AX-2024-005580

Semaglutide · 10 mg declared · Bachem Holding (Suzhou) Co., Ltd. · lot BCH-2402-K7853

PASSPURITY ONLY

Report ID: AX-2024-005580
Compound: Semaglutide
Compound class: Incretin analogues and co-agonists
Supplier: BCH — Bachem Holding (Suzhou) Co., Ltd.
Batch / lot: BCH-2402-K7853
Declared label claim: 10mg
Laboratory: Janoshik Analytical
Assay date: 20 Sep 2024
Submitted: 09 Oct 2024
Quarter: 2024-Q3
Submitter: Contributor #Y-5136
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	98.50	% area	≥ 97.0	PASS
Total impurities	RP-HPLC, sum of reported peaks	1.50	% area	≤ 3.0	PASS
Largest single impurity	RP-HPLC — des-AEEA semaglutide (−145 Da)	0.91	% area	≤ 1.00	PASS
Identity	not ordered on this submission	not determined	—	required for VERIFIED status	NOT TESTED
Total peptide content	by difference from the gravimetric mass balance	85.80	%w/w	—	NOT TESTED
Target-compound content	total peptide content × purity	84.51	%w/w	—	NOT TESTED
Gross fill (as weighed)	five-place balance, under nitrogen	12.15	mg	10 mg declared	NOT TESTED
Recovered target peptide	gross fill × target content	10.268	mg	10 mg claim	NOT TESTED
Recovery against label claim	recovered ÷ claim	102.7	%	90.0 – 110.0	PASS
Water content	Karl Fischer, coulometric, duplicate	3.29	%	≤ 8.0	PASS
Counter-ion (TFA)	anion-exchange ion chromatography	10.27	%	≤ 12.0	PASS
Residual solvent + inorganic residue	estimated — see /methods/residual-solvents-q3c/	0.64	%	—	NOT TESTED
Endotoxin	kinetic chromogenic LAL	0.38	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 powder, no defined cake (melt-back)	—	white to off-white intact cake	FAIL
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	3.32	—	2.5 – 8.0	PASS
Retention time (observed)	RP-HPLC, 30 min gradient	18.51	min	18.42 ± 0.45 (normalised)	PASS
Peak asymmetry (10 % height)	Ph. Eur. 2.2.46	1.34	—	0.80 – 1.50	PASS
Plate count, main peak	N = 5.54 (t/w½)²	51,453	—	≥ 20,000	PASS
Resolution to nearest impurity	vs [D-Aib8]-diastereomer	0.72	—	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 51,453, and skew follows the reported asymmetry factor of 1.34. 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 0.91 % impurity against a 98.50 % 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	18.51	4,787,405	98.50	—
2	des-AEEA semaglutide (−145 Da)	17.69	44,229	0.91	-145.074
3	C18 diacid mono-ester	19.87	15,067	0.31	+14.016
4	[D-Aib8]-diastereomer	18.27	6,804	0.14	0.000
5	deamidated (Asn→Asp, +1 Da)	18.00	3,402	0.07	+0.984
6	des-His1 truncate (−137 Da)	17.37	1,944	0.04	-137.059
7	tBu-protected residual (+56 Da)	20.56	1,458	0.03	+56.063
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.

Component	Determination	%w/w of cake
Water	Karl Fischer	3.29
Counter-ion (TFA)	ion chromatography	10.27
Residual solvent + inorganic residue	estimated	0.64
Total peptide content	by difference	85.80
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)	98.64	98.50	divergence -0.01 pp vs batch median
Total impurities (% area)	not stated	1.50
Largest single impurity (% area)	not stated	0.91
Water (%)	not stated	3.29
Counter-ion (%)	not stated	10.27
Peptide content (%w/w)	not stated	85.80
Endotoxin (EU/mg)	not stated	0.38
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 (3 d) → laboratory (courier, cold pack, 8 d) → assay.
Assay date: 20 Sep 2024
Submitted to the index: 09 Oct 2024
Laboratory: Janoshik Analytical, Ostrava, Czechia
Method basis: 30 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.
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-2402-K7853 n=11

