AX-2026-043598 · Tesamorelin · PPG lot PPG-2608-A6835

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, 15 min gradient, 214 nm	98.91	% area	≥ 97.0	PASS
Total impurities	RP-HPLC, sum of reported peaks	1.09	% area	≤ 3.0	PASS
Largest single impurity	RP-HPLC — truncated (1-40)	0.60	% area	≤ 1.00	PASS
Identity	not ordered on this submission	not determined	—	required for VERIFIED status	NOT TESTED
Total peptide content	by difference from the gravimetric mass balance	91.74	%w/w	—	NOT TESTED
Target-compound content	total peptide content × purity	90.74	%w/w	—	NOT TESTED
Gross fill (as weighed)	five-place balance, under nitrogen	2.21	mg	2 mg declared	NOT TESTED
Recovered target peptide	gross fill × target content	2.005	mg	2 mg claim	NOT TESTED
Recovery against label claim	recovered ÷ claim	100.3	%	90.0 – 110.0	PASS
Water content	Karl Fischer, coulometric, duplicate	2.56	%	≤ 9.0	PASS
Counter-ion (acetate)	anion-exchange ion chromatography	4.91	%	≤ 12.0	PASS
Residual solvent + inorganic residue	estimated — see /methods/residual-solvents-q3c/	0.79	%	—	NOT TESTED
Endotoxin	kinetic chromogenic LAL	10.21	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 after 90 s gentle swirling, no particulates	—	clear, no visible particulates	PASS
pH (reconstituted, 1 mg/mL)	potentiometric, two-point calibration	4.97	—	2.5 – 8.0	PASS
Retention time (observed)	RP-HPLC, 15 min gradient	8.39	min	8.34 ± 0.40 (normalised)	PASS
Peak asymmetry (10 % height)	Ph. Eur. 2.2.46	1.11	—	0.80 – 1.50	PASS
Plate count, main peak	N = 5.54 (t/w½)²	59,218	—	≥ 20,000	PASS
Resolution to nearest impurity	vs deamidated (+1 Da)	0.99	—	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, 15 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 59,218, and skew follows the reported asymmetry factor of 1.11. 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 0.60 % impurity against a 98.91 % 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	8.39	4,807,333	98.91	—
2	truncated (1-40)	7.45	29,162	0.60	-488.259
3	deamidated (+1 Da)	8.25	11,665	0.24	+0.984
4	des-hexenoyl GRF (1-44) (−96 Da)	7.68	6,318	0.13	-96.058
5	Met sulfoxide (+16 Da)	8.07	5,832	0.12	+15.995
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	2.56
Counter-ion (acetate)	ion chromatography	4.91
Residual solvent + inorganic residue	estimated	0.79
Total peptide content	by difference	91.74
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)	99.31	98.91	divergence +0.57 pp vs batch median
Total impurities (% area)	not stated	1.09
Largest single impurity (% area)	not stated	0.60
Water (%)	0.4	2.56
Counter-ion (%)	not stated	4.91
Peptide content (%w/w)	not stated	91.74
Endotoxin (EU/mg)	not stated	10.21
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 (−20 °C, 34 d) → laboratory (courier, dry ice, 9 d) → assay.
Assay date: 26 Jul 2026
Submitted to the index: 03 Aug 2026
Laboratory: Kestrel Bioanalytical, Melbourne, Australia
Method basis: 15 min gradient · unit-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 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.

Contributor #G-886903 Aug 2026

Where the nearest species is a diastereomer of Tesamorelin, resolution is the only thing that separates them at all — no mass measurement will. The compound fingerprint states what is achievable and on what method.

valley_drop03 Aug 2026

The reported figure derives from the plate count and the retention gap, via the pharmacopoeial form with the sum of both peak widths in the denominator. It is a calculated quantity, not a measured one, and it inherits the plate count's uncertainty.

endotoxin_limit03 Aug 2026

Filtration at 0.22 µm removes organisms and not endotoxin. Endotoxin removal needs ultrafiltration or affinity adsorption and neither is routine at this scale.

mk677_standard03 Aug 2026

On small molecules an assay against a named reference standard is both identity and content in one determination. Its absence leaves both open.

Section 7

Related records

Same batch — lot PPG-2608-A6835 n=3

Report	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Flags	Result
AX-2026-043596	PPG-2608-A6835	PeptideMeter	2026-Q3	98.74	1.83	105.1	Buyer-sourced	1	MARGINAL
AX-2026-043597	PPG-2608-A6835	Janoshik	2026-Q3	98.54	1.15	—	Buyer-sourced	0	PASS

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-2026-042704	ERP	ERP-2604-W9463	Janoshik	2026-Q3	99.02	4.08	—	Buyer-sourced	1	MARGINAL
AX-2026-043597	PPG	PPG-2608-A6835	Janoshik	2026-Q3	98.54	1.15	—	Buyer-sourced	0	PASS
AX-2026-043596	PPG	PPG-2608-A6835	PeptideMeter	2026-Q3	98.74	1.83	105.1	Buyer-sourced	1	MARGINAL
AX-2026-043380	WXT	WXT-2601-A2974	Medutest	2026-Q1	97.17	3.06	91.5	Buyer-sourced	0	PASS
AX-2025-021018	WXT	WXT-2505-B3939	Janoshik	2025-Q3	96.86	3.77	95.9	Buyer-sourced	1	FAIL
AX-2025-019141	GSP	GSP-2501-G3708	VendorInvestigate	2025-Q1	98.13	4.76	—	Buyer-sourced	0	PASS
AX-2025-019137	GSP	GSP-2501-G3708	PeptideMeter	2025-Q1	98.06	4.56	—	Buyer-sourced	0	PASS
AX-2025-019142	GSP	GSP-2501-G3708	Medutest	2025-Q1	98.31	4.53	96.0	Buyer-sourced	0	PASS

Other recent PPG records in the index.
Report	Compound	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Flags	Result
AX-2026-043597	Tesamorelin	PPG-2608-A6835	Janoshik	2026-Q3	98.54	1.15	—	Buyer-sourced	0	PASS
AX-2026-043596	Tesamorelin	PPG-2608-A6835	PeptideMeter	2026-Q3	98.74	1.83	105.1	Buyer-sourced	1	MARGINAL
AX-2026-043605	Retatrutide	PPG-2604-X7060	Janoshik	2026-Q2	98.17	4.29	99.7	Buyer-sourced	0	PASS
AX-2026-043601	Retatrutide	PPG-2604-X7060	Janoshik	2026-Q2	98.28	3.96	95.3	Buyer-sourced	0	PASS
AX-2026-043668	AOD-9604	PPG-2602-W8018	PeptideMeter	2026-Q2	99.47	3.06	—	Buyer-sourced	0	PASS
AX-2026-043670	AOD-9604	PPG-2602-W8018	PeptideMeter	2026-Q2	99.56	2.71	104.5	Buyer-sourced	0	PASS
AX-2026-043630	CJC-1295 (no DAC)	PPG-2512-D7211	Janoshik	2026-Q2	99.66	5.11	92.5	Buyer-sourced	0	PASS
AX-2026-043660	MGF	PPG-2512-G7713	Janoshik	2026-Q2	99.30	4.25	95.8	Buyer-sourced	0	PASS