AX-2026-041578

CJC-1295 with DAC · 5 mg declared · Qingdao Sigma Chemical Co., Ltd. · lot QSC-2512-G6894

PASSIDENTITY CONSISTENT

Report ID: AX-2026-041578
Compound: CJC-1295 with DAC
Compound class: Growth-hormone axis peptides
Supplier: QSC — Qingdao Sigma Chemical Co., Ltd.
Batch / lot: QSC-2512-G6894
Declared label claim: 5mg
Laboratory: VendorInvestigate
Assay date: 15 Mar 2026
Submitted: 21 Mar 2026
Quarter: 2026-Q1
Submitter: ke.dahlberg
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.

Parameter	Method	Result	Unit	Index spec
Purity	RP-HPLC, 32 min gradient, 214 nm	98.27	% area	≥ 97.5	PASS
Total impurities	RP-HPLC, sum of reported peaks	1.73	% area	≤ 2.5	PASS
Largest single impurity	RP-HPLC — deamidated (+1 Da)	0.77	% area	≤ 1.00	PASS
Identity — theoretical monoisotopic mass	calculated from molecular formula	3644.9748	Da	—	NOT TESTED
Identity — observed monoisotopic mass	LC-MS, high resolution (ESI-TOF/QTOF)	3644.9825	Da	—	NOT TESTED
Mass accuracy	observed vs theoretical	+2.1	ppm	± 15	PASS
Peptide content	not ordered on this submission	not determined	—	required to check label claim	NOT TESTED
Water content	Karl Fischer, coulometric, duplicate	2.53	%	≤ 9.0	PASS
Counter-ion (acetate)	anion-exchange ion chromatography	3.78	%	≤ 12.0	PASS
Residual solvent + inorganic residue	estimated — see /methods/residual-solvents-q3c/	0.73	%	—	NOT TESTED
Endotoxin	not ordered on this submission	not determined	—	≤ 5.0	NOT TESTED
Sterility	not ordered on this submission	not determined	—	no growth	NOT TESTED
Appearance	visual, diffuse light, black and white background	White lyophilised cake, intact	—	white to off-white intact cake	PASS
Reconstitution clarity	reconstituted per submitter procedure	Faint haze, clearing on standing	—	clear, no visible particulates	FAIL
pH (reconstituted, 1 mg/mL)	potentiometric, two-point calibration	5.61	—	2.5 – 8.0	PASS
Retention time (observed)	RP-HPLC, 32 min gradient	15.55	min	15.52 ± 0.35 (normalised)	PASS
Peak asymmetry (10 % height)	Ph. Eur. 2.2.46	1.35	—	0.80 – 1.50	PASS
Plate count, main peak	N = 5.54 (t/w½)²	98,830	—	≥ 20,000	PASS
Resolution to nearest impurity	vs deamidated (+1 Da)	1.37	—	no index criterion	REPORTED

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.

Figure 1. RP-HPLC trace, 32 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 98,830, and skew follows the reported asymmetry factor of 1.35. 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 0.77 % impurity against a 98.27 % main peak is a line two pixels tall; the main peak runs off-scale there by design.

#	Peak	RT	Area (µV·s)	% area	Δ mass (Da)
1	CJC-1295 with DAC — main peak	15.55	4,776,227	98.27	—
2	deamidated (+1 Da)	15.27	37,424	0.77	+0.984
3	hydrolysed maleimide (+18 Da)	14.89	26,732	0.55	+18.011
4	mod-GRF (1-29) (−279 Da)	13.67	12,637	0.26	-279.235
5	maleimide dimer	18.13	7,290	0.15	+3644.975
Closure check — purity + Σ impurities				100.00	CLOSES

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 3644.9748 Da, computed from C165H269N47O46. All ppm figures on this site are against monoisotopic values — see why that matters.

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 3644.9825 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.

Charge	Theoretical m/z	Observed m/z	Δ m/z	Rel. abundance (%)
5+	730.0022	730.0038	0.0016	8.3
4+	912.2510	912.2529	0.0019	54.2
3+	1215.9989	1216.0014	0.0025	100.0
2+	1823.4947	1823.4985	0.0038	53.2

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.

Figure	Supplier COA	This report	Index note
Purity (% area)	99.27	98.27	divergence +0.43 pp vs batch median
Total impurities (% area)	0.73	1.73
Largest single impurity (% area)	0.36	0.77
Water (%)	1.4	2.53
Counter-ion (%)	not stated	3.78
Peptide content (%w/w)	not stated	not determined
Endotoxin (EU/mg)	not stated	not determined
Method stated on certificate	NO	—	no 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, 25 d) → laboratory (courier, cold pack, 11 d) → assay.
Assay date: 15 Mar 2026
Submitted to the index: 21 Mar 2026
Laboratory: VendorInvestigate, Riga, Latvia
Method basis: 32 min gradient · high-resolution MS
Verification status: IDENTITY CONSISTENT

What this report does not establish

How much of the named compound is in the vial. Peptide content was not determined, so recovered mass cannot be calculated and the label claim cannot be checked.
That the material is free of bacterial endotoxin. Endotoxin was not measured. No chromatographic result bears on it.
That the material is sterile. Sterility was not tested.
That any other vial in the same lot has the same composition. One vial was tested. Within-lot vial-to-vial variation in this index has a median of 0.28 pp and a 90th percentile of 0.74 pp.
That any other lot from the same supplier has the same composition. Batch-to-batch variation is larger than within-batch variation for every supplier here.
That the material is suitable for administration to a human or an animal. These are research compounds. No result on this site is a safety assessment and the index takes no position on use.
That the material was manufactured by the supplier that sold it. Contract synthesis is normal in this market and twenty-nine batches in the index fingerprint to a bulk from a different company than the one named on the label.

