we are largest exporters of LANSOPRAZOLE PELLETS with the following specification .For more details please contact us
CERTIFICATE OF ANALYSIS
PRODUCT : LANSOPRAZOLE PELLETS-8.5%
BATCH No : LSRP00240613
MFG.DATE : JUNE 2011
Qty : 100 KG
RETEST .DATE : MAY 2014
A White to off white color spherical pellets
Off-white colored sphere shaped pellets
The UV spectrum of sample shall exhibit maximum absorbance at 285±2 nm
The Retention time of the main peak in the HPLC chromatogram under assay should be same as that of standard.
Los son Drying (% w/w)
0.70 to 0.90
Gastric Resistance (%,w/w)
NLT 90.0% material should remain undissolved in 0.1 N HCI after 60 minutes.
Dissolution in Phosphate buffer (pH6.8) (% w/w)
NLT 80% of the Lansoprazole should be dissolved in Phosphate buffer (pH 6.8) within 60 minutes.
NLT 95% pellets should be pass through 12 mesh and
NMT 5% pellets should pass through 16 mesh
Assay (Content of Lansoprazole) (% w/w)
NLT 8.10 and NMT 8.90
Remarks: The above material Complies as per the above specification