Tailored solution to overcome challenges associated with Metformin formulation;
High volume and low value product.
Poor compressibility hence need for granulation
Lump formation in API
Lengthy production time
Multiple analysis of RM and in-process
Product
% Drug conc.
API Pharmacopoeia
Lubricated / Non lubricated
Label claim
Tablet weight
Metformin HCl IR Granules
90.00%
IP/USP
Non-Lubricated
Each 555 mg of Non-Lubricated granules contains Metformin 500 mg
>555 mg
95.00%
IP/USP
Non-Lubricated
Each 526 mg of Non-Lubricated granules contains Metformin 500 mg
>526 mg
98.00%
IP/USP
Non-Lubricated
Each 510 mg of Non-Lubricated granules contains Metformin 500 mg
>510 mg
Specification
Details
PSD
90% of particles are less than 850 micron (ASTM 20 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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