Supplier Certificate of Analysis (CoA) is included with product shipment.
Key Features
Accredited by A2LA to ISO/IEC 17025:2017 & ISO 17034:2016
Certified by DQS to ISO 9001:2015
Helps meet the new limits in pharmaceutical products for arsenic, cadmium, lead, and mercury
125 mL bottle
More About this Item
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 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.
Can’t find the standards you are looking for? Spex CertiPrep®can make custom standards to meet your exact needs. Contact us for more information at [email protected] or call us at 732-549-7144.
Chemicals sold by Cole-Parmer are not intended for and should not be (i) used for medical, surgical or other patient oriented applications, or (ii) combined with any food product or ingested in any form.
Hazardous material shipping fees may apply.
Specifications
Concentration13,000 mg/kg (13,000 ppm)
Matrix5% HNO3
Element/IonIron and Zinc
FormLiquid
Volume (mL)125
DOT InformationHazardous; Corrosive liquid, acidic, inorganic, n.o.s, (Nitric acid solution); Class 8, Packing Group III
Storage SymbolAmbient
Hazard SymbolCorrosion
UN NumberUN3264
Shelf Life (months)12
DescriptionElemental Impurities F Standard for ICH, 13,000 mg/kg; 125 mL