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 API
 Pellet
 Intermediate
 Veterinary
 Formulation
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Omeprazole 8.5% Pellet
Specifications:
In-house standard
Characteristics
White to almost white enteric-coated pellets
Identification
Retention time of the peak should be complied with the reference solution’s (in assay)
Drug release
=80%
Acid resistance
=90%
Related substance
=1.0%
Total Microbial Count
=1000 cfu/gm.
Total Fungus Count
=100 cfu/gm.
Colibacillus
None
Live acarid
None
Assay 
8.0% ~ 9.0%
 
 
Packaging:
25 kg/drum
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