Product Overview
Injectable egg yolk lecithin is a natural phospholipid mixture extracted and refined from egg yolks, with main components including phosphatidylcholine (PC), phosphatidylethanolamine (PE), and other substances. It appears as an off-white or pale yellow powder or blocky solid, with a slightly slippery texture. This product is manufactured by Baiyunshan Hanfang and holds two CDE filings (F20200000313 and F20190001049, both in Status A), complying with multiple quality standards including the Chinese Pharmacopoeia (CP), United States Pharmacopeia (USP), and European Pharmacopoeia (EP). As a key pharmaceutical excipient, it is primarily used as an emulsifier for fat emulsions and can also serve as a structural lipid in liposome formulations. With mature production processes, comprehensive compliance qualifications, and excellent physicochemical properties, it is widely employed in the manufacture of various injectable preparations, making it an indispensable core raw material in the pharmaceutical industry.
Working Principle
Injectable egg yolk lecithin boasts outstanding emulsifying capabilities. When added to fat emulsion formulations, it enables thorough blending and uniform dispersion of oil and water phases, ensuring stable emulsion systems that do not separate. In liposome formulations, this ingredient self-assembles upon contact with water into phospholipid bilayer vesicle structures, often paired with cholesterol as the core membrane material to encapsulate active pharmaceutical ingredients, achieving targeted drug delivery and sustained-release effects, thus meeting the formulation design and production requirements of various injectable preparations.
Core Advantages and Selling Points
Fully compliant with global regulations and highly adaptable to market needs
The product simultaneously meets the stringent standards of the ChP, USP, and EP—three major authoritative pharmacopoeias. It is the first domestically produced egg yolk lecithin to obtain registration approval from China’s National Medical Products Administration (National Drug Approval No. F20080006) and also the first domestic product to complete U.S. DMF filing for pharmaceutical excipients (DMF 35483), enabling seamless access to pharmaceutical markets worldwide and satisfying export compliance requirements.
Independent core manufacturing process and mature industrial supply chain
Backed by the National Engineering Research Center for Traditional Chinese Medicine Pharmaceutical Processes and New Drug Development, authorized by the National Development and Reform Commission, this product employs a proprietary core preparation process, pioneering domestic industrial-scale production. Its stable production technology ensures reliable large-volume continuous supply.
Excellent physicochemical properties and high formulation compatibility
The product exhibits exceptional emulsifying performance and good solubility, functioning stably across different dosage forms such as fat emulsions and liposomes, adapting seamlessly to the production requirements of various injectable preparations.
Supports customized specifications
Based on customers’ specific R&D and mass-production needs, we offer custom specifications exceeding standard levels, flexibly accommodating diverse formulation application scenarios.
Target Customer Groups
Manufacturers of fat emulsion injections, producers of liposome-based pharmaceuticals, pharmaceutical formulation R&D institutions, importers and exporters of pharmaceutical excipients, various injectable drug manufacturers, and overseas purchasers of pharmaceutical raw materials.
Application Scenarios
Applications in fat emulsion production
Suitable for long-chain fat emulsion injections, medium- and long-chain fat emulsion injections, various oil-based fat emulsion injections, fat emulsion amino acid glucose injections, and ω-3 fish oil series fat emulsion injections; also applicable to propofol emulsion injections, cyclopropofol injections, aprepitant injections, etomidate medium- and long-chain fat emulsion injections, flurbiprofen ester injections, and other emulsion-type injectable medications.
Applications in liposome formulation production
Can be used in combination with cholesterol, leveraging its self-assembly property into vesicular structures as a core membrane material in various liposome formulations.
Solving Industry Pain Points
Addresses the issue of conventional phospholipid raw materials having limited qualifications, unable to meet multi-national pharmacopoeia standards or overseas DMF filing requirements, thus hindering export compliance; overcomes challenges faced by some similar products relying on imports, resulting in unstable supply and higher procurement costs; improves poor emulsification and inadequate solubility, which often lead to emulsion separation and insufficient formulation stability; while also fulfilling the high-standard production demands of diverse formulations, resolving the pain point of generic specifications failing to adapt to special formulations.
Core Product Value
Baiyunshan Hanfang’s injectable egg yolk lecithin, backed by comprehensive domestic and international compliance certifications, helps pharmaceutical companies streamline overseas market registration and review procedures, reducing export compliance costs; its independently developed mature domestic production process ensures stable supply, effectively mitigating risks associated with imported raw material shortages and extended lead times, while controlling procurement expenses. Superior emulsifying and film-forming properties enhance finished product stability and reduce product scrap and losses. Customized services align with differentiated R&D and production needs, shortening new product development cycles and assisting pharmaceutical enterprises in creating high-quality injectable formulations, thereby boosting product market competitiveness.
Frequently Asked Questions (FAQ)
Q1: What CDE filing information does this product hold?
A: It has two CDE filings, with registration numbers F20200000313 and F20190001049, both currently in Status A.
Q2: Which quality standards does this product comply with?
A: It strictly adheres to the three major international pharmacopoeial standards—the Chinese Pharmacopoeia (CP), the United States Pharmacopeia (USP), and the European Pharmacopoeia (EP).
Q3: In which pharmaceutical preparations is this raw material mainly used?
A: Primarily as an emulsifier for fat emulsions, it can also serve as a membrane material in liposome formulations, suitable for producing numerous injectable preparations.
Q4: What exclusive compliance qualifications does the company possess?
A: It holds the National Drug Approval No. F20080006 and the U.S. DMF filing number DMF 35483, making it the first domestically produced egg yolk lecithin to secure both corresponding approvals and U.S. DMF registration.
Q5: Does the product support specification customization?
A: Yes, we can provide custom specifications meeting higher standards according to customer requirements, tailored to different formulation scenarios.
