The new guidelines set by the United States Pharmacopeia (USP) have pushed the pharmaceutical and nutraceutical industries to provide accurate, quantifiable results for metal analysis in drugs, pharmaceutical substances and raw materials.
USP <232> outlines new limits in pharmaceutical products for arsenic, cadmium, lead, and mercury. ICP-MS instrumentation, along with accurate ICP-MS standards, allow for increased efficiency and accuracy of the analysis necessary to comply with the new regulations.
Use these standards can be used as a calibration or check standard to verify Oral Daily Dose PDE, Parenteral Component Limit or Parenteral Daily Dose PDE as well as Inhalation Component Limit or Daily Dose.
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This multi-component standard contains 3 components.
• USP <232> Revision 40, Parenteral 2B Mix 1 elemental impurities standard is a 125 mL bottle which contains 20 mg/kg (50 ppm) Nickel; 10 mg/kg (10 ppm) Vanadium; and 5 mg/kg (5 ppm) Cobalt in 2% HNO3.
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Specifications
ConcentrationMultiple
Matrix2% HNO3
Element/IonMultiple
FormLiquid
Volume (mL)125
DOT InformationHazardous; Corrosive liquid, acidic, inorganic, n.o.s, (Nitric acid solution); Class 8, Packing Group III
Storage SymbolAmbient
Hazard SymbolIrritant
UN NumberUN3264
Shelf Life (months)12
DescriptionUSP <232> Revision 40, Parenteral 2A Elemental Impurities in 2% HNO3; 125 mL