AX-2025-021136

Tesamorelin · 2 mg declared · WuXi TIDES (WuXi AppTec Testing Division) · lot WXT-2505-B5419

MARGINALPURITY ONLY

Report ID: AX-2025-021136
Compound: Tesamorelin
Compound class: Growth-hormone axis peptides
Supplier: WXT — WuXi TIDES (WuXi AppTec Testing Division)
Batch / lot: WXT-2505-B5419
Declared label claim: 2mg
Laboratory: Janoshik Analytical
Assay date: 08 Jul 2025
Submitted: 30 Jul 2025
Quarter: 2025-Q3
Submitter: n.brandt
Sample provenance: Supplier-supplied

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	97.09	% area	≥ 97.0	PASS
Total impurities	RP-HPLC, sum of reported peaks	2.91	% area	≤ 3.0	PASS
Largest single impurity	RP-HPLC — deamidated (+1 Da)	1.48	% area	≤ 1.00	FAIL
Identity	not ordered on this submission	not determined	—	required for VERIFIED status	NOT TESTED
Total peptide content	by difference from the gravimetric mass balance	90.69	%w/w	—	NOT TESTED
Target-compound content	total peptide content × purity	88.05	%w/w	—	NOT TESTED
Gross fill (as weighed)	five-place balance, under nitrogen	2.08	mg	2 mg declared	NOT TESTED
Recovered target peptide	gross fill × target content	1.831	mg	2 mg claim	NOT TESTED
Recovery against label claim	recovered ÷ claim	91.6	%	90.0 – 110.0	PASS
Water content	Karl Fischer, coulometric, duplicate	4.90	%	≤ 9.0	PASS
Counter-ion (acetate)	anion-exchange ion chromatography	4.25	%	≤ 12.0	PASS
Residual solvent + inorganic residue	estimated — see /methods/residual-solvents-q3c/	0.16	%	—	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	Faint haze, clearing on standing	—	clear, no visible particulates	FAIL
pH (reconstituted, 1 mg/mL)	potentiometric, two-point calibration	4.66	—	2.5 – 8.0	PASS
Retention time (observed)	RP-HPLC, 30 min gradient	15.52	min	15.44 ± 0.40 (normalised)	PASS
Peak asymmetry (10 % height)	Ph. Eur. 2.2.46	1.05	—	0.80 – 1.50	PASS
Plate count, main peak	N = 5.54 (t/w½)²	57,095	—	≥ 20,000	PASS
Resolution to nearest impurity	vs deamidated (+1 Da)	1.05	—	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 57,095, and skew follows the reported asymmetry factor of 1.05. 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 1.48 % impurity against a 97.09 % 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	15.52	4,718,875	97.09	—
2	deamidated (+1 Da)	15.24	71,933	1.48	+0.984
3	Met sulfoxide (+16 Da)	14.88	41,799	0.86	+15.995
4	truncated (1-40)	13.64	14,581	0.30	-488.259
5	des-hexenoyl GRF (1-44) (−96 Da)	14.10	13,123	0.27	-96.058
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 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	4.90
Counter-ion (acetate)	ion chromatography	4.25
Residual solvent + inorganic residue	estimated	0.16
Total peptide content	by difference	90.69
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)	97.18	97.09	divergence +0.09 pp vs batch median
Total impurities (% area)	2.82	2.91
Largest single impurity (% area)	1.50	1.48
Water (%)	3.9	4.90
Counter-ion (%)	not stated	4.25
Peptide content (%w/w)	not stated	90.69
Endotoxin (EU/mg)	not stated	not determined
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, 9 d) → assay. Submitter did not handle the vial.
Assay date: 08 Jul 2025
Submitted to the index: 30 Jul 2025
Laboratory: Janoshik Analytical, Ostrava, Czechia
Method basis: 30 min gradient · high-resolution MS
Verification status: PURITY ONLY

What this report does not establish

That the compound is the compound named. No identity confirmation was ordered on this submission. A purity figure describes chromatographic homogeneity of whatever eluted; it does not name it.
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

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-2505-B5419 n=1

This is the only report on this lot. One report is not a batch characterisation.

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-2026-042536	ERP	ERP-2604-W7280	Janoshik	2026-Q3	98.43	4.33	107.5	Supplier-supplied	2	FAIL
AX-2026-042543	ERP	ERP-2604-W7280	PeptideMeter	2026-Q3	99.16	4.03	—	Supplier-supplied	0	PASS

Other recent WXT records in the index.
Report	Compound	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Flags	Result
AX-2026-043488	Pramlintide	WXT-2603-D6052	Janoshik	2026-Q3	97.87	4.37	—	Supplier-supplied	1	MARGINAL
AX-2026-043406	Semaglutide	WXT-2604-C4728	Janoshik	2026-Q3	97.24	4.65	—	Supplier-supplied	1	MARGINAL
AX-2026-043421	Sermorelin	WXT-2608-P4867	Janoshik	2026-Q3	98.15	3.09	—	Supplier-supplied	0	PASS
AX-2026-043420	Sermorelin	WXT-2608-P4867	Medutest	2026-Q3	98.62	3.07	96.4	Supplier-supplied	0	PASS
AX-2026-043423	Sermorelin	WXT-2608-P4867	Janoshik	2026-Q3	98.28	3.86	98.5	Buyer-sourced	0	PASS
AX-2026-043401	Semaglutide	WXT-2604-C4728	Medutest	2026-Q3	97.70	4.78	91.5	Supplier-supplied	1	MARGINAL
AX-2026-043400	Semaglutide	WXT-2604-C4728	Nordanalyt	2026-Q3	96.86	4.11	106.4	Laboratory-retained	1	FAIL
AX-2026-043422	Sermorelin	WXT-2608-P4867	Medutest	2026-Q3	98.35	3.59	—	Supplier-supplied	1	MARGINAL