AX-2024-005474

VIP · 5 mg declared · Bachem Holding (Suzhou) Co., Ltd. · lot BCH-2405-R6960

MARGINALVERIFIED

Report ID: AX-2024-005474
Compound: VIP
Compound class: Tissue-repair and immunomodulatory peptides
Supplier: BCH — Bachem Holding (Suzhou) Co., Ltd.
Batch / lot: BCH-2405-R6960
Declared label claim: 5mg
Laboratory: Janoshik Analytical
Assay date: 06 Aug 2024
Submitted: 17 Aug 2024
Quarter: 2024-Q3
Submitter: Contributor #M-7735
Sample provenance: Supplier-supplied

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	97.80	% area	≥ 97.5	PASS
Total impurities	RP-HPLC, sum of reported peaks	2.20	% area	≤ 2.5	PASS
Largest single impurity	RP-HPLC — Met17 sulfoxide (+16 Da)	1.15	% 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)	3324.7927	Da	—	NOT TESTED
Mass accuracy	observed vs theoretical	-6.6	ppm	± 15	PASS
Total peptide content	by difference from the gravimetric mass balance	90.05	%w/w	—	NOT TESTED
Target-compound content	total peptide content × purity	88.07	%w/w	—	NOT TESTED
Gross fill (as weighed)	five-place balance, under nitrogen	5.87	mg	5 mg declared	NOT TESTED
Recovered target peptide	gross fill × target content	5.170	mg	5 mg claim	NOT TESTED
Recovery against label claim	recovered ÷ claim	103.4	%	90.0 – 110.0	PASS
Water content	Karl Fischer, coulometric, duplicate	5.85	%	≤ 10.0	PASS
Counter-ion (acetate)	anion-exchange ion chromatography	3.78	%	≤ 12.0	PASS
Residual solvent + inorganic residue	estimated — see /methods/residual-solvents-q3c/	0.32	%	—	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	Faint haze, clearing on standing	—	clear, no visible particulates	FAIL
pH (reconstituted, 1 mg/mL)	potentiometric, two-point calibration	5.20	—	2.5 – 8.0	PASS
Retention time (observed)	RP-HPLC, 30 min gradient	13.00	min	12.98 ± 0.35 (normalised)	PASS
Peak asymmetry (10 % height)	Ph. Eur. 2.2.46	1.12	—	0.80 – 1.50	PASS
Plate count, main peak	N = 5.54 (t/w½)²	73,557	—	≥ 20,000	PASS
Resolution to nearest impurity	vs C-terminal free acid (+1 Da)	1.42	—	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 73,557, and skew follows the reported asymmetry factor of 1.12. 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 1.15 % impurity against a 97.80 % 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	13.00	4,753,383	97.80	—
2	Met17 sulfoxide (+16 Da)	12.34	55,894	1.15	+15.995
3	C-terminal free acid (+1 Da)	13.28	25,274	0.52	+0.984
4	des-His1 (−137 Da)	12.18	16,525	0.34	-137.059
5	deamidated (+1 Da)	12.70	9,235	0.19	+0.984
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 3324.7927 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	665.9658	-0.0044	7.7
4+	832.2109	832.2055	-0.0054	51.2
3+	1109.2788	1109.2715	-0.0073	100.0
2+	1663.4146	1663.4036	-0.0110	57.6

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	5.85
Counter-ion (acetate)	ion chromatography	3.78
Residual solvent + inorganic residue	estimated	0.32
Total peptide content	by difference	90.05
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)	98.0	97.80	divergence +0.44 pp vs batch median
Total impurities (% area)	not stated	2.20
Largest single impurity (% area)	not stated	1.15
Water (%)	not stated	5.85
Counter-ion (%)	not stated	3.78
Peptide content (%w/w)	not stated	90.05
Endotoxin (EU/mg)	not stated	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: Supplier-supplied
Evidentiary weight: Weaker evidence. Read with the caveat below.
Chain of custody: Supplier despatch → laboratory direct (courier, cold pack, 5 d) → assay. Submitter did not handle the vial.
Assay date: 06 Aug 2024
Submitted to the index: 17 Aug 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 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

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 BCH-2405-R6960 n=2

Report	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Flags	Result
AX-2024-005475	BCH-2405-R6960	Medutest	2024-Q3	97.32	5.45	—	Supplier-supplied	2	FAIL

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-2025-019161	TFC	TFC-2503-E5248	Janoshik	2025-Q2	98.65	3.88	—	Supplier-supplied	2	MARGINAL
AX-2025-019160	TFC	TFC-2503-E5248	Nordanalyt	2025-Q2	99.34	3.52	—	Supplier-supplied	1	MARGINAL
AX-2024-005475	BCH	BCH-2405-R6960	Medutest	2024-Q3	97.32	5.45	—	Supplier-supplied	2	FAIL

Other recent BCH records in the index.
Report	Compound	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Flags	Result
AX-2026-043574	N-Acetyl Semax Amide	BCH-2602-E8253	Janoshik	2026-Q3	97.75	8.85	97.9	Supplier-supplied	1	FAIL
AX-2026-043503	BPC-157	BCH-2603-G6422	Janoshik	2026-Q3	98.46	4.32	—	Supplier-supplied	1	MARGINAL
AX-2026-043575	N-Acetyl Semax Amide	BCH-2602-E8253	Janoshik	2026-Q3	97.44	9.19	104.8	Supplier-supplied	1	FAIL
AX-2026-043539	CJC-1295 with DAC	BCH-2607-H7307	Janoshik	2026-Q3	98.12	5.78	100.6	Supplier-supplied	1	MARGINAL
AX-2026-043504	BPC-157	BCH-2603-G6422	Janoshik	2026-Q3	98.38	4.45	95.5	Supplier-supplied	1	MARGINAL
AX-2026-043502	BPC-157	BCH-2603-G6422	PeptideMeter	2026-Q3	97.72	4.86	—	Buyer-sourced	1	FAIL
AX-2026-043501	BPC-157	BCH-2603-G6422	PeptideMeter	2026-Q3	98.37	4.75	100.8	Supplier-supplied	1	MARGINAL
AX-2026-043573	N-Acetyl Semax Amide	BCH-2602-E8253	Janoshik	2026-Q3	97.47	8.59	—	Supplier-supplied	1	FAIL