主要規(guī)格:企業(yè)標(biāo)準(zhǔn)
(1)
性狀
Appearance
白色或類白色結(jié)晶性粉末,無正常視力可見雜質(zhì)
White to off-white crystalline powder, no visible impurity
(2)
鑒別
Identification
紅外光譜應(yīng)與對照品一致 IR conforms to the reference
(3)
透光率
Transmittance of solution
≥95%
(4)
旋光度
Specific Rotation
-68.2?!?/span>-72.0。
(5)
熔點
Melting Point
233~238℃
(6)
干燥失重
Loss on drying
≤ 0.5%
(7)
熾灼殘渣
Residue on ignition
≤ 0.1%
(8)
重金屬
Heavy metal
≤ 10ppm
(9)
氯限量
Limit of chloride
≤ 0.007%
(10)
氨限量
Limit of Ammonia
≤ 0.0004%
(11)
硫酸鹽限量
Limit of sulfate salt
≤ 0.02%
(12)
含量:按干燥品計算 Assay (on the dried basis)
98.0%~102%
(13)
純度
HPLC
≥98%
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