Blogs
Technical and commercial writing on API sourcing, process chemistry and regulatory practice.
Notes on sourcing, quality and process chemistry, written for the people who actually buy and qualify APIs.
Latest articles
How to qualify an API supplier without visiting the site
What a supplier questionnaire actually tells you, which documents are worth requesting, and the questions that reliably separate a manufacturer from a trader.
Manufacturer, trader or broker — telling them apart
Why the distinction matters for your filing, and the practical checks that reveal who actually made the material in the drum.
Why your API supplier should tell you about the failed batch
The commercial logic behind early disclosure of deviations, and what to read into a supplier whose record shows none.
Second sourcing: what it costs and when it pays
The real cost of qualifying a second manufacturer against the cost of a single-source interruption.
Reading a certificate of analysis properly
Which fields matter, what an unusually clean impurity profile can indicate, and how to spot a CoA that was transcribed rather than generated.
Polymorphism and why formulation blames the API
How crystallisation control upstream determines dissolution behaviour downstream, and what to specify to avoid the argument.
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