AX-2025-019993

Follistatin-344 · 0.1 mg declared · Shanghai ERP Biotechnology Co., Ltd. · lot ERP-2411-Y6431

N/AN/A

Report ID: AX-2025-019993
Compound: Follistatin-344
Compound class: Growth-hormone axis peptides
Supplier: ERP — Shanghai ERP Biotechnology Co., Ltd.
Batch / lot: ERP-2411-Y6431
Declared label claim: 0.10mg
Laboratory: Nordanalyt Laboratories
Assay date: 10 Mar 2025
Submitted: 02 Apr 2025
Quarter: 2025-Q1
Submitter: i.steiner
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	not a defined quantity for this substance	N/A	—	not applicable	NOT TESTED
Peptide content	not ordered on this submission	not determined	—	required to check label claim	NOT TESTED
Water content	Karl Fischer, coulometric, duplicate	3.72	%	≤ 9.0	PASS
Counter-ion	no ionisable counter-ion expected	N/A	—	not applicable	NOT TESTED
Residual solvent + inorganic residue	estimated — see /methods/residual-solvents-q3c/	0.80	%	—	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 cake, partial shrinkage from vial wall	—	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	7.12	—	2.5 – 8.0	PASS

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)	99.0	N/A
Total impurities (% area)	not stated	N/A
Largest single impurity (% area)	not stated	N/A
Water (%)	6.3	3.72
Counter-ion (%)	not stated	N/A
Peptide content (%w/w)	not stated	not determined
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: Supplier-supplied
Evidentiary weight: Weaker evidence. Read with the caveat below.
Chain of custody: Supplier despatch → laboratory direct (courier, cold pack, 8 d) → assay. Submitter did not handle the vial.
Assay date: 10 Mar 2025
Submitted to the index: 02 Apr 2025
Laboratory: Nordanalyt Laboratories, Uppsala, Sweden
Method basis: 35 min gradient · high-resolution MS
Verification status: N/A

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.
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 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.
Anything expressible as a purity. This substance is not a single defined chemical entity and a purity figure for it is not a measurement. What was measured is reported above; what was not is everything a purity figure would have told you.
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 ERP-2411-Y6431 n=0

Report	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Flags	Result
AX-2025-019994	ERP-2411-Y6431	Medutest	2025-Q1	N/A	2.74	—	Buyer-sourced	1	N/A
AX-2025-019995	ERP-2411-Y6431	Medutest	2025-Q1	N/A	2.81	—	Supplier-supplied	1	N/A
AX-2025-019996	ERP-2411-Y6431	Medutest	2025-Q1	N/A	2.97	—	Supplier-supplied	1	N/A
AX-2025-019997	ERP-2411-Y6431	VendorInvestigate	2025-Q1	N/A	2.68	—	Buyer-sourced	1	N/A

Batch rollup and reproducibility assessment →

Cross-sections

Other recent Follistatin-344 records in the index.
Report	Supplier	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Flags	Result
AX-2025-019995	ERP	ERP-2411-Y6431	Medutest	2025-Q1	N/A	2.81	—	Supplier-supplied	1	N/A
AX-2025-019997	ERP	ERP-2411-Y6431	VendorInvestigate	2025-Q1	N/A	2.68	—	Buyer-sourced	1	N/A
AX-2025-019996	ERP	ERP-2411-Y6431	Medutest	2025-Q1	N/A	2.97	—	Supplier-supplied	1	N/A
AX-2025-019994	ERP	ERP-2411-Y6431	Medutest	2025-Q1	N/A	2.74	—	Buyer-sourced	1	N/A

Other recent ERP records in the index.
Report	Compound	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Flags	Result
AX-2026-042574	TB-500	ERP-2605-S8022	VendorInvestigate	2026-Q3	99.54	2.91	96.4	Buyer-sourced	1	MARGINAL
AX-2026-042535	Tesamorelin	ERP-2604-W7280	Janoshik	2026-Q3	99.19	3.89	92.7	Supplier-supplied	1	MARGINAL
AX-2026-042577	TB-500	ERP-2605-S8022	Janoshik	2026-Q3	99.51	3.45	—	Supplier-supplied	1	MARGINAL
AX-2026-042542	Tesamorelin	ERP-2604-W7280	Janoshik	2026-Q3	98.54	4.58	103.1	Supplier-supplied	2	FAIL
AX-2026-042547	Survodutide	ERP-2605-E7682	PeptideMeter	2026-Q3	98.25	5.44	93.0	Supplier-supplied	1	MARGINAL
AX-2026-042540	Tesamorelin	ERP-2604-W7280	Kestrel	2026-Q3	99.72	3.47	103.2	Supplier-supplied	1	MARGINAL
AX-2026-042575	TB-500	ERP-2605-S8022	Janoshik	2026-Q3	99.93	3.36	95.5	Supplier-supplied	0	PASS
AX-2026-042539	Tesamorelin	ERP-2604-W7280	Janoshik	2026-Q3	98.77	4.30	89.9	Buyer-sourced	2	MARGINAL