AX-2024-005269 · VIP · BCH lot BCH-2405-R4888

Section 1

Results

Measured against the index acceptance specification for the tissue-repair and immunomodulatory 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	97.34	% area	≥ 97.5	FAIL
Total impurities	RP-HPLC, sum of reported peaks	2.66	% area	≤ 2.5	FAIL
Largest single impurity	RP-HPLC — Met17 sulfoxide (+16 Da)	1.75	% area	≤ 1.00	FAIL
Identity — theoretical monoisotopic mass	calculated from molecular formula	3324.8146	Da	—	NOT TESTED
Identity — observed monoisotopic mass	LC-MS, high resolution (ESI-TOF/QTOF)	3324.8289	Da	—	NOT TESTED
Mass accuracy	observed vs theoretical	+4.3	ppm	± 15	PASS
Total peptide content	by difference from the gravimetric mass balance	88.86	%w/w	—	NOT TESTED
Target-compound content	total peptide content × purity	86.50	%w/w	—	NOT TESTED
Gross fill (as weighed)	five-place balance, under nitrogen	5.76	mg	5 mg declared	NOT TESTED
Recovered target peptide	gross fill × target content	4.982	mg	5 mg claim	NOT TESTED
Recovery against label claim	recovered ÷ claim	99.6	%	90.0 – 110.0	PASS
Water content	Karl Fischer, coulometric, duplicate	5.27	%	≤ 10.0	PASS
Counter-ion (acetate)	anion-exchange ion chromatography	5.68	%	≤ 12.0	PASS
Residual solvent + inorganic residue	estimated — see /methods/residual-solvents-q3c/	0.19	%	—	NOT TESTED
Endotoxin	kinetic chromogenic LAL	0.69	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	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	6.53	—	2.5 – 8.0	PASS
Retention time (observed)	RP-HPLC, 30 min gradient	12.81	min	12.98 ± 0.35 (normalised)	PASS
Peak asymmetry (10 % height)	Ph. Eur. 2.2.46	0.96	—	0.80 – 1.50	PASS
Plate count, main peak	N = 5.54 (t/w½)²	48,937	—	≥ 20,000	PASS
Resolution to nearest impurity	vs C-terminal free acid (+1 Da)	1.18	—	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 48,937, and skew follows the reported asymmetry factor of 0.96. 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 1.75 % impurity against a 97.34 % 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	VIP — main peak	12.81	4,731,026	97.34	—
2	Met17 sulfoxide (+16 Da)	12.15	85,055	1.75	+15.995
3	deamidated (+1 Da)	12.51	21,385	0.44	+0.984
4	C-terminal free acid (+1 Da)	13.09	12,151	0.25	+0.984
5	des-His1 (−137 Da)	11.99	10,693	0.22	-137.059
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 3

Mass spectrum and identity

Theoretical monoisotopic mass 3324.8146 Da, computed from C147H238N44O42S. All ppm figures on this site are against monoisotopic values — see why that matters.

Figure 2. ESI charge-state envelope, high-resolution instrument. Sticks are placed at m/z = (M + z × 1.007276)/z for the observed neutral mass of 3324.8289 Da. Sodium (+21.982/z) and potassium (+37.956/z) adducts are shown where the parent charge state exceeds 25 % relative abundance; they are adducts of the same molecule and are not impurities.

Charge	Theoretical m/z	Observed m/z	Δ m/z	Rel. abundance (%)
5+	665.9702	665.9731	0.0029	8.0
4+	832.2109	832.2145	0.0036	55.8
3+	1109.2788	1109.2836	0.0048	100.0
2+	1663.4146	1663.4217	0.0071	55.1

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	5.27
Counter-ion (acetate)	ion chromatography	5.68
Residual solvent + inorganic residue	estimated	0.19
Total peptide content	by difference	88.86
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)	97.26	97.34	divergence -0.17 pp vs batch median
Total impurities (% area)	2.74	2.66
Largest single impurity (% area)	1.16	1.75
Water (%)	3.3	5.27
Counter-ion (%)	not stated	5.68
Peptide content (%w/w)	not stated	88.86
Endotoxin (EU/mg)	0.63	0.69
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 → third-party forwarder (30 d) → laboratory (courier, cold pack, 3 d) → assay.
Assay date: 15 Sep 2024
Submitted to the index: 22 Sep 2024
Laboratory: Janoshik Analytical, Ostrava, Czechia
Method basis: 30 min gradient · high-resolution MS
Verification status: VERIFIED

What this report does not establish

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.

valley_drop22 Sep 2024

Integration on this trace is unambiguous: Met17 sulfoxide (+16 Da) at 1.75 % is baseline-resolved from the main peak, so 97.34 % is a measurement rather than a boundary decision.

scale_up_delta22 Sep 2024

Purity commonly falls a few tenths between pilot and production scale, and a result below a laboratory-batch figure is the most ordinary thing in this dataset. Comparing a commercial lot against a research-batch certificate compares two different processes.

