Elemental Impurities E, 125 mL

Elemental Impurities E in 5% HNO3, 125 mL



Product Information

Part # :ICH-TXM7

Study Number :

Matrix :5% HNO3

Volume : 125 mL

Units/Pack :1

Expiration : 365 Days / 12 Months

Storage Condition :Ambient

Hazardous Info :

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ICH Standards The new guidelines set by the Internatioal 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 forcus on the use of ICP-MS for the analysis of low level impurities. 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. In addition to the changes enacted by the USP. Developed in accordance with USP <232> Elemental Impurities, SPEX CertiPrep offers hese 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 your ICP-MS analysis, will ensure your company will remain compliant with the new and changing regulations.

Component Concentration Matrix CAS#
Manganese 2,500 mg/kg 5% HNO3
Copper 1,000 mg/kg 5% HNO3
Chromium 250 mg/kg 5% HNO3
Nickel 250 mg/kg 5% HNO3
Cobalt 100 mg/kg 5% HNO3
Molybdenum 100 mg/kg 5% HNO3
Vanadium 100 mg/kg 5% HNO3
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