Heavy Metal & Disintegration Specifications
NOW Foods Specifications
In compliance with cGMPs for dietary supplements, NOW Foods sets many different specifications for ingredients, the manufacture and processing of its products, finished products and packaging. Specifications for heavy metals in finished products and for disintegration of finished products are presented below:
Heavy Metal Specifications for Finished Products
Because there are no universally accepted standards for heavy metals in dietary supplements, and in accordance with cGMPs (21 CFR Sec. 111.70), NOW Foods has established interim standards for heavy metals in the finished dietary supplement products that it manufactures or distributes based on interim specifications set by the American Herbal Products Association. Reference: http://www.ahpa.org/Default.aspx?tabid=69&aId=490&zId=1
NOW Foods applies these interim specifications to all finished dietary supplement products, including those that contain herbal ingredients, that are labeled to be consumed in amounts of 5 grams or less per day. NOW Foods uses the analytical technique Inductively Coupled Plasma Mass Spectroscopy (ICP-MS) to measure heavy metal levels.
Heavy Metal Daily Limit (micrograms/day)
Arsenic (inorganic) 10.0
Disintegration Specification for Finished Products
Disintegration refers to the time it takes for a tablet, capsule or softgel to break down into a soft mass with no palpable firm core. Since dietary supplements are foods, NOW Foods does not use the USP specification for dietary supplements. In accordance with cGMPs (21CFR Sec, 111.70), NOW Foods has established standards for disintegration based on a scientific analysis of food digestion. NOW Foods has determined that food generally takes about 4-5 hours to be emptied from the stomach.
The NOW Foods disintegration specification for dietary supplements is 60 minutes. There are exceptions for specific products. The test method utilized by NOW Foods for disintegration is a slightly modified variation of USP 31 <2040>.