Ranitidine hydrochloride, EP grade CAS 66357-59-3

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CAS: 66357-59-3

MF: C₁₃H₂₂N₄O₃S · HCl

MW: 350.86

Physical Description	White or pale yellow crystalline powder
Identification	A: IR, B: Reaction of chlorides
Solubility (1% in water)	Clear, colourless solution (≤ BY5)
pH (1% in water)	4.5 - 6.0
Impurity A	≤ 0.3% (HPLC)
Impurity J	≤ 0.15% (HPLC)
Any Unspecified Impurity	≤ 0.1% (HPLC)
Total Impurities	≤ 0.5% (HPLC)
Loss on Drying	≤ 0.75%
Sulfated Ash	≤ 0.1%
Assay (Titration)	98.5 - 101.5 % (dried basis)
Pharmacopoeia Specification(s)	EP
Specification Version	1.1