GMP Peptides Specifications
By extending our long-standing RUO custom peptide expertise to GMP Manufacturing, we combine innovation with GMP grade reproducibility, traceability, and consistency. We provide flexible batch sizes from small scale to large scale manufacturing including synthesis, purification and lyophilization up to tailored QC releases.
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QC Testing Attributes
All of our GMP peptides follow a stringent QC process. We systematically check the basic peptide properties such as identity, appearance and purity but we also offer a large range of validated QC methods including water content determination, endotoxin and bioburden measurement, solubility testing and residual water or counter-ion content, among others.
- Added assurance for your high-profile projects
- Production process compliant with 21 CFR part 820 and ISO 13485
- Manufacturing in controlled areas under SOP’s, BR’s, with qualified equipment and staff
- Lot to lot reproducibility, consistency, and traceability
- Comprehensive QC testing and characterization
Testing of our GMP beta-Amyloid peptides goes beyond the standard Purity and Mass spectrometry, by reporting results for Bioburden, Endotoxin, Monomer, and Peptide Content.
- Mass Spectrometry
- Peptide Purity
- Amino Acid Analysis
- Peptide Content
- Monomer Content
- Water Content