Elemental Impurities according to ICH Q3D parenteral, cutaneous and transcutaneous, 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 |
| Application: | Elemental Impurities according to ICH Q3D parenteral, Standard 3 may be used as a reference standard for screening of elemental impurities in pharmaceutical products in compliance with United States Pharmacopoeia (USP) and ICH-Q3D. |
| 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.Download your certificate at https://www.sigma-aldrich to view certified values, including uncertainty, date of expiry, and detailed information about trace impurities. |
| 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,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 |