AssayIndex

AX-2025-021040

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

MARGINALPURITY ONLY
Report ID
AX-2025-021040
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
25 Feb 2025
Submitted
09 Mar 2025
Quarter
2025-Q1
Submitter
sa.demir
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 nm98.02% area≥ 98.0PASS
Total impuritiesRP-HPLC, sum of reported peaks1.98% area≤ 2.0PASS
Largest single impurityRP-HPLC — native GRF (1-29) (−59 Da)1.35% area≤ 1.00FAIL
Identitynot ordered on this submissionnot determinedrequired for VERIFIED statusNOT TESTED
Total peptide contentby difference from the gravimetric mass balance91.02%w/wNOT TESTED
Target-compound contenttotal peptide content × purity89.22%w/wNOT TESTED
Gross fill (as weighed)five-place balance, under nitrogen2.18mg2 mg declaredNOT TESTED
Recovered target peptidegross fill × target content1.945mg2 mg claimNOT TESTED
Recovery against label claimrecovered ÷ claim97.3%90.0 – 110.0PASS
Water contentKarl Fischer, coulometric, duplicate4.63%≤ 9.0PASS
Counter-ion (acetate)anion-exchange ion chromatography3.43%≤ 12.0PASS
Residual solvent + inorganic residueestimated — see /methods/residual-solvents-q3c/0.92%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 calibration5.792.5 – 8.0PASS
Retention time (observed)RP-HPLC, 30 min gradient12.90min12.86 ± 0.30 (normalised)PASS
Peak asymmetry (10 % height)Ph. Eur. 2.2.461.320.80 – 1.50PASS
Plate count, main peakN = 5.54 (t/w½)²50,311≥ 20,000PASS
Resolution to nearest impurityvs deamidated (+1 Da)1.02no 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.

01701340251026803 CJC-1295 (no DAC)12.90 min · 98.02 % 12.56 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 50,311, and skew follows the reported asymmetry factor of 1.32. 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 1.35 % impurity against a 98.02 % 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 peak12.904,764,07698.02
2native GRF (1-29) (−59 Da)12.5665,6141.35-58.995
3des-Tyr1 (−163 Da)12.3613,1230.27-163.063
4deamidated (+1 Da)12.667,2900.15+0.984
5truncated (1-24)11.745,8320.12-570.291
6acetyl adduct (+42 Da)13.344,3740.09+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 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 Fischer4.63
Counter-ion (acetate)ion chromatography3.43
Residual solvent + inorganic residueestimated0.92
Total peptide contentby difference91.02
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)98.8898.02divergence +0.86 pp vs batch median
Total impurities (% area)not stated1.98
Largest single impurity (% area)not stated1.35
Water (%)2.74.63
Counter-ion (%)not stated3.43
Peptide content (%w/w)97.591.02
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, 30 d) → laboratory (courier, dry ice, 4 d) → assay.
Assay date
25 Feb 2025
Submitted to the index
09 Mar 2025
Laboratory
Janoshik Analytical, Ostrava, Czechia
Method basis
30 min gradient · high-resolution MS
Verification status
PURITY ONLY
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.

survivor_lots
Even a perfectly blind purchase is a lot somebody chose to test. Provenance fixes one selection problem and leaves the other standing.
low_n
Strong provenance does not fix small n. One well-sourced record is still one record, and the batch page says how many others exist for BCH-2502-A4465.
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-2025-021041BCH-2502-A4465VendorInvestigate2025-Q198.044.58Buyer-sourced1MARGINAL
AX-2025-021042BCH-2502-A4465Janoshik2025-Q197.834.04Buyer-sourced1FAIL
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