Gelatin for Softgel

Pharmaceutical gelatin is the main raw material of capsule, microcapsule, substitute plasma and sponge.


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Soft Capsule is a kind of oral solid preparation. Because it can cover up the unpleasant odor in the contents, it can make the patients easier to accept, and improve the compliance of patients with medication, easy to swallow. Since its birth, it has become the mainstream dosage form in the pharmaceutical industry. At present, 600 billion gelatin capsules are produced every year, that is, 20000 capsules are produced every second and put into the market. The reason why gelatin capsule is so popular is closely related to its excellent technical performance

Gelatin soft capsule can isolate oxygen, has good moisture resistance, and can effectively improve the stability of the content;

Gelatin soft capsules can rapidly disintegrate, release active components and improve bioavailability after oral administration. 

These properties ensure the safety and effectiveness of active ingredient intake, and ensure people's health and safety. Gelatin excellent solubility, film forming properties, thermo reversible gel properties and easy processing characteristics are all irreversibly functional properties of gelatin in capsule production.

    Gelken provide soft capsule gelatin for the pharmaceutical industry many years. We mainly focus on safety life of people.

Test Criterion:China Pharmacopoeia

2015 edition 2

For Soft Capsule
Physical and Chemical Items  
1.  Jelly Strength (6.67%) 140-200bloom
2.  Viscosity (6.67%  60℃)   30-40mps
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
19. Salmonella Negative/25g

 


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