Warm Congratulations to Pfanstiehl: Its Injectable-Grade Tris Hydrochloride (Tris HCl, Item No.: T-154) Has Obtained CDE Registration Number F20240000584

This marks the 16th CDE registration number secured by Pfanstiehl’s products!

 

Biological buffers play a crucial role in life science research. Tris (tris(hydroxymethyl)aminomethane) and Tris HCl (tris(hydroxymethyl)aminomethane hydrochloride) are widely used buffers in the biopharmaceutical industry, exerting a vital function in maintaining the pH stability of solutions. Tris Base has extensive applications, including pharmaceutical production, organic synthesis, and as a biological buffer. Tris-HCl, a mixture of Tris and hydrochloric acid (HCl), primarily functions to increase the ionic strength of solutions, thereby stabilizing pH values. It is also a key component of other buffers such as TBS (Tris-buffered saline), TBST (Tris-buffered saline with Tween), and TE (Tris-EDTA buffer).

 

Currently, there is no monograph for Tris HCl in pharmacopoeias. Pfanstiehl will sponsor the United States Pharmacopeia (USP) to establish a monograph for Tris HCl. Both Pfanstiehl's Tris Base and Tris HCl are of injectable grade, featuring high purity, ultra-low endotoxin levels, and ultra-low residual metal impurities. They also undergo testing for residues of various enzymes, such as DNase, RNase, phosphatase, and lipase. Additionally, they are the world's first Tris Base and Tris HCl products to incorporate nitrite into quality control standards, meeting the production requirements of biopharmaceuticals and vaccines. At present, Pfanstiehl's Tris Base and Tris HCl have completed filings with both DMF (Drug Master File) and CDE (Center for Drug Evaluation).

 

Product Information

· Product Name: Tris HCl, High Purity, Low Endotoxin, Low Metals

· Chinese Name: 鹽酸氨丁三醇 (Yánsuān āndīngsānchún)

· Molecular Formula: C?H??ClNO?

· Molecular Weight: 157.59 g/mol

· CAS Number: 1185-53-1

· Product Item No.: T-154

Product Features

· High purity, ultra-low endotoxin levels, ultra-low microbial content, and ultra-low residual metal impurities.

· Newly added quality indicators include testing for DNA, RNA, DNase, RNase, and lipase.

· Compliant with ICH Q3D standards.

· Compliant with GMP (Good Manufacturing Practice) standards.

· CDE Registration Number: F20240000584

· DMF Registration Number: 039584

Product Application

· Buffer

 

If you are interested in Pfanstiehl's Tris Base (Item No.: T-153) and Tris HCl (Item No.: T-154), you may contact Beijing XMJ Technology Co., Ltd., Pfanstiehl's authorized distributor in China, to obtain detailed product overview documents. You are also welcome to contact us to request test samples.

 

The latest product series of Pfanstiehl Inc. are listed below. Please feel free to contact Beijing XMJ to receive free 100g samples.

Beijing XMJ Technology Co., Ltd. is the authorized distributor of Pfanstiehl in China, providing customers with comprehensive technical support and after-sales service. For more information, please feel free to send email to info@xmjsci.com or visit the official website at www.gp82.cn.