Elemental impurities determination by ICP-MS

Elemental impurities determination by ICP-MS
 
 
 
 
 
 
Do you need support for ICH Q3D (elemental impurities) compliance? KYMOS offers a solution to you!!
 
KYMOS has wide experience providing analytical and scientific support in the compliance of the ICH Q3D guideline for elemental impurities. We can propose to you the best strategy in terms of time and cost effectivity. KYMOS has a dedicated analytical lab with two instruments (Agilent 7700 and Agilent 7800) and the suitable microwave ovens for sample digestion.
 
ICH Q3D Guideline
or
Elemental Impurities Analytics
 
KYMOS has a dedicated analytical lab with two instruments (Agilent 7700 and Agilent 7800) and the suitable microwave ovens for sample digestion.
 
On December 2017, the ICH Q3D Guideline on Elemental Impurities will come into effect for already approved medicinal products. From June 2016 this requirement is already in force for new marketing authorization applications. Three parts of this guideline are detailed: the evaluation of the toxicity data for potential elemental impurities; the establishment of a Permitted Daily Exposure (PDE) for each element of toxicological concern; and application of a risk-based approach to control elemental impurities in drug products. If the total elemental impurity level from all sources in the drug product is expected to be consistently less than 30% of the PDE, then additional controls are not required, provided that the applicant has appropiately assessed the data and demonstrated adequate controls on elemental impurities.
 
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SEMI-QUANTITATIVE SCREENING
 
 
Semi-Quantitative Screening of 24 elements, including specificity, recovery and detection limits: Class 1 (Cd, Pb, As, Hg), Class 2A (Co, V, Ni), Class 2B (Tl, Au, Pd, Ir, Os, Rh, Ru, Se, Ag, Pt) and Class 3 (Li, Sb, Ba, Mo, Cu, Sn, Cr).
 
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LIMIT TEST AND QUAN-TITATIVE VALIDATION
 
 
Depending on the risk analysis (if the drug product contains impurities above 30% of the PDE), to carry out a limit test or a quantitative validation is highly recommended
 
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SAMPLE ANALYSIS
 
 
The company should define suitable controls on elemental impurities. Initially, in order to asses that the ingredients and the process are under control, a routine sample analysis is strongly recommended. The analysis of on-going stability batches may be a proper strategy as a verification plan.
 
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+34 935 481 848

 
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