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Soybean Oil for Injection

Soybean Oil for Injection Soybean oil

Soybean oil for injection is a medicinal fatty oil extracted from soybean seeds and refined through a multi‑stage purification process. It appears as a pale yellow, clear liquid, and the injection‑grade product adheres to stringent quality‑control standards. This product is manufactured by Baiyunshan Hanfang, with CDE filing registration number Y20190001968 and a filing status of A. It also complies with multiple international quality standards, including the Chinese Pharmacopoeia (CP), the United States Pharmacopeia (USP), and the European Pharmacopoeia (EP). Primarily used as an oil phase and a carrier for lipid‑soluble drugs in various formulations, it can supply essential fatty acids and provide energy to the human body. It is widely suitable for producing nutritional fat emulsions, drug‑loaded fat emulsions, oily injections, eye drops, and animal‑derived pharmaceuticals, making it a commonly used, high‑quality medicinal oil raw material in the pharmaceutical formulation field.

Product Details

    • Product Overview
    • Soybean Oil for Injection is a medicinal fat oil extracted from soybean seeds and refined through a multi-stage purification process. It appears as a pale yellow, clear liquid, and the injection-grade product meets stringent quality control standards. This product is manufactured by Baiyunshan Hanfang, with CDE filing registration number Y20190001968 and filing status A. It also complies with multiple international quality standards, including the Chinese Pharmacopoeia (CP), the United States Pharmacopeia (USP), and the European Pharmacopoeia (EP). The product is primarily used as an oil phase and a carrier for lipid-soluble drugs in various formulations, providing essential fatty acids and energy to the human body. It is widely suitable for producing nutritional fat emulsions, drug-loaded fat emulsions, oily injections, eye drops, and animal pharmaceuticals, making it a commonly used high-quality medicinal oil raw material in the pharmaceutical formulation field.
    • Working Principle
    • Thanks to its excellent lipid-solubility, Soybean Oil for Injection serves as an oil-phase carrier that evenly encapsulates lipid-soluble active ingredients, ensuring stable dispersion of the drug within the formulation system. When used in fat emulsion preparations, it can combine with the emulsification system to form a stable emulsion; when applied in oily injections, it directly acts as a solvent to ensure consistent drug efficacy. After entering the human body, the oil is normally metabolized and broken down, replenishing essential fatty acids and providing energy. Moreover, supported by rigorous purification processes and stable physicochemical properties, it minimizes impurity interference, thereby ensuring the safety of clinical use.
    • Core Advantages and Selling Points
    • Compliant with multiple pharmacopoeias, suitable for the global market
    • The product strictly adheres to the three major authoritative pharmacopoeial standards—ChP, USP, and EP—and holds valid CDE filing qualifications. With a well-established compliance system, it can smoothly access pharmaceutical markets in numerous countries and regions worldwide, reducing the difficulty of overseas product registration and market entry for customers.
    • Outstanding physicochemical indicators and exceptional product stability
    • The raw material exhibits a light color and low absorbance, while acid value, peroxide value, and methoxyaniline value are all precisely controlled. Key indicators perform exceptionally well, with strong antioxidant capacity, making the product resistant to degradation during storage and use, and maintaining overall stability at an industry-leading level.
    • Supports diverse customized specifications, with broad applicability across scenarios
    • Based on customers’ specific formulation recipes, production processes, and internal control requirements, we can provide customized product specifications exceeding standard levels, flexibly adapting to the production needs of fat emulsions, injections, eye drops, and other types of formulations.
    • Target Customer Groups
    • Manufacturers of fat emulsion injections, producers of oily injections, eye drop manufacturers, animal pharmaceutical companies, pharmaceutical formulation R&D institutions, traders of medicinal oils, and overseas buyers of pharmaceutical raw materials.
    • Application Scenarios
    • Nutritional fat emulsion formulations
    • Suitable for producing long-chain fat emulsion injections, medium-/long-chain fat emulsion injections, various oil-based fat emulsion injections, fat emulsion amino acid glucose injections, and ω-3 fish oil series compound fat emulsion injections.
    • Drug-loaded fat emulsion formulations
    • Can be used as a raw material in propofol emulsion injections, cyclopropofol injections, aprepitant injections, etomidate medium-/long-chain fat emulsion injections, flurbiprofen ester injections, and other products.
    • Oily injection products
    • Used as a core ingredient in oil-based injectable preparations such as progesterone injections and artemether injections.
    • Other pharmaceutical formulations
    • Also supports the production and preparation of medical eye drops and various animal pharmaceuticals.
    • Solving Industry Pain Points
    • Addresses the challenge of ordinary medicinal soybean oil being compliant only with a single pharmacopoeia, thus failing to meet export requirements in multiple countries; overcomes issues where some oil raw materials exhibit large fluctuations in acid value, peroxide value, and other indicators, leading to oxidation and deterioration, which in turn cause poor stability and shortened shelf life of finished formulations; improves the current situation where conventional raw materials have poor color and absorbance, affecting the appearance and quality of formulations; and, in response to the needs of high-end formulation production, resolves the pain point of standard specifications not matching stringent internal control standards.
    • Core Product Value
    • Baiyunshan Hanfang’s Soybean Oil for Injection, backed by comprehensive international compliance credentials, helps pharmaceutical companies streamline overseas market declaration and review procedures, effectively reducing compliance costs. Stable and controllable physicochemical indicators significantly lower the risk of raw material spoilage and formulation rejection, minimizing production losses and after-sales issues. Excellent product stability accommodates long-term storage and large-scale mass production, ensuring a smooth supply chain. Customized services can match differentiated formulation R&D and production needs, shortening the time-to-market for new products and helping customers create high-quality pharmaceutical formulations, thereby enhancing overall product competitiveness.
    • Frequently Asked Questions (FAQ)
    • Q1: What is the CDE filing information for this Soybean Oil for Injection?
    • A: The CDE filing registration number is Y20190001968, with a filing status of A.
    • Q2: Which quality standards does the product comply with?
    • A: It complies with the Chinese Pharmacopoeia (CP), the United States Pharmacopeia (USP), and the European Pharmacopoeia (EP)—three major international pharmacopoeial standards.
    • Q3: In which formulations is Soybean Oil for Injection mainly used?
    • A: Primarily as an oil phase or lipid-soluble drug carrier in fat emulsions, oily injections, eye drops, and animal pharmaceuticals.
    • Q4: What advantages does this product offer in terms of physicochemical performance?
    • A: It features a light color, low absorbance, and highly controllable acid value, peroxide value, and methoxyaniline value, with overall product stability at an industry-leading level.
    • Q5: Can special-specification products be customized?
    • A: Yes, we support customizing higher-standard specifications according to customer needs, adapting to different pharmaceutical formulation production scenarios.