AX-2025-020672

SS-31 (Elamipretide) · 20 mg declared · GL Biochem (Shanghai) Ltd. · lot GLBI-2507-R8450

FAILPURITY ONLY

Report ID: AX-2025-020672
Compound: SS-31 (Elamipretide)
Compound class: Metabolic and mitochondrial peptides
Supplier: GL Biochem — GL Biochem (Shanghai) Ltd.
Batch / lot: GLBI-2507-R8450
Declared label claim: 20mg
Laboratory: Janoshik Analytical
Assay date: 07 Jul 2025
Submitted: 30 Jul 2025
Quarter: 2025-Q3
Submitter: custom_synth
Sample provenance: Supplier-supplied

Section 1

Results

Measured against the index acceptance specification for the metabolic and mitochondrial 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	98.12	% area	≥ 98.5	FAIL
Total impurities	RP-HPLC, sum of reported peaks	1.88	% area	≤ 1.5	FAIL
Largest single impurity	RP-HPLC — acetyl adduct (+42 Da)	0.77	% 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	90.90	%w/w	—	NOT TESTED
Target-compound content	total peptide content × purity	89.19	%w/w	—	NOT TESTED
Gross fill (as weighed)	five-place balance, under nitrogen	22.62	mg	20 mg declared	NOT TESTED
Recovered target peptide	gross fill × target content	20.175	mg	20 mg claim	NOT TESTED
Recovery against label claim	recovered ÷ claim	100.9	%	90.0 – 110.0	PASS
Water content	Karl Fischer, coulometric, duplicate	2.39	%	≤ 9.0	PASS
Counter-ion (acetate)	anion-exchange ion chromatography	6.45	%	≤ 12.0	PASS
Residual solvent + inorganic residue	estimated — see /methods/residual-solvents-q3c/	0.26	%	—	NOT TESTED
Endotoxin	kinetic chromogenic LAL	2.00	EU/mg	≤ 5.0	PASS
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	Visible particulates, did not clear	—	clear, no visible particulates	FAIL
pH (reconstituted, 1 mg/mL)	potentiometric, two-point calibration	4.69	—	2.5 – 8.0	PASS
Retention time (observed)	RP-HPLC, 30 min gradient	8.98	min	8.94 ± 0.25 (normalised)	PASS
Peak asymmetry (10 % height)	Ph. Eur. 2.2.46	0.99	—	0.80 – 1.50	PASS
Plate count, main peak	N = 5.54 (t/w½)²	42,019	—	≥ 20,000	PASS
Resolution to nearest impurity	vs [D-Arg1]-epimer	1.00	—	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 42,019, and skew follows the reported asymmetry factor of 0.99. 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 0.77 % impurity against a 98.12 % 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	SS-31 (Elamipretide) — main peak	8.98	4,768,936	98.12	—
2	acetyl adduct (+42 Da)	9.52	37,424	0.77	+42.011
3	C-terminal free acid (+1 Da)	9.18	29,648	0.61	+0.984
4	des-Dmt (−193 Da)	8.26	14,581	0.30	-193.110
5	[D-Arg1]-epimer	8.80	9,721	0.20	0.000
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	2.39
Counter-ion (acetate)	ion chromatography	6.45
Residual solvent + inorganic residue	estimated	0.26
Total peptide content	by difference	90.90
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)	98.44	98.12	divergence +0.26 pp vs batch median
Total impurities (% area)	1.56	1.88
Largest single impurity (% area)	not stated	0.77
Water (%)	2.0	2.39
Counter-ion (%)	6.6	6.45
Peptide content (%w/w)	90.8	90.90
Endotoxin (EU/mg)	not stated	2.00
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: 07 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 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 GLBI-2507-R8450 n=6

Report	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Flags	Result
AX-2025-020668	GLBI-2507-R8450	Medutest	2025-Q3	98.54	2.87	—	Supplier-supplied	2	MARGINAL
AX-2025-020669	GLBI-2507-R8450	Medutest	2025-Q3	98.00	3.59	—	Supplier-supplied	1	FAIL
AX-2025-020670	GLBI-2507-R8450	Janoshik	2025-Q3	98.23	3.48	—	Supplier-supplied	1	FAIL
AX-2025-020671	GLBI-2507-R8450	PeptideMeter	2025-Q3	98.43	2.92	—	Supplier-supplied	1	FAIL
AX-2025-020673	GLBI-2507-R8450	Medutest	2025-Q3	98.09	2.91	89.6	Supplier-supplied	2	FAIL

Batch rollup and reproducibility assessment →

Cross-sections

Other recent SS-31 (Elamipretide) records in the index.
Report	Supplier	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Flags	Result
AX-2026-042067	TFC	TFC-2604-Y7472	Kestrel	2026-Q3	98.66	4.44	—	Supplier-supplied	1	MARGINAL
AX-2026-042068	TFC	TFC-2604-Y7472	Medutest	2026-Q3	98.71	3.63	92.9	Supplier-supplied	2	MARGINAL
AX-2026-042069	TFC	TFC-2604-Y7472	Janoshik	2026-Q3	98.16	3.65	—	Supplier-supplied	2	FAIL
AX-2026-042070	TFC	TFC-2604-Y7472	PeptideMeter	2026-Q3	98.09	3.60	97.9	Supplier-supplied	1	FAIL
AX-2026-042072	TFC	TFC-2604-Y7472	VendorInvestigate	2026-Q3	97.88	3.47	89.5	Buyer-sourced	2	FAIL
AX-2026-042236	Homopeptide	HOMO-2604-D1599	PeptideMeter	2026-Q3	99.61	2.79	—	Supplier-supplied	0	PASS
AX-2026-041951	TFC	TFC-2607-R4363	Medutest	2026-Q3	99.56	5.16	—	Buyer-sourced	0	PASS
AX-2026-042071	TFC	TFC-2604-Y7472	PeptideMeter	2026-Q3	97.71	3.47	93.0	Laboratory-retained	2	FAIL

Other recent GL Biochem records in the index.
Report	Compound	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Flags	Result
AX-2026-043176	Kisspeptin-10	GLBI-2608-N8085	Medutest	2026-Q3	98.22	3.30	92.5	Buyer-sourced	2	FAIL
AX-2026-043180	Kisspeptin-10	GLBI-2608-N8085	Janoshik	2026-Q3	98.69	3.37	103.8	Supplier-supplied	2	MARGINAL
AX-2026-043178	Kisspeptin-10	GLBI-2608-N8085	Janoshik	2026-Q3	98.24	4.44	96.0	Supplier-supplied	2	FAIL
AX-2026-043177	Kisspeptin-10	GLBI-2608-N8085	Janoshik	2026-Q3	98.31	3.87	106.5	Buyer-sourced	2	FAIL
AX-2026-043202	Semaglutide	GLBI-2602-U8631	PeptideMeter	2026-Q3	96.77	6.38	89.7	Supplier-supplied	3	FAIL
AX-2026-043174	Kisspeptin-10	GLBI-2608-N8085	Medutest	2026-Q3	98.18	4.09	—	Laboratory-retained	2	FAIL
AX-2026-043201	Semaglutide	GLBI-2602-U8631	Janoshik	2026-Q3	96.91	5.77	91.2	Supplier-supplied	2	FAIL
AX-2026-043203	Semaglutide	GLBI-2602-U8631	Medutest	2026-Q3	97.45	6.09	—	Supplier-supplied	2	MARGINAL