Lansoprazole Pellets
Color:whtie;
Size:1.0-1.1mm;
Specification:85mg/g---13mg/g USP
Detailed Product Description
Color:whtie;
Size:1.0-1.1mm;
Specification:85mg/g---13mg/g USP
DETERMINATIONS | SPECIFICATION | RESULTS |
Description
| White to Off-white spherical pellets | Off-white spherical Pellets |
Pellets size | 0.9-1.2mm | Complies |
Loss on Drying | Not more than3.0%w/w | 0.9% w/w |
Dissolution App.:KP8,Paddle RPM.:150 Media:500ml Temp.:37±0.5°C Method:UV Spectrometry | 1. pH1.2, 60min.,NMT 5.0%
2. pH6.8, 60min.,NLT 75%
| 0.16%
83.86%
|
Assay(HPLC) Microbe test | 8.0%-9.0% (w/w) Molds < 50/g Bacteria < 500/g No Escherichia coli No acaridae | 8.68% (w/w) Complies Complies Complies Complies |
Storage conditions: Packed in double polythene bags. Kept in drums. Placed in walk in chamber.
Temperature: room temperature.
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