Pharmaceutical manufacturers should check their supplies of the excipient Crospovidone for contamination with peroxide, after elevated levels of the impurity were discovered in material supplied by a Chinese supplier, says the US Food and Drug Administration (FDA).
The peroxide contamination is not thought to be a major health risk directly, but the FDA is concerned that products made using the excipient "will observe a loss of drug potency and the formation of excessive impurities during the product shelf life."
One lot of crospovidone (also known as cross linked polyvinyl N-pyrrolidone) from Chinese manufacturer Tianjin Boai NKY International Ltd was found to have more than four times the maximum level of peroxide recommended in the excipient monograph published in the US Pharmacopoeia (400 parts per million).
Crospovidone is a commonly-used polymer excipient which is used as a disintegrant in tablets, granules and gelatin capsules, and also as a stabiliser in medicine suspensions. Peroxide is an impurity that can emerge from the polymerisation process during its manufacture.
"Other lots of povidone analogs manufactured by this firm may also contain excessive levels of peroxide," said the FDA in an advisory, which recommends that pharmaceutical manufacturers review their Crospovidone supplier history and their batch testing records, and make comparisons with results reported on Certificates of Analysis.
"An Import Alert has been issued to prevent further entry of Tianjin Boai NKY International Ltd Crospovidone into the US market," the agency added.
The complexity of dealing with companies involved in the supply of ingredients is evident from the FDA note, which indicates the company also trades as Friends Union Enterprise (Jianjin) Ltd, Boai New Kaiyuan Pharmaceutical Company, Boai NKY Pharmaceuticals Ltd or Bluetech Chemicals Limited.