AX-2026-041537

Pinealon · 20 mg declared · Qingdao Sigma Chemical Co., Ltd. · lot QSC-2602-V6998

MARGINALMETHOD LIMITED

Report ID: AX-2026-041537
Compound: Pinealon
Compound class: Short bioregulator peptides
Supplier: QSC — Qingdao Sigma Chemical Co., Ltd.
Batch / lot: QSC-2602-V6998
Declared label claim: 20mg
Laboratory: PeptideMeter
Assay date: 14 Jun 2026
Submitted: 24 Jun 2026
Quarter: 2026-Q2
Submitter: d.rahimi
Sample provenance: Laboratory-retained

Section 1

Results

Measured against the index acceptance specification for the short bioregulator 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	99.93	% area	≥ 99.0	PASS
Total impurities	RP-HPLC, sum of reported peaks	0.07	% area	≤ 1.0	PASS
Largest single impurity	RP-HPLC — Glu-Asp dipeptide (−156 Da)	0.04	% 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	83.17	%w/w	—	NOT TESTED
Target-compound content	total peptide content × purity	83.11	%w/w	—	NOT TESTED
Gross fill (as weighed)	five-place balance, under nitrogen	25.25	mg	20 mg declared	NOT TESTED
Recovered target peptide	gross fill × target content	20.985	mg	20 mg claim	NOT TESTED
Recovery against label claim	recovered ÷ claim	104.9	%	90.0 – 110.0	PASS
Water content	Karl Fischer, coulometric, duplicate	7.19	%	≤ 12.0	PASS
Counter-ion (acetate)	anion-exchange ion chromatography	8.88	%	≤ 10.0	PASS
Residual solvent + inorganic residue	estimated — see /methods/residual-solvents-q3c/	0.76	%	—	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	Clear, colourless, no visible particulates	—	clear, no visible particulates	PASS
pH (reconstituted, 1 mg/mL)	potentiometric, two-point calibration	6.42	—	2.5 – 8.0	PASS
Retention time (observed)	RP-HPLC, 28 min gradient	4.42	min	4.56 ± 0.20 (normalised)	PASS
Peak asymmetry (10 % height)	Ph. Eur. 2.2.46	0.86	—	0.80 – 1.50	PASS
Plate count, main peak	N = 5.54 (t/w½)²	94,123	—	≥ 20,000	PASS
Resolution to nearest impurity	vs pyroglutamate (−18 Da)	2.84	—	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 94,123, and skew follows the reported asymmetry factor of 0.86. 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 0.04 % impurity against a 99.93 % 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	Pinealon — main peak	4.42	4,856,908	99.93	—
2	Glu-Asp dipeptide (−156 Da)	4.14	1,944	0.04	-156.101
3	pyroglutamate (−18 Da)	4.59	1,458	0.03	-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	7.19
Counter-ion (acetate)	ion chromatography	8.88
Residual solvent + inorganic residue	estimated	0.76
Total peptide content	by difference	83.17
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)	100.0	99.93	divergence +0.16 pp vs batch median
Total impurities (% area)	0.00	0.07
Largest single impurity (% area)	0.00	0.04
Water (%)	not stated	7.19
Counter-ion (%)	not stated	8.88
Peptide content (%w/w)	not stated	83.17
Endotoxin (EU/mg)	3.03	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: Laboratory-retained
Evidentiary weight: Provenance documented, selection uncontrolled.
Chain of custody: Laboratory retained sample (−20 °C, 28 d since original receipt) → re-assay.
Assay date: 14 Jun 2026
Submitted to the index: 24 Jun 2026
Laboratory: PeptideMeter, Tallinn, Estonia
Method basis: 28 min gradient · high-resolution MS
Verification status: METHOD LIMITED

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 3

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.

coa_reader24 Jun 2026

What resolves this in one email is the batch record rather than the summary sheet: the integration report at full precision, with the reporting threshold stated. It is routinely available.

digit_preference24 Jun 2026

Rounding to the nearest half point loses about 0.25 pp of information in the worst case, which is inside the expanded uncertainty of the measurement anyway. The information loss is real and small.

coa_gap24 Jun 2026

Rounding convention is the least of what a certificate carries. Lot code, method, wavelength and release date are the fields that let a reader reconstruct the figure, and the index scores those separately on the documentation rubric.

Section 7

Related records

Same batch — lot QSC-2602-V6998 n=2

Report	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Flags	Result
AX-2026-041536	QSC-2602-V6998	Janoshik	2026-Q2	99.74	8.23	99.2	Buyer-sourced	1	FAIL

Batch rollup and reproducibility assessment →

Cross-sections

Other recent Pinealon records in the index.
Report	Supplier	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Flags	Result
AX-2026-041536	QSC	QSC-2602-V6998	Janoshik	2026-Q2	99.74	8.23	99.2	Buyer-sourced	1	FAIL
AX-2025-019493	JEEP	JEEP-2507-B8206	Nordanalyt	2025-Q4	99.93	10.42	93.1	Buyer-sourced	0	FAIL

Other recent QSC records in the index.
Report	Compound	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Flags	Result
AX-2026-041599	CJC-1295 (no DAC)	QSC-2606-V7416	VendorInvestigate	2026-Q3	97.96	3.52	—	Buyer-sourced	1	FAIL
AX-2026-041601	CJC-1295 (no DAC)	QSC-2606-V7416	Kestrel	2026-Q3	98.33	4.10	—	Buyer-sourced	1	MARGINAL
AX-2026-041602	CJC-1295 (no DAC)	QSC-2606-V7416	VendorInvestigate	2026-Q3	98.36	3.38	101.8	Buyer-sourced	1	MARGINAL
AX-2026-041477	Triptorelin	QSC-2607-C5749	Nordanalyt	2026-Q3	99.53	3.42	—	Buyer-sourced	0	PASS
AX-2026-041600	CJC-1295 (no DAC)	QSC-2606-V7416	Nordanalyt	2026-Q3	97.74	4.91	100.9	Buyer-sourced	1	FAIL
AX-2026-041603	CJC-1295 (no DAC)	QSC-2606-V7416	PeptideMeter	2026-Q3	98.43	4.20	—	Buyer-sourced	1	MARGINAL
AX-2026-041606	CJC-1295 (no DAC)	QSC-2606-V7416	Janoshik	2026-Q3	98.03	3.58	—	Buyer-sourced	1	MARGINAL
AX-2026-041585	Liraglutide	QSC-2605-W7381	Medutest	2026-Q3	99.59	5.09	92.8	Laboratory-retained	0	PASS