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