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BROMELAIN Bromelain is a natural anti-inflammatory for conditions such as arthritis. It's one of the most popular supplements for the treatment of inflammation and swelling of the nose and sinuses due to surgery or injury.
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PARAMETER
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SPECIFICATION
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RESULT
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Temp specificity
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Optimum Temperature
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50-600C
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Complies
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pH
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Optimum pH
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4.5 5.5
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Complies
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Inactivation pH
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< 3.0 & > 9.5
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Complies
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Appearance
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Creamish colored powder,Hygroscopic
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Complies
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Odour
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Characteristic pineapple odor
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Complies
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Taste
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Natural
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Complies
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Particle Size (mesh): Sieve test
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100 % passage through 70-80 mesh
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Complies
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Bulk density(Kg/lit)
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0.4 -0.5
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Complies
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Loss of drying
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< 4% at 600C,4 h and 0.7 kPa
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3.20%
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Residue on lgnition
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<6%
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Complies
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Solubility in water
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Soluble in water; insoluble in organic solvent
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Complies
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Identification
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Identifiable activity
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+ Ve proteolytic activity
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Complies
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Activity
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Proteolytic activity
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1200 GDU/gram
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1240 GDU/gram
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Microbiological Quality
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As per current EP/IP
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Complies
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Total viable aerobic count (TVAC)
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<10000/gram
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Complies
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Total combined yeast/moulds count (TYMC)
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<100/gram
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Complies
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E.coli:
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Absent/gram
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Complies
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Salmonella Spp:
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Absent/10 gram
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Complies
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Staphylococcus aureus:
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Absent/gram
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Complies
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Heavy Metals
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Heavy Metal content
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< 5 ppm
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Complies
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Added Excipient/Carrier
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Maltodextrin
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Complies
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Storage
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Store at 2-80C in airtight and light resistant containers. Bromelain is stable up to 2 years.
Note: If stored at temperatures higher than 250C,the specific activity should be retested in 3 months intervals.
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The product complies with the above said specification
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Approved by Q C
Authorized signature
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