Bromelina (1200GDU/g)
Ciudad: LV, Marupe
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 |