Items

Specifications

Results

Appearance

White crystalline powder

Conforms

Solubility

Freely soluble in water, soluble in methanol,sparingly soluble in alcohol,slightly soluble in isopropyl alcohol

Conforms

Clarity and color of solution

Clarity

Not less clear than water

Conforms

Absorbance

≤0.1

0.03

PH

7.0-7.6

7.23

Identification，IR

Exhibits maxima as that of reference standard

Conforms

Loss on drying

Not more than 0.2%

0.04%

Residue on ignition

Not more than 0.1%

0.05%

Heavy metals

Not more than 10ppm

Conforms

Related substance(TLC)

Individual Impurity :Not more than 0.2%

N/D

Related substance
(HPLC)

Individual A: Not more than 0.1%
Individual B: Not more than 0.1%
Individual C: Not more than 0.1%
Individual D: Not more than 0.1%
Any individual unspecified impurity: Not more than 0.1%
Total Impurity: Not more than 0.3%

＜0.1%
N/D
＜0.1%
N/D
RRT0.48:0.06%
0.09%

Residual solvents, GC

Toluene ≤100ppm

0.1ppm

Ethanol ≤1000ppm

330.1ppm

Assay (HPLC)

98.0%-102.0%

100.5%

Content of succinic ion by titration
(on dried basis)

17.7%-18.5%

18.06%

Conclusion: The Results Conforms To the Standard Of USP34
Storage ：Store in cool and dry place
Store in well-closed containers