In one go, four products of Hubei Gedian Renfu Medicine Auxiliary were successfully registered for the record.

At the end of October,

Hubei Gedian Renfu Pharmaceutical Accessories Co., Ltd.

Submitting an application for registration and filing

4 pharmaceutical excipients in succession

The CDE registration platform has announced:

Maltose, Registration No:F20210000347

Glyceryl tricaprylate, registration number: F20210000393

Soybean phospholipids, registration number: F20180001536

Liquid titanium dioxide, registration number: F20180001521

Maltose (registration number: F20210000347)It is a disaccharide formed by the condensation of a water molecule from two glucose molecules. High-purity maltose is a white crystalline powder similar to glucose, which is soluble in water and has a sweet taste. The osmotic pressure of maltose is lower than that of glucose. It needs to be hydrolyzed first and then absorbed in the organism. It can be used for some special patients and made into large infusion for diabetes and hypertension patients to supplement energy clinically. Maltose is the second low endotoxin variety submitted by our company for registration and filing. Its microbial related indicators are endotoxin <2EU/g, total aerobic bacteria <100CFU/g, mold and yeast <100CFU/g.

AndTrehalose (Registration No.: F20210000072)It is the first low endotoxin product registered by our company. Its sweetness is equivalent to 45% of sucrose, and its taste is refreshing, safe and non-toxic. It can be degraded into glucose in the body and absorbed and utilized. Dihydrate crystalline trehalose has no hygroscopicity and is often used as freeze-drying protectant. This family of products is designed to provide quality-assured small molecule lyoprotectants for high-risk formulations.

Glyceryl tricaprylate (registration number: F20210000393)The glyceryl trioctanoate used in pharmaceutical formulations is a neutral active pharmaceutical carrier, absorption enhancer and solubilizer. Our company's glyceryl tricaprylate reference United States Pharmacopoeia (USP43) to develop internal control standards, product quality can be effectively guaranteed.

Soybean phospholipids (registration number: F20180001536)It is one of the important components of human tissue and has no immune reaction in the body. Therefore, soybean phospholipid, as an emulsifier and solubilizer, is the most common liposome excipient. It is used to prepare the carrier of specific drugs and make the drugs have targeting. Its microbial limit is controlled as the total number of aerobic bacteria (TAMC)≤ 102CFU/g, and the total number of mold/yeast (TYMC)≤ 102CFU/g, escherichia coli and Salmonella spp. shall not be detected.

Liquid titanium dioxide (registration number: F20180001521)Liquid titanium dioxide is a premixed auxiliary material, which is a mixture of titanium dioxide and glycerin and can contain a small amount of water. Its main functional component is titanium dioxide. It is used as a coating agent, a coloring agent and an ultraviolet absorber in pharmaceutical preparations, and is used in the preparation of coated tablets, pills, granules, capsules and external preparations.