Physical Description
White or almost white crystalline powder
Identification
A, B, C, D according to EP
Appearance of Solution
Solutions A, B to pass test
Absorbance
≤ 0.15 (solution B, 430nm)
Solubility (5% in water)
Clear, colourless to very faint yellow solution
pH (10% in water)
8.0 - 10.0
Specific Optical Rotation
+258 - +287 ° (anhydrous substance)
Any Other Individual Impurity
≤ 2.0%
N,N-Dimethylaniline
≤ 20ppm
2-Ethylhexanoic acid
≤ 0.8%
Methylene Chloride
≤ 0.2%
Assay
91.0 - 102.0 % (anhydrous substance)
Pharmacopoeia Specification(s)
EP
Specification Version
1.0
Hazard statements
H315: Causes skin irritation.
H317: May cause an allergic skin reaction.
H319: Causes serious eye irritation.
H334: May cause allergy or asthma symptoms or breathing difficulties if inhaled.
H335: May cause respiratory irritation.
Precautionary statements
P261: Avoid breathing dust/fume/gas/mist/vapours/spray.
P280: Wear protective gloves/protective clothing/eye protection/face protection.
P302 + P350: IF ON SKIN: Gently wash with plenty of soap and water.
P305 + P351 + P338: IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.
P342 + P311: If experiencing respiratory symptoms: Call a POISON CENTER or doctor/physician.
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