AX-2024-004708 · Oxytocin · Homopeptide lot HOMO-2405-U3389

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	99.93	% area	≥ 98.5	PASS
Total impurities	RP-HPLC, sum of reported peaks	0.07	% area	≤ 1.5	PASS
Largest single impurity	RP-HPLC — deamidated Gln4 (+1 Da)	0.04	% area	≤ 1.00	PASS
Identity — theoretical monoisotopic mass	calculated from molecular formula	1006.4365	Da	—	NOT TESTED
Identity — observed monoisotopic mass	LC-MS, high resolution (ESI-TOF/QTOF)	1006.4370	Da	—	NOT TESTED
Mass accuracy	observed vs theoretical	+0.5	ppm	± 15	PASS
Total peptide content	by difference from the gravimetric mass balance	87.76	%w/w	—	NOT TESTED
Target-compound content	total peptide content × purity	87.70	%w/w	—	NOT TESTED
Gross fill (as weighed)	five-place balance, under nitrogen	2.06	mg	2 mg declared	NOT TESTED
Recovered target peptide	gross fill × target content	1.807	mg	2 mg claim	NOT TESTED
Recovery against label claim	recovered ÷ claim	90.4	%	90.0 – 110.0	PASS
Water content	Karl Fischer, coulometric, duplicate	5.74	%	≤ 8.0	PASS
Counter-ion (acetate)	anion-exchange ion chromatography	5.70	%	≤ 10.0	PASS
Residual solvent + inorganic residue	estimated — see /methods/residual-solvents-q3c/	0.80	%	—	NOT TESTED
Endotoxin	kinetic chromogenic LAL	5.97	EU/mg	≤ 5.0	FAIL
Sterility	not ordered on this submission	not determined	—	no growth	NOT TESTED
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	Clear, colourless, no visible particulates	—	clear, no visible particulates	PASS
pH (reconstituted, 1 mg/mL)	potentiometric, two-point calibration	4.95	—	2.5 – 8.0	PASS
Retention time (observed)	RP-HPLC, 30 min gradient	7.89	min	7.92 ± 0.25 (normalised)	PASS
Peak asymmetry (10 % height)	Ph. Eur. 2.2.46	1.23	—	0.80 – 1.50	PASS
Plate count, main peak	N = 5.54 (t/w½)²	57,166	—	≥ 20,000	PASS
Resolution to nearest impurity	vs deamidated Gln4 (+1 Da)	1.63	—	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 57,166, and skew follows the reported asymmetry factor of 1.23. 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 0.04 % 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	Oxytocin — main peak	7.89	4,856,908	99.93	—
2	deamidated Gln4 (+1 Da)	7.67	1,944	0.04	+0.984
3	des-Gly9 (−57 Da)	7.59	1,458	0.03	-57.021
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 1006.4365 Da, computed from C43H66N12O12S2. 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 1006.4370 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+	336.4861	336.4863	0.0002	9.0
2+	504.2255	504.2258	0.0003	57.6
1+	1007.4438	1007.4443	0.0005	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	5.74
Counter-ion (acetate)	ion chromatography	5.70
Residual solvent + inorganic residue	estimated	0.80
Total peptide content	by difference	87.76
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)	99.73	99.93	divergence -0.20 pp vs batch median
Total impurities (% area)	0.27	0.07
Largest single impurity (% area)	not stated	0.04
Water (%)	5.5	5.74
Counter-ion (%)	not stated	5.70
Peptide content (%w/w)	not stated	87.76
Endotoxin (EU/mg)	4.09	5.97
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 → submitter (−20 °C, 24 d) → laboratory (courier, dry ice, 10 d) → assay.
Assay date: 08 Sep 2024
Submitted to the index: 23 Sep 2024
Laboratory: Janoshik Analytical, Ostrava, Czechia
Method basis: 30 min gradient · high-resolution MS
Verification status: VERIFIED

What this report does not establish

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 4

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.

diode_array23 Sep 2024

Photodiode-array spectral homogeneity across the main peak would convert 99.93 % from a good number into a checked one. It is a free measurement on any instrument that already has the detector.

units_pedant23 Sep 2024

A closed balance is what converts a purity figure into a mass. 87.70 %w/w target content on a 2 mg claim gives 1.81 mg recovered, and every step of that is on the record.

salt_exchange23 Sep 2024

Incomplete salt exchange leaves two counter-ions in the cake and only one gets measured. That is the commonest way a real balance acquires a genuine remainder.

spec_vs_result23 Sep 2024

A balance that closes says nothing about whether any of the four values is within specification. Consistency and compliance are different properties and this record demonstrates the first.

