AX-2024-004489

Semaglutide · 10 mg declared · Shenzhen Hybio Pharmaceutical Co., Ltd. · lot HYB-2407-V6435

PASSIDENTITY CONSISTENT

Report ID: AX-2024-004489
Compound: Semaglutide
Compound class: Incretin analogues and co-agonists
Supplier: HYB — Shenzhen Hybio Pharmaceutical Co., Ltd.
Batch / lot: HYB-2407-V6435
Declared label claim: 10mg
Laboratory: Janoshik Analytical
Assay date: 08 Dec 2024
Submitted: 12 Dec 2024
Quarter: 2024-Q4
Submitter: c.okonkwo
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, 30 min gradient, 214 nm	98.71	% area	≥ 97.0	PASS
Total impurities	RP-HPLC, sum of reported peaks	1.29	% area	≤ 3.0	PASS
Largest single impurity	RP-HPLC — tBu-protected residual (+56 Da)	0.90	% area	≤ 1.00	PASS
Identity — theoretical monoisotopic mass	calculated from molecular formula	4111.0524	Da	—	NOT TESTED
Identity — observed monoisotopic mass	LC-MS, high resolution (ESI-TOF/QTOF)	4111.0738	Da	—	NOT TESTED
Mass accuracy	observed vs theoretical	+5.2	ppm	± 15	PASS
Peptide content	not ordered on this submission	not determined	—	required to check label claim	NOT TESTED
Water content	Karl Fischer, coulometric, duplicate	4.53	%	≤ 8.0	PASS
Counter-ion (TFA)	anion-exchange ion chromatography	7.56	%	≤ 12.0	PASS
Residual solvent + inorganic residue	estimated — see /methods/residual-solvents-q3c/	0.92	%	—	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	3.72	—	2.5 – 8.0	PASS
Retention time (observed)	RP-HPLC, 30 min gradient	18.47	min	18.42 ± 0.45 (normalised)	PASS
Peak asymmetry (10 % height)	Ph. Eur. 2.2.46	1.20	—	0.80 – 1.50	PASS
Plate count, main peak	N = 5.54 (t/w½)²	56,455	—	≥ 20,000	PASS
Resolution to nearest impurity	vs [D-Aib8]-diastereomer	0.75	—	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 56,455, and skew follows the reported asymmetry factor of 1.20. 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 0.90 % impurity against a 98.71 % 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	18.47	4,797,612	98.71	—
2	tBu-protected residual (+56 Da)	20.52	43,743	0.90	+56.063
3	des-AEEA semaglutide (−145 Da)	17.65	9,235	0.19	-145.074
4	[D-Aib8]-diastereomer	18.23	6,318	0.13	0.000
5	des-His1 truncate (−137 Da)	17.33	2,430	0.05	-137.059
6	Met(O) sulfoxide (+16 Da)	17.79	486	0.01	+15.995
7	deamidated (Asn→Asp, +1 Da)	17.96	486	0.01	+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 4111.0524 Da, computed from C187H291N45O59. 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 4111.0738 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 (%)
6+	686.1827	686.1862	0.0035	8.0
5+	823.2178	823.2220	0.0042	50.9
4+	1028.7704	1028.7757	0.0053	100.0
3+	1371.3581	1371.3652	0.0071	52.5
2+	2056.5335	2056.5442	0.0107	9.0

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.

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)	99.54	98.71	divergence +0.61 pp vs batch median
Total impurities (% area)	0.46	1.29
Largest single impurity (% area)	0.25	0.90
Water (%)	3.3	4.53
Counter-ion (%)	4.3	7.56
Peptide content (%w/w)	91.8	not determined
Endotoxin (EU/mg)	0.50	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: Buyer-sourced
Evidentiary weight: Strongest available evidence in this index.
Chain of custody: Domestic warehouse despatch → submitter (2–8 °C, 13 d) → laboratory (courier, cold pack, 4 d) → assay.
Assay date: 08 Dec 2024
Submitted to the index: 12 Dec 2024
Laboratory: Janoshik Analytical, Ostrava, Czechia
Method basis: 30 min gradient · high-resolution MS
Verification status: IDENTITY CONSISTENT

What this report does not establish

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 1

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.

epitalon_bAsp12 Dec 2024

A beta-aspartyl isomer sits a tenth of a minute away and is mass-identical. That is the archetype of a pair where resolution is a compound property and no rule should adjudicate it.

Section 7

Related records

Same batch — lot HYB-2407-V6435 n=11

Report	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Flags	Result
AX-2024-004487	HYB-2407-V6435	Janoshik	2024-Q4	98.93	4.15	—	Buyer-sourced	0	PASS
AX-2024-004488	HYB-2407-V6435	VendorInvestigate	2024-Q4	99.11	4.63	—	Buyer-sourced	0	PASS
AX-2024-004490	HYB-2407-V6435	Medutest	2024-Q4	98.89	4.50	94.5	Buyer-sourced	0	PASS
AX-2024-004491	HYB-2407-V6435	PeptideMeter	2024-Q4	98.51	4.27	88.5	Buyer-sourced	1	MARGINAL
AX-2024-004492	HYB-2407-V6435	Janoshik	2024-Q4	98.98	4.09	97.9	Buyer-sourced	0	PASS
AX-2025-019353	HYB-2407-V6435	Janoshik	2024-Q4	98.76	4.67	—	Buyer-sourced	0	PASS
AX-2024-004493	HYB-2407-V6435	Janoshik	2024-Q4	98.79	4.48	—	Buyer-sourced	0	PASS
AX-2024-004494	HYB-2407-V6435	Janoshik	2024-Q4	99.56	4.70	—	Buyer-sourced	0	PASS
AX-2024-004495	HYB-2407-V6435	Kestrel	2024-Q4	99.65	4.26	—	Buyer-sourced	0	PASS
AX-2024-004496	HYB-2407-V6435	Medutest	2024-Q4	99.01	4.29	103.4	Buyer-sourced	0	PASS

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 HYB records in the index.
Report	Compound	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Flags	Result
AX-2026-042083	MOTS-c	HYB-2606-D7858	Medutest	2026-Q3	99.93	2.02	—	Buyer-sourced	0	PASS
AX-2026-042090	MOTS-c	HYB-2606-D7858	Janoshik	2026-Q3	99.57	2.36	—	Buyer-sourced	1	FAIL
AX-2026-042084	MOTS-c	HYB-2606-D7858	Janoshik	2026-Q3	99.28	2.79	107.3	Buyer-sourced	0	PASS
AX-2026-042087	MOTS-c	HYB-2606-D7858	Janoshik	2026-Q3	99.54	3.05	—	Buyer-sourced	0	PASS
AX-2026-042085	MOTS-c	HYB-2606-D7858	Janoshik	2026-Q3	99.51	2.31	—	Buyer-sourced	0	PASS
AX-2026-042088	MOTS-c	HYB-2606-D7858	PeptideMeter	2026-Q3	99.22	2.21	—	Buyer-sourced	0	PASS
AX-2026-042086	MOTS-c	HYB-2606-D7858	Janoshik	2026-Q3	99.93	3.02	—	Buyer-sourced	1	MARGINAL
AX-2026-042091	CJC-1295 with DAC	HYB-2608-E7391	Janoshik	2026-Q3	99.38	5.53	—	Buyer-sourced	0	PASS