AX-2025-020705 · MGF · SGN lot SGN-2503-S9261

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, 28 min gradient, 214 nm	99.35	% area	≥ 97.5	PASS
Total impurities	RP-HPLC, sum of reported peaks	0.65	% area	≤ 2.5	PASS
Largest single impurity	RP-HPLC — deamidated (+1 Da)	0.28	% 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	92.68	%w/w	—	NOT TESTED
Target-compound content	total peptide content × purity	92.08	%w/w	—	NOT TESTED
Gross fill (as weighed)	five-place balance, under nitrogen	2.01	mg	2 mg declared	NOT TESTED
Recovered target peptide	gross fill × target content	1.851	mg	2 mg claim	NOT TESTED
Recovery against label claim	recovered ÷ claim	92.6	%	90.0 – 110.0	PASS
Water content	Karl Fischer, coulometric, duplicate	3.18	%	≤ 9.0	PASS
Counter-ion (acetate)	anion-exchange ion chromatography	3.90	%	≤ 12.0	PASS
Residual solvent + inorganic residue	estimated — see /methods/residual-solvents-q3c/	0.24	%	—	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	White cake, partially collapsed	—	white to off-white intact cake	FAIL
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	4.64	—	2.5 – 8.0	PASS
Retention time (observed)	RP-HPLC, 28 min gradient	10.91	min	10.91 ± 0.30 (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	57,545	—	≥ 20,000	PASS
Resolution to nearest impurity	vs deamidated (+1 Da)	1.20	—	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, 28 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 57,545, 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 0.28 % impurity against a 99.35 % 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	MGF — main peak	10.91	4,828,718	99.35	—
2	deamidated (+1 Da)	10.69	13,609	0.28	+0.984
3	acetyl adduct (+42 Da)	11.28	11,179	0.23	+42.011
4	truncated (1-20)	9.77	3,888	0.08	-486.271
5	aspartimide (−18 Da)	11.21	2,916	0.06	-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 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	3.18
Counter-ion (acetate)	ion chromatography	3.90
Residual solvent + inorganic residue	estimated	0.24
Total peptide content	by difference	92.68
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)	99.49	99.35	divergence +0.10 pp vs batch median
Total impurities (% area)	0.51	0.65
Largest single impurity (% area)	0.25	0.28
Water (%)	not stated	3.18
Counter-ion (%)	not stated	3.90
Peptide content (%w/w)	not stated	92.68
Endotoxin (EU/mg)	0.31	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: Retail purchase → submitter (−20 °C, 25 d) → laboratory (courier, dry ice, 6 d) → assay.
Assay date: 12 Jun 2025
Submitted to the index: 19 Jun 2025
Laboratory: PeptideMeter, Tallinn, Estonia
Method basis: 28 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 2

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.

peak_integrator19 Jun 2025

99.35 % on MGF sits at the top of what this index sees. Read it with the method: PeptideMeter ran a 28 min gradient here, and the compound fingerprint names a mass-identical species that a shorter run folds into the main peak. On this gradient the figure is well founded.

moq_reality19 Jun 2025

Retail purchases test the retail channel. Manufacturer-tier material bought at kilogram scale is a different product with different documentation, and this index sees very little of it.

Section 7

Related records

Same batch — lot SGN-2503-S9261 n=3

Report	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Flags	Result
AX-2025-020704	SGN-2503-S9261	PeptideMeter	2025-Q2	99.39	3.50	104.6	Buyer-sourced	0	PASS
AX-2025-020706	SGN-2503-S9261	Janoshik	2025-Q2	99.48	3.35	—	Buyer-sourced	1	MARGINAL

Batch rollup and reproducibility assessment →

Cross-sections

Other recent MGF records in the index.
Report	Supplier	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Result
AX-2026-043660	PPG	PPG-2512-G7713	Janoshik	2026-Q2	99.30	4.25	95.8	Buyer-sourced	PASS
AX-2026-043656	PPG	PPG-2512-G7713	PeptideMeter	2026-Q2	99.09	4.22	99.3	Buyer-sourced	PASS
AX-2026-043657	PPG	PPG-2512-G7713	Janoshik	2026-Q2	99.06	4.25	107.0	Buyer-sourced	PASS
AX-2026-043466	BCH	BCH-2511-D5168	Janoshik	2026-Q2	99.04	5.33	103.5	Buyer-sourced	PASS
AX-2026-043464	BCH	BCH-2511-D5168	VendorInvestigate	2026-Q2	99.39	5.79	100.2	Buyer-sourced	PASS
AX-2026-043655	PPG	PPG-2512-G7713	Medutest	2026-Q2	99.03	4.14	99.6	Buyer-sourced	PASS
AX-2026-043467	BCH	BCH-2511-D5168	Janoshik	2026-Q2	99.46	5.95	—	Supplier-supplied	PASS
AX-2026-043652	PPG	PPG-2512-G7713	Janoshik	2026-Q2	99.33	3.87	101.6	Buyer-sourced	PASS

Other recent SGN records in the index.
Report	Compound	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Flags	Result
AX-2026-043233	Afamelanotide	SGN-2602-Y9306	Janoshik	2026-Q3	98.76	4.02	92.2	Buyer-sourced	1	MARGINAL
AX-2026-043234	Afamelanotide	SGN-2602-Y9306	Kestrel	2026-Q3	99.93	4.16	—	Buyer-sourced	0	PASS
AX-2026-043240	SLU-PP-332	SGN-2602-X9377	Janoshik	2026-Q2	98.82	5.46	97.0	Buyer-sourced	0	PASS
AX-2026-043222	ARA-290	SGN-2605-X9069	PeptideMeter	2026-Q2	98.32	7.36	—	Buyer-sourced	0	PASS
AX-2026-043237	SLU-PP-332	SGN-2602-X9377	Janoshik	2026-Q2	98.47	6.22	100.0	Supplier-supplied	0	PASS
AX-2026-043227	ARA-290	SGN-2605-X9069	PeptideMeter	2026-Q2	98.38	7.21	95.6	Buyer-sourced	0	PASS
AX-2026-043239	SLU-PP-332	SGN-2602-X9377	VendorInvestigate	2026-Q2	98.28	5.37	—	Buyer-sourced	0	PASS
AX-2026-043229	ARA-290	SGN-2605-X9069	Janoshik	2026-Q2	98.21	7.43	—	Buyer-sourced	0	PASS