AX-2025-020596 · Sermorelin · SSA lot SSA-2409-X7161

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	98.46	% area	≥ 98.0	PASS
Total impurities	RP-HPLC, sum of reported peaks	1.54	% area	≤ 2.0	PASS
Largest single impurity	RP-HPLC — deamidated Asn8 (+1 Da)	1.08	% area	≤ 1.00	FAIL
Identity — theoretical monoisotopic mass	calculated from molecular formula	3355.7245	Da	—	NOT TESTED
Identity — observed monoisotopic mass	LC-MS, unit resolution (single quadrupole)	3355.6339	Da	—	NOT TESTED
Mass accuracy	observed vs theoretical	-27.0	ppm	± 15	FAIL
Total peptide content	by difference from the gravimetric mass balance	91.00	%w/w	—	NOT TESTED
Target-compound content	total peptide content × purity	89.60	%w/w	—	NOT TESTED
Gross fill (as weighed)	five-place balance, under nitrogen	11.26	mg	10 mg declared	NOT TESTED
Recovered target peptide	gross fill × target content	10.089	mg	10 mg claim	NOT TESTED
Recovery against label claim	recovered ÷ claim	100.9	%	90.0 – 110.0	PASS
Water content	Karl Fischer, coulometric, duplicate	4.84	%	≤ 9.0	PASS
Counter-ion (acetate)	anion-exchange ion chromatography	3.59	%	≤ 12.0	PASS
Residual solvent + inorganic residue	estimated — see /methods/residual-solvents-q3c/	0.57	%	—	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	Off-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	4.58	—	2.5 – 8.0	PASS
Retention time (observed)	RP-HPLC, 25 min gradient	10.51	min	10.52 ± 0.30 (normalised)	PASS
Peak asymmetry (10 % height)	Ph. Eur. 2.2.46	1.18	—	0.80 – 1.50	PASS
Plate count, main peak	N = 5.54 (t/w½)²	76,381	—	≥ 20,000	PASS
Resolution to nearest impurity	vs deamidated Asn8 (+1 Da)	1.60	—	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 76,381, and skew follows the reported asymmetry factor of 1.18. 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 1.08 % impurity against a 98.46 % 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	10.51	4,785,461	98.46	—
2	deamidated Asn8 (+1 Da)	10.26	52,491	1.08	+0.984
3	des-Tyr1 (−163 Da)	10.08	9,721	0.20	-163.063
4	truncated (1-25)	9.64	7,290	0.15	-455.248
5	aspartimide (−18 Da)	10.81	5,346	0.11	-18.011
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 3355.6339 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	672.1341	-0.0181	9.3
4+	839.9384	839.9158	-0.0226	57.4
3+	1119.5821	1119.5519	-0.0302	100.0
2+	1678.8695	1678.8242	-0.0453	60.7

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	4.84
Counter-ion (acetate)	ion chromatography	3.59
Residual solvent + inorganic residue	estimated	0.57
Total peptide content	by difference	91.00
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)	98.71	98.46	divergence +0.20 pp vs batch median
Total impurities (% area)	not stated	1.54
Largest single impurity (% area)	not stated	1.08
Water (%)	4.2	4.84
Counter-ion (%)	not stated	3.59
Peptide content (%w/w)	not stated	91.00
Endotoxin (EU/mg)	not stated	not determined
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: Domestic warehouse despatch → submitter (2–8 °C, 13 d) → laboratory (courier, cold pack, 3 d) → assay.
Assay date: 02 Feb 2025
Submitted to the index: 20 Feb 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 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 3

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.

ms_confirm20 Feb 2025

Two instruments or it is not confirmed. One instrument reading -27.0 ppm off is an instrument problem until a second one agrees with it.

ppm_error20 Feb 2025

A single excursion of this size against a clean run of prior results on the same instrument is a calibration event with a date on it. The laboratory's own sequence log would place it; the index does not hold one.

aaa_hydrolysis20 Feb 2025

Content by hydrolysis assumes complete recovery of every residue. Where it disagrees with the balance by a percent or two, the hydrolysis is the more likely culprit.

Section 7

Related records

Same batch — lot SSA-2409-X7161 n=6

Report	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Result
AX-2025-020595	SSA-2409-X7161	Janoshik	2025-Q1	98.29	5.14	107.4	Buyer-sourced	PASS
AX-2025-020597	SSA-2409-X7161	Janoshik	2025-Q1	98.35	4.66	92.8	Buyer-sourced	PASS
AX-2025-020598	SSA-2409-X7161	Janoshik	2025-Q1	98.63	4.81	—	Buyer-sourced	PASS
AX-2025-020599	SSA-2409-X7161	Medutest	2025-Q1	98.96	4.50	—	Supplier-supplied	PASS
AX-2025-020600	SSA-2409-X7161	Janoshik	2025-Q1	98.55	4.96	105.3	Buyer-sourced	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 SSA records in the index.
Report	Compound	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Flags	Result
AX-2026-043135	BPC-157	SSA-2601-N6863	Nordanalyt	2026-Q2	98.16	4.66	92.8	Buyer-sourced	1	MARGINAL
AX-2026-043160	GHK-Cu	SSA-2604-V7731	Janoshik	2026-Q2	98.01	4.02	91.8	Buyer-sourced	0	PASS
AX-2026-043157	GHK-Cu	SSA-2604-V7731	Medutest	2026-Q2	99.19	5.14	—	Supplier-supplied	0	PASS
AX-2026-043141	BPC-157	SSA-2601-N6863	Janoshik	2026-Q2	98.06	4.06	94.6	Buyer-sourced	1	MARGINAL
AX-2026-043154	GHK-Cu	SSA-2604-V7731	PeptideMeter	2026-Q2	97.82	4.82	101.6	Buyer-sourced	0	PASS
AX-2026-043137	BPC-157	SSA-2601-N6863	PeptideMeter	2026-Q2	98.17	4.14	—	Buyer-sourced	1	MARGINAL
AX-2026-043162	GHK-Cu	SSA-2604-V7731	Janoshik	2026-Q2	98.50	4.36	—	Supplier-supplied	0	PASS
AX-2026-043134	BPC-157	SSA-2601-N6863	Medutest	2026-Q2	97.89	4.01	—	Buyer-sourced	1	FAIL