AssayIndex

AX-2025-020214

Desmopressin · 2 mg declared · Nantong Guangyuan Chemical Co., Ltd. · lot GGPE-2511-Y1573

FAILVERIFIED
Report ID
AX-2025-020214
Compound
Desmopressin
Compound class
Hypothalamic and posterior-pituitary hormones
Supplier
GGPeps — Nantong Guangyuan Chemical Co., Ltd.
Batch / lot
GGPE-2511-Y1573
Declared label claim
2mg
Laboratory
VendorInvestigate
Assay date
04 Nov 2025
Submitted
12 Nov 2025
Quarter
2025-Q4
Submitter
k.guerrero
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.

ParameterMethodResultUnitIndex spec
PurityRP-HPLC, 32 min gradient, 214 nm98.44% area≥ 98.5FAIL
Total impuritiesRP-HPLC, sum of reported peaks1.56% area≤ 1.5FAIL
Largest single impurityRP-HPLC — open-chain (reduced disulfide, +2 Da)1.03% area≤ 1.00FAIL
Identity — theoretical monoisotopic masscalculated from molecular formula1068.4265Da—NOT TESTED
Identity — observed monoisotopic massLC-MS, high resolution (ESI-TOF/QTOF)1068.4289Da—NOT TESTED
Mass accuracyobserved vs theoretical+2.2ppm± 15PASS
Peptide contentnot ordered on this submissionnot determined—required to check label claimNOT TESTED
Water contentKarl Fischer, coulometric, duplicate3.42%≤ 8.0PASS
Counter-ion (acetate)anion-exchange ion chromatography5.95%≤ 10.0PASS
Residual solvent + inorganic residueestimated — see /methods/residual-solvents-q3c/0.78%—NOT TESTED
Endotoxinkinetic chromogenic LAL1.03EU/mg≤ 5.0PASS
Sterilitymembrane filtration, USP <71>, 14 dNo growth at 14 d—no growthPASS
Appearancevisual, diffuse light, black and white backgroundOff-white lyophilised cake, intact—white to off-white intact cakePASS
Reconstitution clarityreconstituted per submitter procedureClear with a single visible fibre—clear, no visible particulatesFAIL
pH (reconstituted, 1 mg/mL)potentiometric, two-point calibration5.11—2.5 – 8.0PASS
Retention time (observed)RP-HPLC, 32 min gradient8.56min8.64 ± 0.25 (normalised)PASS
Peak asymmetry (10 % height)Ph. Eur. 2.2.461.12—0.80 – 1.50PASS
Plate count, main peakN = 5.54 (t/w½)²58,752—≥ 20,000PASS
Resolution to nearest impurityvs [L-Arg8]-diastereomer (vasopressin-like)1.33—no index criterionREPORTED
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.

030446088913212176 Desmopressin8.56 min · 98.44 % 7.9810.95 same trace · ×50 vertical expansion, baseline-corrected · main peak off-scale reporting threshold 0.05 % area 05101520253035 Retention time (min) Response (mAU)
Figure 1. RP-HPLC trace, 32 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 58,752, and skew follows the reported asymmetry factor of 1.12. 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 1.03 % impurity against a 98.44 % main peak is a line two pixels tall; the main peak runs off-scale there by design.
#PeakRTArea (µV·s)% areaΔ mass (Da)
1Desmopressin — main peak8.564,784,48998.44—
2open-chain (reduced disulfide, +2 Da)7.9850,0611.03+2.016
3[L-Arg8]-diastereomer (vasopressin-like)8.3713,1230.270.000
4des-amino artefact (+16 Da)8.246,3180.13+15.995
5desmopressin dimer10.956,3180.13+1066.411
Closure check — purity + Σ impurities 100.00CLOSES

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.

