AX-2025-018975

Oxytocin · 10 mg declared · Asymchem Laboratories (Tianjin) Co., Ltd. · lot ASY-{CAT}-1898

PASSVERIFIED

Report ID: AX-2025-018975
Compound: Oxytocin
Compound class: Hypothalamic and posterior-pituitary hormones
Supplier: ASY — Asymchem Laboratories (Tianjin) Co., Ltd.
Batch / lot: ASY-{CAT}-1898
Declared label claim: 10mg
Laboratory: PeptideMeter
Assay date: 27 Nov 2025
Submitted: 10 Dec 2025
Quarter: 2025-Q4
Submitter: label_claim
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, 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)	0.04	% 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)	1006.4343	Da	—	NOT TESTED
Mass accuracy	observed vs theoretical	-2.2	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	3.12	%	≤ 8.0	PASS
Counter-ion (acetate)	anion-exchange ion chromatography	4.27	%	≤ 10.0	PASS
Residual solvent + inorganic residue	estimated — see /methods/residual-solvents-q3c/	0.74	%	—	NOT TESTED
Endotoxin	kinetic chromogenic LAL	0.31	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 lyophilised cake, intact	—	white to off-white intact cake	PASS
Reconstitution clarity	reconstituted per submitter procedure	Visible particulates, did not clear	—	clear, no visible particulates	FAIL
pH (reconstituted, 1 mg/mL)	potentiometric, two-point calibration	4.89	—	2.5 – 8.0	PASS
Retention time (observed)	RP-HPLC, 28 min gradient	7.48	min	7.43 ± 0.25 (normalised)	PASS
Peak asymmetry (10 % height)	Ph. Eur. 2.2.46	0.89	—	0.80 – 1.50	PASS
Plate count, main peak	N = 5.54 (t/w½)²	58,280	—	≥ 20,000	PASS
Resolution to nearest impurity	vs deamidated Gln4 (+1 Da)	1.62	—	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 58,280, and skew follows the reported asymmetry factor of 0.89. 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	7.48	4,856,908	99.93	—
2	open-chain (reduced disulfide, +2 Da)	6.99	1,944	0.04	+2.016
3	deamidated Gln4 (+1 Da)	7.27	1,458	0.03	+0.984
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 1006.4343 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	336.4854	-0.0007	8.4
2+	504.2255	504.2244	-0.0011	56.1
1+	1007.4438	1007.4416	-0.0022	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)	99.61	99.93	divergence -0.32 pp vs batch median
Total impurities (% area)	0.39	0.07
Largest single impurity (% area)	0.28	0.04
Water (%)	2.8	3.12
Counter-ion (%)	not stated	4.27
Peptide content (%w/w)	not stated	not determined
Endotoxin (EU/mg)	not stated	0.31
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: Retail purchase → submitter (ambient, 20 d) → laboratory (courier, cold pack, 7 d) → assay.
Assay date: 27 Nov 2025
Submitted to the index: 10 Dec 2025
Laboratory: PeptideMeter, Tallinn, Estonia
Method basis: 28 min gradient · high-resolution MS
Verification status: VERIFIED

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 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 2

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.

peak_integrator10 Dec 2025

99.93 % is normalised area, so it is silent on how much peptide is in the vial. Content and water are the numbers that answer that, and both are on this record. Purity is the good news; content is the actionable news.

uncertainty_budget10 Dec 2025

Expanded uncertainty on a well-resolved main peak is about ±0.48 pp at 95 % confidence. 99.93 % should be read as a band, and the band is still comfortably above the class specification.

Section 7

Related records

Same batch — lot ASY-{CAT}-1898 n=13

Report	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Result
AX-2025-018971	ASY-{CAT}-1898	Medutest	2025-Q4	99.93	3.51	—	Buyer-sourced	PASS
AX-2025-018972	ASY-{CAT}-1898	Janoshik	2025-Q4	99.93	3.50	94.3	Buyer-sourced	PASS
AX-2025-018973	ASY-{CAT}-1898	Janoshik	2025-Q4	99.93	3.80	93.5	Buyer-sourced	PASS
AX-2025-018974	ASY-{CAT}-1898	VendorInvestigate	2025-Q4	99.84	3.91	—	Buyer-sourced	PASS
AX-2026-041772	ASY-{CAT}-1898	VendorInvestigate	2025-Q4	99.28	3.31	101.2	Buyer-sourced	PASS
AX-2025-018976	ASY-{CAT}-1898	VendorInvestigate	2025-Q4	99.63	3.96	98.0	Buyer-sourced	PASS
AX-2025-018977	ASY-{CAT}-1898	Janoshik	2025-Q4	99.63	3.90	96.7	Buyer-sourced	PASS
AX-2025-018978	ASY-{CAT}-1898	VendorInvestigate	2025-Q4	99.90	3.36	91.8	Buyer-sourced	PASS
AX-2025-018979	ASY-{CAT}-1898	Janoshik	2025-Q4	99.65	4.00	101.9	Buyer-sourced	PASS
AX-2025-018980	ASY-{CAT}-1898	Medutest	2025-Q4	99.93	4.00	—	Buyer-sourced	PASS
AX-2025-018981	ASY-{CAT}-1898	Janoshik	2025-Q4	99.93	3.40	101.6	Buyer-sourced	PASS
AX-2025-018982	ASY-{CAT}-1898	Janoshik	2025-Q4	99.93	4.26	97.3	Buyer-sourced	PASS

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 ASY records in the index.
Report	Compound	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Flags	Result
AX-2026-041776	TB-500	ASY-{CAT}-2167	Janoshik	2026-Q3	99.92	4.61	98.2	Buyer-sourced	0	PASS
AX-2026-041777	TB-500	ASY-{CAT}-2167	PeptideMeter	2026-Q3	99.78	4.09	92.8	Buyer-sourced	0	PASS
AX-2026-041786	Retatrutide	ASY-{CAT}-2288	VendorInvestigate	2026-Q3	98.78	6.59	—	Buyer-sourced	0	PASS
AX-2026-041782	TB-500	ASY-{CAT}-2167	Nordanalyt	2026-Q3	99.93	3.94	—	Buyer-sourced	0	PASS
AX-2026-041793	Retatrutide	ASY-{CAT}-2288	Nordanalyt	2026-Q3	98.34	6.16	104.8	Buyer-sourced	0	PASS
AX-2026-041784	Retatrutide	ASY-{CAT}-2288	PeptideMeter	2026-Q3	98.15	6.26	91.9	Buyer-sourced	0	PASS
AX-2026-041774	TB-500	ASY-{CAT}-2167	PeptideMeter	2026-Q3	99.93	4.41	96.2	Buyer-sourced	0	PASS
AX-2026-041780	TB-500	ASY-{CAT}-2167	Janoshik	2026-Q3	99.93	3.48	102.5	Buyer-sourced	1	FAIL