AX-2024-004141

KPV · 5 mg declared · Wuhan Wansheng Biotechnology Co., Ltd. · lot WWB-2312-S1875

FAILIDENTITY CONSISTENT

Report ID: AX-2024-004141
Compound: KPV
Compound class: Tissue-repair and immunomodulatory peptides
Supplier: WWB — Wuhan Wansheng Biotechnology Co., Ltd.
Batch / lot: WWB-2312-S1875
Declared label claim: 5mg
Laboratory: Kestrel Bioanalytical
Assay date: 10 Jun 2024
Submitted: 21 Jun 2024
Quarter: 2024-Q2
Submitter: w.sorensen
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, 15 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 — Pro-Val dipeptide (−128 Da)	0.05	% area	≤ 1.00	PASS
Identity — theoretical monoisotopic mass	calculated from molecular formula	342.2267	Da	—	NOT TESTED
Identity — observed monoisotopic mass	LC-MS, unit resolution (single quadrupole)	342.2315	Da	—	NOT TESTED
Mass accuracy	observed vs theoretical	+14.1	ppm	± 15	PASS
Total peptide content	by difference from the gravimetric mass balance	79.95	%w/w	—	NOT TESTED
Target-compound content	total peptide content × purity	79.89	%w/w	—	NOT TESTED
Gross fill (as weighed)	five-place balance, under nitrogen	5.81	mg	5 mg declared	NOT TESTED
Recovered target peptide	gross fill × target content	4.642	mg	5 mg claim	NOT TESTED
Recovery against label claim	recovered ÷ claim	92.8	%	90.0 – 110.0	PASS
Water content	Karl Fischer, coulometric, duplicate	5.31	%	≤ 10.0	PASS
Counter-ion (acetate)	anion-exchange ion chromatography	13.83	%	≤ 12.0	FAIL
Residual solvent + inorganic residue	estimated — see /methods/residual-solvents-q3c/	0.91	%	—	NOT TESTED
Endotoxin	kinetic chromogenic LAL	0.24	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 to pale-yellow 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	5.99	—	2.5 – 8.0	PASS
Retention time (observed)	RP-HPLC, 15 min gradient	2.81	min	2.83 ± 0.20 (normalised)	PASS
Peak asymmetry (10 % height)	Ph. Eur. 2.2.46	0.98	—	0.80 – 1.50	PASS
Plate count, main peak	N = 5.54 (t/w½)²	62,273	—	≥ 20,000	PASS
Resolution to nearest impurity	vs acetyl-KPV (+42 Da)	3.25	—	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, 15 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 62,273, and skew follows the reported asymmetry factor of 0.98. 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 0.05 % 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	KPV — main peak	2.81	4,856,908	99.93	—
2	Pro-Val dipeptide (−128 Da)	2.59	2,430	0.05	-128.095
3	acetyl-KPV (+42 Da)	2.96	972	0.02	+42.011
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 3

Mass spectrum and identity

Theoretical monoisotopic mass 342.2267 Da, computed from C16H30N4O4. All ppm figures on this site are against monoisotopic values — see why that matters.

Figure 2. ESI charge-state envelope, unit-resolution instrument. Sticks are placed at m/z = (M + z × 1.007276)/z for the observed neutral mass of 342.2315 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 (%)
1+	343.2340	343.2388	0.0048	100.0

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	5.31
Counter-ion (acetate)	ion chromatography	13.83
Residual solvent + inorganic residue	estimated	0.91
Total peptide content	by difference	79.95
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)	99.90	99.93	divergence -0.03 pp vs batch median
Total impurities (% area)	0.10	0.07
Largest single impurity (% area)	not stated	0.05
Water (%)	3.1	5.31
Counter-ion (%)	5.4	13.83
Peptide content (%w/w)	90.9	79.95
Endotoxin (EU/mg)	0.19	0.24
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, 10 d) → assay. Submitter did not handle the vial.
Assay date: 10 Jun 2024
Submitted to the index: 21 Jun 2024
Laboratory: Kestrel Bioanalytical, Melbourne, Australia
Method basis: 15 min gradient · unit-resolution MS
Verification status: IDENTITY CONSISTENT

What this report does not establish

That the compound is not a near-isobaric alternative. Identity was confirmed at unit mass resolution, which cannot exclude species differing by 1 or 2 Da. The specific alternatives not excluded are named in the identity block above.
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 WWB-2312-S1875 n=1

This is the only report on this lot. One report is not a batch characterisation.

Batch rollup and reproducibility assessment →

Cross-sections

Other recent KPV records in the index.
Report	Supplier	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Flags	Result
AX-2026-042618	GGPeps	GGPE-2511-K8830	Janoshik	2026-Q2	98.62	5.19	103.1	Supplier-supplied	1	FAIL
AX-2026-042624	GGPeps	GGPE-2511-K8830	Nordanalyt	2026-Q2	98.14	4.25	90.1	Buyer-sourced	0	FAIL
AX-2026-042619	GGPeps	GGPE-2511-K8830	Nordanalyt	2026-Q2	98.59	4.57	97.5	Supplier-supplied	2	FAIL
AX-2026-042623	GGPeps	GGPE-2511-K8830	VendorInvestigate	2026-Q2	97.47	5.07	103.3	Buyer-sourced	1	FAIL
AX-2026-042622	GGPeps	GGPE-2511-K8830	PeptideMeter	2026-Q2	98.62	5.19	—	Supplier-supplied	1	FAIL
AX-2026-042616	GGPeps	GGPE-2511-K8830	Medutest	2026-Q2	98.67	5.59	—	Supplier-supplied	1	FAIL
AX-2026-042617	GGPeps	GGPE-2511-K8830	Janoshik	2026-Q2	97.77	4.66	93.1	Buyer-sourced	1	FAIL
AX-2026-042621	GGPeps	GGPE-2511-K8830	Janoshik	2026-Q2	98.74	5.02	99.7	Supplier-supplied	1	FAIL

Other recent WWB records in the index.
Report	Compound	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Flags	Result
AX-2026-041275	Liraglutide	WWB-2607-X2189	Nordanalyt	2026-Q3	99.61	5.03	97.3	Supplier-supplied	0	PASS
AX-2026-041387	BPC-157	WWB-2606-H3906	Janoshik	2026-Q3	98.95	4.64	—	Laboratory-retained	1	MARGINAL
AX-2026-041334	Semaglutide	WWB-2606-N3192	Janoshik	2026-Q3	98.83	5.04	—	Supplier-supplied	1	MARGINAL
AX-2026-041337	Semaglutide	WWB-2606-N3192	Nordanalyt	2026-Q3	98.96	4.81	—	Supplier-supplied	1	MARGINAL
AX-2026-041385	BPC-157	WWB-2606-H3906	Medutest	2026-Q3	99.31	4.31	—	Supplier-supplied	1	MARGINAL
AX-2026-041390	BPC-157	WWB-2606-H3906	Medutest	2026-Q3	99.47	4.84	99.3	Supplier-supplied	1	MARGINAL
AX-2026-041386	BPC-157	WWB-2606-H3906	VendorInvestigate	2026-Q3	99.32	4.88	99.2	Buyer-sourced	1	MARGINAL
AX-2026-041335	Semaglutide	WWB-2606-N3192	Janoshik	2026-Q3	99.55	4.55	100.5	Supplier-supplied	1	MARGINAL