AX-2026-042536 · Tesamorelin · ERP lot ERP-2604-W7280

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, 30 min gradient, 214 nm	98.43	% area	≥ 97.0	PASS
Total impurities	RP-HPLC, sum of reported peaks	1.57	% area	≤ 3.0	PASS
Largest single impurity	RP-HPLC — Met sulfoxide (+16 Da)	0.88	% area	≤ 1.00	PASS
Identity — theoretical monoisotopic mass	calculated from molecular formula	5131.9276	Da	—	NOT TESTED
Identity — observed monoisotopic mass	LC-MS, high resolution (ESI-TOF/QTOF)	5131.9230	Da	—	NOT TESTED
Mass accuracy	observed vs theoretical	-0.9	ppm	± 15	PASS
Total peptide content	by difference from the gravimetric mass balance	91.04	%w/w	—	NOT TESTED
Target-compound content	total peptide content × purity	89.61	%w/w	—	NOT TESTED
Gross fill (as weighed)	five-place balance, under nitrogen	1.20	mg	1 mg declared	NOT TESTED
Recovered target peptide	gross fill × target content	1.075	mg	1 mg claim	NOT TESTED
Recovery against label claim	recovered ÷ claim	107.5	%	90.0 – 110.0	PASS
Water content	Karl Fischer, coulometric, duplicate	4.33	%	≤ 9.0	PASS
Counter-ion (acetate)	anion-exchange ion chromatography	3.88	%	≤ 12.0	PASS
Residual solvent + inorganic residue	estimated — see /methods/residual-solvents-q3c/	0.75	%	—	NOT TESTED
Endotoxin	kinetic chromogenic LAL	7.21	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	4.45	—	2.5 – 8.0	PASS
Retention time (observed)	RP-HPLC, 30 min gradient	15.45	min	15.44 ± 0.40 (normalised)	PASS
Peak asymmetry (10 % height)	Ph. Eur. 2.2.46	1.14	—	0.80 – 1.50	PASS
Plate count, main peak	N = 5.54 (t/w½)²	57,781	—	≥ 20,000	PASS
Resolution to nearest impurity	vs deamidated (+1 Da)	1.06	—	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 57,781, and skew follows the reported asymmetry factor of 1.14. 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 0.88 % impurity against a 98.43 % 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	Tesamorelin — main peak	15.45	4,784,003	98.43	—
2	Met sulfoxide (+16 Da)	14.81	42,771	0.88	+15.995
3	des-hexenoyl GRF (1-44) (−96 Da)	14.03	20,413	0.42	-96.058
4	truncated (1-40)	13.57	7,290	0.15	-488.259
5	deamidated (+1 Da)	15.17	5,832	0.12	+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 5131.9276 Da, computed from C221H366N72O67S. 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 5131.9230 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 (%)
7+	734.1398	734.1391	-0.0007	8.4
6+	856.3285	856.3278	-0.0007	57.3
5+	1027.3928	1027.3919	-0.0009	100.0
4+	1283.9892	1283.9880	-0.0012	57.5
3+	1711.6498	1711.6483	-0.0015	7.6

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	4.33
Counter-ion (acetate)	ion chromatography	3.88
Residual solvent + inorganic residue	estimated	0.75
Total peptide content	by difference	91.04
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)	98.79	98.43	divergence -0.01 pp vs batch median
Total impurities (% area)	1.21	1.57
Largest single impurity (% area)	not stated	0.88
Water (%)	not stated	4.33
Counter-ion (%)	not stated	3.88
Peptide content (%w/w)	91.7	91.04
Endotoxin (EU/mg)	not stated	7.21
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: Supplier-supplied
Evidentiary weight: Weaker evidence. Read with the caveat below.
Chain of custody: Supplier despatch → laboratory direct (courier, cold pack, 2 d) → assay. Submitter did not handle the vial.
Assay date: 24 Aug 2026
Submitted to the index: 27 Aug 2026
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.

adipotide_klak27 Aug 2026

No endotoxin figure on this record, which is true of roughly three quarters of the index. It is the one measurement that cannot be inferred from any other and the one most often omitted.

tfa_counter27 Aug 2026

Purity 98.43 % and endotoxin 7.21 EU/mg are unrelated — purity measures synthesis quality, endotoxin measures fill-step water quality. The combination here is coherent and expected together.

asymmetry_1p227 Aug 2026

Endotoxin assay but no bacterial viability or total count. The two are independent: dead endotoxin-bearing bacteria contribute to the burden, living ones that produce endotoxins do not.

tri_agonist27 Aug 2026

7.21 EU/mg is at the sensitivity limit of Janoshik's LAL method. The true value is unspecified; treating this as a point estimate is overstating precision.

