AX-2026-043065

Desmopressin · 2 mg declared · Zhuhai Kerui Biotechnology Co., Ltd. · lot KP-2512-U5694

PASSPURITY ONLY

Report ID: AX-2026-043065
Compound: Desmopressin
Compound class: Hypothalamic and posterior-pituitary hormones
Supplier: KP — Zhuhai Kerui Biotechnology Co., Ltd.
Batch / lot: KP-2512-U5694
Declared label claim: 2mg
Laboratory: Janoshik Analytical
Assay date: 29 Apr 2026
Submitted: 17 May 2026
Quarter: 2026-Q2
Submitter: lyo_cycle
Sample provenance: Buyer-sourced

Section 1

Results

Measured against the index acceptance specification for the hypothalamic and posterior-pituitary hormones 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	98.65	% area	≥ 98.5	PASS
Total impurities	RP-HPLC, sum of reported peaks	1.35	% area	≤ 1.5	PASS
Largest single impurity	RP-HPLC — des-amino artefact (+16 Da)	0.82	% area	≤ 1.00	PASS
Identity	not ordered on this submission	not determined	—	required for VERIFIED status	NOT TESTED
Total peptide content	by difference from the gravimetric mass balance	91.87	%w/w	—	NOT TESTED
Target-compound content	total peptide content × purity	90.63	%w/w	—	NOT TESTED
Gross fill (as weighed)	five-place balance, under nitrogen	2.23	mg	2 mg declared	NOT TESTED
Recovered target peptide	gross fill × target content	2.021	mg	2 mg claim	NOT TESTED
Recovery against label claim	recovered ÷ claim	101.1	%	90.0 – 110.0	PASS
Water content	Karl Fischer, coulometric, duplicate	3.28	%	≤ 8.0	PASS
Counter-ion (acetate)	anion-exchange ion chromatography	4.34	%	≤ 10.0	PASS
Residual solvent + inorganic residue	estimated — see /methods/residual-solvents-q3c/	0.51	%	—	NOT TESTED
Endotoxin	kinetic chromogenic LAL	0.33	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 cake, partial shrinkage from vial wall	—	white to off-white intact cake	FAIL
Reconstitution clarity	reconstituted per submitter procedure	Visible particulates, did not clear	—	clear, no visible particulates	FAIL
pH (reconstituted, 1 mg/mL)	potentiometric, two-point calibration	5.24	—	2.5 – 8.0	PASS
Retention time (observed)	RP-HPLC, 30 min gradient	8.01	min	8.14 ± 0.25 (normalised)	PASS
Peak asymmetry (10 % height)	Ph. Eur. 2.2.46	1.07	—	0.80 – 1.50	PASS
Plate count, main peak	N = 5.54 (t/w½)²	51,521	—	≥ 20,000	PASS
Resolution to nearest impurity	vs [L-Arg8]-diastereomer (vasopressin-like)	1.24	—	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 51,521, and skew follows the reported asymmetry factor of 1.07. 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 0.82 % impurity against a 98.65 % 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	Desmopressin — main peak	8.01	4,794,696	98.65	—
2	des-amino artefact (+16 Da)	7.71	39,855	0.82	+15.995
3	desmopressin dimer	10.25	15,067	0.31	+1066.411
4	open-chain (reduced disulfide, +2 Da)	7.47	6,318	0.13	+2.016
5	[L-Arg8]-diastereomer (vasopressin-like)	7.83	4,374	0.09	0.000
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.

Component	Determination	%w/w of cake
Water	Karl Fischer	3.28
Counter-ion (acetate)	ion chromatography	4.34
Residual solvent + inorganic residue	estimated	0.51
Total peptide content	by difference	91.87
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)	98.21	98.65	divergence -0.45 pp vs batch median
Total impurities (% area)	1.79	1.35
Largest single impurity (% area)	not stated	0.82
Water (%)	not stated	3.28
Counter-ion (%)	not stated	4.34
Peptide content (%w/w)	91.7	91.87
Endotoxin (EU/mg)	not stated	0.33
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: Buyer-sourced
Evidentiary weight: Strongest available evidence in this index.
Chain of custody: Retail purchase → submitter (ambient, 34 d) → laboratory (courier, cold pack, 2 d) → assay.
Assay date: 29 Apr 2026
Submitted to the index: 17 May 2026
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.
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 KP-2512-U5694 n=12

