AX-2025-021222

BPC-157 · 5 mg declared · PolyPeptide Group (Hangzhou) Co., Ltd. · lot PPG-2412-N7907

PASSPURITY ONLY

Report ID: AX-2025-021222
Compound: BPC-157
Compound class: Tissue-repair and immunomodulatory peptides
Supplier: PPG — PolyPeptide Group (Hangzhou) Co., Ltd.
Batch / lot: PPG-2412-N7907
Declared label claim: 5mg
Laboratory: Nordanalyt Laboratories
Assay date: 27 Mar 2025
Submitted: 18 Apr 2025
Quarter: 2025-Q1
Submitter: m.halvorsen
Sample provenance: Buyer-sourced

Section 1

Results

Measured against the index acceptance specification for the tissue-repair and immunomodulatory 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, 35 min gradient, 214 nm	99.90	% area	≥ 98.0	PASS
Total impurities	RP-HPLC, sum of reported peaks	0.10	% area	≤ 2.0	PASS
Largest single impurity	RP-HPLC — des-Gly truncate (−57 Da)	0.05	% 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	88.74	%w/w	—	NOT TESTED
Target-compound content	total peptide content × purity	88.65	%w/w	—	NOT TESTED
Gross fill (as weighed)	five-place balance, under nitrogen	5.15	mg	5 mg declared	NOT TESTED
Recovered target peptide	gross fill × target content	4.565	mg	5 mg claim	NOT TESTED
Recovery against label claim	recovered ÷ claim	91.3	%	90.0 – 110.0	PASS
Water content	Karl Fischer, coulometric, duplicate	3.72	%	≤ 10.0	PASS
Counter-ion (acetate)	anion-exchange ion chromatography	7.31	%	≤ 12.0	PASS
Residual solvent + inorganic residue	estimated — see /methods/residual-solvents-q3c/	0.23	%	—	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 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	5.73	—	2.5 – 8.0	PASS
Retention time (observed)	RP-HPLC, 35 min gradient	11.17	min	11.10 ± 0.25 (normalised)	PASS
Peak asymmetry (10 % height)	Ph. Eur. 2.2.46	0.86	—	0.80 – 1.50	PASS
Plate count, main peak	N = 5.54 (t/w½)²	61,233	—	≥ 20,000	PASS
Resolution to nearest impurity	vs [D-Val]-diastereomer	0.88	—	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, 35 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 61,233, and skew follows the reported asymmetry factor of 0.86. 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 0.05 % impurity against a 99.90 % 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	BPC-157 — main peak	11.17	4,855,450	99.90	—
2	des-Gly truncate (−57 Da)	10.77	2,430	0.05	-57.021
3	truncated (1-12)	10.05	1,458	0.03	-285.132
4	[D-Val]-diastereomer	11.01	972	0.02	0.000
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	3.72
Counter-ion (acetate)	ion chromatography	7.31
Residual solvent + inorganic residue	estimated	0.23
Total peptide content	by difference	88.74
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)	99.90	99.90	divergence +0.08 pp vs batch median
Total impurities (% area)	0.10	0.10
Largest single impurity (% area)	0.04	0.05
Water (%)	2.7	3.72
Counter-ion (%)	not stated	7.31
Peptide content (%w/w)	92.5	88.74
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: Domestic warehouse despatch → submitter (2–8 °C, 17 d) → laboratory (courier, cold pack, 11 d) → assay.
Assay date: 27 Mar 2025
Submitted to the index: 18 Apr 2025
Laboratory: Nordanalyt Laboratories, Uppsala, Sweden
Method basis: 35 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 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 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.

buyer_sourced18 Apr 2025

Independently purchased, at the submitter's own cost, forwarded without the supplier's involvement. That is the definition and this record meets it.

shipping_temp18 Apr 2025

A data logger in the box would upgrade this record further. Custody is documented; temperature history is inferred, and inference is weaker than measurement.

c18_2p618 Apr 2025

Core-shell packing at 2.6 µm gains roughly 40 % in resolution over a 5 µm fully porous bed at the same length and pressure. On a pair this close, that is the difference between two peaks and one.

