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Product Information

Part #: USP-TXM5B
Matrix: 5% HNO3
Volume: 125 mL
Units/Pack: 1
Storage Condition: Ambient
Shipping Info*: Hazardous
Method Reference: 232USP 232
Product Notes:
SDS: Safety Data Sheet
Expiration (Months): 12
*Based on US shipping regulations. For shipments outside the US, please contact your sales representative for a quotation.

SPEX CertiPrep is accredited by A2LA for Organic and Inorganic Certified Reference Materials. In addition to being registered as an ISO 9001 facility, SPEX CertiPrep is accredited by A2LA as complying with the requirements of ISO/IEC 17025 and ISO 17034. Our scope is the most comprehensive in the industry.

USP Parenteral Elemental Impurities C

USP Parenteral Elemental Impurities C
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USP Elemental Impurities Standard
Parenteral Elemental Impurities C

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.

Components Concentration
Molybdenum 1500 mg/kg
Chromium 1100 mg/kg
Copper 300 mg/kg
Nickel 20 mg/kg
Vanadium 10 mg/kg

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