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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 (USP 43-NF 38*), Zinc sulfate compounded injection assay should be carried with a column filled with L76 packing material and meets following requirements. The use of a cation column, IC YK-421, confirmed the requirements were met.

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

*The version at the time of the application acquisition. 

Sample : 10 μL
Zinc sulfate 0.01 mg/mL

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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