Gelatin for Hard Capsules
Hard capsule refers to a certain amount of medicinal material extract and powder or auxiliary materials into uniform powder or particles. Gelatin is used as the packaging of medicine.
PRODUCT DESCRIPTION
With the development of the pharmaceutical industry, complex and strict multi-functional requirements are put forward for the performance of materials, which are difficult to meet by most metal materials and inorganic materials.
Gelatin is a natural polymer material, which has a very similar structure to the organism. It has good physical and chemical properties, bio-compatibility, and biodegradability, as well as simple production, processing, and molding characteristics, making it an absolute advantage in the field of bio-medicine.
When pharmaceutical gelatin is used to produce hollow hard capsules, it has the main characteristics such as proper viscosity at high concentration, high mechanical strength, thermal invertibility, a low/suitable freezing point, sufficient strength, high transparency, and gloss of the gelatin that forms the capsule wall.
The reason why medical gelatin has a long history is that the first gelatin soft capsule was born in 1833. Since then, gelatin has been widely used in the pharmaceutical industry and become an indispensable part of it.
| Test Criterion: China Pharmacopoeia 2015 edition 2 | For Hard Capsule |
|---|---|
| Physical and Chemical Items | |
| 1. Jelly Strength (6.67%) | 200-260 bloom |
| 2. Viscosity (6.67% 60℃) | 40-50 mps |
| 3. Mesh | 4-60 mesh |
| 4. Moisture | ≤12% |
| 5. Ashes(650℃) | ≤2.0% |
| 6. Transparency (5%, 40°C) mm | ≥500 mm |
| 7. PH(1%) 35℃ | 5.0-6.5 |
| 8. Electrical Conductivity | ≤0.5 mS/cm |
| 9. H2O2 | Negative |
| 10. Transmittance 450nm | ≥70% |
| 11. Transmittance 620nm | ≥90% |
| 12. Arsenic | ≤0.0001% |
| 13. Chrome | ≤2 ppm |
| 14. Heavy Metals | ≤30 ppm |
| 15. SO2 | ≤30 ppm |
| 16. Insoluble substance in water | ≤0.1% |
| 17. Total Bacteria Count | ≤10 cfu/g |
| 18. Escherichia coli | Negative/25g |
| Salmonella | Negative/25g |