Research Guides

Quality & Testing

Analytical methods and how to read the documents that come with a lot.

Quality & Testing

How Stability Is Studied: Long-Term, Accelerated and Stress Testing (ICH Q1A/Q1B)

An explainer on how chemical stability is formally studied, based on the ICH Q1A(R2) and Q1B guidelines: stress testing, long-term and accelerated storage conditions, time points, what a re-test period is, photostability exposure, and how to read a stability claim about a lyophilized peptide critically.

8 min read

Quality & Testing

Is the Test Method Fit for Purpose? Analytical Method Validation Basics (ICH Q2)

A plain-language guide to analytical method validation for peptide testing, based on the ICH Q2(R2) guideline: what specificity, range, linearity, accuracy, precision, detection and quantitation limits, robustness and system suitability mean, and what questions to ask about the method behind a purity number.

8 min read

Quality & Testing

Peptide-Related Impurities, Explained

What the small peaks on a peptide chromatogram are: deletion, insertion and truncated sequences, racemized and incompletely deprotected forms, aspartimide, oxidation and deamidation products, and how labs detect and limit them.

9 min read

Quality & Testing

Purity Is Not Content: Net Peptide Content, Counter-Ions and Water

Why a peptide that is 99% pure by HPLC is not 99% peptide by weight: how counter-ions such as trifluoroacetate and residual water make up part of the powder, how each is measured, and why the label mass is not the same as the peptide mass.

7 min read

Quality & Testing

What "Endotoxin" Means on a Lab Report

A plain-language explanation of the endotoxin line on an analytical report: what endotoxins are, how the LAL test detects them, how results are expressed, and how to read the number against its limit.

4 min read

Quality & Testing

How to Read a Peptide Analytical Report

A section-by-section walkthrough of a typical analytical report: lot number, identity by mass spectrometry, purity by HPLC, appearance and what each value tells you.

9 min read