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Certificate of Analysis

Representative sample showing the documentation that accompanies every B&H Bio batch. Each batch is tested independently by Eurofins VRL.

Matrix — MSC Exosome Material

Batch: MAT-2026-003
Date: 2026-06-15

Test	Method	Result
Sterility	USP <71>	PASS — No growth detected
Endotoxin	USP <85>	<0.5 EU/mL
Particle Size (mean)	NTA	82 nm
Particle Size (range)	NTA	50–100 nm
Particle Concentration	NTA	1.2 × 10¹² particles/mL
pH	USP <791>	7.2
Appearance	Visual	Clear to slightly opalescent, free of visible particulates
Osmolality	USP <785>	285 mOsm/kg
Protein Content	BCA	0.85 mg/mL
Donor Screening	21 CFR 1271	PASS — All markers negative

What this means: Each batch is tested for sterility (no microbial contamination) and endotoxin (toxin levels) by Eurofins VRL, an independent third-party laboratory. These are the two most critical quality indicators for MSC exosome material.

Laboratory: Eurofins VRL Laboratories
Testing Standards: USP <71> (Sterility), USP <85> (Endotoxin)
Certificate: Issued per batch — not a master COA
Sample: Values shown are representative. Actual COA varies per batch.

What's tested in every batch

Sterility (USP <71>) — Confirms the material is free of microbial contamination. Tested via membrane filtration method. This is the gold standard for injectable-grade biological materials.

Endotoxin (USP <85>) — Measures bacterial endotoxin levels. The acceptable threshold is <5 EU/mL; our typical result is <0.5 EU/mL — ten times below the standard limit.

Particle Characterization (NTA) — Nanoparticle Tracking Analysis measures particle size distribution and concentration. Expected range: 50–100 nm, consistent with MSC-derived exosomes.

Donor Screening (21 CFR 1271) — Donors are age 18–45 and tested negative for HIV, HBV, HCV, CMV, HTLV, syphilis, West Nile, Zika, and SARS-CoV-2. Social and health history screening completed.

Regulatory notice: No exosome product is FDA-approved for therapeutic use in humans. This documentation is for informational and professional evaluation purposes only.

Request the current-batch COA for your evaluation.

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What ships with every batch

01 — Eurofins Certificate of Analysis — Independent third-party testing results per batch.
02 — Product Specification Sheet — Exosome count, growth factor panel, particle size, source, processing parameters.
03 — Batch-Level Traceability — Every vial traces back to a screened donor and documented manufacturing run.
04 — Donor Screening Records — Documentation per FDA 21 CFR 1271, including infectious disease testing.