Bromelain Sterile Injectable Sterility Testing
Project Description
MULTIPLE TESTING
Contract Laboratory needed for testing pharmaceutical/medical grade bromelain (2400 GDU/g) derived from stem sources. We are interested in developing a sterile injectable formulation of bromelain meeting specific criteria.
We are reaching out to inquire if your esteemed laboratory can refine bromelain to our detailed specifications, ensuring the final product is sterile and appropriately packaged for injection purposes.
Project Requirements:
Ingredients:
Bromelain (2400 GDU/g stem derived) - this is readily vailable.
Acidic solution (e.g., 0.3 M acetic acid with 1% ascorbic acid)
Optional antioxidant (e.g., ascorbic acid)
Optional wetting agent (e.g., n-octanol)
Filter aid (e.g., silica or natural diatomite)
Ammonium sulfate salt
Procedure:
1. Suspension Preparation: Suspend bromelain in an acidic solution (pH 2.4 - 2.6) with 1% ascorbic acid and optional n-octanol.
2. pH Adjustment: Modify the pH to a range of 2.5 - 3.5.
3. Filter Aid Addition: Incorporate silica as a filter aid.
4. Filtration: Employ a filter press to eliminate insoluble components.
5. Ammonium Sulfate Addition: Achieve 40% saturation with ammonium sulfate salt (285 g/L).
6. Further pH Adjustment: Adjust pH to a range of 2.5 - 3.5 again.
7. Incubation: Maintain the solution at 4°C for 12-24 hours.
8. Centrifugation: Isolate the ammonium sulfate precipitate via centrifugation.
9. Dissolution of Precipitate: Redissolve in 0.3 M acetic acid with 1% ascorbic acid (pH 2.4 - 2.6).
10. Ultra-Filtration: Employ a 10 kDa ultra-filter.
11. Sterile Filtration: Use a filter membrane (?0.5 ?m) for sterility.
12. Lyophilization: Freeze-dry the sterile solution.
13. Storage: Ensure lyophilized powder is stored in a dry, sterile environment.
We are particularly interested in understanding whether your facility can adhere to the above process and the associated costs for producing an initial batch of 100g. This preliminary batch will allow us to verify compliance with our specifications and conduct necessary tests before proceeding with larger orders.
Project Information
Number:24-00311
Industry:Pharmaceuticals
