Physical Description
White to off-white crystalline powder
Identification
A, B according to USP
pH (5% in water)
3.0 - 5.5
Specific Optical Rotation ([α]20/D)
+149 - +158 ° (c=0.5, pH 4.4, phthalate buffer)
Any Individual Impurity (HPLC)
≤ 1.0%
Total Impurities (HPLC)
≤ 5.0%
N,N-Dimethylaniline
To pass test
Assay
950 - 1030 μg/mg (C16H17N3O4S, anhydrous basis)
Pharmacopoeia Specification(s)
USP
Specification Version
1.0
Hazard statements
H317: May cause an allergic skin reaction.
H334: May cause allergy or asthma symptoms or breathing difficulties if inhaled.
Precautionary statements
P261: Avoid breathing dust/fume/gas/mist/vapours/spray.
P280: Wear protective gloves/protective clothing/eye protection/face protection.
P342 + P311: If experiencing respiratory symptoms: Call a POISON CENTER or doctor/physician.
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