CAS Number:
57-15-8
Appearance:
White or almost white crystalline powder or crystals
Solubility:
Soluble in water and alcohol; solubility may vary depending on the form (anhydrous/hemihydrate)
Melting Range:
Approximately 77–81 °C
Identification:
By IR; must comply with the reference standard
Moisture by KF:
NMT 1.00% w/w
Solution in NaOH — Absorbance:
NMT 0.040
Assay by Titration (NaOH):
NLT 98.0% w/w and NMT 102.0% w/w, as applicable to the specified standard
Residue on Ignition:
NMT 0.1% w/w
Aspect of Solution:
Clear and colourless or practically clear solution
Related Substances:
Should comply with the applicable pharmacopoeial/supplier specification
Easily Visible Dark Particles:
NMT 2 particles per gram, where this requirement is applicable
