“Pharmaceutical Grade” is the status afforded to a compound used as human medicine. It is sometimes also referred to as “medical or medicinal grade”. Pharmaceutical grade means that purity and other physicochemical and pharmacological parameters are certified as having met the highest regulatory standards by a qualified independent party. Such third-party verification is rigorous and detailed. The process includes, but is not limited to, good manufacturing practice (GMP) audits of facilities and operations; reviews of compound manufacturing and controls (CMC) documentation; and laboratory testing that verifies product conformity.
“Reagent-grade” refers to compounds rendered into sufficient purity for use in chemical analyses, chemical reactions or physical testing. This purity standard is typically established under the aegis of entities like the American Society for Testing and Materials (ASTM), an international organization that develops technical standards for a wide range of materials or products, or by the American Chemical Society through its Committee on Analytical Reagents. Reagent grade is the highest quality commercially available for a compound. In that regard, an occasional confounding factor is that reagent-grade specifications can be national rather than global in nature. Thus, American standards may specify different assay and impurity limits than do the British, European, or Japanese ones. There have been concerted international efforts to reduce or eliminate such discrepancies.documentation; and laboratory testing that verifies product conformity.
Nutraceutical Grade is a classification introduced in 1990 by the Food and Nutrition Board of the United States Institute of Medicine to describe functional food products that offer medical and/or health benefits. Health Canada defines the term as, “a product isolated or purified from foods that is generally sold in medicinal [or therapeutic] forms not usually associated with food. A nutraceutical is [ideally] demonstrated to have a physiological benefit or provide protection against chronic disease.” Such products may range from isolated nutrients, dietary supplements and specific diets to genetically engineered foods, herbal products, and processed foods like cereals, soups, and beverages. With recent developments in cellular-level nutraceutical agents, medical practitioners have been developing ways to integrate and assess information from clinical studies on complementary and alternative therapies into responsible medical practice. The United States Congress passed the Dietary Supplement Health and Education Act of 1994 (DSHE). The DSHEA establishes a legal structure for regulation of nutraceuticals by making these a new category of regulation within the framework of food and apart from drugs. The DSHEA enacted the following: (1) definitions of supplements and dietary ingredients; (2) dietary supplement safety provisions; (3) labeling requirements; (4) statements of nutritional support; (5) regulations pertaining to new dietary ingredients; (6) good manufacturing practices; (7) establishment of a Commission on Dietary Supplement Labels; and (8) establishment of the Office of Dietary Supplements.