AX-2025-020942 · Sermorelin · WXT lot WXT-2506-D3300

Section 1

Results

Measured against the index acceptance specification for the growth-hormone axis peptides 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, 25 min gradient, 214 nm	98.90	% area	≥ 98.0	PASS
Total impurities	RP-HPLC, sum of reported peaks	1.10	% area	≤ 2.0	PASS
Largest single impurity	RP-HPLC — des-Tyr1 (−163 Da)	0.46	% area	≤ 1.00	PASS
Identity — theoretical monoisotopic mass	calculated from molecular formula	3355.7245	Da	—	NOT TESTED
Identity — observed monoisotopic mass	LC-MS, unit resolution (single quadrupole)	3355.6782	Da	—	NOT TESTED
Mass accuracy	observed vs theoretical	-13.8	ppm	± 15	PASS
Total peptide content	by difference from the gravimetric mass balance	88.15	%w/w	—	NOT TESTED
Target-compound content	total peptide content × purity	87.18	%w/w	—	NOT TESTED
Gross fill (as weighed)	five-place balance, under nitrogen	16.89	mg	15 mg declared	NOT TESTED
Recovered target peptide	gross fill × target content	14.725	mg	15 mg claim	NOT TESTED
Recovery against label claim	recovered ÷ claim	98.2	%	90.0 – 110.0	PASS
Water content	Karl Fischer, coulometric, duplicate	6.40	%	≤ 9.0	PASS
Counter-ion (acetate)	anion-exchange ion chromatography	4.80	%	≤ 12.0	PASS
Residual solvent + inorganic residue	estimated — see /methods/residual-solvents-q3c/	0.65	%	—	NOT TESTED
Endotoxin	kinetic chromogenic LAL	0.33	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	Clear, colourless, no visible particulates	—	clear, no visible particulates	PASS
pH (reconstituted, 1 mg/mL)	potentiometric, two-point calibration	4.98	—	2.5 – 8.0	PASS
Retention time (observed)	RP-HPLC, 25 min gradient	10.50	min	10.52 ± 0.30 (normalised)	PASS
Peak asymmetry (10 % height)	Ph. Eur. 2.2.46	1.01	—	0.80 – 1.50	PASS
Plate count, main peak	N = 5.54 (t/w½)²	48,895	—	≥ 20,000	PASS
Resolution to nearest impurity	vs deamidated Asn8 (+1 Da)	1.28	—	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, 25 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 48,895, and skew follows the reported asymmetry factor of 1.01. 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 0.46 % impurity against a 98.90 % 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	Sermorelin — main peak	10.50	4,806,847	98.90	—
2	des-Tyr1 (−163 Da)	10.07	22,357	0.46	-163.063
3	aspartimide (−18 Da)	10.80	13,123	0.27	-18.011
4	deamidated Asn8 (+1 Da)	10.25	11,665	0.24	+0.984
5	truncated (1-25)	9.63	6,318	0.13	-455.248
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 3355.7245 Da, computed from C149H246N44O42. All ppm figures on this site are against monoisotopic values — see why that matters.

Figure 2. ESI charge-state envelope, unit-resolution instrument. Sticks are placed at m/z = (M + z × 1.007276)/z for the observed neutral mass of 3355.6782 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 (%)
5+	672.1522	672.1429	-0.0093	8.5
4+	839.9384	839.9268	-0.0116	53.5
3+	1119.5821	1119.5667	-0.0154	100.0
2+	1678.8695	1678.8464	-0.0231	54.9

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	6.40
Counter-ion (acetate)	ion chromatography	4.80
Residual solvent + inorganic residue	estimated	0.65
Total peptide content	by difference	88.15
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)	98.98	98.90	divergence -0.01 pp vs batch median
Total impurities (% area)	not stated	1.10
Largest single impurity (% area)	not stated	0.46
Water (%)	5.3	6.40
Counter-ion (%)	not stated	4.80
Peptide content (%w/w)	not stated	88.15
Endotoxin (EU/mg)	not stated	0.33
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 (2–8 °C, 18 d) → laboratory (courier, ambient, 4 d) → assay.
Assay date: 24 Sep 2025
Submitted to the index: 20 Oct 2025
Laboratory: Medutest, Ljubljana, Slovenia
Method basis: 25 min gradient · unit-resolution MS
Verification status: IDENTITY CONSISTENT

What this report does not establish

That the compound is not a near-isobaric alternative. Identity was confirmed at unit mass resolution, which cannot exclude species differing by 1 or 2 Da. The specific alternatives not excluded are named in the identity block above.
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 WXT-2506-D3300 n=2

Report	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Flags	Result
AX-2025-020943	WXT-2506-D3300	PeptideMeter	2025-Q3	99.07	5.87	103.2	Supplier-supplied	0	PASS

Batch rollup and reproducibility assessment →

Cross-sections

Other recent Sermorelin records in the index.
Report	Supplier	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Flags	Result
AX-2026-042339	TFC	TFC-2605-Y2176	Kestrel	2026-Q3	99.93	4.14	—	Supplier-supplied	1	FAIL
AX-2026-043389	WXT	WXT-2608-P3387	Medutest	2026-Q3	98.97	3.44	99.6	Supplier-supplied	0	PASS
AX-2026-042338	TFC	TFC-2605-Y2176	Janoshik	2026-Q3	98.96	3.27	—	Supplier-supplied	0	PASS
AX-2026-042341	TFC	TFC-2605-Y2176	Janoshik	2026-Q3	98.55	3.45	—	Buyer-sourced	0	PASS
AX-2026-042340	TFC	TFC-2605-Y2176	Medutest	2026-Q3	99.34	3.73	106.9	Buyer-sourced	0	PASS
AX-2026-041954	AMB	AMB-2512-V5420	Medutest	2026-Q2	99.07	3.72	—	Buyer-sourced	0	PASS
AX-2026-041958	AMB	AMB-2512-V5420	Janoshik	2026-Q2	99.14	4.48	—	Buyer-sourced	1	FAIL
AX-2026-041955	AMB	AMB-2512-V5420	Janoshik	2026-Q2	99.10	3.17	—	Buyer-sourced	0	PASS

Other recent WXT records in the index.
Report	Compound	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Flags	Result
AX-2026-043376	Semaglutide	WXT-2604-C3248	Janoshik	2026-Q3	97.08	4.22	—	Buyer-sourced	1	MARGINAL
AX-2026-043429	L-Glutathione (reduced)	WXT-2605-B3833	Nordanalyt	2026-Q3	98.48	6.58	96.9	Supplier-supplied	1	FAIL
AX-2026-043347	Leuprolide	WXT-2604-K2596	PeptideMeter	2026-Q3	99.16	5.99	93.6	Buyer-sourced	0	PASS
AX-2026-043353	Leuprolide	WXT-2604-K2596	Janoshik	2026-Q3	99.19	4.90	95.3	Laboratory-retained	0	PASS
AX-2026-043345	Leuprolide	WXT-2604-K2596	Janoshik	2026-Q3	98.93	5.28	—	Buyer-sourced	0	PASS
AX-2026-043424	L-Glutathione (reduced)	WXT-2605-B3833	PeptideMeter	2026-Q3	98.37	6.86	—	Buyer-sourced	0	FAIL
AX-2026-043374	Semaglutide	WXT-2604-C3248	Janoshik	2026-Q3	97.00	3.56	—	Buyer-sourced	1	MARGINAL
AX-2026-043377	Semaglutide	WXT-2604-C3248	PeptideMeter	2026-Q3	97.20	4.08	—	Buyer-sourced	1	MARGINAL