HARDLY A DAY goes by without mention of a newly emerging active pharmaceutical ingredient (API) nitrosamine, eg, nitrosamine propranolol.1 This has led to a great deal of pre-competitive data sharing. For instance, Lhasa initiated a Nitrites in Excipients database to facilitate risk assessment of drug products, which was recently published.2,3 The database categorises excipients thus: 1) excipients show varying nitrite contents with pronounced batch-to-batch variance, 2) the nitrite impact is dependent on the amount of excipient in a product, 3) these excipients show low nitrite levels and low variability, resulting in an average value of 1 μg/g nitrite, and 4) different excipient vendors show pronounced differences in nitrite levels. As the data is anonymised it will not be possible to select excipient suppliers based on lowest available nitrite levels, but it may prompt some suppliers to publish this information as it could provide a competitive advantage…
