AX-2026-043464 · MGF · BCH lot BCH-2511-D5168

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, 32 min gradient, 214 nm	99.39	% area	≥ 97.5	PASS
Total impurities	RP-HPLC, sum of reported peaks	0.61	% area	≤ 2.5	PASS
Largest single impurity	RP-HPLC — acetyl adduct (+42 Da)	0.35	% area	≤ 1.00	PASS
Identity — theoretical monoisotopic mass	calculated from molecular formula	2886.5117	Da	—	NOT TESTED
Identity — observed monoisotopic mass	LC-MS, high resolution (ESI-TOF/QTOF)	2886.5134	Da	—	NOT TESTED
Mass accuracy	observed vs theoretical	+0.6	ppm	± 15	PASS
Total peptide content	by difference from the gravimetric mass balance	89.09	%w/w	—	NOT TESTED
Target-compound content	total peptide content × purity	88.55	%w/w	—	NOT TESTED
Gross fill (as weighed)	five-place balance, under nitrogen	5.66	mg	5 mg declared	NOT TESTED
Recovered target peptide	gross fill × target content	5.012	mg	5 mg claim	NOT TESTED
Recovery against label claim	recovered ÷ claim	100.2	%	90.0 – 110.0	PASS
Water content	Karl Fischer, coulometric, duplicate	5.79	%	≤ 9.0	PASS
Counter-ion (acetate)	anion-exchange ion chromatography	4.82	%	≤ 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	Clear, colourless, no visible particulates	—	clear, no visible particulates	PASS
pH (reconstituted, 1 mg/mL)	potentiometric, two-point calibration	5.30	—	2.5 – 8.0	PASS
Retention time (observed)	RP-HPLC, 32 min gradient	12.36	min	12.33 ± 0.30 (normalised)	PASS
Peak asymmetry (10 % height)	Ph. Eur. 2.2.46	1.10	—	0.80 – 1.50	PASS
Plate count, main peak	N = 5.54 (t/w½)²	50,555	—	≥ 20,000	PASS
Resolution to nearest impurity	vs deamidated (+1 Da)	1.14	—	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, 32 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 50,555, and skew follows the reported asymmetry factor of 1.10. 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 0.35 % impurity against a 99.39 % 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	MGF — main peak	12.36	4,830,662	99.39	—
2	acetyl adduct (+42 Da)	12.79	17,011	0.35	+42.011
3	aspartimide (−18 Da)	12.70	5,832	0.12	-18.011
4	truncated (1-20)	11.06	4,860	0.10	-486.271
5	deamidated (+1 Da)	12.10	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 3

Mass spectrum and identity

Theoretical monoisotopic mass 2886.5117 Da, computed from C121H200N42O37. 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 2886.5134 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 (%)
5+	578.3096	578.3100	0.0004	7.6
4+	722.6352	722.6356	0.0004	54.3
3+	963.1778	963.1784	0.0006	100.0
2+	1444.2631	1444.2640	0.0009	56.7

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	5.79
Counter-ion (acetate)	ion chromatography	4.82
Residual solvent + inorganic residue	estimated	0.30
Total peptide content	by difference	89.09
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)	99.71	99.39	divergence +0.49 pp vs batch median
Total impurities (% area)	0.29	0.61
Largest single impurity (% area)	not stated	0.35
Water (%)	5.0	5.79
Counter-ion (%)	2.3	4.82
Peptide content (%w/w)	92.1	89.09
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: Domestic warehouse despatch → submitter (2–8 °C, 34 d) → laboratory (courier, cold pack, 2 d) → assay.
Assay date: 20 May 2026
Submitted to the index: 26 May 2026
Laboratory: VendorInvestigate, Riga, Latvia
Method basis: 32 min gradient · high-resolution MS
Verification status: VERIFIED

What this report does not establish

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 3

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.

peak_integrator26 May 2026

Nothing adverse on this record. Purity 99.39 %, largest single impurity acetyl adduct (+42 Da) at 0.35 %, and a mass balance that closes. It is a clean record and the index has no note to add to it.

buyer_sourced26 May 2026

Provenance and purity together are what make a figure like this usable. An independently purchased vial at 99.39 % is worth several supplier-selected ones.

ms_confirm26 May 2026

+0.6 ppm at this mass is a clean identity confirmation. With retention at 12.36 min, MGF is established as the species measured. Note what it does not exclude: a mass-identical diastereomer, which no mass measurement of any resolution can.

