Analytical Standards
Purity, proven on
every batch.
Every lot is independently tested via HPLC and mass spectrometry, screened for endotoxins, and documented with a batch-specific certificate of analysis. Pharmaceutical-grade processes in a cGMP-compliant facility — held to a ≥99% purity standard.
Purity standard
≥99%
by HPLC, on every released lot
- Identity
- MS confirmed
- Endotoxin
- Per batch
The Method
How each batch is verified
Three complementary analytical methods establish identity, purity, and a clean endotoxin profile before a lot is released.
HPLC
High-Performance Liquid Chromatography
Identity & purityHPLC separates a reconstituted sample into its individual components by passing it through a column under high pressure. The resulting chromatogram resolves the target peptide from related substances — truncated sequences, deletion products, and process residues. The area under the main peak relative to total peak area gives the quantitative purity figure. Every Cellvita batch is held to a ≥99% purity standard by HPLC.
Mass Spectrometry
Molecular weight confirmation
Identity confirmationMass spectrometry ionizes the peptide and measures its mass-to-charge ratio, returning the observed molecular weight. Comparing the measured mass against the theoretical mass calculated from the amino-acid sequence confirms that the correct compound was synthesized and that no unexpected adducts or modifications are present. MS is the orthogonal identity check that pairs with HPLC purity.
Endotoxin Screening
Bacterial endotoxin limits
Contaminant controlEndotoxins are heat-stable lipopolysaccharides shed by Gram-negative bacteria that can confound sensitive in-vitro assays. Screening — typically by the Limulus Amebocyte Lysate (LAL) method — quantifies endotoxin load against defined limits so that a vial entering a research workflow carries a documented, low endotoxin profile.
The Specification
One standard, published across the catalog
We hold the same specification across the catalog so a researcher knows exactly what arrives. Reconstitution behavior, appearance, and storage are documented per product; identity and purity are documented per batch.
Cellvita purity specification
Per batch- Purity (HPLC)
- ≥99%
- Identity
- Mass spectrometry confirmed
- Endotoxin
- Screened per batch
- Manufacturing
- cGMP-compliant U.S. facility
- Documentation
- Batch-specific COA on file
- Form
- Lyophilized powder
Chain of Custody
From synthesis to vial
A documented chain of custody from manufacture through fulfillment.
Synthesized
Solid-phase synthesis in a cGMP-compliant U.S. facility.
Analyzed
HPLC purity + mass-spec identity on every lot.
Documented
Batch-specific certificate of analysis issued and filed.
Shipped
Lyophilized, temperature-aware, discreet tracked shipping.
Analytical results characterize the material as supplied for laboratory research use only. Products are not for human or animal consumption and are not intended to diagnose, treat, cure, or prevent any disease. Purity figures describe the compound as manufactured and do not constitute any representation of biological activity.