Section 7

Related records

Same batch — lot ERP-2604-W7280 n=12

Report	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Flags	Result
AX-2026-042534	ERP-2604-W7280	Janoshik	2026-Q3	99.06	3.90	92.8	Supplier-supplied	1	MARGINAL
AX-2026-042535	ERP-2604-W7280	Janoshik	2026-Q3	99.19	3.89	92.7	Supplier-supplied	1	MARGINAL
AX-2026-042537	ERP-2604-W7280	PeptideMeter	2026-Q3	98.52	3.95	94.1	Supplier-supplied	1	MARGINAL
AX-2026-042538	ERP-2604-W7280	Kestrel	2026-Q3	98.26	4.37	—	Supplier-supplied	1	MARGINAL
AX-2026-042539	ERP-2604-W7280	Janoshik	2026-Q3	98.77	4.30	89.9	Buyer-sourced	2	MARGINAL
AX-2026-042540	ERP-2604-W7280	Kestrel	2026-Q3	99.72	3.47	103.2	Supplier-supplied	1	MARGINAL
AX-2026-042541	ERP-2604-W7280	PeptideMeter	2026-Q3	98.79	3.70	—	Supplier-supplied	1	MARGINAL
AX-2026-042542	ERP-2604-W7280	Janoshik	2026-Q3	98.54	4.58	103.1	Supplier-supplied	2	FAIL
AX-2026-042543	ERP-2604-W7280	PeptideMeter	2026-Q3	99.16	4.03	—	Supplier-supplied	0	PASS
AX-2026-042544	ERP-2604-W7280	VendorInvestigate	2026-Q3	98.80	3.88	—	Buyer-sourced	2	FAIL
AX-2026-042545	ERP-2604-W7280	Janoshik	2026-Q3	99.32	3.85	101.4	Supplier-supplied	2	FAIL

Batch rollup and reproducibility assessment →

Cross-sections

Other recent Tesamorelin records in the index.
Report	Supplier	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Flags	Result
AX-2026-042535	ERP	ERP-2604-W7280	Janoshik	2026-Q3	99.19	3.89	92.7	Supplier-supplied	1	MARGINAL
AX-2026-042542	ERP	ERP-2604-W7280	Janoshik	2026-Q3	98.54	4.58	103.1	Supplier-supplied	2	FAIL
AX-2026-042540	ERP	ERP-2604-W7280	Kestrel	2026-Q3	99.72	3.47	103.2	Supplier-supplied	1	MARGINAL
AX-2026-042539	ERP	ERP-2604-W7280	Janoshik	2026-Q3	98.77	4.30	89.9	Buyer-sourced	2	MARGINAL
AX-2026-042544	ERP	ERP-2604-W7280	VendorInvestigate	2026-Q3	98.80	3.88	—	Buyer-sourced	2	FAIL
AX-2026-042534	ERP	ERP-2604-W7280	Janoshik	2026-Q3	99.06	3.90	92.8	Supplier-supplied	1	MARGINAL
AX-2026-042543	ERP	ERP-2604-W7280	PeptideMeter	2026-Q3	99.16	4.03	—	Supplier-supplied	0	PASS
AX-2026-042537	ERP	ERP-2604-W7280	PeptideMeter	2026-Q3	98.52	3.95	94.1	Supplier-supplied	1	MARGINAL

Other recent ERP records in the index.
Report	Compound	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Flags	Result
AX-2026-042574	TB-500	ERP-2605-S8022	VendorInvestigate	2026-Q3	99.54	2.91	96.4	Buyer-sourced	1	MARGINAL
AX-2026-042535	Tesamorelin	ERP-2604-W7280	Janoshik	2026-Q3	99.19	3.89	92.7	Supplier-supplied	1	MARGINAL
AX-2026-042577	TB-500	ERP-2605-S8022	Janoshik	2026-Q3	99.51	3.45	—	Supplier-supplied	1	MARGINAL
AX-2026-042542	Tesamorelin	ERP-2604-W7280	Janoshik	2026-Q3	98.54	4.58	103.1	Supplier-supplied	2	FAIL
AX-2026-042547	Survodutide	ERP-2605-E7682	PeptideMeter	2026-Q3	98.25	5.44	93.0	Supplier-supplied	1	MARGINAL
AX-2026-042540	Tesamorelin	ERP-2604-W7280	Kestrel	2026-Q3	99.72	3.47	103.2	Supplier-supplied	1	MARGINAL
AX-2026-042575	TB-500	ERP-2605-S8022	Janoshik	2026-Q3	99.93	3.36	95.5	Supplier-supplied	0	PASS
AX-2026-042539	Tesamorelin	ERP-2604-W7280	Janoshik	2026-Q3	98.77	4.30	89.9	Buyer-sourced	2	MARGINAL