Promethazine hydrochloride, EP grade CAS 58-33-3

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CAS: 58-33-3

MF: C₁₇H₂₀N₂S · HCl

MW: 320.88

Physical Description	White or faint yellow crystalline powder
Identification	A, B, C, D according to EP
Solubility (10% in water)	Clear, colourless to light-yellow solution
pH (10% in water)	4.0 - 5.0
Impurity A	≤ 0.1%
Impurity B	≤ 0.8%
Impurity C	≤ 0.2%
Impurity D	≤ 0.1%
Any Unspecified Impurity	≤ 0.1%
Total Impurities	≤ 1.2%
Sulfated Ash	≤ 0.1%
Loss on Drying	≤ 0.5% (105°C)
Assay (Titration)	99.0 - 101.0 % (dried substance)
Pharmacopoeia Specification(s)	EP
Specification Version	1.0