质量标准
项目
|
CP2010
|
BP2009(A型)
|
USP31(NF26)
|
比旋度
|
+159°~+164°
|
+160°~+164°
|
+160°~+164°
|
酸碱度
|
5.0~8.0
|
5.0~8.0
|
|
溶液的澄清度与颜色
|
+
|
+
|
+
|
干燥失重
|
≤14.0%
|
≤16.0%
|
≤14.0%
|
氯化物
|
≤0.018%
|
|
|
炽灼残渣
|
≤0.1%
|
≤0.1%
|
≤0.1%
|
还原糖
|
≤1.0%
|
≤0.2%
|
≤1.0%
|
重金属
|
≤百万分之十
|
≤百万分之十
|
≤百万分之五
|
含量测定
|
96.0%~102.0%
|
98.0%~101.0%
|
98.0%~101.0%
|
吸光性杂质
|
+
|
+
|
|
有关物质
|
|
+
|
|
残留溶剂
|
|
+
|
|
微生物限度
|
+
|
+
|
+
|