Section 7

Related records

Same batch — lot BCH-2511-D5168 n=4

Report	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Result
AX-2026-043465	BCH-2511-D5168	Janoshik	2026-Q2	98.59	5.36	99.0	Buyer-sourced	PASS
AX-2026-043466	BCH-2511-D5168	Janoshik	2026-Q2	99.04	5.33	103.5	Buyer-sourced	PASS
AX-2026-043467	BCH-2511-D5168	Janoshik	2026-Q2	99.46	5.95	—	Supplier-supplied	PASS

Batch rollup and reproducibility assessment →

Cross-sections

Other recent MGF records in the index.
Report	Supplier	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Result
AX-2026-043660	PPG	PPG-2512-G7713	Janoshik	2026-Q2	99.30	4.25	95.8	Buyer-sourced	PASS
AX-2026-043656	PPG	PPG-2512-G7713	PeptideMeter	2026-Q2	99.09	4.22	99.3	Buyer-sourced	PASS
AX-2026-043657	PPG	PPG-2512-G7713	Janoshik	2026-Q2	99.06	4.25	107.0	Buyer-sourced	PASS
AX-2026-043466	BCH	BCH-2511-D5168	Janoshik	2026-Q2	99.04	5.33	103.5	Buyer-sourced	PASS
AX-2026-043655	PPG	PPG-2512-G7713	Medutest	2026-Q2	99.03	4.14	99.6	Buyer-sourced	PASS
AX-2026-043467	BCH	BCH-2511-D5168	Janoshik	2026-Q2	99.46	5.95	—	Supplier-supplied	PASS
AX-2026-043652	PPG	PPG-2512-G7713	Janoshik	2026-Q2	99.33	3.87	101.6	Buyer-sourced	PASS
AX-2026-043653	PPG	PPG-2512-G7713	Janoshik	2026-Q2	99.21	4.69	102.4	Buyer-sourced	PASS

Other recent BCH records in the index.
Report	Compound	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Flags	Result
AX-2026-043445	BPC-157	BCH-2603-G4350	Nordanalyt	2026-Q3	98.42	4.87	93.6	Buyer-sourced	1	MARGINAL
AX-2026-043440	BPC-157	BCH-2603-G4350	VendorInvestigate	2026-Q3	98.61	4.11	—	Buyer-sourced	1	MARGINAL
AX-2026-043442	BPC-157	BCH-2603-G4350	Janoshik	2026-Q3	98.65	4.78	—	Buyer-sourced	1	MARGINAL
AX-2026-043471	CJC-1295 with DAC	BCH-2607-H5235	Janoshik	2026-Q3	97.46	5.48	—	Buyer-sourced	1	FAIL
AX-2026-043477	CJC-1295 with DAC	BCH-2607-H5235	VendorInvestigate	2026-Q3	97.62	5.32	99.6	Buyer-sourced	1	MARGINAL
AX-2026-043449	BPC-157	BCH-2603-G4350	Kestrel	2026-Q3	99.74	4.92	91.3	Supplier-supplied	2	MARGINAL
AX-2026-043448	BPC-157	BCH-2603-G4350	Janoshik	2026-Q3	98.55	4.69	106.9	Buyer-sourced	1	MARGINAL
AX-2026-043470	CJC-1295 with DAC	BCH-2607-H5235	Janoshik	2026-Q3	97.76	6.11	99.3	Supplier-supplied	1	MARGINAL