Section 7

Related records

Same batch — lot PPG-2412-N7907 n=5

Report	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Flags	Result
AX-2025-021223	PPG-2412-N7907	Janoshik	2025-Q1	99.82	4.06	—	Buyer-sourced	0	PASS
AX-2025-021224	PPG-2412-N7907	Janoshik	2025-Q1	99.93	4.38	95.6	Buyer-sourced	0	PASS
AX-2025-021225	PPG-2412-N7907	Janoshik	2025-Q1	99.75	4.14	92.2	Buyer-sourced	0	PASS
AX-2025-021226	PPG-2412-N7907	Nordanalyt	2025-Q1	99.44	4.83	106.2	Buyer-sourced	1	MARGINAL

Batch rollup and reproducibility assessment →

Cross-sections

Other recent BPC-157 records in the index.
Report	Supplier	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Flags	Result
AX-2026-043319	CPC	CPC-2602-W1610	Medutest	2026-Q3	98.82	2.88	103.5	Buyer-sourced	2	MARGINAL
AX-2026-041766	TFS	TFS-{CAT}-1156	Janoshik	2026-Q3	99.54	6.34	—	Buyer-sourced	1	MARGINAL
AX-2026-043445	BCH	BCH-2603-G4350	Nordanalyt	2026-Q3	98.42	4.87	93.6	Buyer-sourced	1	MARGINAL
AX-2026-043440	BCH	BCH-2603-G4350	VendorInvestigate	2026-Q3	98.61	4.11	—	Buyer-sourced	1	MARGINAL
AX-2026-043442	BCH	BCH-2603-G4350	Janoshik	2026-Q3	98.65	4.78	—	Buyer-sourced	1	MARGINAL
AX-2026-043449	BCH	BCH-2603-G4350	Kestrel	2026-Q3	99.74	4.92	91.3	Supplier-supplied	2	MARGINAL
AX-2026-043448	BCH	BCH-2603-G4350	Janoshik	2026-Q3	98.55	4.69	106.9	Buyer-sourced	1	MARGINAL
AX-2026-043318	CPC	CPC-2602-W1610	VendorInvestigate	2026-Q3	98.47	3.12	104.1	Buyer-sourced	1	MARGINAL

Other recent PPG records in the index.
Report	Compound	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Flags	Result
AX-2026-043598	Tesamorelin	PPG-2608-A6835	Kestrel	2026-Q3	98.91	2.56	100.3	Buyer-sourced	1	FAIL
AX-2026-043597	Tesamorelin	PPG-2608-A6835	Janoshik	2026-Q3	98.54	1.15	—	Buyer-sourced	0	PASS
AX-2026-043596	Tesamorelin	PPG-2608-A6835	PeptideMeter	2026-Q3	98.74	1.83	105.1	Buyer-sourced	1	MARGINAL
AX-2026-043605	Retatrutide	PPG-2604-X7060	Janoshik	2026-Q2	98.17	4.29	99.7	Buyer-sourced	0	PASS
AX-2026-043601	Retatrutide	PPG-2604-X7060	Janoshik	2026-Q2	98.28	3.96	95.3	Buyer-sourced	0	PASS
AX-2026-043668	AOD-9604	PPG-2602-W8018	PeptideMeter	2026-Q2	99.47	3.06	—	Buyer-sourced	0	PASS
AX-2026-043670	AOD-9604	PPG-2602-W8018	PeptideMeter	2026-Q2	99.56	2.71	104.5	Buyer-sourced	0	PASS
AX-2026-043630	CJC-1295 (no DAC)	PPG-2512-D7211	Janoshik	2026-Q2	99.66	5.11	92.5	Buyer-sourced	0	PASS