AX-2024-004158

Desmopressin · 2 mg declared · Wuhan Wansheng Biotechnology Co., Ltd. · lot WWB-2312-E2908

PASSPURITY ONLY

Report ID: AX-2024-004158
Compound: Desmopressin
Compound class: Hypothalamic and posterior-pituitary hormones
Supplier: WWB — Wuhan Wansheng Biotechnology Co., Ltd.
Batch / lot: WWB-2312-E2908
Declared label claim: 2mg
Laboratory: Janoshik Analytical
Assay date: 15 Feb 2024
Submitted: 04 Mar 2024
Quarter: 2024-Q1
Submitter: y.bergstrom
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	99.55	% area	≥ 98.5	PASS
Total impurities	RP-HPLC, sum of reported peaks	0.45	% area	≤ 1.5	PASS
Largest single impurity	RP-HPLC — des-amino artefact (+16 Da)	0.21	% 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	87.62	%w/w	—	NOT TESTED
Target-compound content	total peptide content × purity	87.23	%w/w	—	NOT TESTED
Gross fill (as weighed)	five-place balance, under nitrogen	2.25	mg	2 mg declared	NOT TESTED
Recovered target peptide	gross fill × target content	1.963	mg	2 mg claim	NOT TESTED
Recovery against label claim	recovered ÷ claim	98.2	%	90.0 – 110.0	PASS
Water content	Karl Fischer, coulometric, duplicate	5.91	%	≤ 8.0	PASS
Counter-ion (acetate)	anion-exchange ion chromatography	5.93	%	≤ 10.0	PASS
Residual solvent + inorganic residue	estimated — see /methods/residual-solvents-q3c/	0.54	%	—	NOT TESTED
Endotoxin	kinetic chromogenic LAL	0.30	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 to pale-yellow 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	5.50	—	2.5 – 8.0	PASS
Retention time (observed)	RP-HPLC, 30 min gradient	8.04	min	8.14 ± 0.25 (normalised)	PASS
Peak asymmetry (10 % height)	Ph. Eur. 2.2.46	1.10	—	0.80 – 1.50	PASS
Plate count, main peak	N = 5.54 (t/w½)²	52,555	—	≥ 20,000	PASS
Resolution to nearest impurity	vs [L-Arg8]-diastereomer (vasopressin-like)	1.25	—	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 52,555, and skew follows the reported asymmetry factor of 1.10. 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 0.21 % impurity against a 99.55 % 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	8.04	4,838,439	99.55	—
2	des-amino artefact (+16 Da)	7.74	10,207	0.21	+15.995
3	[L-Arg8]-diastereomer (vasopressin-like)	7.86	6,318	0.13	0.000
4	desmopressin dimer	10.28	3,402	0.07	+1066.411
5	open-chain (reduced disulfide, +2 Da)	7.50	1,944	0.04	+2.016
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	5.91
Counter-ion (acetate)	ion chromatography	5.93
Residual solvent + inorganic residue	estimated	0.54
Total peptide content	by difference	87.62
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)	99.45	99.55	divergence -0.11 pp vs batch median
Total impurities (% area)	0.55	0.45
Largest single impurity (% area)	0.31	0.21
Water (%)	4.4	5.91
Counter-ion (%)	not stated	5.93
Peptide content (%w/w)	not stated	87.62
Endotoxin (EU/mg)	not stated	0.30
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 → third-party forwarder (29 d) → laboratory (courier, cold pack, 10 d) → assay.
Assay date: 15 Feb 2024
Submitted to the index: 04 Mar 2024
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 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.

dedupe_logic04 Mar 2024

Two retail purchases of the same lot from different buyers are genuinely independent. Two aliquots of one purchase are not, and the index does not treat them as such.

triptorelin_dtrp04 Mar 2024

Enantiomeric and epimeric impurities are the extreme case: identical mass, near-identical retention, and separable only by a method chosen for the purpose.

hplc_ola04 Mar 2024

Nothing on this record is flagged for resolution and nothing will be. The figure exists so the reader can weight the purity number, which is its only purpose.

Section 7

Related records

Same batch — lot WWB-2312-E2908 n=8

Report	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Result
AX-2024-004153	WWB-2312-E2908	Janoshik	2024-Q1	99.54	5.52	101.8	Buyer-sourced	PASS
AX-2024-004154	WWB-2312-E2908	PeptideMeter	2024-Q1	99.57	4.76	99.1	Buyer-sourced	PASS
AX-2024-004155	WWB-2312-E2908	Nordanalyt	2024-Q1	99.35	5.31	—	Buyer-sourced	PASS
AX-2024-004156	WWB-2312-E2908	Janoshik	2024-Q1	99.74	4.81	—	Laboratory-retained	PASS
AX-2024-004157	WWB-2312-E2908	Janoshik	2024-Q1	99.64	5.87	101.1	Buyer-sourced	PASS
AX-2024-004159	WWB-2312-E2908	PeptideMeter	2024-Q1	99.48	5.55	107.3	Buyer-sourced	PASS
AX-2024-004160	WWB-2312-E2908	Medutest	2024-Q1	99.93	5.46	—	Laboratory-retained	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-2026-043067	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-2026-043065	KP	KP-2512-U5694	Janoshik	2026-Q2	98.65	3.28	101.1	Buyer-sourced	PASS

Other recent WWB records in the index.
Report	Compound	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Flags	Result
AX-2026-041275	Liraglutide	WWB-2607-X2189	Nordanalyt	2026-Q3	99.33	4.39	—	Buyer-sourced	1	MARGINAL
AX-2026-041334	Semaglutide	WWB-2606-N3192	Janoshik	2026-Q3	98.93	4.62	99.9	Buyer-sourced	0	PASS
AX-2026-041337	Semaglutide	WWB-2606-N3192	Nordanalyt	2026-Q3	99.52	3.92	—	Buyer-sourced	0	PASS
AX-2026-041335	Semaglutide	WWB-2606-N3192	Janoshik	2026-Q3	99.15	4.27	98.9	Buyer-sourced	0	PASS
AX-2026-041271	Liraglutide	WWB-2607-X2189	Medutest	2026-Q3	99.52	4.57	97.4	Buyer-sourced	1	MARGINAL
AX-2026-041328	Semaglutide	WWB-2606-N3192	Janoshik	2026-Q3	98.99	4.47	106.1	Buyer-sourced	0	PASS
AX-2026-041333	Semaglutide	WWB-2606-N3192	Janoshik	2026-Q3	99.18	4.51	90.4	Laboratory-retained	0	PASS
AX-2026-041273	Liraglutide	WWB-2607-X2189	Janoshik	2026-Q3	99.31	5.52	104.8	Buyer-sourced	1	MARGINAL