Bromelain

PARAMETER

SPECIFICATION

RESULT

Temp specificity

Optimum Temperature

50-60⁰C

Complies

pH

Optimum pH

4.5  5.5

Complies

Inactivation pH

< 3.0 & > 9.5

Complies

Appearance

Creamish colored powder,Hygroscopic

Complies

Odour

Characteristic pineapple odor

Complies

Taste

Natural

Complies

Particle Size (mesh): Sieve test

100 % passage through 70-80 mesh

Complies

Bulk density(Kg/lit)

0.4 -0.5

Complies

Loss of drying

< 4% at 60⁰C,4 h and 0.7 kPa

3.20%

Residue on lgnition

<6%

Complies

Solubility in water

Soluble in water; insoluble in organic solvent

Complies

Identification

Identifiable activity

+ Ve proteolytic activity

Complies

Activity

Proteolytic activity

1200 GDU/gram

1240 GDU/gram

Microbiological Quality

As per current EP/IP

Complies

Total viable aerobic count (TVAC)

<10000/gram

Complies

Total combined yeast/moulds count (TYMC)

<100/gram

Complies

E.coli:

Absent/gram

Complies

Salmonella Spp:

Absent/10 gram

Complies

Staphylococcus aureus:

Absent/gram

Complies

Heavy Metals

Heavy Metal content

< 5 ppm

Complies

Added Excipient/Carrier

Maltodextrin

Complies

Storage

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.

The product complies with the above said specification

Approved by Q C

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