AssayIndex

AX-2025-021042

CJC-1295 (no DAC) · 2 mg declared · Bachem Holding (Suzhou) Co., Ltd. · lot BCH-2502-A4465

FAILIDENTITY CONSISTENT
Report ID
AX-2025-021042
Compound
CJC-1295 (no DAC)
Compound class
Growth-hormone axis peptides
Supplier
BCH — Bachem Holding (Suzhou) Co., Ltd.
Batch / lot
BCH-2502-A4465
Declared label claim
2mg
Laboratory
Janoshik Analytical
Assay date
28 Feb 2025
Submitted
06 Mar 2025
Quarter
2025-Q1
Submitter
Contributor #N-3320
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, 30 min gradient, 214 nm97.83% area≥ 98.0FAIL
Total impuritiesRP-HPLC, sum of reported peaks2.17% area≤ 2.0FAIL
Largest single impurityRP-HPLC — native GRF (1-29) (−59 Da)1.48% area≤ 1.00FAIL
Identity — theoretical monoisotopic masscalculated from molecular formula3365.7402DaNOT TESTED
Identity — observed monoisotopic massLC-MS, high resolution (ESI-TOF/QTOF)3365.7432DaNOT TESTED
Mass accuracyobserved vs theoretical+0.9ppm± 15PASS
Peptide contentnot ordered on this submissionnot determinedrequired to check label claimNOT TESTED
Water contentKarl Fischer, coulometric, duplicate4.04%≤ 9.0PASS
Counter-ion (acetate)anion-exchange ion chromatography5.54%≤ 12.0PASS
Residual solvent + inorganic residueestimated — see /methods/residual-solvents-q3c/0.16%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 after 90 s gentle swirling, no particulatesclear, no visible particulatesPASS
pH (reconstituted, 1 mg/mL)potentiometric, two-point calibration5.302.5 – 8.0PASS
Retention time (observed)RP-HPLC, 30 min gradient13.12min12.86 ± 0.30 (normalised)PASS
Peak asymmetry (10 % height)Ph. Eur. 2.2.461.330.80 – 1.50PASS
Plate count, main peakN = 5.54 (t/w½)²60,569≥ 20,000PASS
Resolution to nearest impurityvs deamidated (+1 Da)1.10no 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.

01823364754707294 CJC-1295 (no DAC)13.12 min · 97.83 % 12.78 same trace · ×20 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 60,569, and skew follows the reported asymmetry factor of 1.33. 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 1.48 % impurity against a 97.83 % 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 peak13.124,754,84197.83
2native GRF (1-29) (−59 Da)12.7871,9331.48-58.995
3des-Tyr1 (−163 Da)12.5814,5810.30-163.063
4deamidated (+1 Da)12.887,7760.16+0.984
5truncated (1-24)11.966,3180.13-570.291
6acetyl adduct (+42 Da)13.564,8600.10+42.011
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 3365.7432 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+674.1553674.15590.00068.3
4+842.4423842.44310.000854.3
3+1122.92071122.92170.0010100.0
2+1683.87741683.87890.001556.9
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)98.8897.83divergence +0.86 pp vs batch median
Total impurities (% area)not stated2.17
Largest single impurity (% area)not stated1.48
Water (%)2.74.04
Counter-ion (%)not stated5.54
Peptide content (%w/w)97.5not determined
Endotoxin (EU/mg)1.43not 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 (−20 °C, 25 d) → laboratory (courier, dry ice, 12 d) → assay.
Assay date
28 Feb 2025
Submitted to the index
06 Mar 2025
Laboratory
Janoshik Analytical, Ostrava, Czechia
Method basis
30 min gradient · high-resolution MS
Verification status
IDENTITY CONSISTENT
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 native GRF (1-29) (−59 Da) from retention alone, check the mass defect on the impurity peak. Plausible and implausible assignments separate cleanly and the check costs nothing.
selection_bias
Provenance handles supplier selection. It does not handle submitter selection, which is the larger confounder and the one the index cannot measure.
buyer_sourced
Ordering under an unremarkable name and address is the whole method. It requires no cooperation from anybody and it produces the strongest evidence this index holds.
Section 7

Related records

Same batch — lot BCH-2502-A4465 n=5

ReportLotLabQuarterPurity %Water %Recovery %ProvenanceFlagsResult
AX-2025-021039BCH-2502-A4465PeptideMeter2025-Q198.234.10Buyer-sourced1MARGINAL
AX-2025-021040BCH-2502-A4465Janoshik2025-Q198.024.6397.3Buyer-sourced1MARGINAL
AX-2025-021041BCH-2502-A4465VendorInvestigate2025-Q198.044.58Buyer-sourced1MARGINAL
AX-2025-021043BCH-2502-A4465Medutest2025-Q197.414.17104.0Buyer-sourced1FAIL
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 BCH records in the index.
ReportCompoundLotLabQuarterPurity %Water %Recovery %ProvenanceFlagsResult
AX-2026-043445BPC-157BCH-2603-G4350Nordanalyt2026-Q398.424.8793.6Buyer-sourced1MARGINAL
AX-2026-043440BPC-157BCH-2603-G4350VendorInvestigate2026-Q398.614.11Buyer-sourced1MARGINAL
AX-2026-043442BPC-157BCH-2603-G4350Janoshik2026-Q398.654.78Buyer-sourced1MARGINAL
AX-2026-043471CJC-1295 with DACBCH-2607-H5235Janoshik2026-Q397.465.48Buyer-sourced1FAIL
AX-2026-043477CJC-1295 with DACBCH-2607-H5235VendorInvestigate2026-Q397.625.3299.6Buyer-sourced1MARGINAL
AX-2026-043449BPC-157BCH-2603-G4350Kestrel2026-Q399.744.9291.3Supplier-supplied2MARGINAL
AX-2026-043448BPC-157BCH-2603-G4350Janoshik2026-Q398.554.69106.9Buyer-sourced1MARGINAL
AX-2026-043470CJC-1295 with DACBCH-2607-H5235Janoshik2026-Q397.766.1199.3Supplier-supplied1MARGINAL