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1 Kilogram |
Negotiable |
Esomeprazole sodium ESOMEPRAZOLE SODIUM 1H-BENZIMIDAZOLE, 5-METHOXY-2-[[(4-METHOXY-3,5-DIMETHYL-2-PYRIDINYL)METHYL]SULFINYL]-, SODIUM SALT
USP standard
Description |
White to an off-white powder ;hygroscopic in nature |
Solubility |
Freely soluble in water ,soluble in propylene glycol;sparingly soluble in alcohol and methanol |
Identification by
|
|
Appearance of solution (2.0 % w/v aqueous solution ) |
Should be clear |
PH (2.0 % w/v aqueous solution ) |
10.3 to 11.3 |
Water by KF (%w/w) |
NMT 6.0% |
Specific Rotation at 25 ℃(1.0% w/v solution in methanol) |
-38 °~ –48.0° |
Heavy metals as pb |
NMT20ppm |
Purity and related substances by HPLC (%)
|
a) Purity NLT 99.5% b) Total impurities NMT 0.5% c) individual impurity NMT 0.2% |
Assay by HPLC (% w/w) (On Anhydrous Basis) |
98.0 % to 102.0% |
Residual Solvents by GC-HS (ppm)
|
a) Methylene Chloride NMT 600ppm b) Methanol NMT 3000ppm c) Ethyl Acetate NMT 5000ppm d) Toluene NMT 890ppm |
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