AX-2024-005223

IGF-1 DES (1-3) · 0.1 mg declared · Shanghai Sigma-Audley New Material Technology Co., Ltd. · lot SSA-2403-F6661

MARGINALVERIFIED

Report ID: AX-2024-005223
Compound: IGF-1 DES (1-3)
Compound class: Growth-hormone axis peptides
Supplier: SSA — Shanghai Sigma-Audley New Material Technology Co., Ltd.
Batch / lot: SSA-2403-F6661
Declared label claim: 0.10mg
Laboratory: Janoshik Analytical
Assay date: 14 Apr 2024
Submitted: 30 Apr 2024
Quarter: 2024-Q2
Submitter: i.vogel
Sample provenance: Supplier-supplied

Section 1

Results

Measured against the index acceptance specification for the growth-hormone axis 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	98.51	% area	≥ 95.0	PASS
Total impurities	RP-HPLC, sum of reported peaks	1.49	% area	≤ 5.0	PASS
Largest single impurity	RP-HPLC — des(1-4) over-truncate (−87 Da)	1.01	% area	≤ 1.00	FAIL
Identity — theoretical monoisotopic mass	calculated from molecular formula	7365.7188	Da	—	NOT TESTED
Identity — observed monoisotopic mass	LC-MS, high resolution (ESI-TOF/QTOF)	7365.7144	Da	—	NOT TESTED
Mass accuracy	observed vs theoretical	-0.6	ppm	± 15	PASS
Total peptide content	by difference from the gravimetric mass balance	88.98	%w/w	—	NOT TESTED
Target-compound content	total peptide content × purity	87.65	%w/w	—	NOT TESTED
Gross fill (as weighed)	five-place balance, under nitrogen	0.10	mg	0.1 mg declared	NOT TESTED
Recovered target peptide	gross fill × target content	0.088	mg	0.1 mg claim	NOT TESTED
Recovery against label claim	recovered ÷ claim	88.0	%	90.0 – 110.0	FAIL
Water content	Karl Fischer, coulometric, duplicate	3.75	%	≤ 9.0	PASS
Counter-ion (acetate)	anion-exchange ion chromatography	6.39	%	≤ 12.0	PASS
Residual solvent + inorganic residue	estimated — see /methods/residual-solvents-q3c/	0.88	%	—	NOT TESTED
Endotoxin	kinetic chromogenic LAL	2.31	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	Off-white lyophilised 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	4.23	—	2.5 – 8.0	PASS
Retention time (observed)	RP-HPLC, 30 min gradient	15.92	min	15.86 ± 0.50 (normalised)	PASS
Peak asymmetry (10 % height)	Ph. Eur. 2.2.46	0.95	—	0.80 – 1.50	PASS
Plate count, main peak	N = 5.54 (t/w½)²	67,961	—	≥ 20,000	PASS
Resolution to nearest impurity	vs des(1-4) over-truncate (−87 Da)	1.44	—	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 67,961, and skew follows the reported asymmetry factor of 0.95. 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 1.01 % impurity against a 98.51 % 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	IGF-1 DES (1-3) — main peak	15.92	4,787,891	98.51	—
2	des(1-4) over-truncate (−87 Da)	15.56	49,089	1.01	-87.032
3	disulfide-scrambled isomer	16.50	11,179	0.23	0.000
4	full-length IGF-1 (+343 Da)	16.40	8,263	0.17	+342.166
5	aggregated dimer	18.97	3,888	0.08	+7365.719
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 7365.7188 Da, computed from C317H508N92O95S7. 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 7365.7144 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 (%)
9+	819.4205	819.4200	-0.0005	7.9
8+	921.7221	921.7216	-0.0005	55.6
7+	1053.2528	1053.2522	-0.0006	100.0
6+	1228.6271	1228.6263	-0.0008	55.8
5+	1474.1510	1474.1502	-0.0008	8.2

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	3.75
Counter-ion (acetate)	ion chromatography	6.39
Residual solvent + inorganic residue	estimated	0.88
Total peptide content	by difference	88.98
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)	98.92	98.51	divergence -0.54 pp vs batch median
Total impurities (% area)	1.08	1.49
Largest single impurity (% area)	0.49	1.01
Water (%)	2.8	3.75
Counter-ion (%)	not stated	6.39
Peptide content (%w/w)	92.4	88.98
Endotoxin (EU/mg)	not stated	2.31
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: Supplier-supplied
Evidentiary weight: Weaker evidence. Read with the caveat below.
Chain of custody: Supplier despatch → laboratory direct (courier, cold pack, 7 d) → assay. Submitter did not handle the vial.
Assay date: 14 Apr 2024
Submitted to the index: 30 Apr 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 sterile. Sterility was not tested.
That the protein is correctly folded. Reverse-phase chromatography measures hydrophobic heterogeneity. A correctly-massed, chromatographically-homogeneous recombinant protein can be entirely mis-paired at its disulfides. Purity here is an upper bound and nothing more.
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 SSA-2403-F6661 n=8

