| Item | Content |
|---|---|
| Model (Subtype) | FBH-D Type (Low Viscosity & Instant Soluble) |
| Core Characteristics | Low viscosity, solubility: 100% (instant soluble), loss on drying: 4.0% - 5.0%, reducing sugar: 0.05g - 0.08g |
| Application Scenarios | Suitable for preparations requiring high dissolution rate, such as oral suspensions and effervescent tablets, as well as the production of all granular dosage forms |
| Standards | Iron Salt: ＜0.005% Heavy Metals: ＜0.002% Reducing Sugar: 0.05g - 0.08g Loss on Drying: 4.0% - 5.0% Residue on Ignition: ＜0.5% Solubility: 100% Microbial Limit: Aerobes ＜600cfu/g, molds and yeasts ＜60cfu/g, no Escherichia coli Mesh Size: 120 mesh |
| Item | Content |
|---|---|
| Generic Name | Dextrin |
| Chinese Phonetic Alphabet | Hujing |
| English Name | Dextrin |
| Registration Number | F20209990372 |
| CAS Number | 9004-53-9 |
| Source and Preparation | A polymer prepared by heating and modifying corn starch in the presence of a small amount of acid under dry conditions |
| Executive Standards | Chinese Pharmacopoeia 2020 Edition Volume IV, Chinese Pharmacopoeia 2025 Edition Volume IV |
| Implementation Date | July 7, 2025 |
| Storage Requirements | Store in a tightly closed container |
| Product Status | This product is a white or off-white amorphous powder, odorless, with a slightly sweet taste. It is easily soluble in boiling water and insoluble in ethanol or ether. According to relevant standards, strict limits are imposed on indicators such as loss on drying and heavy metal content of dextrin. For example, for loss on drying: take this product, dry it at 105°C to constant weight, and the weight loss shall not exceed 10.0%; for heavy metals: take the residue left under the item of residue on ignition, inspect in accordance with the specified method, and the heavy metal content shall not exceed 20 parts per million. All indicators of the dextrin produced by the company meet or exceed national standards and industry standards, ensuring reliable product quality. |
| Packaging Specification | Woven bags lined with pharmaceutical-grade polyethylene film bags, 25 kg per piece |
| Product Category | Filler, Disintegrant, Binder, Forming Agent, Thickener, Emulsifying Stabilizer |
| Specific Uses | In the pharmaceutical industry, dextrin is mainly used as a binder for pharmaceutical preparations. It can enhance the cohesion between drug powders and make dosage forms such as tablets easier to form; In the food industry, it can be used as a thickener, stabilizer and filler in beverages, candies, baked foods, etc., which can improve the physical properties of food and extend the shelf life of food; In the papermaking, textile and other industries, dextrin also plays an important role. For example, it is used for paper sizing to improve the water resistance and strength of paper, and as a printing paste in textile printing and dyeing to help dyes adhere evenly to fabrics. |
| Item | 2025 Edition Pharmacopoeia Standard | In-house Standard | Subtype Standard (Implementing 2020 Edition Pharmacopoeia) | Testing Basis |
|---|---|---|---|---|
| Character | White or off-white powder; easily soluble in boiling water, insoluble in ethanol | Same as pharmacopoeia standard | White or off-white amorphous powder, odorless, slightly sweet in taste; slightly soluble in cold water, soluble in boiling water to form a viscous solution, insoluble in alcohol and ether | ChP2020/2025 |
| Identification | 1. Turns reddish-brown to dark blue when added with iodine test solution; 2. Under microscope, single granules are polygonal/round/elliptical (diameter 2-35μm) with central hilum, showing cross under polarizing microscope | Same as pharmacopoeia standard | Same as 2025 Edition Pharmacopoeia identification standard | ChP2020/2025 |
| Acidity | Shall show pink color | Conforms to standard | Regular, medium-viscosity, high-viscosity, and low-viscosity instant types all meet the requirements | ChP2020/2025 |
| Reducing Sugar | ≤0.20g | ＜0.18g | Regular type: 0.2g - 0.70g; Medium-viscosity type: 0.08g - 0.12g; High-viscosity type: 0.15g - 0.19g; Low-viscosity instant type: 0.05g - 0.08g | ChP2020/2025 |
| Chloride | ≤0.2% | ＜0.2% | - | ChP2025 |
| Sulfate | ≤0.1% | ＜0.1% | - | ChP2025 |
| Nitrate | ≤0.2% | ＜0.2% | - | ChP2025 |
| Loss on Drying | ≤10.0% | ＜9.0% | Regular and medium-viscosity types: 6.0% - 7.0%; High-viscosity and low-viscosity instant types: 4.0% - 5.0% | ChP2020/2025 |
| Residue on Ignition | ≤0.5% | ＜0.5% | Regular, medium-viscosity, high-viscosity, and low-viscosity instant types all ＜0.5% | ChP2020/2025 |
| Iron Salt | ≤0.001% | ＜0.001% | Regular, medium-viscosity, high-viscosity, and low-viscosity instant types all ＜0.005% | ChP2020/2025 |
| Heavy Metals | - | - | Regular, medium-viscosity, high-viscosity, and low-viscosity instant types all ＜0.002% | ChP2020 |
| Total Aerobes | ≤10²cfu/g | ＜600cfu/g | Regular type: ＜600cfu/g; Medium-viscosity, high-viscosity, and low-viscosity instant types: Not specified | ChP2020/2025 |
| Molds and Yeasts | ≤10²cfu/g | ＜60cfu/g | Regular type: ＜60cfu/g; Medium-viscosity, high-viscosity, and low-viscosity instant types: Not specified | ChP2020/2025 |
| Escherichia coli | Shall not be detected | Shall not be detected | Regular, medium-viscosity, high-viscosity, and low-viscosity instant types all shall not be detected | ChP2020/2025 |
