Pre-launch research catalogue · Research use only · Not for human use

Analytical Methods

HPLC

High-performance liquid chromatography separates components of a sample chromatographically. In peptide analytics, HPLC is commonly used for method-linked assessment of purity and secondary components.

Principle

Separate before evaluating.

Chromatography distributes sample components between a stationary and a mobile phase. In modern liquid chromatography, the sample moves through a chromatographic system and separated components are detected.

In a peptide report

The context belongs with the value.

AXIOM presents a purity value only together with batch, laboratory, test date and the actual report. The number is not copied from supplier marketing or another batch.

Read the report

Five points to check first.

01

Sample / batch

The report must clearly correspond to the tested sample or batch.

02

Method

Column, mobile phase, detection and other method parameters determine how separation is achieved.

03

Chromatogram

Peaks represent detected components at specific retention times.

04

Main peak & secondary peaks

An area-percent value is method-dependent and does not automatically establish identity, amount or sterility.

05

Acceptance criterion

A limit is meaningful only when it belongs to the validated method and the specific product specification.

Terminology
IUPAC Gold Book · Liquid chromatographyCurrent terminology reference
IUPAC ↗
Method validation
ICH Q2(R2) · Validation of Analytical ProceduresFDA / ICH · Final guidance
FDA ↗