| Item | Content |
|---|---|
| Model (Subtype) | FBD-D Type (Low Bacteria) |
| Core Characteristics | Strict microbial limit: Aerobes ＜100cfu/g, molds and yeasts ＜20cfu/g |
| Application Scenarios | Suitable for scenarios with high microbial control requirements, such as sterile preparations and oral suspensions, e.g., cephalosporin and penicillin drug preparations |
| Quality Standards | Acidity: Conforms to regulations Iron Salt: Conforms to regulations Ash: ＜0.3% Sulfur Dioxide: ＜0.004% Loss on Drying: 7.0% - 8.0% Oxidizing Substances: ＜1.4ml Microbial Limit: Aerobes ＜100cfu/g, molds and yeasts ＜20cfu/g, no Escherichia coli Mesh Size: 120 mesh |
| Item | Content |
|---|---|
| Generic Name | Maize Starch |
| English Name | Maize Starch |
| Registration Number | F20209990371 |
| CAS Number | 9005 - 25 - 8 (supplementary) |
| Source and Preparation | Obtained from the caryopsis of Zea mays L., a plant of the Gramineae family |
| Executive Standards | Chinese Pharmacopoeia 2020 Edition Volume IV, Chinese Pharmacopoeia 2025 Edition Volume IV |
| Storage Requirements | Store in a sealed container (Note: This product is hygroscopic and needs to be protected from moisture) |
| Labeling Requirements | The source of starch (maize) and the clarity of the solution shall be indicated |
| Product Status | White or off-white amorphous powder, odorless, tasteless; poor compressibility, hygroscopic but not deliquescent, swells when exposed to water; insoluble in cold water or ethanol |
| Packaging Specification | Woven bag lined with pharmaceutical-grade polyethylene film bag, 25 kg per piece |
| Product Category | Filler, binder, diluent, disintegrant |
| Uses | 1. In the pharmaceutical field, maize starch can be used as a diluent and disintegrant for tablets, helping drugs to form and disintegrate in the body and promoting drug absorption. 2. In the food industry, it is often used for thickening, 勾芡 (thickening sauces), making pastries, etc., which can improve the texture and taste of food. 3. It is also widely used in chemical and other industries, for example, as a raw material for the production of starch sugar, amino acids and other products. 4. Maize is recognized worldwide as a "golden crop", with the content of fat, phosphorus, and vitamin B2 ranking first among cereal foods. Maize starch made from maize as raw material also has certain nutritional value. It is suitable for the general population to eat, especially suitable for patients with arteriosclerosis, coronary heart disease, hypertension, fatty liver, obesity, etc. to eat appropriately. |
| Item | 2025 Edition Pharmacopoeia Standard | In-house Standard | Subtype Standard (Implementing 2020 Edition Pharmacopoeia) | Testing Basis |
|---|---|---|---|---|
| Character | White or off-white powder; insoluble in water and ethanol | Same as pharmacopoeia standard | White or off-white amorphous powder, odorless, tasteless, poor compressibility, hygroscopic but not deliquescent, swells in water, insoluble in cold water and ethanol | ChP2020/2025 |
| Identification | 1. Under microscope, single granules are polygonal/round/elliptical (diameter 2-35μm) with central hilum; shows cross under polarizing microscope; 2. Boiled with water, cooled to form off-white translucent gel; 3. Gel turns bluish-black or purplish-black with iodine test solution, fades when heated | Same as pharmacopoeia standard | Same as 2025 Edition Pharmacopoeia identification standard | ChP2020/2025 |
| Acidity | 4.5 - 7.0 | 4.8 - 6.8 | Regular, low-moisture, ultra-fine, and low-bacteria types all meet the requirements | ChP2020/2025 |
| Foreign Substances | No starch granules of other varieties allowed | Conforms to standard | - | ChP2025 |
| Sulfur Dioxide | ≤0.004% | ＜0.004% | Regular, low-moisture, ultra-fine, and low-bacteria types all ＜0.004% | ChP2020/2025 |
| Oxidizing Substances | ≤1.4ml | ＜1.4ml | Regular, low-moisture, ultra-fine, and low-bacteria types all ＜1.4ml | ChP2020/2025 |
| Loss on Drying | ≤14.0% | ＜13.0% | Regular type: 7.0% - 8.0%; Low-moisture type: 4.0% - 7.0%; Ultra-fine type: 7.0% - 8.0%; Low-bacteria type: 7.0% - 8.0% | ChP2020/2025 |
| Residue on Ignition (Ash) | ≤0.6% | ＜0.6% | Regular, low-moisture, ultra-fine, and low-bacteria types all ＜0.3% | ChP2020/2025 |
| Heavy Metals | Not more than 20 parts per million | Conforms to standard | - | ChP2025 |
| Iron Salt | ≤0.005% | ＜0.005% | Regular, low-moisture, ultra-fine, and low-bacteria types all meet the requirements | ChP2020/2025 |
| Total Aerobes | ≤10³cfu/g | ＜600cfu/g | Regular type: ＜600cfu/g; Low-bacteria type: ＜100cfu/g; Ultra-fine type: Not specified; Low-bacteria type: ＜100cfu/g | ChP2020/2025 |
| Molds and Yeasts | ≤10²cfu/g | ＜60cfu/g | Regular type: ＜60cfu/g; Low-bacteria type: ＜20cfu/g; Ultra-fine type: Not specified | ChP2020/2025 |
| Escherichia coli | Shall not be detected | Shall not be detected | Regular, low-moisture, ultra-fine, and low-bacteria types all shall not be detected | ChP2020/2025 |
| Mesh Size | Regular, low-moisture, and low-bacteria types: 120 mesh; Ultra-fine type: 200 mesh | Enterprise in-house standard | - | - |
