Warm Congratulations! The CDE Registration Number F20190000351 for Pfanstiehl’s D-Mannitol (For Injection / M-109-7) Has Been Activated!

Mannitol is a sugar alcohol, usually produced by the reduction of mannose. It is an isomer of sorbitol, highly soluble in water, appearing as a white crystalline powder with a sweetness similar to sucrose. Mannitol is a widely used lyoprotectant for proteins. Its protein-protecting effect is closely related to its concentration and morphological structure. It is generally believed that amorphous mannitol has the ability to stabilize proteins, while crystalline mannitol loses this protective function. The purity of mannitol is crucial for maintaining the stability of the proteins it protects.

Pfanstiehl’s D-Mannitol adheres to the brand’s consistent commitment to high quality. Produced in compliance with the ICH Q7 quality system, it features high purity, ultra-low endotoxin levels, and ultra-low microbial counts. Additionally, the content of 29 types of metal ions is tested individually (at ppb level). This product meets the standards of pharmacopoeias from multiple countries, satisfying the production requirements for injectable-grade mannitol in biopharmaceuticals and vaccines.

Product Information

· Product Name: D-Mannitol (Plant Derived) High Purity/Low Endotoxin-Low Metals USP/EP/JP/ChP

· Chinese Name: D - 甘露醇 (D-Ganluchun)

· Molecular Formula: C?H??O?

· Molecular Weight: 182.17 g/mol

· CAS Number: 69-65-8

· Product SKU: M-109-7

Product Features

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

· Compliant with pharmacopoeias of multiple countries: USP (United States Pharmacopeia), EP (European Pharmacopoeia), JP (Japanese Pharmacopoeia), ChP (Chinese Pharmacopoeia)

· Compliant with ICH Q3D guidelines

· Compliant with GMP injectable-grade standards

· Plant-derived

· US DMF Number: 032464

· Chinese CDE Registration Number: F20190000351 (Activated)

Product Application

· Lyoprotectant

If you are interested in Pfanstiehl’s D-Mannitol (M-109-7), 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.

Since entering the Chinese market in 2015, Pfanstiehl Inc. has obtained 13 CDE (Center for Drug Evaluation) registration numbers. Its main products include trehalose, sucrose, D-mannitol, histidine, histidine hydrochloride, arginine, arginine hydrochloride, sodium succinate, and methionine. Among these, the CDE registration numbers for trehalose (F20170000098), sucrose (cane-derived, F20180001457; beet-derived, F20170000125), and D-mannitol (F20190000351) have all been activated.

In 2023, Pfanstiehl Inc. launched injectable-grade Tris and Tris HCl as a major new offering—products that represent global high-quality standards for Tris and Tris HCl. As a century-old enterprise, Pfanstiehl Inc. also continues to invest in expanding its product pipeline and production capacity to meet and support the rapid development of the global biopharmaceutical industry, and in particular, to better contribute to the development needs of China’s biopharmaceutical sector.

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.rmb365.cn.