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Paediatric Co-trimoxazole Oral Suspension BP 240mg/5ml – BI-SEPTIN-NEO

60ml Amber Coloured Glass Bottle

2.3.P.5.5 Characteristic of impurities


Характеристика примесей

Following are the organic Impurities in drug Product:

Impurities Limit
For Trimethoprim
Any Individual Impurity NMT 0.5%
Total Impurities NMT 1.0%
For Sulfamethoxazole
Any Individual Impurity NMT 0.5%
Total Impurities NMT 1.0%

For Drug substance impurities, please refer 3.2.S.3.2

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