KEARNY, NJ, OCT. 30, 2003 – Chemir Pharma Services, an independent laboratory, has validated the scientific method used for quality assurance testing of (Pharmachem's) Phase 2 Starch Neutralizer®, according to Wayne Way, PhD, director of pharmaceutical development.
“Validation testing, in conjunction with our quality control mechanisms, indicates that the method, called an amylase inhibition assay, is a robust and reproducible method for testing Phase 2 to ensure it meets consistently high standards,” said Way.
Tom Glucksman, Vice President of Technical Affairs for Pharmachem Laboratories, supplier of Phase 2, said “The validation of our test method is an extremely important step in our efforts to ensure the on-going quality of Phase 2. We will continue to spend considerable resources on the clinical and laboratory study of Phase 2.”
According to Pharmachem Biochemist, Dilip Chokshi, “The validation of our assay method guarantees that the analytical protocol we’ve developed properly quantifies the activity of Phase 2 starch neutralizer, both in raw material and dosage form."
The amylase inhibition assay is similar to a method established by the U.S. Pharmacopeia, and is routinely conducted by Chemir to measure the activity level of Phase 2, an extract of the white kidney bean, in neutralizing the digestive enzyme known as alpha amylase. When alpha amylase is neutralized, it converts less starch into glucose, and glucose into fat. Thus, carbohydrates may pass through the system with less caloric intake.
Pharmachem laboratories, Kearny, NJ, is the supplier of Phase 2® starch neutralizer, an ingredient used in a variety of weight loss products sold in health food stores and pharmacies, worldwide. The company develops, supplies and manufactures a variety of high-quality, efficacious food supplements under the strictest quality control according to cGMP standards. For more information on Phase 2, log-on to www.phase2info.com, or call 1-800-526-0609.