MISSOULA, Mont. (December 6, 2006) – TSI Health Sciences announced today that its PUREFLEX Chondroitin Sulfate Sodium USP grade ingredients have been found to be in compliance with the requirements of the USP (United States Pharmacopeia) Ingredient Verification Program.
The ingredients were approved based upon a Good Manufacturing Practices audit of the company's wholly owned TSI-Jiangyin Pharmaceutical Co., Ltd. dedicated Chondroitin Sulfate manufacturing facility. Additionally, USP conducted a review of TSI's manufacturing and quality control documentation, along with a laboratory evaluation of ingredient samples for compliance with label claims and USP program requirements.
The USP verification means the ingredients:
• Are consistent in quality from batch to batch;
• Meet label or certificate of analysis claims for identity, strength, purity, and quality;
• Are prepared in accordance with accepted manufacturing processes; and
• Meet requirements for acceptable limits of contamination.
"TSI remains committed to providing our clients with pure, consistent, and safe ingredients. We wanted to validate our industry leading quality systems by inviting a well known and respected third-party organization to audit our facilities and confirm the quality of our ingredients," said Larry Kolb, TSI Health Sciences president, U.S. operations. "Our customers have the added confidence of knowing that our PUREFLEX Chondroitin Sulfate ingredients are USP certified. We understand the importance of this certification and, unfortunately, some companies make claims that they offer high-quality, unadulterated, ingredients when in reality they do not. Consumers continue to be misled and cheated as a result. TSI asks other ingredients manufacturers to certify their facilities, for the benefit of the entire industry."
TSI Health Sciences
TSI Health Sciences, www.tsiinc.com, has evolved throughout the last decade to focus primarily on in-
house, high-end ingredient production and has become a leading developer, producer and marketer of nutraceutical ingredients to the dietary supplement, pharmaceutical and food and beverage industries. With US operations based in Missoula, Mont., TSI was founded in 1996 and has offices worldwide, including a 60-acre, fully integrated manufacturing, research, quality assurance and quality control campus in Jiangyin, China. The company's comprehensive product range includes botanical, marine and natural product extracts, as well as synthesized compounds. TSI guarantees full-service cGMP manufacturing through TSI Manufacturing Systems, with divisions specializing in small and large-scale botanical and natural product extraction, large-scale chemical synthesis production and secondary processing capabilities.
United States Pharmacopeia
The United States Pharmacopeia (USP) is a private, non-profit, standards-setting organization that advances public health by ensuring the quality and consistency of medicines, promoting the safe and proper use of medications, and verifying ingredients in dietary supplements. These standards, which are recognized worldwide, are developed by a unique process of public involvement through the contributions of volunteers representing pharmacy, medicine, and other health care professions, as well as science, academia, government, the pharmaceutical industry, and consumer organizations. For more information about USP and its public health programs, visit www.usp.org.
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