Risk Assessment of the Leachables’ Profile for Small-Molecule Pharmaceutical Drug Substances

2021 ◽  
Author(s):  
Rajarathnam E. Reddy ◽  
Wenbin Hu ◽  
Brian R. Lowry ◽  
Jace L. Fogle ◽  
Robert E. Malick ◽  
...  
Keyword(s):  
Risk Assessment ◽  
Small Molecule ◽  
Pharmaceutical Drug ◽  
Drug Substances

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 SIMULTANEOUS TRACE LEVEL DETERMINATION OF BENZENE AND 1, 2-DICHLOROETHANE BY GC-HS/GC-MS IN SEVERAL PHARMACEUTICAL DRUG SUBSTANCES

2019 ◽  
Vol 11 (1) ◽  
pp. 82
Author(s):  
Sayeeda Sultana ◽  
Balaji Nagarajan
Keyword(s):  
Mobile Phase ◽  
Gas Chromatography Mass Spectrometry ◽  
Trace Level ◽  
Pharmaceutical Drug ◽  
Drug Substances ◽  
Successful Separation ◽  
Test Concentration ◽  
Spectrometry Technique ◽  
Trace Level Determination

Objective: We herein report the simultaneous trace level determination of benzene and 1,2-dichloroethane in several active pharmaceutical substances by GC-HS (gas chromatograph-head space) using a DB-624 column.Methods: This GC-HS method was developed based on an oven-programmed approach using nitrogen gas as the mobile phase. Our method is also compatible with the GC-MS (gas chromatography-mass spectrometry) technique using helium as the mobile phase instead of nitrogen. The successful separation of benzene and 1,2-dichloroethane was established by confirmation of their corresponding specific molecular masses.Results: The retention time of benzene and 1,2-dichloroethane were found to be 34.8 min and 35.6 min, respectively. The linearity was found in the range of concentration of 0.63-4.22 ppm and 1.49-9.96 ppm for benzene and 1,2-dichloroethane. The detection limit and quantification limit for benzene were 0.2 and 0.6 ppm, while those of 1,2-dichloroethane were 0.6 ppm and 1.5 ppm. These values were calculated using our developed method with respect to the test concentration of 500 mg/ml. The recovery of benzene and 1,2-dichloroethane were found to be 89–110% and 91–105%, respectively for the various pharmaceutical drug substances. The specificity of the method was studied using 20 solvents which include benzene and 1,2-dichloroethane.Conclusion: We expect that our method will be applicable for the simultaneous trace level determination of benzene and 1,2-dichloroethane during the control of manufacturing processes, and for use in rapid analysis for quality control in the pharmaceutical industry. Finally, this method was validated according to the International Conference on Harmonization (ICH) Validation Guidelines Q2 (R1).

scholarly journals Analysis of Benzenoid Substitution Patterns in Small Molecule Active Pharmaceutical Ingredients

2019 ◽  
Author(s):  
Aleksandra Nilova ◽  
David Stuart
Keyword(s):  
Natural Product ◽  
Small Molecule ◽  
Structural Variation ◽  
Electrophilic Aromatic Substitution ◽  
Active Pharmaceutical Ingredients ◽  
Aromatic Substitution ◽  
Pharmaceutical Ingredients ◽  
Drug Substances

An analysis of benzenoid substitution patterns in small molecule active pharmaceutical ingredients (APIs) approved by the FDA reveals a preference for 1,4-substituted (<i>para</i>), 1-substituted (<i>mono</i>), 1,2,4-substituted, and 1,2-substituted (<i>ortho</i>) arenes. Notably, these substitution patterns are widely commercially available and readily accessible by electrophilic aromatic substitution (S<sub>E</sub>Ar), but more highly substituted and contra-electronic substitution patterns are severely underrepresented in drug substances. Finally, structural variation decreases with increasing substitution and there is a strong reliance on natural product scaffolds in drugs with more highly substituted benzenoid rings.

Applicability of surface sampling and calculation of surface limits for pharmaceutical drug substances for occupational health purposes

2018 ◽  
Vol 95 ◽  
pp. 434-441
Author(s):  
Camille Jandard ◽  
Helena Hemming ◽  
Maarten Prause ◽  
Claudia Sehner ◽  
Markus Schwind ◽  
...  
Keyword(s):  
Occupational Health ◽  
Surface Sampling ◽  
Pharmaceutical Drug ◽  
Drug Substances
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