Section 7

Related records

Same batch — lot BCH-2405-R4888 n=9

Report	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Result
AX-2024-005264	BCH-2405-R4888	Janoshik	2024-Q3	97.41	5.93	90.7	Buyer-sourced	FAIL
AX-2024-005265	BCH-2405-R4888	Medutest	2024-Q3	97.62	5.82	100.3	Buyer-sourced	PASS
AX-2024-005266	BCH-2405-R4888	Janoshik	2024-Q3	97.43	4.81	—	Supplier-supplied	FAIL
AX-2024-005267	BCH-2405-R4888	Janoshik	2024-Q3	97.52	5.68	90.8	Buyer-sourced	PASS
AX-2024-005268	BCH-2405-R4888	Kestrel	2024-Q3	97.70	4.42	106.9	Buyer-sourced	PASS
AX-2024-005270	BCH-2405-R4888	VendorInvestigate	2024-Q3	97.39	5.41	96.9	Buyer-sourced	FAIL
AX-2024-005271	BCH-2405-R4888	VendorInvestigate	2024-Q3	96.37	5.04	93.4	Buyer-sourced	FAIL
AX-2024-005272	BCH-2405-R4888	Nordanalyt	2024-Q3	97.61	5.22	—	Buyer-sourced	PASS

Batch rollup and reproducibility assessment →

Cross-sections

Other recent VIP records in the index.
Report	Supplier	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Flags	Result
AX-2025-019550	TFC	TFC-2503-E9984	Janoshik	2025-Q2	98.82	4.23	90.1	Buyer-sourced	0	PASS
AX-2025-019551	TFC	TFC-2503-E9984	PeptideMeter	2025-Q2	98.95	4.08	92.4	Buyer-sourced	1	FAIL
AX-2025-019549	TFC	TFC-2503-E9984	Medutest	2025-Q2	99.28	3.92	89.6	Buyer-sourced	1	MARGINAL
AX-2024-005266	BCH	BCH-2405-R4888	Janoshik	2024-Q3	97.43	4.81	—	Supplier-supplied	0	FAIL
AX-2024-005265	BCH	BCH-2405-R4888	Medutest	2024-Q3	97.62	5.82	100.3	Buyer-sourced	0	PASS
AX-2024-005264	BCH	BCH-2405-R4888	Janoshik	2024-Q3	97.41	5.93	90.7	Buyer-sourced	0	FAIL
AX-2024-005272	BCH	BCH-2405-R4888	Nordanalyt	2024-Q3	97.61	5.22	—	Buyer-sourced	0	PASS
AX-2024-005267	BCH	BCH-2405-R4888	Janoshik	2024-Q3	97.52	5.68	90.8	Buyer-sourced	0	PASS

Other recent BCH records in the index.
Report	Compound	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Flags	Result
AX-2026-043445	BPC-157	BCH-2603-G4350	Nordanalyt	2026-Q3	98.42	4.87	93.6	Buyer-sourced	1	MARGINAL
AX-2026-043440	BPC-157	BCH-2603-G4350	VendorInvestigate	2026-Q3	98.61	4.11	—	Buyer-sourced	1	MARGINAL
AX-2026-043442	BPC-157	BCH-2603-G4350	Janoshik	2026-Q3	98.65	4.78	—	Buyer-sourced	1	MARGINAL
AX-2026-043471	CJC-1295 with DAC	BCH-2607-H5235	Janoshik	2026-Q3	97.46	5.48	—	Buyer-sourced	1	FAIL
AX-2026-043477	CJC-1295 with DAC	BCH-2607-H5235	VendorInvestigate	2026-Q3	97.62	5.32	99.6	Buyer-sourced	1	MARGINAL
AX-2026-043449	BPC-157	BCH-2603-G4350	Kestrel	2026-Q3	99.74	4.92	91.3	Supplier-supplied	2	MARGINAL
AX-2026-043448	BPC-157	BCH-2603-G4350	Janoshik	2026-Q3	98.55	4.69	106.9	Buyer-sourced	1	MARGINAL
AX-2026-043470	CJC-1295 with DAC	BCH-2607-H5235	Janoshik	2026-Q3	97.76	6.11	99.3	Supplier-supplied	1	MARGINAL