) (−59 Da)0.41% area≤ 1.00PASS
Identity — theoretical monoisotopic masscalculated from molecular formula3365.7402DaNOT TESTED
Identity — observed monoisotopic massLC-MS, unit resolution (single quadrupole)3365.7540DaNOT TESTED
Mass accuracyobserved vs theoretical+4.1ppm± 15PASS
Peptide contentnot ordered on this submissionnot determinedrequired to check label claimNOT TESTED
Water contentKarl Fischer, coulometric, duplicate5.49%≤ 9.0PASS
Counter-ion (acetate)anion-exchange ion chromatography5.35%≤ 12.0PASS
Residual solvent + inorganic residueestimated — see /methods/residual-solvents-q3c/0.25%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, colourless, no visible particulatesclear, no visible particulatesPASS
pH (reconstituted, 1 mg/mL)potentiometric, two-point calibration5.332.5 – 8.0PASS
Retention time (observed)RP-HPLC, 25 min gradient10.83min10.89 ± 0.30 (normalised)PASS
Peak asymmetry (10 % height)Ph. Eur. 2.2.460.980.80 – 1.50PASS
Plate count, main peakN = 5.54 (t/w½)²64,304≥ 20,000PASS
Resolution to nearest impurityvs deamidated (+1 Da)1.14no 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.

027125423813510846 CJC-1295 (no DAC)10.83 min · 99.04 % 10.55 same trace · ×100 vertical expansion, baseline-corrected · main peak off-scale reporting threshold 0.05 % area 0481216202428 Retention time (min) Response (mAU)
Figure 1. RP-HPLC trace, 25 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 64,304, and skew follows the reported asymmetry factor of 0.98. 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 0.41 % impurity against a 99.04 % 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 peak10.834,813,65199.04
2native GRF (1-29) (−59 Da)10.5519,9270.41-58.995
3truncated (1-24)9.8617,0110.35-570.291
4deamidated (+1 Da)10.634,3740.09+0.984
5acetyl adduct (+42 Da)11.202,9160.06+42.011
6des-Tyr1 (−163 Da)10.382,4300.05-163.063
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 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+1122.93[M+4H]4+842.45[M+2H]2+1683.88 m/z Relative abundance (%)
Figure 2. ESI charge-state envelope, unit-resolution instrument. Sticks are placed at m/z = (M + z × 1.007276)/z for the observed neutral mass of 3365.7540 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+674.1553674.15810.00289.2
4+842.4423842.44580.003559.8
3+1122.92071122.92530.0046100.0
2+1683.87741683.88430.006954.9
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)99.5799.04divergence +0.57 pp vs batch median
Total impurities (% area)not stated0.96
Largest single impurity (% area)not stated0.41
Water (%)4.35.49
Counter-ion (%)6.55.35
Peptide content (%w/w)88.6not determined
Endotoxin (EU/mg)8.82not 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, 9 d) → laboratory (hand-carried, 6 d) → assay.
Assay date
09 Nov 2025
Submitted to the index
18 Nov 2025
Laboratory
Medutest, Ljubljana, Slovenia
Method basis
25 min gradient · unit-resolution MS
Verification status
IDENTITY CONSISTENT
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 AMB-2506-G6519 n=4

ReportLotLabQuarterPurity %Water %Recovery %ProvenanceFlagsResult
AX-2025-019316AMB-2506-G6519Janoshik2025-Q498.825.82Buyer-sourced0PASS
AX-2025-019317AMB-2506-G6519PeptideMeter2025-Q498.955.94Buyer-sourced1FAIL
AX-2025-019318AMB-2506-G6519Medutest2025-Q499.326.0399.1Buyer-sourced0PASS
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 AMB records in the index.
ReportCompoundLotLabQuarterPurity %Water %Recovery %ProvenanceFlagsResult
AX-2026-042002SemaglutideAMB-2607-N6274VendorInvestigate2026-Q398.236.3797.1Buyer-sourced1MARGINAL
AX-2026-042012GHRP-6AMB-2603-S5667Janoshik2026-Q399.375.9088.8Laboratory-retained1MARGINAL
AX-2026-041974TirzepatideAMB-2603-C5112Nordanalyt2026-Q398.203.41Buyer-sourced0PASS
AX-2026-041975TirzepatideAMB-2603-C5112Medutest2026-Q397.883.45106.9Laboratory-retained0PASS
AX-2026-042005SemaglutideAMB-2607-N6274PeptideMeter2026-Q398.096.4898.6Buyer-sourced1MARGINAL
AX-2026-042008EpitalonAMB-2602-Y6433Janoshik2026-Q399.308.75105.1Buyer-sourced0PASS
AX-2026-042021TB-500AMB-2602-P5987VendorInvestigate2026-Q399.864.79101.4Buyer-sourced0PASS
AX-2026-042015GHRP-6AMB-2603-S5667Janoshik2026-Q399.546.4497.1Buyer-sourced0PASS