USP Parenteral Elemental Impurities D, 125 mL (Heavy Metal Standard)

SKU:
USP-TXM6A
  • $147.00

    • Description

    USP Parenteral Elemental Impurities D, 125 mL (Heavy Metal Standard)

    Product Information

    Part #: USP-TXM6A
    Matrix: 5% HNO3 / 1% HCL
    Volume: 125 mL
    Units/Pack: 1
    Storage Condition: Ambient
    Shipping Info: Hazardous
    Method Reference: 232USP 232

     

    Components Concentration
    Arsenic 15 mg/kg
    Lead 5 mg/kg
    Mercury 3 mg/kg
    Cadmium 2 mg/kg

    USP Elemental Impurities Standard 
    Parenteral Elemental Impurities D

    The new guidelines set by the United States Pharmacopeia (USP) and the International Conference on Harmonization (ICH) 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. The procedures focus on the use of ICP-MS for the analysis of low level impurities. ICP-MS instrumentation, along with accurate ICP-MS standards, allows for increased efficiency and accuracy of the analysis necessary to comply with the new regulations. In addition to the changes enacted by the USP.

    Developed in accordance with USP <232> Elemental Impurities, SPEX CertiPrep offers these additions to our Consumer Safety Compliance Standards line. 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. Our extensive experience in creating quality trace metal standards, coupled with our ICP-MS analysis, will ensure your company will remain compliant with the new and changing regulations.