AX-2024-005279 · CJC-1295 (no DAC) · GL Biochem lot GLBI-2407-U8370

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	97.67	% area	≥ 98.0	FAIL
Total impurities	RP-HPLC, sum of reported peaks	2.33	% area	≤ 2.0	FAIL
Largest single impurity	RP-HPLC — native GRF (1-29) (−59 Da)	1.59	% area	≤ 1.00	FAIL
Identity — theoretical monoisotopic mass	calculated from molecular formula	3365.7402	Da	—	NOT TESTED
Identity — observed monoisotopic mass	LC-MS, high resolution (ESI-TOF/QTOF)	3365.7375	Da	—	NOT TESTED
Mass accuracy	observed vs theoretical	-0.8	ppm	± 15	PASS
Total peptide content	by difference from the gravimetric mass balance	89.84	%w/w	—	NOT TESTED
Target-compound content	total peptide content × purity	87.75	%w/w	—	NOT TESTED
Gross fill (as weighed)	five-place balance, under nitrogen	2.30	mg	2 mg declared	NOT TESTED
Recovered target peptide	gross fill × target content	2.018	mg	2 mg claim	NOT TESTED
Recovery against label claim	recovered ÷ claim	100.9	%	90.0 – 110.0	PASS
Water content	Karl Fischer, coulometric, duplicate	5.54	%	≤ 9.0	PASS
Counter-ion (acetate)	anion-exchange ion chromatography	3.65	%	≤ 12.0	PASS
Residual solvent + inorganic residue	estimated — see /methods/residual-solvents-q3c/	0.97	%	—	NOT TESTED
Endotoxin	not ordered on this submission	not determined	—	≤ 5.0	NOT TESTED
Sterility	membrane filtration, USP <71>, 14 d	No growth at 14 d	—	no growth	PASS
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 after 90 s gentle swirling, no particulates	—	clear, no visible particulates	PASS
pH (reconstituted, 1 mg/mL)	potentiometric, two-point calibration	5.27	—	2.5 – 8.0	PASS
Retention time (observed)	RP-HPLC, 32 min gradient	13.46	min	13.65 ± 0.30 (normalised)	PASS
Peak asymmetry (10 % height)	Ph. Eur. 2.2.46	1.22	—	0.80 – 1.50	PASS
Plate count, main peak	N = 5.54 (t/w½)²	65,573	—	≥ 20,000	PASS
Resolution to nearest impurity	vs deamidated (+1 Da)	1.19	—	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 65,573, and skew follows the reported asymmetry factor of 1.22. 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 1.59 % impurity against a 97.67 % 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	CJC-1295 (no DAC) — main peak	13.46	4,747,065	97.67	—
2	native GRF (1-29) (−59 Da)	13.10	77,279	1.59	-58.995
3	des-Tyr1 (−163 Da)	12.88	15,553	0.32	-163.063
4	deamidated (+1 Da)	13.20	8,263	0.17	+0.984
5	truncated (1-24)	12.22	7,290	0.15	-570.291
6	acetyl adduct (+42 Da)	13.93	4,860	0.10	+42.011
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 3365.7402 Da, computed from C152H252N44O42. 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 3365.7375 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+	674.1553	674.1548	-0.0005	8.5
4+	842.4423	842.4417	-0.0006	60.4
3+	1122.9207	1122.9198	-0.0009	100.0
2+	1683.8774	1683.8760	-0.0014	60.3

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	5.54
Counter-ion (acetate)	ion chromatography	3.65
Residual solvent + inorganic residue	estimated	0.97
Total peptide content	by difference	89.84
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)	98.5	97.67	divergence +0.58 pp vs batch median
Total impurities (% area)	1.50	2.33
Largest single impurity (% area)	1.00	1.59
Water (%)	3.0	5.54
Counter-ion (%)	not stated	3.65
Peptide content (%w/w)	not stated	89.84
Endotoxin (EU/mg)	not stated	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: Retail purchase → submitter (ambient, 21 d) → laboratory (courier, cold pack, 12 d) → assay.
Assay date: 18 Jul 2024
Submitted to the index: 31 Jul 2024
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 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 GLBI-2407-U8370 n=4

Report	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Flags	Result
AX-2024-005278	GLBI-2407-U8370	Janoshik	2024-Q3	97.97	4.61	98.7	Supplier-supplied	2	FAIL
AX-2024-005280	GLBI-2407-U8370	Nordanalyt	2024-Q3	97.86	5.75	105.0	Supplier-supplied	3	FAIL
AX-2024-005281	GLBI-2407-U8370	Janoshik	2024-Q3	98.06	5.40	—	Supplier-supplied	3	MARGINAL

Batch rollup and reproducibility assessment →

Cross-sections

Other recent CJC-1295 (no DAC) records in the index.
Report	Supplier	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Flags	Result
AX-2026-041683	QSC	QSC-2606-V8637	Janoshik	2026-Q3	99.93	3.63	97.1	Supplier-supplied	1	FAIL
AX-2026-042669	GGPeps	GGPE-2606-E8495	Medutest	2026-Q3	98.61	4.06	95.5	Supplier-supplied	0	PASS
AX-2026-042665	GGPeps	GGPE-2606-E8495	Janoshik	2026-Q3	98.44	4.00	93.2	Supplier-supplied	1	MARGINAL
AX-2026-042663	GGPeps	GGPE-2606-E8495	Medutest	2026-Q3	97.96	4.14	90.0	Laboratory-retained	2	FAIL
AX-2026-042662	GGPeps	GGPE-2606-E8495	Janoshik	2026-Q3	97.89	4.11	95.1	Supplier-supplied	0	FAIL
AX-2026-041686	QSC	QSC-2606-V8637	Janoshik	2026-Q3	99.93	4.04	—	Supplier-supplied	0	PASS
AX-2026-042666	GGPeps	GGPE-2606-E8495	Janoshik	2026-Q3	97.87	3.74	94.3	Buyer-sourced	2	FAIL
AX-2026-042668	GGPeps	GGPE-2606-E8495	Nordanalyt	2026-Q3	98.02	4.53	103.9	Supplier-supplied	1	MARGINAL

Other recent GL Biochem records in the index.
Report	Compound	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Flags	Result
AX-2026-043176	Kisspeptin-10	GLBI-2608-N8085	Medutest	2026-Q3	98.22	3.30	92.5	Buyer-sourced	2	FAIL
AX-2026-043180	Kisspeptin-10	GLBI-2608-N8085	Janoshik	2026-Q3	98.69	3.37	103.8	Supplier-supplied	2	MARGINAL
AX-2026-043178	Kisspeptin-10	GLBI-2608-N8085	Janoshik	2026-Q3	98.24	4.44	96.0	Supplier-supplied	2	FAIL
AX-2026-043177	Kisspeptin-10	GLBI-2608-N8085	Janoshik	2026-Q3	98.31	3.87	106.5	Buyer-sourced	2	FAIL
AX-2026-043202	Semaglutide	GLBI-2602-U8631	PeptideMeter	2026-Q3	96.77	6.38	89.7	Supplier-supplied	3	FAIL
AX-2026-043174	Kisspeptin-10	GLBI-2608-N8085	Medutest	2026-Q3	98.18	4.09	—	Laboratory-retained	2	FAIL
AX-2026-043201	Semaglutide	GLBI-2602-U8631	Janoshik	2026-Q3	96.91	5.77	91.2	Supplier-supplied	2	FAIL
AX-2026-043203	Semaglutide	GLBI-2602-U8631	Medutest	2026-Q3	97.45	6.09	—	Supplier-supplied	2	MARGINAL