Analysis of Zinc Sulfate Compounded Injection According to USP-NF Method (YK-421)

Zinc sulfate compounded injection is a trace element formulation and is usually used to supplement zinc for those who have difficulties obtaining it orally or through the intestinal tract. According to the United States Pharmacopeia and the National Formulary Pharmacopeial Forum (USP 43-NF 38*), "ASSAY" for "Zinc Sulfate Compounded Injection" should be carried out with a column filled with L76 packing material. The IC YK-421, a column filled with L76 packing material, confirmed the requirements were met.

System suitability requirements Tailing factor (Standard solution): ≤ 2.0
Relative standard deviation (RSD) (Standard solution): ≤ 2.0%


*The version at the time of the application acquisition.

Sample: 10 µL
(Standard solution) Zinc sulfate 0.01 mg/mL in H2O

  1.  
Column
Shodex IC YK-421 (4.6 mm I.D. x 125 mm)
Eluent
3 mM Nitric acid aq.
Flow rate
0.9 mL/min
Detector
Non-suppressed conductivity
Column temp.
40 ℃

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