Report	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Flags	Result
AX-2024-005217	SSA-2403-F6661	Janoshik	2024-Q2	99.68	4.52	100.0	Supplier-supplied	1	MARGINAL
AX-2024-005218	SSA-2403-F6661	Janoshik	2024-Q2	99.00	4.05	88.0	Supplier-supplied	1	MARGINAL
AX-2024-005219	SSA-2403-F6661	Janoshik	2024-Q2	99.93	3.85	—	Supplier-supplied	1	MARGINAL
AX-2024-005220	SSA-2403-F6661	Medutest	2024-Q2	99.93	3.91	106.0	Supplier-supplied	0	PASS
AX-2024-005221	SSA-2403-F6661	PeptideMeter	2024-Q2	99.28	3.45	92.0	Supplier-supplied	0	PASS
AX-2024-005222	SSA-2403-F6661	Janoshik	2024-Q2	98.94	3.46	99.0	Buyer-sourced	0	PASS
AX-2024-005224	SSA-2403-F6661	Janoshik	2024-Q2	99.63	3.96	107.0	Supplier-supplied	1	MARGINAL

Batch rollup and reproducibility assessment →

Cross-sections

Other recent IGF-1 DES (1-3) records in the index.
Report	Supplier	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Flags	Result
AX-2026-042428	SWB	SWB-2601-Y5870	PeptideMeter	2026-Q2	98.74	3.82	—	Supplier-supplied	1	MARGINAL
AX-2026-042429	SWB	SWB-2601-Y5870	Janoshik	2026-Q2	98.11	4.09	97.0	Supplier-supplied	1	MARGINAL
AX-2026-042437	SWB	SWB-2601-Y5870	Janoshik	2026-Q2	97.72	4.18	98.0	Buyer-sourced	1	MARGINAL
AX-2026-042434	SWB	SWB-2601-Y5870	Janoshik	2026-Q2	98.00	4.05	—	Supplier-supplied	1	MARGINAL
AX-2026-042432	SWB	SWB-2601-Y5870	Nordanalyt	2026-Q2	97.56	4.26	—	Buyer-sourced	2	MARGINAL
AX-2026-042441	SWB	SWB-2601-Y5870	Janoshik	2026-Q2	98.55	4.26	—	Supplier-supplied	2	MARGINAL
AX-2026-042438	SWB	SWB-2601-Y5870	Janoshik	2026-Q2	97.94	3.70	—	Laboratory-retained	2	MARGINAL
AX-2026-042440	SWB	SWB-2601-Y5870	Janoshik	2026-Q2	97.88	4.00	98.0	Supplier-supplied	1	MARGINAL

Other recent SSA records in the index.
Report	Compound	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Flags	Result
AX-2026-043144	GHK-Cu	SSA-2604-V7620	Janoshik	2026-Q2	98.35	5.25	105.8	Supplier-supplied	0	PASS
AX-2026-043141	Semax	SSA-2604-L7628	Kestrel	2026-Q2	98.84	8.58	93.2	Supplier-supplied	2	MARGINAL
AX-2026-043117	Mazdutide	SSA-2605-G6781	Janoshik	2026-Q2	99.23	3.67	90.4	Supplier-supplied	1	MARGINAL
AX-2026-043136	BPC-157	SSA-2601-N6752	Janoshik	2026-Q2	97.75	4.32	—	Supplier-supplied	2	FAIL
AX-2026-043118	Mazdutide	SSA-2605-G6781	Medutest	2026-Q2	98.29	2.65	88.7	Buyer-sourced	2	MARGINAL
AX-2026-043138	BPC-157	SSA-2601-N6752	Janoshik	2026-Q2	98.00	4.30	101.0	Supplier-supplied	1	MARGINAL
AX-2026-043137	BPC-157	SSA-2601-N6752	Janoshik	2026-Q2	97.41	4.36	104.5	Laboratory-retained	1	FAIL
AX-2026-043146	Enclomiphene citrate	SSA-2603-C6950	Medutest	2026-Q2	97.92	3.11	92.9	Buyer-sourced	2	FAIL