About Elemental Impurities according to ICH Q3D oral, Standard 2
Elemental Impurities according to ICH Q3D oral, Standard 2shelf life limited shelf life, nexpiry date on the labelcomposition Au, 100mg/LIr, 100mg/LOs, 100mg/LPd, 100mg/LPt, 100mg/LRh, 100mg/LRu, 100mg/Lconcentration 10% in hydrochloric acid
FAQs of Elemental Impurities according to ICH Q3D oral, Standard 2:
Q: What is the main application of Elemental Impurities according to ICH Q3D oral, Standard 2?
A: Elemental Impurities are used to control and monitor elemental impurities in drug products in compliance with ICH Q3D guidelines for pharmaceutical quality control.
Q: How should Elemental Impurities be stored?
A: Elemental Impurities should be stored in a clean, dry, well-ventilated area at room temperature.
Q: What form does Elemental Impurities typically appear in?
A: Elemental Impurities may appear as a powder or a colorless liquid depending on the supplied material.
Q: Is Elemental Impurities poisonous?
A: No, Elemental Impurities are not poisonous.
Q: What is the pH level of Elemental Impurities according to ICH Q3D oral, Standard 2?
A: The pH level of Elemental Impurities is neutral, with a value of 7.0.
Q: What is the shelf life of Elemental Impurities?
A: Elemental Impurities are stable when stored as instructed.
Q: What grade is Elemental Impurities classified under?
A: Elemental Impurities are classified under the pharmaceutical standard grade for regulatory testing.