AX-2025-020341

CJC-1295 (no DAC) · 2 mg declared · Xi'an Mokemei Biotechnology Co., Ltd. · lot MKM-2504-K3480

MARGINALPURITY ONLY

Report ID: AX-2025-020341
Compound: CJC-1295 (no DAC)
Compound class: Growth-hormone axis peptides
Supplier: MKM — Xi'an Mokemei Biotechnology Co., Ltd.
Batch / lot: MKM-2504-K3480
Declared label claim: 2mg
Laboratory: Janoshik Analytical
Assay date: 22 Sep 2025
Submitted: 14 Oct 2025
Quarter: 2025-Q3
Submitter: so.moreau
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	98.78	% area	≥ 98.0	PASS
Total impurities	RP-HPLC, sum of reported peaks	1.22	% area	≤ 2.0	PASS
Largest single impurity	RP-HPLC — des-Tyr1 (−163 Da)	0.50	% area	≤ 1.00	PASS
Identity	not ordered on this submission	not determined	—	required for VERIFIED status	NOT TESTED
Peptide content	not ordered on this submission	not determined	—	required to check label claim	NOT TESTED
Water content	Karl Fischer, coulometric, duplicate	4.82	%	≤ 9.0	PASS
Counter-ion (acetate)	anion-exchange ion chromatography	4.63	%	≤ 12.0	PASS
Residual solvent + inorganic residue	estimated — see /methods/residual-solvents-q3c/	0.61	%	—	NOT TESTED
Endotoxin	kinetic chromogenic LAL	0.47	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	6.20	—	2.5 – 8.0	PASS
Retention time (observed)	RP-HPLC, 30 min gradient	13.50	min	12.86 ± 0.30 (normalised)	FAIL
Peak asymmetry (10 % height)	Ph. Eur. 2.2.46	1.13	—	0.80 – 1.50	PASS
Plate count, main peak	N = 5.54 (t/w½)²	57,547	—	≥ 20,000	PASS
Resolution to nearest impurity	vs deamidated (+1 Da)	1.04	—	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 57,547, and skew follows the reported asymmetry factor of 1.13. 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 0.50 % impurity against a 98.78 % 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	13.50	4,801,014	98.78	—
2	des-Tyr1 (−163 Da)	12.96	24,302	0.50	-163.063
3	acetyl adduct (+42 Da)	13.94	21,871	0.45	+42.011
4	truncated (1-24)	12.34	7,776	0.16	-570.291
5	deamidated (+1 Da)	13.26	3,402	0.07	+0.984
6	native GRF (1-29) (−59 Da)	13.16	1,944	0.04	-58.995
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 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)	98.23	98.78	divergence -0.36 pp vs batch median
Total impurities (% area)	1.77	1.22
Largest single impurity (% area)	0.74	0.50
Water (%)	2.6	4.82
Counter-ion (%)	not stated	4.63
Peptide content (%w/w)	not stated	not determined
Endotoxin (EU/mg)	0.23	0.47
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, 5 d) → assay. Submitter did not handle the vial.
Assay date: 22 Sep 2025
Submitted to the index: 14 Oct 2025
Laboratory: Janoshik Analytical, Ostrava, Czechia
Method basis: 30 min gradient · high-resolution MS
Verification status: PURITY ONLY

What this report does not establish

That the compound is the compound named. No identity confirmation was ordered on this submission. A purity figure describes chromatographic homogeneity of whatever eluted; it does not name it.
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 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 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.

bootstrap_ci14 Oct 2025

A confidence interval on a provenance gap needs paired lots, not paired records. Most suppliers have too few to support one and the index does not print what it cannot compute.

peak_integrator14 Oct 2025

Anyone comparing this purity figure against a result from a longer method should expect a difference of a few tenths in a predictable direction. The inter-lab page quantifies it per laboratory.

Section 7

Related records

Same batch — lot MKM-2504-K3480 n=6

Report	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Flags	Result
AX-2025-020339	MKM-2504-K3480	Kestrel	2025-Q3	98.89	4.69	—	Buyer-sourced	0	PASS
AX-2025-020340	MKM-2504-K3480	PeptideMeter	2025-Q3	98.21	5.00	—	Buyer-sourced	0	PASS
AX-2025-020342	MKM-2504-K3480	Janoshik	2025-Q3	98.04	4.12	91.2	Buyer-sourced	0	PASS
AX-2025-020343	MKM-2504-K3480	Janoshik	2025-Q3	98.42	4.62	103.6	Buyer-sourced	0	PASS
AX-2025-020344	MKM-2504-K3480	Medutest	2025-Q3	98.76	4.96	89.1	Buyer-sourced	1	MARGINAL

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-2026-042942	MKM	MKM-2603-V3346	Janoshik	2026-Q3	99.52	3.43	—	Supplier-supplied	0	PASS
AX-2026-041599	QSC	QSC-2606-V7416	VendorInvestigate	2026-Q3	97.96	3.52	—	Buyer-sourced	1	FAIL
AX-2026-042784	GGPeps	GGPE-2606-E1234	Medutest	2026-Q3	98.27	4.55	—	Buyer-sourced	0	PASS
AX-2026-042939	MKM	MKM-2603-V3346	PeptideMeter	2026-Q3	99.44	3.39	—	Buyer-sourced	0	PASS
AX-2026-041601	QSC	QSC-2606-V7416	Kestrel	2026-Q3	98.33	4.10	—	Buyer-sourced	1	MARGINAL
AX-2026-042945	MKM	MKM-2603-V3346	PeptideMeter	2026-Q3	99.39	3.54	—	Laboratory-retained	0	PASS
AX-2026-042786	GGPeps	GGPE-2606-E1234	Janoshik	2026-Q3	98.22	3.77	—	Buyer-sourced	0	PASS
AX-2026-041602	QSC	QSC-2606-V7416	VendorInvestigate	2026-Q3	98.36	3.38	101.8	Buyer-sourced	1	MARGINAL

Other recent MKM records in the index.
Report	Compound	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Result
AX-2026-042942	CJC-1295 (no DAC)	MKM-2603-V3346	Janoshik	2026-Q3	99.52	3.43	—	Supplier-supplied	PASS
AX-2026-043019	Adipotide	MKM-2606-K5012	Janoshik	2026-Q3	97.61	5.77	105.1	Buyer-sourced	PASS
AX-2026-042939	CJC-1295 (no DAC)	MKM-2603-V3346	PeptideMeter	2026-Q3	99.44	3.39	—	Buyer-sourced	PASS
AX-2026-043020	Adipotide	MKM-2606-K5012	Medutest	2026-Q3	97.73	5.74	—	Buyer-sourced	PASS
AX-2026-043022	Adipotide	MKM-2606-K5012	Kestrel	2026-Q3	97.69	6.33	106.9	Buyer-sourced	PASS
AX-2026-043023	Adipotide	MKM-2606-K5012	Medutest	2026-Q3	97.48	5.56	103.7	Supplier-supplied	PASS
AX-2026-042945	CJC-1295 (no DAC)	MKM-2603-V3346	PeptideMeter	2026-Q3	99.39	3.54	—	Laboratory-retained	PASS
AX-2026-042938	CJC-1295 (no DAC)	MKM-2603-V3346	Nordanalyt	2026-Q3	99.47	3.67	95.0	Buyer-sourced	PASS