Reconstitution Solvent Selection
The diluent used to reconstitute a lyophilized research peptide is not chemically inert and is not buffered. What the published data actually shows.
The diluent used to reconstitute a lyophilized research peptide is not chemically inert and is not buffered. What the published data actually shows.
Freeze-drying literature describes formulations built around excipients. A research peptide vial usually contains none — and that changes the data.
A test date is not an expiry date. What ICH Q1A(R2) requires before anyone can claim a shelf life, and why no research peptide COA carries one.
A purity percentage counts molecules. A bioassay measures function. Why ICH Q6B treats potency as a separate specification, and what our COA omits.
Capillary electrophoresis separates peptides by charge, not hydrophobicity — and catches the impurities an HPLC-UV purity number cannot see.
A purity percentage is the output of a procedure. ICH Q2(R2), adopted by FDA in 2024, defines what makes that output worth believing.
A purity figure is a comparison, and comparisons need a standard. What happens when national metrology labs measure the same peptide batch.
Amino acid analysis takes the peptide apart and counts the residues. What net peptide content measures that purity and fill weight cannot.
HPLC purity is a ratio; qNMR is a count. What quantitative NMR measures that a purity percentage cannot, and what our COAs report instead.
Why water content is the one certificate value that changes after the certificate is issued, what Karl Fischer titration measures, and what our COAs omit.