Pentamidine isethionate salt, USP grade CAS 140-64-7

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CAS: 140-64-7

MF: C₁₉H₂₄N₄O₂ · 2C₂H₆O₄S

MW: 592.68

Physical Description	White or almost white crystalline powder, or colourless crystals
Identification (IR)	To conform to standard
Identification	O2 combustion (Test B)
Identification (HPLC)	Retention time to conform
Solubility (10% in water)	Clear, colourless solution
pH (5% in water)	4.5 - 6.5
Heavy Metals	≤ 20ppm
Residue on Ignition	≤ 0.1%
Melting Point	187 - 191 °C
Ammonium Isethionate	≤ 1.0%
1,5-Dibromopentane	≤ 0.1%
Monoamide Impurity	≤ 0.4% (HPLC)
Bisamide Impurity	≤ 0.2% (HPLC)
Any Other Individual Impurity	≤ 0.05% (HPLC)
Total Impurities	≤ 0.7% (HPLC)
Loss on Drying	≤ 4.0%
Assay (Titration)	98.5 - 101.5 %
Pharmacopoeia Specification(s)	USP
Specification Version	1.0