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Appearance
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White to off white crystalline powder
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Purity (by HPLC; on dry basis)
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Min 98.0%
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|
Purity (by HPLC)
|
Min 99.0%
|
|
Solubility
|
Freely Soluble in DMF, Soluble in methanol & dioxane
|
|
Identity (IR)
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Spectrum of sample should be concordant with the IR spectrum of ref std.
|
|
Identification by HPLC
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The RT of sample should match with RT of WS
|
|
Melting range
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202°C- 206°C
|
|
Loss on drying
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Max 1.0%w/w
|
|
Specific optical rotation
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Min +59.00°
|
|
Residue on ignition
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Max 0.1%
|
|
Related Substances
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Trans hydroxy lactam
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Max 0.2%
|
|
Amino ester
|
Max 0.1%
|
|
Unknown impurities
|
Max 0.1%
|