AssayIndex

AX-2026-043471

CJC-1295 with DAC · 2 mg declared · Bachem Holding (Suzhou) Co., Ltd. · lot BCH-2607-H5235

FAILPURITY ONLY
Report ID
AX-2026-043471
Compound
CJC-1295 with DAC
Compound class
Growth-hormone axis peptides
Supplier
BCH — Bachem Holding (Suzhou) Co., Ltd.
Batch / lot
BCH-2607-H5235
Declared label claim
2mg
Laboratory
Janoshik Analytical
Assay date
22 Aug 2026
Submitted
10 Sep 2026
Quarter
2026-Q3
Submitter
f.lokken
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 nm97.46% area≥ 97.5FAIL
Total impuritiesRP-HPLC, sum of reported peaks2.54% area≤ 2.5FAIL
Largest single impurityRP-HPLC — maleimide dimer0.90% area≤ 1.00PASS
Identitynot ordered on this submissionnot determinedrequired for VERIFIED statusNOT TESTED
Peptide contentnot ordered on this submissionnot determinedrequired to check label claimNOT TESTED
Water contentKarl Fischer, coulometric, duplicate5.48%≤ 9.0PASS
Counter-ion (acetate)anion-exchange ion chromatography4.67%≤ 12.0PASS
Residual solvent + inorganic residueestimated — see /methods/residual-solvents-q3c/0.19%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 calibration5.402.5 – 8.0PASS
Retention time (observed)RP-HPLC, 30 min gradient14.52min14.62 ± 0.35 (normalised)PASS
Peak asymmetry (10 % height)Ph. Eur. 2.2.460.860.80 – 1.50PASS
Plate count, main peakN = 5.54 (t/w½)²40,428≥ 20,000PASS
Resolution to nearest impurityvs deamidated (+1 Da)0.88no 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.

01644328949336578 CJC-1295 with DAC14.52 min · 97.46 % 13.9016.94 same trace · ×50 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 40,428, 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 0.90 % impurity against a 97.46 % 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 with DAC — main peak14.524,736,85897.46
2maleimide dimer16.9443,7430.90+3644.975
3hydrolysed maleimide (+18 Da)13.9040,8270.84+18.011
4mod-GRF (1-29) (−279 Da)12.7622,3570.46-279.235
5deamidated (+1 Da)14.2616,5250.34+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.

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)98.097.46divergence +0.37 pp vs batch median
Total impurities (% area)2.002.54
Largest single impurity (% area)1.190.90
Water (%)not stated5.48
Counter-ion (%)not stated4.67
Peptide content (%w/w)91.7not determined
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 → submitter (ambient, 25 d) → laboratory (courier, cold pack, 2 d) → assay.
Assay date
22 Aug 2026
Submitted to the index
10 Sep 2026
Laboratory
Janoshik Analytical, Ostrava, Czechia
Method basis
30 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.

coa_template
The index publishes the declared figure and the measured figure side by side and does not adjudicate between them. Both are on this page and the difference is stated rather than characterised.
digit_preference
Rule AX-R04 carries the lowest severity in the rule set for a reason. It is a finding about how a number was written down.
fill_homogeneity
One retail vial is one draw from a fill. Two or three from the same lot would separate fill variation from lot quality, and that is the cheapest useful experiment in this whole field.
Section 7

Related records

Same batch — lot BCH-2607-H5235 n=9

ReportLotLabQuarterPurity %Water %Recovery %ProvenanceFlagsResult
AX-2026-043470BCH-2607-H5235Janoshik2026-Q397.766.1199.3Supplier-supplied1MARGINAL
AX-2026-043472BCH-2607-H5235PeptideMeter2026-Q397.585.93Laboratory-retained1MARGINAL
AX-2026-043473BCH-2607-H5235Janoshik2026-Q397.476.1795.6Buyer-sourced1FAIL
AX-2026-043474BCH-2607-H5235Janoshik2026-Q397.826.05Buyer-sourced1MARGINAL
AX-2026-043475BCH-2607-H5235Janoshik2026-Q397.916.09Buyer-sourced1MARGINAL
AX-2026-043476BCH-2607-H5235Nordanalyt2026-Q397.835.39Buyer-sourced1MARGINAL
AX-2026-043477BCH-2607-H5235VendorInvestigate2026-Q397.625.3299.6Buyer-sourced1MARGINAL
AX-2026-043478BCH-2607-H5235PeptideMeter2026-Q397.635.4290.1Buyer-sourced1MARGINAL
Other recent CJC-1295 with DAC records in the index.
ReportSupplierLotLabQuarterPurity %Water %Recovery %ProvenanceFlagsResult
AX-2026-041681TFSTFS-{CAT}-9675PeptideMeter2026-Q398.823.67Buyer-sourced0PASS
AX-2026-041867SinoPepSNP-2607-C3886Janoshik2026-Q399.245.12Laboratory-retained1FAIL
AX-2026-041682TFSTFS-{CAT}-9675Nordanalyt2026-Q398.943.24Buyer-sourced0PASS
AX-2026-041683TFSTFS-{CAT}-9675Medutest2026-Q398.683.4697.0Buyer-sourced0PASS
AX-2026-043477BCHBCH-2607-H5235VendorInvestigate2026-Q397.625.3299.6Buyer-sourced1MARGINAL
AX-2026-043470BCHBCH-2607-H5235Janoshik2026-Q397.766.1199.3Supplier-supplied1MARGINAL
AX-2026-043478BCHBCH-2607-H5235PeptideMeter2026-Q397.635.4290.1Buyer-sourced1MARGINAL
AX-2026-043475BCHBCH-2607-H5235Janoshik2026-Q397.916.09Buyer-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-2026-043477CJC-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
AX-2026-043478CJC-1295 with DACBCH-2607-H5235PeptideMeter2026-Q397.635.4290.1Buyer-sourced1MARGINAL