Report	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Flags	Result
AX-2026-043056	KP-2512-U5694	Janoshik	2026-Q2	98.54	2.71	95.2	Buyer-sourced	0	PASS
AX-2026-043057	KP-2512-U5694	VendorInvestigate	2026-Q2	98.15	2.72	—	Buyer-sourced	0	FAIL
AX-2026-043058	KP-2512-U5694	Medutest	2026-Q2	98.83	2.97	92.2	Buyer-sourced	0	PASS
AX-2026-043059	KP-2512-U5694	Janoshik	2026-Q2	98.72	3.21	106.4	Buyer-sourced	0	PASS
AX-2026-043060	KP-2512-U5694	Medutest	2026-Q2	98.67	2.57	89.2	Buyer-sourced	1	MARGINAL
AX-2026-043061	KP-2512-U5694	Janoshik	2026-Q2	98.28	2.18	90.1	Buyer-sourced	0	FAIL
AX-2026-043062	KP-2512-U5694	Janoshik	2026-Q2	98.37	2.67	100.9	Buyer-sourced	0	FAIL
AX-2026-043063	KP-2512-U5694	Janoshik	2026-Q2	98.74	2.92	—	Buyer-sourced	0	PASS
AX-2026-043064	KP-2512-U5694	Janoshik	2026-Q2	98.83	3.27	—	Buyer-sourced	0	PASS
AX-2026-043066	KP-2512-U5694	Medutest	2026-Q2	98.68	3.29	—	Buyer-sourced	0	PASS
AX-2026-043067	KP-2512-U5694	Janoshik	2026-Q2	98.48	2.98	—	Buyer-sourced	0	FAIL

Batch rollup and reproducibility assessment →

Cross-sections

Other recent Desmopressin records in the index.
Report	Supplier	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Result
AX-2026-043061	KP	KP-2512-U5694	Janoshik	2026-Q2	98.28	2.18	90.1	Buyer-sourced	FAIL
AX-2026-043059	KP	KP-2512-U5694	Janoshik	2026-Q2	98.72	3.21	106.4	Buyer-sourced	PASS
AX-2026-043062	KP	KP-2512-U5694	Janoshik	2026-Q2	98.37	2.67	100.9	Buyer-sourced	FAIL
AX-2026-043056	KP	KP-2512-U5694	Janoshik	2026-Q2	98.54	2.71	95.2	Buyer-sourced	PASS
AX-2026-043066	KP	KP-2512-U5694	Medutest	2026-Q2	98.68	3.29	—	Buyer-sourced	PASS
AX-2026-043067	KP	KP-2512-U5694	Janoshik	2026-Q2	98.48	2.98	—	Buyer-sourced	FAIL
AX-2026-043063	KP	KP-2512-U5694	Janoshik	2026-Q2	98.74	2.92	—	Buyer-sourced	PASS
AX-2026-043057	KP	KP-2512-U5694	VendorInvestigate	2026-Q2	98.15	2.72	—	Buyer-sourced	FAIL

Other recent KP records in the index.
Report	Compound	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Flags	Result
AX-2026-043095	Retatrutide	KP-2607-H5774	Janoshik	2026-Q3	95.81	5.48	105.2	Buyer-sourced	0	FAIL
AX-2026-043094	Retatrutide	KP-2607-H5774	PeptideMeter	2026-Q3	96.32	6.40	—	Buyer-sourced	0	FAIL
AX-2026-043096	Retatrutide	KP-2607-H5774	VendorInvestigate	2026-Q3	96.48	6.05	104.9	Buyer-sourced	0	FAIL
AX-2026-043090	Retatrutide	KP-2607-H5774	Janoshik	2026-Q3	96.46	5.81	—	Buyer-sourced	0	FAIL
AX-2026-043091	Retatrutide	KP-2607-H5774	Janoshik	2026-Q3	96.13	5.94	—	Buyer-sourced	0	FAIL
AX-2026-043077	TB-500	KP-2605-C5214	Janoshik	2026-Q2	99.61	5.64	90.2	Buyer-sourced	0	PASS
AX-2026-043093	Retatrutide	KP-2607-H5774	Janoshik	2026-Q3	96.54	5.54	—	Buyer-sourced	0	PASS
AX-2026-043092	Retatrutide	KP-2607-H5774	Medutest	2026-Q3	96.64	6.12	—	Buyer-sourced	1	FAIL