AX-2024-005560

Selank · 20 mg declared · Bachem Holding (Suzhou) Co., Ltd. · lot BCH-2407-M7005

MARGINALPURITY ONLY

Report ID: AX-2024-005560
Compound: Selank
Compound class: Neuroactive and cognitive peptides
Supplier: BCH — Bachem Holding (Suzhou) Co., Ltd.
Batch / lot: BCH-2407-M7005
Declared label claim: 20mg
Laboratory: Janoshik Analytical
Assay date: 20 Jul 2024
Submitted: 27 Jul 2024
Quarter: 2024-Q3
Submitter: h.stanescu
Sample provenance: Laboratory-retained

Section 1

Results

Measured against the index acceptance specification for the neuroactive and cognitive 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	99.29	% area	≥ 99.0	PASS
Total impurities	RP-HPLC, sum of reported peaks	0.71	% area	≤ 1.0	PASS
Largest single impurity	RP-HPLC — tuftsin fragment (−417 Da)	0.39	% area	≤ 1.00	PASS
Identity	not ordered on this submission	not determined	—	required for VERIFIED status	NOT TESTED
Peptide content	not ordered on this submission	not determined	—	required to check label claim	NOT TESTED
Water content	Karl Fischer, coulometric, duplicate	7.11	%	≤ 12.0	PASS
Counter-ion (acetate)	anion-exchange ion chromatography	6.28	%	≤ 10.0	PASS
Residual solvent + inorganic residue	estimated — see /methods/residual-solvents-q3c/	0.53	%	—	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 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	5.40	—	2.5 – 8.0	PASS
Retention time (observed)	RP-HPLC, 30 min gradient	6.41	min	6.42 ± 0.25 (normalised)	PASS
Peak asymmetry (10 % height)	Ph. Eur. 2.2.46	1.13	—	0.80 – 1.50	PASS
Plate count, main peak	N = 5.54 (t/w½)²	55,749	—	≥ 20,000	PASS
Resolution to nearest impurity	vs diketopiperazine (−18 Da)	1.62	—	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 55,749, and skew follows the reported asymmetry factor of 1.13. 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 0.39 % impurity against a 99.29 % 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	Selank — main peak	6.41	4,825,802	99.29	—
2	tuftsin fragment (−417 Da)	5.79	18,955	0.39	-417.235
3	des-Thr (−101 Da)	6.15	6,804	0.14	-101.048
4	acetyl adduct (+42 Da)	6.75	5,832	0.12	+42.011
5	diketopiperazine (−18 Da)	6.59	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.

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)	99.5	99.29	divergence +0.24 pp vs batch median
Total impurities (% area)	0.50	0.71
Largest single impurity (% area)	not stated	0.39
Water (%)	6.5	7.11
Counter-ion (%)	not stated	6.28
Peptide content (%w/w)	not stated	not determined
Endotoxin (EU/mg)	not stated	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: Laboratory-retained
Evidentiary weight: Provenance documented, selection uncontrolled.
Chain of custody: Laboratory retained sample (−20 °C, 32 d since original receipt) → re-assay.
Assay date: 20 Jul 2024
Submitted to the index: 27 Jul 2024
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.
How much of the named compound is in the vial. Peptide content was not determined, so recovered mass cannot be calculated and the label claim cannot be checked.
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.

round_numbers27 Jul 2024

The certificate for lot BCH-2407-M7005 states purity as a round figure. Integrated areas do not land on halves, so this is either a rounded presentation of a real integration or a release specification carried into the result field. Independent measurement here is 99.29 %, which is consistent with either.

sig_figs27 Jul 2024

The declared figure for BCH-2407-M7005 and the independent median differ by less than the inter-lab limits of agreement. That is the comparison that matters and the rounding does not change it.

Section 7

Related records

Same batch — lot BCH-2407-M7005 n=7

Report	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Flags	Result
AX-2024-005556	BCH-2407-M7005	Janoshik	2024-Q3	99.02	6.99	—	Buyer-sourced	1	MARGINAL
AX-2024-005557	BCH-2407-M7005	PeptideMeter	2024-Q3	99.32	6.98	88.7	Buyer-sourced	2	MARGINAL
AX-2024-005558	BCH-2407-M7005	PeptideMeter	2024-Q3	99.26	6.86	97.7	Buyer-sourced	2	FAIL
AX-2024-005559	BCH-2407-M7005	PeptideMeter	2024-Q3	98.89	6.80	—	Buyer-sourced	1	FAIL
AX-2024-005561	BCH-2407-M7005	PeptideMeter	2024-Q3	98.98	6.69	104.1	Buyer-sourced	1	FAIL
AX-2024-005562	BCH-2407-M7005	Janoshik	2024-Q3	99.42	6.83	—	Buyer-sourced	1	MARGINAL

Batch rollup and reproducibility assessment →

Cross-sections

Other recent Selank records in the index.
Report	Supplier	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Flags	Result
AX-2026-043000	GGPeps	GGPE-2602-G3499	PeptideMeter	2026-Q3	98.68	8.10	89.6	Buyer-sourced	1	FAIL
AX-2026-042924	GGPeps	GGPE-2603-J2151	Medutest	2026-Q3	99.18	8.75	100.1	Buyer-sourced	0	PASS
AX-2026-042987	GGPeps	GGPE-2601-J2834	Janoshik	2026-Q2	99.69	9.52	92.5	Buyer-sourced	0	PASS
AX-2026-042770	ERP	ERP-2605-M9199	Janoshik	2026-Q2	99.47	6.15	101.1	Buyer-sourced	0	PASS
AX-2026-042762	ERP	ERP-2605-M9199	Janoshik	2026-Q2	99.30	6.05	89.8	Buyer-sourced	1	MARGINAL
AX-2026-042992	GGPeps	GGPE-2601-J2834	Janoshik	2026-Q2	99.67	9.70	107.2	Buyer-sourced	0	PASS
AX-2026-042985	GGPeps	GGPE-2601-J2834	Janoshik	2026-Q2	99.64	9.27	105.7	Buyer-sourced	0	PASS
AX-2026-042993	GGPeps	GGPE-2601-J2834	Janoshik	2026-Q2	99.92	9.59	—	Supplier-supplied	0	PASS

Other recent BCH records in the index.
Report	Compound	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Flags	Result
AX-2026-043691	BPC-157	BCH-2603-L7768	Janoshik	2026-Q3	98.66	5.12	—	Supplier-supplied	1	MARGINAL
AX-2026-043693	BPC-157	BCH-2603-L7768	PeptideMeter	2026-Q3	97.82	5.21	94.9	Buyer-sourced	0	FAIL
AX-2026-043686	BPC-157	BCH-2603-L7768	VendorInvestigate	2026-Q3	97.64	5.27	—	Buyer-sourced	0	FAIL
AX-2026-043695	BPC-157	BCH-2603-L7768	Janoshik	2026-Q3	97.61	5.42	—	Buyer-sourced	0	FAIL
AX-2026-043726	N-Acetyl Semax Amide	BCH-2602-E8475	Janoshik	2026-Q3	97.89	9.67	104.2	Buyer-sourced	0	FAIL
AX-2026-043688	BPC-157	BCH-2603-L7768	Janoshik	2026-Q3	97.94	5.56	—	Buyer-sourced	0	FAIL
AX-2026-043658	BPC-157	BCH-2603-G6644	Janoshik	2026-Q3	98.45	4.37	101.8	Supplier-supplied	0	PASS
AX-2026-043692	BPC-157	BCH-2603-L7768	VendorInvestigate	2026-Q3	97.60	5.61	—	Buyer-sourced	0	FAIL