AX-2026-042940

CJC-1295 (no DAC) · 2 mg declared · Xi'an Mokemei Biotechnology Co., Ltd. · lot MKM-2512-Y3111

FAILVERIFIED

Report ID: AX-2026-042940
Compound: CJC-1295 (no DAC)
Compound class: Growth-hormone axis peptides
Supplier: MKM — Xi'an Mokemei Biotechnology Co., Ltd.
Batch / lot: MKM-2512-Y3111
Declared label claim: 2mg
Laboratory: Janoshik Analytical
Assay date: 16 Apr 2026
Submitted: 07 May 2026
Quarter: 2026-Q2
Submitter: endotoxin_limit
Sample provenance: Supplier-supplied

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, 30 min gradient, 214 nm	97.49	% area	≥ 98.0	FAIL
Total impurities	RP-HPLC, sum of reported peaks	2.51	% area	≤ 2.0	FAIL
Largest single impurity	RP-HPLC — des-Tyr1 (−163 Da)	0.93	% area	≤ 1.00	PASS
Identity — theoretical monoisotopic mass	calculated from molecular formula	3365.7402	Da	—	NOT TESTED
Identity — observed monoisotopic mass	LC-MS, high resolution (ESI-TOF/QTOF)	3365.7537	Da	—	NOT TESTED
Mass accuracy	observed vs theoretical	+4.0	ppm	± 15	PASS
Total peptide content	by difference from the gravimetric mass balance	91.00	%w/w	—	NOT TESTED
Target-compound content	total peptide content × purity	88.72	%w/w	—	NOT TESTED
Gross fill (as weighed)	five-place balance, under nitrogen	2.40	mg	2 mg declared	NOT TESTED
Recovered target peptide	gross fill × target content	2.129	mg	2 mg claim	NOT TESTED
Recovery against label claim	recovered ÷ claim	106.5	%	90.0 – 110.0	PASS
Water content	Karl Fischer, coulometric, duplicate	4.60	%	≤ 9.0	PASS
Counter-ion (acetate)	anion-exchange ion chromatography	3.63	%	≤ 12.0	PASS
Residual solvent + inorganic residue	estimated — see /methods/residual-solvents-q3c/	0.77	%	—	NOT TESTED
Endotoxin	kinetic chromogenic LAL	0.52	EU/mg	≤ 5.0	PASS
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	Clear, colourless, no visible particulates	—	clear, no visible particulates	PASS
pH (reconstituted, 1 mg/mL)	potentiometric, two-point calibration	5.13	—	2.5 – 8.0	PASS
Retention time (observed)	RP-HPLC, 30 min gradient	12.50	min	12.86 ± 0.30 (normalised)	FAIL
Peak asymmetry (10 % height)	Ph. Eur. 2.2.46	1.33	—	0.80 – 1.50	PASS
Plate count, main peak	N = 5.54 (t/w½)²	67,494	—	≥ 20,000	PASS
Resolution to nearest impurity	vs deamidated (+1 Da)	1.22	—	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, 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 67,494, 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 0.93 % impurity against a 97.49 % 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 (no DAC) — main peak	12.50	4,738,316	97.49	—
2	des-Tyr1 (−163 Da)	11.96	45,201	0.93	-163.063
3	native GRF (1-29) (−59 Da)	12.16	36,452	0.75	-58.995
4	truncated (1-24)	11.34	24,788	0.51	-570.291
5	acetyl adduct (+42 Da)	12.94	8,263	0.17	+42.011
6	deamidated (+1 Da)	12.26	7,290	0.15	+0.984
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 3365.7402 Da, computed from C152H252N44O42. 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 3365.7537 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+	674.1553	674.1580	0.0027	8.7
4+	842.4423	842.4457	0.0034	52.6
3+	1122.9207	1122.9252	0.0045	100.0
2+	1683.8774	1683.8841	0.0067	49.3

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.

Component	Determination	%w/w of cake
Water	Karl Fischer	4.60
Counter-ion (acetate)	ion chromatography	3.63
Residual solvent + inorganic residue	estimated	0.77
Total peptide content	by difference	91.00
Total		100.00 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.

