Elemental Impurities according to ICH Q3D oral, Standard 1
SIAL/19041 - TraceCERT®, (in 12% nitric acid), applicable for testing acc. to USP<232>, Ph.Eur. Gen. Chapter 5.20
Synonym: TraceCERT Elemental Impurities according to ICH Q3D oral
Product Type: Chemical
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| agency | according to ICH Q3D |
| according to Ph. Eur. | |
| according to USP | |
| composition | Ag, 150 mg/L |
| As, 15 mg/L | |
| Cd, 5 mg/L | |
| Co, 50 mg/L | |
| Hg, 30 mg/L | |
| Ni, 200 mg/L | |
| Pb, 5 mg/L | |
| Se, 150 mg/L | |
| Tl, 8 mg/L | |
| V, 100 mg/L | |
| concentration | (in 12% nitric acid) |
| format | multi-component solution |
| grade | TraceCERT® |
| certified reference material | |
| product line | TraceCERT® |
| Quality Level | 300  |
| shelf life | limited shelf life, expiry date on the label |
| technique(s) | ICP: suitable |
| Disclaimer: | For U.S. Customers: Contains mercury; Do not place in trash - dispose according to local, state, or federal laws. |
| General description: | This certified reference material (CRM) is produced in accordance with ISO 17034 and characterized in accordance with ISO/IEC 17025. This CRM is traceable to SI unit kg and measured against primary material from a National Metrology Institute (NMI), e.g. NIST. Please visit ISO certificates and Site Quality Self-Assessments to access the current certificates of accreditation.Search & download your certificate here. |
| Legal Information: | TraceCERT is a registered trademark of Merck KGaA, Darmstadt, Germany |
| Other Notes: | We provide a diverse range of certified reference materials, including various elemental impurity mixes and single elements, with concentration limits that comply with ICH Q3D guidelines. For more information please visit our Inorganic Elemental Impurity Mix Standards. In our effort to be more sustainable, we′re going digital with COAs-download them directly from our website. |
| Preparation Note: | For the preparation of this CRM only materials of highest purity were used. |
| Symbol |  GHS05 |
| Signal word | Danger |
| Hazard statements | H290 - H314 - H412 |
| Precautionary statements | P234 - P273 - P280 - P303 + P361 + P353 - P304 + P340 + P310 - P305 + P351 + P338 |
| RIDADR | UN 2031B 8 / PGII |
| WGK Germany | WGK 3 |
| Flash Point(F) | Not applicable |
| Flash Point(C) | Not applicable |
| Supplemental Hazard Statements | EUH071 |
| UNSPSC | 41116107 |