Analytical and methodological standards

Applies to synthetic peptides of 3 to 60 amino-acid residues supplied as lyophilised powders or solutions, including acylated analogues. Does not apply to recombinant glycoproteins, antibody conjugates, undefined extracts, or non-peptide…

Applies to synthetic peptides where an expected molecular formula or average mass is available. Sets the minimum resolution required to distinguish the near-isobaric compound pairs recorded in the Institute’s monograph series.

Applies to all synthetic peptides supplied as lyophilised powders. Establishes the Institute’s position that purity and content are independent quantities and that a certificate reporting one without the other is incomplete.

Applies to lyophilised peptide powders. Coulometric titration is specified rather than volumetric because sample availability is typically limited to a few milligrams.

Applies to any peptide preparation that will be reconstituted and administered parenterally, including all material supplied for research use that is presented in a vial with a rubber closure. The Institute records that this determination…

Applies to lyophilised or solution presentations intended for parenteral administration. The Institute records that no supplier in its assessment set reports a sterility determination for research-supply material.

Applies to reconstituted peptide solutions intended for parenteral administration, and to the assessment of whether a lyophilised cake reconstitutes to a solution free of visible and sub-visible particles.

Applies to synthetic peptides where the impurity profile is to be characterised rather than merely quantified in aggregate. Covers the isobaric impurity classes that CEI-MS-01 and CEI-MS-02 cannot detect: enantiomeric substitutions…

Visual and low-technology assessment of a lyophilised presentation: cake appearance, collapse, shrinkage, colour, reconstitution time, clarity of the reconstituted solution and the presence of visible particulate or fibrillar material.

Applies to all synthetic peptides supplied as salts, which in practice means all of them. Establishes that counter-ion identity and content are part of the specification and not a residue to be disregarded.

Applies to peptides and proteins prone to self-association, and mandatorily to the amylin analogue class, to Fc-fusion and antibody-conjugate products, and to cationic amphipathic peptides. Reverse-phase purity does not detect aggregates…

Applies to synthetic peptides and small molecules where solvents of ICH class 1 or 2 were used in synthesis or purification. The Institute records that this determination is absent from the research-supply channel entirely.

Applies to the validation of any chromatographic method intended to support a purity or content claim over time. A method that has not been shown to separate the analyte from its degradation products cannot detect degradation and cannot…

Applies to the documentation accompanying any synthetic peptide preparation. Defines the fields the Institute treats as critical and as recommended, and the basis on which a certificate is recorded as conformant or not conformant in a…

Applies where a preparation is to be independently verified by a laboratory that has no commercial relationship with the supplier. Defines the chain-of-custody, blinding and reporting requirements that make an independent result…

Applies to peptides below approximately 800 daltons, to peptides with a net negative charge and minimal hydrophobic surface, and to any peptide whose main peak elutes with a retention factor below 1.0 under CEI-MS-01. This class includes…

Applies to peptides containing tryptophan, tyrosine, methionine or cysteine, to copper complexes, and to any compound whose monograph records a photolytic degradation route. Several of the most widely supplied research peptides fall in…

Applies to the assessment of any in-use period claimed for a reconstituted peptide solution, and to the practice of freezing reconstituted solutions for later use. The Institute publishes no in-use claim for reconstituted research material…