Figure	Supplier COA	This report	Index note
Purity (% area)	98.36	97.49	divergence +0.69 pp vs batch median
Total impurities (% area)	1.64	2.51
Largest single impurity (% area)	0.65	0.93
Water (%)	4.8	4.60
Counter-ion (%)	not stated	3.63
Peptide content (%w/w)	not stated	91.00
Endotoxin (EU/mg)	not stated	0.52
Method stated on certificate	YES	—	column, 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: Supplier-supplied
Evidentiary weight: Weaker evidence. Read with the caveat below.
Chain of custody: Supplier despatch → laboratory direct (courier, cold pack, 4 d) → assay. Submitter did not handle the vial.
Assay date: 16 Apr 2026
Submitted to the index: 07 May 2026
Laboratory: Janoshik Analytical, Ostrava, Czechia
Method basis: 30 min gradient · high-resolution MS
Verification status: VERIFIED

What this report does not establish

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 MKM-2512-Y3111 n=2

Report	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Flags	Result
AX-2026-042941	MKM-2512-Y3111	PeptideMeter	2026-Q2	97.85	4.89	—	Supplier-supplied	2	FAIL

Batch rollup and reproducibility assessment →

Cross-sections

Other recent CJC-1295 (no DAC) records in the index.
Report	Supplier	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Flags	Result
AX-2026-041683	QSC	QSC-2606-V8637	Janoshik	2026-Q3	99.93	3.63	97.1	Supplier-supplied	1	FAIL
AX-2026-042669	GGPeps	GGPE-2606-E8495	Medutest	2026-Q3	98.61	4.06	95.5	Supplier-supplied	0	PASS
AX-2026-042665	GGPeps	GGPE-2606-E8495	Janoshik	2026-Q3	98.44	4.00	93.2	Supplier-supplied	1	MARGINAL
AX-2026-042663	GGPeps	GGPE-2606-E8495	Medutest	2026-Q3	97.96	4.14	90.0	Laboratory-retained	2	FAIL
AX-2026-042662	GGPeps	GGPE-2606-E8495	Janoshik	2026-Q3	97.89	4.11	95.1	Supplier-supplied	0	FAIL
AX-2026-041686	QSC	QSC-2606-V8637	Janoshik	2026-Q3	99.93	4.04	—	Supplier-supplied	0	PASS
AX-2026-042666	GGPeps	GGPE-2606-E8495	Janoshik	2026-Q3	97.87	3.74	94.3	Buyer-sourced	2	FAIL
AX-2026-042668	GGPeps	GGPE-2606-E8495	Nordanalyt	2026-Q3	98.02	4.53	103.9	Supplier-supplied	1	MARGINAL

Other recent MKM records in the index.
Report	Compound	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Flags	Result
AX-2026-042943	Adipotide	MKM-2606-K4013	Janoshik	2026-Q3	97.92	6.31	—	Supplier-supplied	1	MARGINAL
AX-2026-042891	CJC-1295 (no DAC)	MKM-2603-V2347	Janoshik	2026-Q3	99.28	3.63	—	Supplier-supplied	1	MARGINAL
AX-2026-042942	Adipotide	MKM-2606-K4013	VendorInvestigate	2026-Q3	97.04	5.56	94.6	Buyer-sourced	1	FAIL
AX-2026-042914	Gonadorelin	MKM-2604-A2596	Janoshik	2026-Q2	99.93	5.19	—	Supplier-supplied	0	PASS
AX-2026-042884	BPC-157	MKM-2605-X2575	Nordanalyt	2026-Q2	98.12	2.89	—	Laboratory-retained	1	MARGINAL
AX-2026-042946	Tirzepatide	MKM-2601-L3752	Medutest	2026-Q2	97.71	8.10	—	Supplier-supplied	1	FAIL
AX-2026-042911	Gonadorelin	MKM-2604-A2596	Medutest	2026-Q2	99.08	5.55	—	Buyer-sourced	1	MARGINAL
AX-2026-042932	L-Glutathione (reduced)	MKM-2511-F2902	Janoshik	2026-Q2	98.57	8.41	92.9	Supplier-supplied	1	MARGINAL