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Lactose for pharmaceutical applications needs to comply with the highest quality standards. Qualified pharmaceutical lactose manufacturers therefore work in accordance with GMP guidelines. Only very few lactose manufacturers are able to meet these strict standards and produce pharmaceutical lactose in FDA-inspected facilities. GMP guidelines for excipients are issued by IPEC.
The various pharmacopoeias present two monographs, one for monohydrate lactose and one for anhydrous lactose. Monographs described in the main pharmacopoeias (American, European and Japanese) have been harmonised.
All pharmacopoeias describe test methods specifically for lactose in detail.
A draft monograph for inhalation grade lactose is under review.
For more information about quality standards applicable to lactose, please visit the related websites or contact us.
Related websites:
www.fda.com
www.ipec.org |