Section 7

Related records

Same batch — lot HOMO-2405-U3389 n=14

Report	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Flags	Result
AX-2024-004706	HOMO-2405-U3389	Janoshik	2024-Q3	99.93	5.57	104.1	Buyer-sourced	0	PASS
AX-2024-004707	HOMO-2405-U3389	Janoshik	2024-Q3	99.93	6.28	94.4	Buyer-sourced	0	PASS
AX-2024-004709	HOMO-2405-U3389	Janoshik	2024-Q3	99.93	5.12	—	Buyer-sourced	0	PASS
AX-2024-004710	HOMO-2405-U3389	Janoshik	2024-Q3	99.93	6.56	101.4	Buyer-sourced	0	PASS
AX-2024-004711	HOMO-2405-U3389	Nordanalyt	2024-Q3	99.92	5.88	104.0	Buyer-sourced	0	PASS
AX-2024-004712	HOMO-2405-U3389	VendorInvestigate	2024-Q3	99.73	6.24	92.2	Buyer-sourced	0	PASS
AX-2024-004713	HOMO-2405-U3389	VendorInvestigate	2024-Q3	99.63	5.73	102.3	Laboratory-retained	0	PASS
AX-2024-004714	HOMO-2405-U3389	Nordanalyt	2024-Q3	99.93	6.78	105.5	Supplier-supplied	0	PASS
AX-2024-004715	HOMO-2405-U3389	Janoshik	2024-Q3	99.93	6.44	—	Buyer-sourced	0	PASS
AX-2024-004716	HOMO-2405-U3389	Janoshik	2024-Q3	99.93	5.57	—	Buyer-sourced	0	FAIL
AX-2024-004717	HOMO-2405-U3389	Medutest	2024-Q3	99.86	6.13	—	Buyer-sourced	0	PASS
AX-2024-004718	HOMO-2405-U3389	Janoshik	2024-Q3	99.93	6.05	—	Buyer-sourced	0	PASS
AX-2024-004719	HOMO-2405-U3389	Medutest	2024-Q3	99.73	5.50	—	Buyer-sourced	1	MARGINAL

Batch rollup and reproducibility assessment →

Cross-sections

Other recent Oxytocin records in the index.
Report	Supplier	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Flags	Result
AX-2026-041398	QYB	QYB-2601-V4429	Medutest	2026-Q2	99.60	4.73	91.8	Buyer-sourced	0	PASS
AX-2026-041400	QYB	QYB-2601-V4429	Medutest	2026-Q2	99.51	4.55	—	Buyer-sourced	1	MARGINAL
AX-2026-041393	QYB	QYB-2601-V4429	PeptideMeter	2026-Q2	99.69	4.63	—	Buyer-sourced	0	PASS
AX-2026-041395	QYB	QYB-2601-V4429	Janoshik	2026-Q2	99.93	4.24	101.7	Buyer-sourced	0	PASS
AX-2026-041950	AMB	AMB-2602-G4870	Janoshik	2026-Q2	99.82	3.21	—	Buyer-sourced	0	PASS
AX-2026-041397	QYB	QYB-2601-V4429	Janoshik	2026-Q2	99.62	4.38	102.8	Buyer-sourced	0	PASS
AX-2026-041396	QYB	QYB-2601-V4429	PeptideMeter	2026-Q2	99.69	3.97	—	Buyer-sourced	0	PASS
AX-2026-041394	QYB	QYB-2601-V4429	Medutest	2026-Q2	99.66	5.17	—	Buyer-sourced	0	PASS

Other recent Homopeptide records in the index.
Report	Compound	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Result
AX-2026-042437	Retatrutide	HOMO-2605-V4718	Nordanalyt	2026-Q3	98.68	3.67	102.8	Buyer-sourced	PASS
AX-2026-042424	Semaglutide	HOMO-2604-X3806	PeptideMeter	2026-Q3	98.85	4.87	92.0	Buyer-sourced	PASS
AX-2026-042503	IGF-1 LR3	HOMO-2607-P5131	Janoshik	2026-Q3	99.36	5.99	—	Buyer-sourced	PASS
AX-2026-042492	SS-31 (Elamipretide)	HOMO-2604-D5484	Medutest	2026-Q3	99.93	2.40	—	Buyer-sourced	PASS
AX-2026-042491	SS-31 (Elamipretide)	HOMO-2604-D5484	Kestrel	2026-Q3	99.93	3.24	—	Supplier-supplied	PASS
AX-2026-042473	LL-37	HOMO-2602-G5165	Janoshik	2026-Q3	99.01	5.00	—	Buyer-sourced	PASS
AX-2026-042441	Retatrutide	HOMO-2605-V4718	Medutest	2026-Q3	98.93	4.22	—	Buyer-sourced	PASS
AX-2026-042474	LL-37	HOMO-2602-G5165	Janoshik	2026-Q3	99.18	5.44	—	Buyer-sourced	PASS