Chromium in Gelatin Capsules
Recently, there are manufacturers using quicklime processing leather waste to manufacture industrial gelatin capsules. Tanning agents containing chromium was applied during the manufacturing, leading to a presence of chromium residue in gelatin capsules. The chromium content of gelatin capsules is about 90 times higher than the limitation set by the State Food and Drug Administration (SFDA) in China. Hence, SFDA took actions to recall these medicines.
Gelatin is the main raw material of vacant capsules. It makes the capsules solidified and more flexible. According to 2010 edition of Chinese Pharmacopoeia Part II, the chromium content of vacant gelatin capsule shall not exceed 2mg/kg.
Chromium is a kind of heavy metal. Its high toxicity can bring acute and long term health effect to human. It is highly oxidative and can damage blood cells, kidney and liver function, and to the worst case, it can lead to failure of liver and kidney. Chromium is known as a carcinogen. High dosage of it can certainly cause induced mutation.
Apart from Chromium limitation, Chinese Pharmacopoeia also restricts the total amount of methylparaben, ethylparaben, propylparaben and butylparaben as no more than 0.05%. The total bacterial amount and combined yeast and mould shall not more than 1000cfu/g and 100cfu/g respectively. E. coli per gram of sample and Salmonella per 10 gram of sample must not be detected and etc.
If you have any queries, please contact our customer service representatives.
For more details, please refer to the official webpage of SFDA.
Download information on the Chromium in Gelatin Capsules. (PDF 291 KB)
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