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. Hard capsule, gelatin is used as the packaging of medicine. 


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With the development of 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, biocompatibility, biodegradability, as well as simple  production, processing and molding characteristics, making it an absolute advantage in the field of biomedicine.

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%) 200-260bloom
2.  Viscosity (6.67%  60℃)   40-50mps
3  Mesh 4-60mesh
4.  Moisture ≤12%
5.  Ashes(650℃) ≤2.0%
6.  Transparency (5%, 40°C) mm ≥500mm
7.  PH  (1%)  35℃ 5.0-6.5
  1. Electrical Conductivity
≤0.5mS/cm
  1. H2O2
Negative
10.  Transmittance 450nm ≥70%
11. Transmittance 620nm ≥90%
12. Arsenic ≤0.0001%
13. Chrome ≤2ppm
14. Heavy   Metals ≤30ppm
15. SO2 ≤30ppm
16. Insoluble substance in water ≤0.1%
17 .Total  Bacteria  Count ≤10 cfu/g
18. Escherichia coli Negative/25g
Salmonella Negative/25g

 

 


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