Elemental Impurities according to ICH Q3D parenteral, Standard 2
SIAL/89922 - TraceCERT®, (in 10% hydrochloric acid), applicable for testing acc. to USP<232>, Ph.Eur. Gen. Chapter 5.20
Synonym: ICH Q3D Elemental Impurity Standard 2
Product Type: Chemical
| agency | according to ICH Q3D |
| according to Ph. Eur. | |
| according to USP | |
| composition | Au, 100 mg/L |
| Ir, 10 mg/L | |
| Os, 10 mg/L | |
| Pd, 10 mg/L | |
| Pt, 10 mg/L | |
| Rh, 10 mg/L | |
| Ru, 10 mg/L | |
| concentration | (in 10% hydrochloric 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: | <ul> <li><strong>Determination of ICH-Q3D Elemental Impurity Leachables in Glass Vials:</strong> This study applies inductively coupled plasma mass spectrometry to assess ICH-Q3D elemental impurity leachables in glass vials used for parenteral applications, providing a crucial methodology for ensuring compliance with pharmaceutical heavy metal analysis standards (Breckenridge et al., 2023  ).</li><li><strong>Application of ICH Guidelines for Assessment and Control of Elemental Impurities in Parecoxib Sodium:</strong> Utilizing graphite-digestion and ICP-MS, this research conforms to the ICH Q3D guidelines for evaluating elemental impurities in parecoxib sodium, highlighting a robust approach for elemental impurity analysis in injectable pharmaceuticals (Hao et al., 2022 ).</li><li><strong>Risk-Based Approach to Evaluate and Control Elemental Impurities in Therapeutic Proteins:</strong> This study introduces a risk-based strategy for the assessment and control of elemental impurities in therapeutic proteins, which aligns with the requirements of USP <232> <233> compliance and aids in the development of safer parenteral medications (Luo et al., 2020 ).</li><li><strong>Assessment of Extractable Elements from Elastomers:</strong> Investigating the potential for elemental impurities to leach from elastomers, this research is vital for the risk assessment of elemental contaminants in parenteral formulations, ensuring safety and compliance with ICH Q3D standards (Paskiet et al., 2019 ).</li></ul> |
| 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 | Warning |
| Hazard statements | H290 - H315 - H319 - H335 |
| Precautionary statements | P234 - P261 - P264 - P271 - P302 + P352 - P305 + P351 + P338 |
| RIDADR | UN 1789 8 / PGII |
| WGK Germany | WGK 1 |
| Flash Point(F) | Not applicable |
| Flash Point(C) | Not applicable |
| UNSPSC | 41116107 |