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DRUG INTERMEDIATE OMEPRAZOLE CHLORO
o1
S.NoTestSpecification
1.DescriptionA white to creamish white coloured crystalline powder
2.SolubilitySoluble in methylene chloride and methanol
3.Identification by IRIR absorption spectrum of sample should be concordant with standard
4.Loss on drying (At 60°C under vacuum) Not more than 1.0 %w/w
5.Sulphated ashNot more than 0.5%w/w
6.Related impurities by HPLC 
1. 2-Hydroxy methyl -3,5- dimethyl- 4-methoxy pyridine Not more than 0.5%
2. 4-Hydroxy-2-chloromethyl-3,5-dimethyl pyridine HCl Not more than 0.5%
3. Any Unknown Impurity Not more than 0.5%
4. Total impurities Not more than 2.0%
7.Assay by chemicalNot less than 98.0% w/w on dried basis
DRUG INTERMEDIATE OMEPRAZOLE SULPHIDE (UFIPRAZOLE)
o1
S.NoTestSpecification
1.DescriptionA white to off white powder
2.SolublitySoluble in methanol insoluble in water.
3.Identification by HPLCThe RT of the major peak in the sample chromatogram is same as that of standard chromatogram
4.Loss on dryingNot more than 1.0 %w/w
5.Melting rangeBetween 118°C and 125°C
6.Purity by HPLCNot less than 99.0% w/w