Unstable, prone to Hydrolysis, Oxidation and Photo-degradation
Process Complexities (multi-step)
Lengthy production time
Multiple analysis of RM and in-process
Product
% Drug conc.
API Pharmacopoeia
Lubricated / Non lubricated
Label claim
Tablet weight
Pantoprazole Granules
36.36%
IP/USP
Lubricated
Each 110.00 mg / 55.00 mg of Lubricated granules contains Pantoprazole Sodium equivalent to Pantoprazole 40 mg / 20 mg respectively
110.00 mg / 55 mg (core tablet, without coating) for 40 mg / 20 mg strengths respectively
40.00%
IP/USP
Non-Lubricated
Each 100.00 mg / 50 mg of Non-Lubricated granules contains Pantoprazole Sodium equivalent to Pantoprazole 40 mg / 20 mg respectively
210.00 mg
Specification
Details
PSD
90% of particles are less than 250 micron (ASTM 60 passed)(PSD can be customized based on customer requirements)
Pharmacopoeia
IH Specification
Shelf life
2 years re-test
Pack size (MOQ)
5 kg, 10 kg, 20 kg
Batch size
Up to 500 kgs
Lead time
45 to 60 days (will be confirmed at the time of purchase order)
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