025507510025040055070085010001150 [M+1H]1+1069.44[M+2H]2+535.22 m/z Relative abundance (%)
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 1068.4289 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.
ChargeTheoretical m/zObserved m/zΔ m/zRel. abundance (%)
3+357.1494357.15020.00088.6
2+535.2205535.22170.001258.3
1+1069.43381069.43620.0024100.0
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.

FigureSupplier COAThis reportIndex note
Purity (% area)99.7198.44divergence +0.30 pp vs batch median
Total impurities (% area)0.291.56
Largest single impurity (% area)0.131.03
Water (%)not stated3.42
Counter-ion (%)not stated5.95
Peptide content (%w/w)not statednot determined
Endotoxin (EU/mg)0.841.03
Method stated on certificateYES—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 (−20 °C, 29 d) → laboratory (courier, dry ice, 11 d) → assay.
Assay date
04 Nov 2025
Submitted to the index
12 Nov 2025
Laboratory
VendorInvestigate, Riga, Latvia
Method basis
32 min gradient · high-resolution MS
Verification status
VERIFIED
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 GGPE-2511-Y1573 n=4

ReportLotLabQuarterPurity %Water %Recovery %ProvenanceFlagsResult
AX-2025-020213GGPE-2511-Y1573Janoshik2025-Q499.363.52—Supplier-supplied2FAIL
AX-2025-020215GGPE-2511-Y1573Janoshik2025-Q499.463.77—Supplier-supplied1MARGINAL
AX-2025-020216GGPE-2511-Y1573Janoshik2025-Q499.483.67—Supplier-supplied2MARGINAL

Cross-sections

Other recent Desmopressin records in the index.
ReportSupplierLotLabQuarterPurity %Water %Recovery %ProvenanceFlagsResult
AX-2026-042988KPKP-2512-U5139Janoshik2026-Q298.723.00—Supplier-supplied1MARGINAL
AX-2026-042985KPKP-2512-U5139Janoshik2026-Q298.462.18—Supplier-supplied1FAIL
AX-2026-042983KPKP-2512-U5139PeptideMeter2026-Q298.392.6495.6Buyer-sourced1FAIL
AX-2026-042982KPKP-2512-U5139Janoshik2026-Q298.343.07100.0Buyer-sourced1FAIL
AX-2026-042986KPKP-2512-U5139Janoshik2026-Q298.792.56101.6Supplier-supplied1MARGINAL
AX-2026-042989KPKP-2512-U5139Medutest2026-Q298.772.79107.0Supplier-supplied2MARGINAL
AX-2026-042981KPKP-2512-U5139PeptideMeter2026-Q299.262.49105.5Supplier-supplied2MARGINAL
AX-2026-042987KPKP-2512-U5139VendorInvestigate2026-Q298.352.86—Buyer-sourced1FAIL
Other recent GGPeps records in the index.
ReportCompoundLotLabQuarterPurity %Water %Recovery %ProvenanceFlagsResult
AX-2026-042737SelankGGPE-2603-J9708Janoshik2026-Q398.409.1497.4Buyer-sourced0FAIL
AX-2026-042804SelankGGPE-2602-G2056Janoshik2026-Q398.507.97—Supplier-supplied0FAIL
AX-2026-042803SelankGGPE-2602-G2056Janoshik2026-Q398.488.01—Laboratory-retained1FAIL
AX-2026-042802SelankGGPE-2602-G2056Janoshik2026-Q398.747.0996.0Supplier-supplied0FAIL
AX-2026-042796SelankGGPE-2602-G2056Janoshik2026-Q398.267.5697.5Buyer-sourced0FAIL
AX-2026-042648Melanotan IIGGPE-2603-P8735Janoshik2026-Q399.106.97—Supplier-supplied4MARGINAL
AX-2026-042797SelankGGPE-2602-G2056Medutest2026-Q398.467.92—Buyer-sourced0FAIL
AX-2026-042669CJC-1295 (no DAC)GGPE-2606-E8495Medutest2026-Q398.614.0695.5Supplier-supplied0PASS