Risk Assessment, Screening and Control of Elemental Impurities in Pharmaceutical Drug Products: A Review

2020 ◽  
Vol 16 (7) ◽  
pp. 801-805
Author(s):  
Rajesh Kumar Chawla ◽  
Subhranshu Panda ◽  
Kulandaivelu Umasankar ◽  
Siva Prasad Panda ◽  
Dalu Damayanthi
Keyword(s):  
Risk Assessment ◽  
Inductively Coupled Plasma ◽  
Optical Emission ◽  
The United States ◽  
Emission Spectrometry ◽  
Exposure Limits ◽  
Pharmaceutical Drug ◽  
Inductively Coupled ◽  
Drug Products ◽  
Elemental Impurities

This article describes and reviews the steps involved in risk assessment of the twenty-four (24) potential elemental impurities in pharmaceutical drug products, as per the permitted daily exposure limits. Screening and estimation of prescribed elemental impurities in pharmaceutical drug substances, inactive excipients and drug products by inductively coupled plasma mass spectrometry or inductively coupled plasma optical emission spectrometry and their controls involved are also reviewed, as referred in the general chapters <232> & <233> of the United States Pharmacopoeia, Q3D guideline for elemental impurities as per international conference on harmonization and q3d elemental impurities: guidance for industry as per U. S., Food and Drug Administration USFDA.

scholarly journals Determination of Arsenic, Cadmium, Cobalt, Chromium, Lead, Molybdenum, Nickel, and Selenium in Fertilizers by Microwave Digestion and Inductively Coupled Plasma-Optical Emission Spectrometry Detection: Collaborative Study

2006 ◽  
Vol 89 (6) ◽  
pp. 1447-1466 ◽  
Author(s):  
Peter F Kane ◽  
William L Hall ◽  
J Bartos ◽  
R Boles ◽  
M Dupuis ◽  
...  
Keyword(s):  
Inductively Coupled Plasma ◽  
Microwave Digestion ◽  
Optical Emission ◽  
The United States ◽  
Optical Emission Spectrometry ◽  
Emission Spectrometry ◽  
Cobalt Chromium ◽  
Method Performance ◽  
Inductively Coupled ◽  
Plasma Optical Emission Spectrometry

Abstract There is increasing regulatory interest in the non-nutritive metals content of fertilizer materials, but at present there is no consensus analytical method for acid digestion and instrument detection of those elements in fertilizer matrixes. This lack of method standardization has resulted in unacceptable variability of results between fertilizer laboratories performing metals analysis. A method has been developed using microwave digestion with nitric acid at 200C, followed by inductively coupled plasma-optical emission spectrometry instrument detection, for the elements arsenic, cadmium, cobalt, chromium, molybdenum, nickel, lead, and selenium. The method has been collaboratively studied, and statistical results are here reported. Fourteen collaborators were sent 62 sample materials in a blind duplicate design. Materials represented a broad cross section of fertilizer types, including phosphateore, manufactured phosphate products, N-P-K blends, organic fertilizers, and micro-nutrient materials. As much as possible within the limit of the number of samples, materials were selected from different regions of the United States and the world. Limit of detection (LOD) was determined using synthetic fertilizers consisting of reagent grade chemicals with near zero levels of the non-nutritive elements, analyzed blindly. Samples with high iron content caused the most variability between laboratories. Most samples reasonably above LOD gave HorRat values within the range 0.5 to 2.0, indicating acceptable method performance according to AOAC guidelines for analyses in the mg/kg range. The method is recommended for AOAC Official First Action status.

scholarly journals Development of Green Methods for the Determination of Elemental Impurities in Commercial Pharmaceutical Tablets

2021 ◽  
Vol 14 (1) ◽  
pp. 422
Author(s):  
Vitoria Hagemann Cauduro ◽  
Alessandra Schneider Henn ◽  
Rochele Sogari Picoloto ◽  
Edson Irineu Muller ◽  
Marcia Foster Mesko ◽  
...  
Keyword(s):  
Inductively Coupled Plasma ◽  
Optical Emission ◽  
Emission Spectrometry ◽  
Pharmaceutical Drugs ◽  
Pharmaceutical Tablets ◽  
Inductively Coupled ◽  
Microwave Assisted ◽  
Elemental Impurities ◽  
Class 1

In this study, two methods based on the use of diluted acids were developed: microwave-assisted wet digestion (MAWD) and microwave-assisted ultraviolet digestion (MAWD-UV). These methods are evaluated for the digestion of oral pharmaceutical drugs and further determination of elemental impurities from classes 1 (As, Cd, Hg and Pb) and 2A (Co, Ni and V) by inductively coupled plasma optical emission spectrometry (ICP-OES). Commercial drugs for the treatment of type 2 diabetes are used. No prior comminution is performed. For MAWD, the optimized conditions were 2 mol L−1 or 3 mol L−1 HNO3, 1 mL of 50% H2O2 and a 45 min or 55 min irradiation program. For MAWD-UV, the condition using 1 mol L−1 HNO3, 1.6 mL of 50% H2O2 and a 55 min irradiation program enabled the digestion of all samples. In this way, efficient methods are proposed for the digestion of commercial pharmaceutical tablets for further determination of class 1 and 2A elemental impurities (ICH Q3D guidelines).

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