AX-2026-043031

Semaglutide · 5 mg declared · Zhuhai Kerui Biotechnology Co., Ltd. · lot KP-2601-K5213

PASSPURITY ONLY

Report ID: AX-2026-043031
Compound: Semaglutide
Compound class: Incretin analogues and co-agonists
Supplier: KP — Zhuhai Kerui Biotechnology Co., Ltd.
Batch / lot: KP-2601-K5213
Declared label claim: 5mg
Laboratory: Nordanalyt Laboratories
Assay date: 13 Jun 2026
Submitted: 23 Jun 2026
Quarter: 2026-Q2
Submitter: l.ndiaye
Sample provenance: Buyer-sourced

Section 1

Results

Measured against the index acceptance specification for the incretin analogues and co-agonists 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, 35 min gradient, 214 nm	98.20	% area	≥ 97.0	PASS
Total impurities	RP-HPLC, sum of reported peaks	1.80	% area	≤ 3.0	PASS
Largest single impurity	RP-HPLC — des-His1 truncate (−137 Da)	0.92	% 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	5.42	%	≤ 8.0	PASS
Counter-ion (TFA)	anion-exchange ion chromatography	8.22	%	≤ 12.0	PASS
Residual solvent + inorganic residue	estimated — see /methods/residual-solvents-q3c/	0.30	%	—	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	Faint haze, clearing on standing	—	clear, no visible particulates	FAIL
pH (reconstituted, 1 mg/mL)	potentiometric, two-point calibration	4.32	—	2.5 – 8.0	PASS
Retention time (observed)	RP-HPLC, 35 min gradient	21.20	min	21.24 ± 0.45 (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	85,511	—	≥ 20,000	PASS
Resolution to nearest impurity	vs [D-Aib8]-diastereomer	0.94	—	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, 35 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 85,511, 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 0.92 % impurity against a 98.20 % 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	Semaglutide — main peak	21.20	4,772,824	98.20	—
2	des-His1 truncate (−137 Da)	19.87	44,715	0.92	-137.059
3	C18 diacid mono-ester	22.79	17,497	0.36	+14.016
4	des-AEEA semaglutide (−145 Da)	20.24	17,497	0.36	-145.074
5	[D-Aib8]-diastereomer	20.92	3,402	0.07	0.000
6	Met(O) sulfoxide (+16 Da)	20.41	2,430	0.05	+15.995
7	deamidated (Asn→Asp, +1 Da)	20.61	1,944	0.04	+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 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)	98.61	98.20	divergence +0.22 pp vs batch median
Total impurities (% area)	not stated	1.80
Largest single impurity (% area)	not stated	0.92
Water (%)	3.2	5.42
Counter-ion (%)	3.1	8.22
Peptide content (%w/w)	93.1	not determined
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: Buyer-sourced
Evidentiary weight: Strongest available evidence in this index.
Chain of custody: Retail purchase → third-party forwarder (12 d) → laboratory (courier, cold pack, 6 d) → assay.
Assay date: 13 Jun 2026
Submitted to the index: 23 Jun 2026
Laboratory: Nordanalyt Laboratories, Uppsala, Sweden
Method basis: 35 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

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 KP-2601-K5213 n=9

Report	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Flags	Result
AX-2026-043028	KP-2601-K5213	VendorInvestigate	2026-Q2	98.49	5.39	—	Buyer-sourced	0	PASS
AX-2026-043029	KP-2601-K5213	Janoshik	2026-Q2	98.38	5.54	92.7	Buyer-sourced	0	PASS
AX-2026-043030	KP-2601-K5213	Janoshik	2026-Q2	98.18	5.45	—	Buyer-sourced	0	PASS
AX-2026-043032	KP-2601-K5213	PeptideMeter	2026-Q2	98.39	5.16	107.4	Buyer-sourced	0	PASS
AX-2026-043033	KP-2601-K5213	Medutest	2026-Q2	98.55	4.85	—	Buyer-sourced	1	FAIL
AX-2026-043034	KP-2601-K5213	PeptideMeter	2026-Q2	98.47	4.69	100.7	Buyer-sourced	0	PASS
AX-2026-043035	KP-2601-K5213	Janoshik	2026-Q2	98.37	5.63	—	Buyer-sourced	0	PASS
AX-2026-043036	KP-2601-K5213	Kestrel	2026-Q2	99.83	5.82	101.3	Supplier-supplied	1	MARGINAL

Batch rollup and reproducibility assessment →

Cross-sections

Other recent Semaglutide records in the index.
Report	Supplier	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Flags	Result
AX-2026-043376	WXT	WXT-2604-C3248	Janoshik	2026-Q3	97.08	4.22	—	Buyer-sourced	1	MARGINAL
AX-2026-042424	Homopeptide	HOMO-2604-X3806	PeptideMeter	2026-Q3	98.85	4.87	92.0	Buyer-sourced	0	PASS
AX-2026-041643	FGP	FGP-2602-M8547	Janoshik	2026-Q3	99.31	2.79	100.7	Buyer-sourced	0	PASS
AX-2026-041334	WWB	WWB-2606-N3192	Janoshik	2026-Q3	98.93	4.62	99.9	Buyer-sourced	0	PASS
AX-2026-042002	AMB	AMB-2607-N6274	VendorInvestigate	2026-Q3	98.23	6.37	97.1	Buyer-sourced	1	MARGINAL
AX-2026-041337	WWB	WWB-2606-N3192	Nordanalyt	2026-Q3	99.52	3.92	—	Buyer-sourced	0	PASS
AX-2026-042595	HJ	HJ-2608-C7002	Janoshik	2026-Q3	99.50	3.55	—	Buyer-sourced	1	MARGINAL
AX-2026-042217	TFC	TFC-2604-X9037	PeptideMeter	2026-Q3	98.95	4.61	96.9	Buyer-sourced	0	PASS

Other recent KP records in the index.
Report	Compound	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Flags	Result
AX-2026-043095	Retatrutide	KP-2607-H5774	Janoshik	2026-Q3	95.81	5.48	105.2	Buyer-sourced	0	FAIL
AX-2026-043094	Retatrutide	KP-2607-H5774	PeptideMeter	2026-Q3	96.32	6.40	—	Buyer-sourced	0	FAIL
AX-2026-043096	Retatrutide	KP-2607-H5774	VendorInvestigate	2026-Q3	96.48	6.05	104.9	Buyer-sourced	0	FAIL
AX-2026-043090	Retatrutide	KP-2607-H5774	Janoshik	2026-Q3	96.46	5.81	—	Buyer-sourced	0	FAIL
AX-2026-043091	Retatrutide	KP-2607-H5774	Janoshik	2026-Q3	96.13	5.94	—	Buyer-sourced	0	FAIL
AX-2026-043077	TB-500	KP-2605-C5214	Janoshik	2026-Q2	99.61	5.64	90.2	Buyer-sourced	0	PASS
AX-2026-043093	Retatrutide	KP-2607-H5774	Janoshik	2026-Q3	96.54	5.54	—	Buyer-sourced	0	PASS
AX-2026-043092	Retatrutide	KP-2607-H5774	Medutest	2026-Q3	96.64	6.12	—	Buyer-sourced	1	FAIL