Elemental Impurities according to ICH Q3D oral, Standard 3
SIAL/69729 - 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
Synonym: ICH Q3D oral elemental impurities
Product Type: Chemical
| agency | according to ICH Q3D |
| according to Ph. Eur. | |
| according to USP | |
| composition | Ba, 140 mg/L |
| Cr, 1100 mg/L | |
| Cu, 300 mg/L | |
| Li, 55 mg/L | |
| Mo, 300 mg/L | |
| Sb, 120 mg/L | |
| Sn, 600 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: | • ICH Q3D elemental impurities testing guidelines: A study conducted rapid screening of pharmaceutical products for elemental impurities using a high-resolution portable energy dispersive X-ray fluorescence spectrometer. This method adheres to ICH Q3D guidelines for oral dosage forms, offering an efficient tool for routine quality control in pharmaceutical manufacturing (Zhu et al., 2023  ).• Elemental impurity analysis for pharmaceuticals: Research focused on the human health risk assessment of total chromium impurities in cough syrups. This study aligns with ICH Q3D regulations, emphasizing the need for rigorous testing of oral pharmaceuticals to ensure consumer safety, particularly regarding the toxic potential of elemental impurities (Jurowski and Krosniak, 2024 ).• Pharmaceutical trace metal contamination standards: The determination of ICH-Q3D elemental impurity leachables in glass vials was explored using Inductively Coupled Plasma Mass Spectrometry (ICP-MS). This research underscores the importance of assessing leachable heavy metals in drug packaging to prevent contamination of oral drug products (Breckenridge et al., 2023 ). |
| 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 |