主要规格:企业标准
(1)
性状
Appearance
白色或类白色结晶性粉末,无正常视力可见杂质
White to off-white crystalline powder, no visible impurity
(2)
鉴别
Identification
红外光谱应与对照品一致 IR conforms to the reference
(3)
透光率
Transmittance of solution
≥95%
(4)
旋光度
Specific Rotation
-68.2。~-72.0。
(5)
熔点
Melting Point
233~238℃
(6)
干燥失重
Loss on drying
≤ 0.5%
(7)
炽灼残渣
Residue on ignition
≤ 0.1%
(8)
重金属
Heavy metal
≤ 10ppm
(9)
氯限量
Limit of chloride
≤ 0.007%
(10)
氨限量
Limit of Ammonia
≤ 0.0004%
(11)
硫酸盐限量
Limit of sulfate salt
≤ 0.02%
(12)
含量:按干燥品计算 Assay (on the dried basis)
98.0%~102%
(13)
纯度
HPLC
≥98%
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