Elemental Impurities according to ICH Q3D parenteral, Standard 3
SIAL/07368 - TraceCERT®, in nitric acid and hydrofluoric acid (5% nitric acid and <0.5% hydrofluoric acid ), applicable for testing acc. to USP<232>, Ph.Eur. Gen. Chapter 5.20
Product Type: Chemical
| agency | according to ICH Q3D |
| according to Ph. Eur. | |
| according to USP | |
| composition | Ba, 70 mg/L |
| Cr, 110 mg/L | |
| Cu, 30 mg/L | |
| Li, 25 mg/L | |
| Mo, 150 mg/L | |
| Sb, 9 mg/L | |
| Sn, 60 mg/L | |
| concentration | in nitric acid and hydrofluoric acid (5% nitric acid and <0.5% hydrofluoric 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 |
| General description: | This certified reference material (CRM) is produced and certified in accordance with ISO/IEC 17025 and ISO 17034. This CRM is traceable to SI unit kg and measured against primary material from an NMI, e.g. NIST. Certified content incl. uncertainty and expiry date are given on the certificate. Download your certificate at: http://www.sigma-aldrich. |
| Legal Information: | TraceCERT is a registered trademark of Merck KGaA, Darmstadt, Germany |
| Preparation Note: | For the preparation of this CRM only materials of highest purity were used. |
| Symbol |   GHS05,GHS07 |
| Signal word | Danger |
| Hazard statements | H290 - H302 + H312 - H314 |
| Precautionary statements | P234 - P270 - P280 - P301 + P312 - P303 + P361 + P353 - P305 + P351 + P338 |
| RIDADR | UN 2031B 8 / PGII |
| WGK Germany | WGK 1 |
| Flash Point(F) | Not applicable |
| Flash Point(C) | Not applicable |
| Supplemental Hazard Statements | EUH071 |
| UNSPSC | 41116107 |