Warm Congratulations! The CDE Registration Number F20200000337 for Pfanstiehl's Injectable-Grade L-Histidine Hydrochloride (H-117) Has Been Activated!

Pfanstiehl has been receiving a string of good news this year. Following the successive activations of its Injectable-Grade L-Histidine (H-116) and L-Arginine (A-170) earlier this year, the CDE Registration Number F20200000337 for its Injectable-Grade L-Histidine Hydrochloride (H-117) has finally been activated and converted to Category A!

Pfanstiehl's Injectable-Grade L-Histidine Hydrochloride (H-117) adhering to its consistent high-quality philosophy, Pfanstiehl's Injectable-Grade L-Histidine Hydrochloride (H-117) features ultra-high purity, ultra-low endotoxins, and ultra-low metal residues. It undergoes individual testing for 29 types of metal ions and complies with the regulations of multiple pharmacopoeias (USP, EP, JP, ChP). This product can be used in the production of biotherapeutic drugs and vaccines.

The quality indicators of Pfanstiehl's Injectable-Grade L-Histidine and L-Histidine Hydrochloride have been fully upgraded in March 2025: the quality control indicators for 29 metal ions have been further narrowed down to the ppb level; 10 additional nitrite quality control items have been added in accordance with the nitrite guidelines issued by the FDA and EMA; and controls for various enzymes such as DNA, RNA, DNase, RNase, lipase, phosphatase, and protease have been incorporated. These upgrades further reduce potential negative impacts on protein stability and the degradation of other excipients (e.g., Tween) that may be introduced by the histidine buffer system.

Product Information

· Product Name: L-Histidine Hydrochloride Monohydrate, High Purity, Low Endotoxin, Low Metals, BP, EP, JP, ChP (H-117)

· Molecular Formula: C?H??ClN?O?·H?O

· Molecular Weight: 209.62 g/mol

· CAS Number: 5934-29-2

· Product Code: H-117

Product Features

· Ultra-high purity, ultra-low endotoxins, ultra-low microbial content, and ultra-low residual metal impurities

· Newly added quality control tests for DNA, RNA, DNase, RNase, lipase, and nitrites in quality indicators

· Compliant with multiple pharmacopoeias: USP, EP, BP, JP, ChP

· Compliant with ICH Q3D guidelines

· Compliant with GMP standards

Product Application

· Buffer

If you are interested in Pfanstiehl's Injectable-Grade L-Histidine Hydrochloride (H-117), please contact Beijing XMJ Technology Co., Ltd., the authorized distributor of Pfanstiehl in China, to obtain the following detailed product overview documents. You are also welcome to contact us to request test samples.

The product series of Pfanstiehl Inc. are as follows. Please contact Beijing XMJ Technology Co., Ltd. to obtain free samples in 100g packaging.

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 call XMJ's customer service hotline at 400-050-4006 or visit the official website at m.258044.cn.