165 related articles for article (PubMed ID: 34673095)
1. ICH Q3D Drug Product Elemental Risk Assessment: The Use of An Elemental Impurities Excipients Database.
Torres S; Boetzel R; Gatimu E; Gomes DZ; King F; Kocks G; Jones R; Day C; Lewen N; Harris L; Teasdale A
J Pharm Sci; 2022 May; 111(5):1421-1428. PubMed ID: 34673095
[TBL] [Abstract][Full Text] [Related]
2. An Elemental Impurities Excipient Database: A Viable Tool for ICH Q3D Drug Product Risk Assessment.
Boetzel R; Ceszlak A; Day C; Drumm P; Gil Bejar J; Glennon J; Harris L; Heghes CI; Horga R; Jacobs PL; Keurentjes WJTM; King F; Lee CW; Lewen N; Marchant CA; Maris FA; Nye W; Powell S; Rockstroh H; Rutter L; Schweitzer M; Shannon E; Smallshaw L; Teasdale A; Thompson S; Wilkinson D
J Pharm Sci; 2018 Sep; 107(9):2335-2340. PubMed ID: 29679706
[TBL] [Abstract][Full Text] [Related]
3. Determination of ICH-Q3D Elemental Impurity Leachables in Glass Vials by Inductively Coupled Plasma Mass Spectrometry.
Breckenridge L; Oni Y; Evans C; Franck J; Wood S; Xu M; Sahin E; Zacour B
PDA J Pharm Sci Technol; 2023; 77(3):197-210. PubMed ID: 36241213
[TBL] [Abstract][Full Text] [Related]
4. A Risk-Based Approach to Evaluate and Control Elemental Impurities in Therapeutic Proteins.
Luo Y; Sekhar C; Lee H; Fujimori K; Ronk M; Semin D; Nashed-Samuel Y
J Pharm Sci; 2020 Nov; 109(11):3378-3385. PubMed ID: 32745562
[TBL] [Abstract][Full Text] [Related]
5. Elemental Impurities in Pharmaceutical Excipients.
Li G; Schoneker D; Ulman KL; Sturm JJ; Thackery LM; Kauffman JF
J Pharm Sci; 2015 Dec; 104(12):4197-4206. PubMed ID: 26398581
[TBL] [Abstract][Full Text] [Related]
6. Assessment of Extractable Elements from Elastomers.
Paskiet D; Kraft C; Tullo E; Hunter J; Zurbriggen D
PDA J Pharm Sci Technol; 2019; 73(1):83-91. PubMed ID: 30030347
[TBL] [Abstract][Full Text] [Related]
7. Application of X-ray fluorescence spectrometry for screening pharmaceutical products for Elemental Impurities according to ICH guideline Q3D.
Sauer B; Xiao Y; Zoontjes M; Kroll C
J Pharm Biomed Anal; 2020 Feb; 179():113005. PubMed ID: 31812806
[TBL] [Abstract][Full Text] [Related]
8. How One Might Experimentally Determine if Container Closure Systems and Their Components and Materials of Construction Contribute Elemental Impurities To Packaged Pharmaceutical Drug Products.
Jenke D
PDA J Pharm Sci Technol; 2019; 73(2):181-190. PubMed ID: 30232139
[TBL] [Abstract][Full Text] [Related]
9. A direct LA-ICP-MS screening of elemental impurities in pharmaceutical products in compliance with USP and ICH-Q3D.
Pluháček T; Ručka M; Maier V
Anal Chim Acta; 2019 Oct; 1078():1-7. PubMed ID: 31358206
[TBL] [Abstract][Full Text] [Related]
10. Reactive impurities in excipients: profiling, identification and mitigation of drug-excipient incompatibility.
Wu Y; Levons J; Narang AS; Raghavan K; Rao VM
AAPS PharmSciTech; 2011 Dec; 12(4):1248-63. PubMed ID: 21948318
[TBL] [Abstract][Full Text] [Related]
11. ICH Q3D based elemental impurities study in liquid pharmaceutical dosage form with high daily intake - comparative analysis by ICP-OES and ICP-MS.
Janchevska K; Stafilov T; Memed-Sejfulah S; Bogdanoska M; Ugarkovic S; Petrushevski G
Drug Dev Ind Pharm; 2020 Mar; 46(3):456-461. PubMed ID: 31999195
[TBL] [Abstract][Full Text] [Related]
12. Study of the compatibility of oral magnesium oxide preparations sold in Japan with the ICH-Q3D guideline for elemental impurities.
Satoh M; Motokawa K; Uesawa Y; Ishikawa Y; Maeda H; Iida K; Tanaka H; Kosugi T; Nishizawa K
Drug Discov Ther; 2021 Nov; 15(5):227-235. PubMed ID: 34719603
[TBL] [Abstract][Full Text] [Related]
13. The Level of Cadmium Impurities in Traditional Herbal Medicinal Products with Plantago lanceolata L., folium (Ribwort Plantain Leaves) Available in Polish Pharmacies - Comprehensive Toxicological Risk Assessment Including Regulatory Point of View and ICH Q3D Elemental Impurities Guideline.
Jurowski K; Fołta M; Tatar B; Krośniak M
Biol Trace Elem Res; 2022 Jun; 200(6):2963-2969. PubMed ID: 34373979
[TBL] [Abstract][Full Text] [Related]
14. Elemental impurities in pharmaceutical products adding fuel to the fire.
Maithani M; Raturi R; Sharma P; Gupta V; Bansal P
Regul Toxicol Pharmacol; 2019 Nov; 108():104435. PubMed ID: 31376414
[TBL] [Abstract][Full Text] [Related]
15. A Nitrite Excipient Database: A Useful Tool to Support N-Nitrosamine Risk Assessments for Drug Products.
Boetzel R; Schlingemann J; Hickert S; Korn C; Kocks G; Luck B; Blom G; Harrison M; François M; Allain L; Wu Y; Bousraf Y
J Pharm Sci; 2023 Jun; 112(6):1615-1624. PubMed ID: 35500671
[TBL] [Abstract][Full Text] [Related]
16. Study of the use of axial viewed inductively coupled plasma atomic emission spectrometry with ultrasonic nebulization for the determination of select elemental impurities in oral drug products.
Menoutis J; Parisi A; Verma N
J Pharm Biomed Anal; 2018 Apr; 152():12-16. PubMed ID: 29414002
[TBL] [Abstract][Full Text] [Related]
17. Rapid screening of pharmaceutical products for elemental impurities by a high-resolution portable energy dispersive X-ray fluorescence spectrometer using an efficient fundamental parameter method.
Zhu L; Teng Y; Han W; Yin L; Teng X
Analyst; 2023 Feb; 148(5):1116-1122. PubMed ID: 36723086
[TBL] [Abstract][Full Text] [Related]
18. Materials in Manufacturing and Packaging Systems as Sources of Elemental Impurities in Packaged Drug Products: An Updated Literature Review.
Jenke D
PDA J Pharm Sci Technol; 2020; 74(3):324-347. PubMed ID: 31843988
[TBL] [Abstract][Full Text] [Related]
19. Purification of pharmaceutical excipients with supercritical fluid extraction.
Ashraf-Khorassani M; Taylor LT; Waterman KC; Narayan P; Brannegan DR; Reid GL
Pharm Dev Technol; 2005; 10(4):507-16. PubMed ID: 16370180
[TBL] [Abstract][Full Text] [Related]
20. