AX-2026-043067

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

FAILIDENTITY CONSISTENT

Report ID: AX-2026-043067
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: 26 May 2026
Submitted: 04 Jun 2026
Quarter: 2026-Q2
Submitter: sa.lindqvist
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	98.48	% area	≥ 98.5	FAIL
Total impurities	RP-HPLC, sum of reported peaks	1.52	% area	≤ 1.5	FAIL
Largest single impurity	RP-HPLC — des-amino artefact (+16 Da)	0.92	% area	≤ 1.00	PASS
Identity — theoretical monoisotopic mass	calculated from molecular formula	1068.4265	Da	—	NOT TESTED
Identity — observed monoisotopic mass	LC-MS, high resolution (ESI-TOF/QTOF)	1068.4356	Da	—	NOT TESTED
Mass accuracy	observed vs theoretical	+8.5	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	2.98	%	≤ 8.0	PASS
Counter-ion (acetate)	anion-exchange ion chromatography	5.17	%	≤ 10.0	PASS
Residual solvent + inorganic residue	estimated — see /methods/residual-solvents-q3c/	0.70	%	—	NOT TESTED
Endotoxin	not ordered on this submission	not determined	—	≤ 5.0	NOT TESTED
Sterility	membrane filtration, USP <71>, 14 d	No growth at 14 d	—	no growth	PASS
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	Slow dissolution, >5 min to clarity	—	clear, no visible particulates	FAIL
pH (reconstituted, 1 mg/mL)	potentiometric, two-point calibration	5.25	—	2.5 – 8.0	PASS
Retention time (observed)	RP-HPLC, 30 min gradient	8.07	min	8.14 ± 0.25 (normalised)	PASS
Peak asymmetry (10 % height)	Ph. Eur. 2.2.46	1.17	—	0.80 – 1.50	PASS
Plate count, main peak	N = 5.54 (t/w½)²	58,438	—	≥ 20,000	PASS
Resolution to nearest impurity	vs [L-Arg8]-diastereomer (vasopressin-like)	1.32	—	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 58,438, and skew follows the reported asymmetry factor of 1.17. 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 0.92 % impurity against a 98.48 % 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	8.07	4,786,433	98.48	—
2	des-amino artefact (+16 Da)	7.77	44,715	0.92	+15.995
3	desmopressin dimer	10.31	17,011	0.35	+1066.411
4	open-chain (reduced disulfide, +2 Da)	7.53	6,804	0.14	+2.016
5	[L-Arg8]-diastereomer (vasopressin-like)	7.89	5,346	0.11	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 3

Mass spectrum and identity

Theoretical monoisotopic mass 1068.4265 Da, computed from C46H64N14O12S2. 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 1068.4356 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 (%)
3+	357.1494	357.1525	0.0031	8.5
2+	535.2205	535.2251	0.0046	55.3
1+	1069.4338	1069.4429	0.0091	100.0

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)	98.21	98.48	divergence -0.45 pp vs batch median
Total impurities (% area)	1.79	1.52
Largest single impurity (% area)	not stated	0.92
Water (%)	not stated	2.98
Counter-ion (%)	not stated	5.17
Peptide content (%w/w)	91.7	not determined
Endotoxin (EU/mg)	not stated	not determined
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: Domestic warehouse despatch → submitter (2–8 °C, 16 d) → laboratory (courier, cold pack, 10 d) → assay.
Assay date: 26 May 2026
Submitted to the index: 04 Jun 2026
Laboratory: Janoshik Analytical, Ostrava, Czechia
Method basis: 30 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 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 3

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.

label_claim04 Jun 2026

A retail vial is also a test of the label. Declared claim 2 mg against what the gravimetry recovers is a question only a purchased vial can answer honestly.

shipping_temp04 Jun 2026

Reduction in transit needs a reducing environment, which is unusual in a dry cake and common in a reconstituted solution. Where the material was shipped reconstituted, that is the first hypothesis.

iso_audit04 Jun 2026

A supplier's water-system qualification would make a burden estimate possible without measuring every lot. No such document exists in this market as far as the index can tell.

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-2026-043065	KP-2512-U5694	Janoshik	2026-Q2	98.65	3.28	101.1	Buyer-sourced	0	PASS
AX-2026-043066	KP-2512-U5694	Medutest	2026-Q2	98.68	3.29	—	Buyer-sourced	0	PASS

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-2026-043063	KP	KP-2512-U5694	Janoshik	2026-Q2	98.74	2.92	—	Buyer-sourced	PASS
AX-2026-043065	KP	KP-2512-U5694	Janoshik	2026-Q2	98.65	3.28	101.1	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