Dextrin Monohydrate (Capsule Filler, USP/BP)
Food
Code: 7428
Dextrin Monohydrate (Capsule Filler) is commonly used to fill capsules.
USP/BP conforms when you order 25kg pack size
Dextrin can be utilized in both capsule filling and tablet formulations due to its versatility. Here’s how it functions in each application:
1. Dextrin in Capsule Filling:
- Filler/Diluent: Dextrin can be used as a filler or bulking agent in capsules. It helps ensure uniform filling, especially when the active ingredients are present in small quantities. It ensures that the capsule is filled to the desired volume.
- Flowability: Dextrin enhances the flowability of powders, which is important for the automated capsule filling process, helping ensure that the capsules are consistently filled without clogging the machinery.
- Stability: It provides good compatibility with various capsule materials (gelatin or HPMC) and ensures that the ingredients remain stable over time.
2. Dextrin in Tableting:
- Binder: Dextrin helps bind the ingredients of a tablet together during compression, improving the mechanical strength of the tablet.
- Disintegrant: It also serves as a disintegrant, helping the tablet break apart quickly in the digestive system for faster release of the active ingredients.
- Water Solubility: The solubility of dextrin assists in the disintegration and dissolution processes, which is essential for the bioavailability of the active compounds.
Advantages of Using Dextrin:
- Non-toxic and Generally Recognized as Safe (GRAS): It is widely considered safe for use in pharmaceutical formulations.
- Compatibility: Dextrin works well with a wide variety of APIs and excipients, making it a flexible option for both tablets and capsules.
- Room (25-40C)
- 24 Months from manufacturing or testing date.
- Add into water phase. Heat tolerant.
- Avoid heat above 80C
- 0.00 - 0.00
- Soluble in Water
- -
| Test Name | Specification |
|---|---|
| Appearance | White or white like amorphous powder; odorless, slightly sweet taste. It is soluble in boiling water but insoluble in ethanol or |
| Identification | Should be positive reaction; compatible with the microscopic characteristics of corn starch |
| Acidity | Conform to regulations |
| Reducing sugar | 0.2g Max |
| Solution clarity | Not thicker than No. 3 standard turbidity solution. |
| Chlorinated substance | 0.2% Max |
| Sulphate | 0.1% Max |
| Nitrate | 0.2% Max |
| Loss on drying | 10% Max |
| Residue on ignition | 0.5% Max |
| Heavy metals | 0.002% Max |
| Iron Salt | 0.005% Max |
| Total aerobic bacteria | 1000CFU/g Max |
| Mold and yeast count | 100CFU/g Max |
| E.Coli | Negative |
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