AX-2025-018866 · Desmopressin · QSC lot QSC-2505-N8999

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, 28 min gradient, 214 nm	99.93	% area	≥ 98.5	PASS
Total impurities	RP-HPLC, sum of reported peaks	0.07	% area	≤ 1.5	PASS
Largest single impurity	RP-HPLC — open-chain (reduced disulfide, +2 Da)	0.05	% 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)	1068.4247	Da	—	NOT TESTED
Mass accuracy	observed vs theoretical	-1.7	ppm	± 15	PASS
Total peptide content	by difference from the gravimetric mass balance	88.97	%w/w	—	NOT TESTED
Target-compound content	total peptide content × purity	88.91	%w/w	—	NOT TESTED
Gross fill (as weighed)	five-place balance, under nitrogen	1.07	mg	1 mg declared	NOT TESTED
Recovered target peptide	gross fill × target content	0.951	mg	1 mg claim	NOT TESTED
Recovery against label claim	recovered ÷ claim	95.1	%	90.0 – 110.0	PASS
Water content	Karl Fischer, coulometric, duplicate	4.57	%	≤ 8.0	PASS
Counter-ion (acetate)	anion-exchange ion chromatography	5.65	%	≤ 10.0	PASS
Residual solvent + inorganic residue	estimated — see /methods/residual-solvents-q3c/	0.81	%	—	NOT TESTED
Endotoxin	not ordered on this submission	not determined	—	≤ 5.0	NOT TESTED
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	Faint haze, clearing on standing	—	clear, no visible particulates	FAIL
pH (reconstituted, 1 mg/mL)	potentiometric, two-point calibration	4.74	—	2.5 – 8.0	PASS
Retention time (observed)	RP-HPLC, 28 min gradient	7.82	min	7.64 ± 0.25 (normalised)	PASS
Peak asymmetry (10 % height)	Ph. Eur. 2.2.46	1.05	—	0.80 – 1.50	PASS
Plate count, main peak	N = 5.54 (t/w½)²	76,160	—	≥ 20,000	PASS
Resolution to nearest impurity	vs [L-Arg8]-diastereomer (vasopressin-like)	1.45	—	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, 28 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 76,160, and skew follows the reported asymmetry factor of 1.05. 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 0.05 % impurity against a 99.93 % 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	7.82	4,856,908	99.93	—
2	open-chain (reduced disulfide, +2 Da)	7.32	2,430	0.05	+2.016
3	[L-Arg8]-diastereomer (vasopressin-like)	7.65	972	0.02	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 1068.4247 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	357.1488	-0.0006	8.4
2+	535.2205	535.2196	-0.0009	52.6
1+	1069.4338	1069.4320	-0.0018	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.

Component	Determination	%w/w of cake
Water	Karl Fischer	4.57
Counter-ion (acetate)	ion chromatography	5.65
Residual solvent + inorganic residue	estimated	0.81
Total peptide content	by difference	88.97
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)	99.90	99.93	divergence +0.28 pp vs batch median
Total impurities (% area)	0.10	0.07
Largest single impurity (% area)	0.05	0.05
Water (%)	2.6	4.57
Counter-ion (%)	2.4	5.65
Peptide content (%w/w)	94.4	88.97
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: Supplier-supplied
Evidentiary weight: Weaker evidence. Read with the caveat below.
Chain of custody: Supplier despatch → laboratory direct (courier, cold pack, 11 d) → assay. Submitter did not handle the vial.
Assay date: 15 Jul 2025
Submitted to the index: 22 Jul 2025
Laboratory: PeptideMeter, Tallinn, Estonia
Method basis: 28 min gradient · high-resolution MS
Verification status: VERIFIED

What this report does not establish

That the material is free of bacterial endotoxin. Endotoxin was not measured. No chromatographic result bears on 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 QSC-2505-N8999 n=12