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 QSC-2512-G6894 n=10

Report	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Flags	Result
AX-2026-041573	QSC-2512-G6894	Janoshik	2026-Q1	98.79	2.72	91.4	Supplier-supplied	1	MARGINAL
AX-2026-041574	QSC-2512-G6894	Janoshik	2026-Q1	98.83	2.41	90.5	Supplier-supplied	1	MARGINAL
AX-2026-041575	QSC-2512-G6894	Janoshik	2026-Q1	98.14	2.73	95.5	Supplier-supplied	1	MARGINAL
AX-2026-041576	QSC-2512-G6894	VendorInvestigate	2026-Q1	98.22	2.23	101.0	Buyer-sourced	1	MARGINAL
AX-2026-041577	QSC-2512-G6894	Janoshik	2026-Q1	99.02	2.67	107.4	Supplier-supplied	0	PASS
AX-2026-041579	QSC-2512-G6894	Janoshik	2026-Q1	98.90	2.51	94.6	Supplier-supplied	1	MARGINAL
AX-2026-041580	QSC-2512-G6894	Nordanalyt	2026-Q1	98.85	2.69	—	Supplier-supplied	1	MARGINAL
AX-2026-041581	QSC-2512-G6894	Medutest	2026-Q1	99.34	2.46	—	Supplier-supplied	2	FAIL
AX-2026-041582	QSC-2512-G6894	Medutest	2026-Q1	99.29	2.85	98.4	Supplier-supplied	1	MARGINAL

Batch rollup and reproducibility assessment →

Cross-sections

Other recent CJC-1295 with DAC records in the index.
Report	Supplier	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Flags	Result
AX-2026-041727	QSC	QSC-2602-E9474	Janoshik	2026-Q3	98.88	6.62	105.3	Supplier-supplied	1	MARGINAL
AX-2026-041728	QSC	QSC-2602-E9474	VendorInvestigate	2026-Q3	98.42	7.04	—	Buyer-sourced	1	MARGINAL
AX-2026-041734	QSC	QSC-2602-E9474	Medutest	2026-Q3	99.43	7.17	105.5	Supplier-supplied	2	FAIL
AX-2026-043539	BCH	BCH-2607-H7307	Janoshik	2026-Q3	98.12	5.78	100.6	Supplier-supplied	1	MARGINAL
AX-2026-041730	QSC	QSC-2602-E9474	PeptideMeter	2026-Q3	98.79	6.93	95.4	Supplier-supplied	1	MARGINAL
AX-2026-041731	QSC	QSC-2602-E9474	VendorInvestigate	2026-Q3	99.07	7.18	99.6	Buyer-sourced	1	MARGINAL
AX-2026-041725	QSC	QSC-2602-E9474	Medutest	2026-Q3	99.06	7.04	107.3	Supplier-supplied	2	FAIL
AX-2026-043537	BCH	BCH-2607-H7307	Janoshik	2026-Q3	98.45	5.49	103.1	Supplier-supplied	1	MARGINAL

Other recent QSC records in the index.
Report	Compound	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Flags	Result
AX-2026-041683	CJC-1295 (no DAC)	QSC-2606-V8637	Janoshik	2026-Q3	99.93	3.63	97.1	Supplier-supplied	1	FAIL
AX-2026-041727	CJC-1295 with DAC	QSC-2602-E9474	Janoshik	2026-Q3	98.88	6.62	105.3	Supplier-supplied	1	MARGINAL
AX-2026-041728	CJC-1295 with DAC	QSC-2602-E9474	VendorInvestigate	2026-Q3	98.42	7.04	—	Buyer-sourced	1	MARGINAL
AX-2026-041734	CJC-1295 with DAC	QSC-2602-E9474	Medutest	2026-Q3	99.43	7.17	105.5	Supplier-supplied	2	FAIL
AX-2026-041652	Liraglutide	QSC-2605-W8602	Nordanalyt	2026-Q3	99.33	6.55	—	Supplier-supplied	0	PASS
AX-2026-041730	CJC-1295 with DAC	QSC-2602-E9474	PeptideMeter	2026-Q3	98.79	6.93	95.4	Supplier-supplied	1	MARGINAL
AX-2026-041686	CJC-1295 (no DAC)	QSC-2606-V8637	Janoshik	2026-Q3	99.93	4.04	—	Supplier-supplied	0	PASS
AX-2026-041653	Liraglutide	QSC-2605-W8602	VendorInvestigate	2026-Q3	98.82	5.95	—	Buyer-sourced	0	PASS