Report	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Result
AX-2024-005573	BCH-2402-K7853	Nordanalyt	2024-Q3	99.19	3.72	—	Supplier-supplied	PASS
AX-2024-005574	BCH-2402-K7853	PeptideMeter	2024-Q3	98.94	3.79	—	Buyer-sourced	PASS
AX-2024-005575	BCH-2402-K7853	Janoshik	2024-Q3	98.45	3.16	107.0	Buyer-sourced	PASS
AX-2024-005576	BCH-2402-K7853	Janoshik	2024-Q3	98.43	3.01	100.6	Buyer-sourced	PASS
AX-2024-005577	BCH-2402-K7853	Janoshik	2024-Q3	98.28	2.97	91.1	Buyer-sourced	PASS
AX-2024-005578	BCH-2402-K7853	Janoshik	2024-Q3	98.65	3.33	—	Buyer-sourced	PASS
AX-2024-005579	BCH-2402-K7853	VendorInvestigate	2024-Q3	98.58	3.82	—	Buyer-sourced	PASS
AX-2024-005581	BCH-2402-K7853	VendorInvestigate	2024-Q3	99.44	3.33	107.4	Buyer-sourced	PASS
AX-2024-005582	BCH-2402-K7853	Janoshik	2024-Q3	98.95	3.09	91.5	Buyer-sourced	PASS
AX-2024-005583	BCH-2402-K7853	Janoshik	2024-Q3	99.20	2.84	93.5	Supplier-supplied	PASS

Batch rollup and reproducibility assessment →

Cross-sections

Other recent Semaglutide records in the index.
Report	Supplier	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Result
AX-2026-042336	Homopeptide	HOMO-2604-X1993	Nordanalyt	2026-Q3	98.87	4.67	—	Buyer-sourced	PASS
AX-2026-041764	FGP	FGP-2602-M9916	Janoshik	2026-Q3	99.37	2.78	101.1	Buyer-sourced	PASS
AX-2026-042534	HJ	HJ-2608-C5744	Janoshik	2026-Q3	99.08	3.52	95.5	Buyer-sourced	PASS
AX-2026-042529	HJ	HJ-2608-C5744	Nordanalyt	2026-Q3	99.38	3.55	—	Buyer-sourced	PASS
AX-2026-042602	SWB	SWB-2602-X6980	Janoshik	2026-Q3	98.77	4.03	95.3	Supplier-supplied	PASS
AX-2026-041334	WWB	WWB-2606-N3192	Janoshik	2026-Q3	98.93	4.62	99.9	Buyer-sourced	PASS
AX-2026-041761	FGP	FGP-2602-M9916	Janoshik	2026-Q3	99.27	1.98	—	Buyer-sourced	PASS
AX-2026-043345	GL Biochem	GLBI-2602-U9408	Janoshik	2026-Q3	97.06	6.05	95.1	Buyer-sourced	PASS

Other recent BCH records in the index.
Report	Compound	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Flags	Result
AX-2026-043691	BPC-157	BCH-2603-L7768	Janoshik	2026-Q3	98.66	5.12	—	Supplier-supplied	1	MARGINAL
AX-2026-043693	BPC-157	BCH-2603-L7768	PeptideMeter	2026-Q3	97.82	5.21	94.9	Buyer-sourced	0	FAIL
AX-2026-043686	BPC-157	BCH-2603-L7768	VendorInvestigate	2026-Q3	97.64	5.27	—	Buyer-sourced	0	FAIL
AX-2026-043695	BPC-157	BCH-2603-L7768	Janoshik	2026-Q3	97.61	5.42	—	Buyer-sourced	0	FAIL
AX-2026-043726	N-Acetyl Semax Amide	BCH-2602-E8475	Janoshik	2026-Q3	97.89	9.67	104.2	Buyer-sourced	0	FAIL
AX-2026-043688	BPC-157	BCH-2603-L7768	Janoshik	2026-Q3	97.94	5.56	—	Buyer-sourced	0	FAIL
AX-2026-043658	BPC-157	BCH-2603-G6644	Janoshik	2026-Q3	98.45	4.37	101.8	Supplier-supplied	0	PASS
AX-2026-043692	BPC-157	BCH-2603-L7768	VendorInvestigate	2026-Q3	97.60	5.61	—	Buyer-sourced	0	FAIL