12.21.21
TSI’s MyHMB has become the only beta-hydroxy beta-methylbutyrate (HMB) ingredient in the world to receive verification from third-party tester USP, signifying that the service approved of the ingredient in its good manufacturing practices audits and assessment of ingredient quality. USP has been in operation for over 200 years, assessing the quality of medicines, dietary supplements, and foods.
HMB, a metabolite of the amino acid leucine, has been clinically studied for benefits to muscle health, including muscle protein synthesis, and has become popular in sports nutrition and healthy aging applications.
While there are thousands of sources for dietary ingredients, TSI notes that only 20 brands are listed on the USP website as being USP-verified.
“This is a significant way for TSI to differentiate the quality of MyHMB from other HMB products. It’s one thing to say that the ingredient you’re producing is better than any other manufacturer’s, it’s another to have such a highly respected third party verify that what you are doing meets their strict standards,” TSI Group president Larry Kolb said. “For 25 years, TSI has been committed to providing safe, quality-driven products and ingredients to the marketplace. Working with USP for MyHMB ingredient certification is another example of how we are leading the competition. As a stamp of approval, USP verification is important for our customers as well as regulatory bodies around the world.”
USP’s program involves periodic, rigorous GMP audits and testing programs, along with a complete evaluation of a manufacturer’s quality system, ensuring that the controls in place provide consistency from batch to batch. Further, the verification process verifies that an ingredient meets the service’s own specifications along with specifications that the manufacturer sets. This entails specifications for identity, strength, and purity through an annual random batch testing, and tests of batch-to-batch consistency through annual facility audits.
“USP bears more weight than many other certifications,” Kolb said. “For companies partnering with TSI, as well as regulators looking at our quality dossier, this adds an extra layer of independent quality assurance that will help to expedite the regulatory process and approvals globally. And, for consumers, we expect that seeing the USP logo would instill confidence in MyHMB’s quality versus the competition.”
HMB, a metabolite of the amino acid leucine, has been clinically studied for benefits to muscle health, including muscle protein synthesis, and has become popular in sports nutrition and healthy aging applications.
While there are thousands of sources for dietary ingredients, TSI notes that only 20 brands are listed on the USP website as being USP-verified.
“This is a significant way for TSI to differentiate the quality of MyHMB from other HMB products. It’s one thing to say that the ingredient you’re producing is better than any other manufacturer’s, it’s another to have such a highly respected third party verify that what you are doing meets their strict standards,” TSI Group president Larry Kolb said. “For 25 years, TSI has been committed to providing safe, quality-driven products and ingredients to the marketplace. Working with USP for MyHMB ingredient certification is another example of how we are leading the competition. As a stamp of approval, USP verification is important for our customers as well as regulatory bodies around the world.”
USP’s program involves periodic, rigorous GMP audits and testing programs, along with a complete evaluation of a manufacturer’s quality system, ensuring that the controls in place provide consistency from batch to batch. Further, the verification process verifies that an ingredient meets the service’s own specifications along with specifications that the manufacturer sets. This entails specifications for identity, strength, and purity through an annual random batch testing, and tests of batch-to-batch consistency through annual facility audits.
“USP bears more weight than many other certifications,” Kolb said. “For companies partnering with TSI, as well as regulators looking at our quality dossier, this adds an extra layer of independent quality assurance that will help to expedite the regulatory process and approvals globally. And, for consumers, we expect that seeing the USP logo would instill confidence in MyHMB’s quality versus the competition.”
