Bromelain (1200GDU/g)
City: LV, Marupe
Please avoid sudden changes in temperature and humidity, as they may affect the condition of derivative ingredients and tablets.
The shelf life begins from the date of manufacture at the factory.
Taking into account logistical and transportation stages, the remaining shelf life of the product is always shorter than the full shelf life.
We ship products to our customers with a remaining shelf life of no less than 70%.
Organoleptic Characteristics
Analysis Item | Specification | Result |
Description | Off white to white colour hygroscopic powder | Complies |
Odour | Characteristic | Complies |
Physical & Chemical Characteristics
Analysis Item | Specification | Result |
Activity | 1200 GDU/g | 1345 GDU/g |
Loss on drying | ≤ 5.0% | 3.8% |
Bulk density | 0.4 – 0.7 g/cc | 0.42 g/cc |
Solubility | Soluble in water | Complies |
pH of 10% solution | 5 – 7 | 5.5 |
Identification test | Positive for proteolytic test | Complies |
Residual solvents | To comply as per USP | Complies |
Residual pesticide | To comply as per USP | Complies |
Particle size | 90% 80 Mesh | Complies |
Sum of Ethylene Oxide and 2-Chloro-Ethanol | ≤ 0.01 ppm/MRL | Complies |
Heavy Metals
Analysis Item | Specification | Result |
Heavy metals (total) | ≤ 8 ppm | Complies |
Arsenic (As) | ≤ 1 mg/kg | Complies |
Lead (Pb) | ≤ 1 mg/kg | Complies |
Cadmium (Cd) | ≤ 1 mg/kg | Complies |
Mercury (Hg) | ≤ 0.1 mg/kg | Complies |
Microbiological Characteristics
Analysis Item | Specification | Result |
Total plate count | ≤ 10,000 CFU/g | 140 CFU/g |
Mould & Yeast | ≤ 100 CFU/g | 3 CFU/g |
Escherichia coli | Negative/10g | Complies |
Salmonella | Negative/10g | Complies |
Staphylococcus aureus | Negative/10g | Complies |
Enterobacteriaceae | Absent in 1 g | Complies |
Pseudomonas aeruginosa | Absent in 10 g | Complies |