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Appearance
|
White crystalline powder
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|
Assay (by HClO4 titration; on dried basis)
|
98.5 - 101.5%
|
|
Identification
|
To comply USP test
|
|
Chloride content
|
19.0 -19.6%
|
|
Specific optical rotation ([α]20/D; c=6 in HCl; on dried substance)
|
+20.4 to +21.4°
|
|
Loss on drying (at 105°C ; 3 hrs)
|
Max 0.4%
|
|
Residue on ignition
|
Max 0.1%
|
|
Iron (Fe)
|
Max 0.003%
|
|
Heavy metal (as Pb)
|
Max 0.0015%
|
|
Sulphate (SO4)
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Max 0.03%
|
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Chromatographic purity (by TLC)
|
To comply USP test
|
|
Residual solvents
|
To meet the requirement
|