Report	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Flags	Result
AX-2025-018856	QSC-2505-N8999	PeptideMeter	2025-Q3	99.93	4.36	89.0	Supplier-supplied	1	MARGINAL
AX-2025-018857	QSC-2505-N8999	Janoshik	2025-Q3	99.52	4.30	—	Supplier-supplied	0	PASS
AX-2025-018858	QSC-2505-N8999	Medutest	2025-Q3	99.93	4.92	—	Supplier-supplied	0	PASS
AX-2025-018859	QSC-2505-N8999	Janoshik	2025-Q3	99.93	4.31	—	Supplier-supplied	0	PASS
AX-2025-018860	QSC-2505-N8999	PeptideMeter	2025-Q3	99.82	5.00	103.4	Supplier-supplied	1	MARGINAL
AX-2025-018861	QSC-2505-N8999	Kestrel	2025-Q3	99.31	4.25	93.6	Supplier-supplied	2	FAIL
AX-2025-018862	QSC-2505-N8999	Janoshik	2025-Q3	99.63	4.07	—	Supplier-supplied	1	FAIL
AX-2025-018863	QSC-2505-N8999	PeptideMeter	2025-Q3	99.57	4.52	—	Supplier-supplied	0	PASS
AX-2025-018864	QSC-2505-N8999	Janoshik	2025-Q3	99.61	4.56	—	Supplier-supplied	1	FAIL
AX-2025-018865	QSC-2505-N8999	Janoshik	2025-Q3	99.48	4.06	100.2	Supplier-supplied	0	PASS
AX-2025-018867	QSC-2505-N8999	Janoshik	2025-Q3	99.35	4.22	95.4	Supplier-supplied	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	Flags	Result
AX-2026-042988	KP	KP-2512-U5139	Janoshik	2026-Q2	98.72	3.00	—	Supplier-supplied	1	MARGINAL
AX-2026-042985	KP	KP-2512-U5139	Janoshik	2026-Q2	98.46	2.18	—	Supplier-supplied	1	FAIL
AX-2026-042983	KP	KP-2512-U5139	PeptideMeter	2026-Q2	98.39	2.64	95.6	Buyer-sourced	1	FAIL
AX-2026-042982	KP	KP-2512-U5139	Janoshik	2026-Q2	98.34	3.07	100.0	Buyer-sourced	1	FAIL
AX-2026-042986	KP	KP-2512-U5139	Janoshik	2026-Q2	98.79	2.56	101.6	Supplier-supplied	1	MARGINAL
AX-2026-042989	KP	KP-2512-U5139	Medutest	2026-Q2	98.77	2.79	107.0	Supplier-supplied	2	MARGINAL
AX-2026-042981	KP	KP-2512-U5139	PeptideMeter	2026-Q2	99.26	2.49	105.5	Supplier-supplied	2	MARGINAL
AX-2026-042987	KP	KP-2512-U5139	VendorInvestigate	2026-Q2	98.35	2.86	—	Buyer-sourced	1	FAIL

Other recent QSC records in the index.
Report	Compound	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Flags	Result
AX-2026-041683	CJC-1295 (no DAC)	QSC-2606-V8637	Janoshik	2026-Q3	99.93	3.63	97.1	Supplier-supplied	1	FAIL
AX-2026-041727	CJC-1295 with DAC	QSC-2602-E9474	Janoshik	2026-Q3	98.88	6.62	105.3	Supplier-supplied	1	MARGINAL
AX-2026-041728	CJC-1295 with DAC	QSC-2602-E9474	VendorInvestigate	2026-Q3	98.42	7.04	—	Buyer-sourced	1	MARGINAL
AX-2026-041734	CJC-1295 with DAC	QSC-2602-E9474	Medutest	2026-Q3	99.43	7.17	105.5	Supplier-supplied	2	FAIL
AX-2026-041652	Liraglutide	QSC-2605-W8602	Nordanalyt	2026-Q3	99.33	6.55	—	Supplier-supplied	0	PASS
AX-2026-041730	CJC-1295 with DAC	QSC-2602-E9474	PeptideMeter	2026-Q3	98.79	6.93	95.4	Supplier-supplied	1	MARGINAL
AX-2026-041686	CJC-1295 (no DAC)	QSC-2606-V8637	Janoshik	2026-Q3	99.93	4.04	—	Supplier-supplied	0	PASS
AX-2026-041653	Liraglutide	QSC-2605-W8602	VendorInvestigate	2026-Q3	98.82	5.95	—	Buyer-sourced	0	PASS