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DRUG INTERMEDIATE OMEPRAZOLE CHLORO
o1
S.No Test Specification
1. Description A white to creamish white coloured crystalline powder
2. Solubility Soluble in methylene chloride and methanol
3. Identification by IR IR 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 ash Not 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 chemical Not less than 98.0% w/w on dried basis
DRUG INTERMEDIATE OMEPRAZOLE SULPHIDE (UFIPRAZOLE)
o1
S.No Test Specification
1. Description A white to off white powder
2. Solublity Soluble in methanol insoluble in water.
3. Identification by HPLC The RT of the major peak in the sample chromatogram is same as that of standard chromatogram
4. Loss on drying Not more than 1.0 %w/w
5. Melting range Between 118°C and 125°C
6. Purity by HPLC Not less than 99.0% w/w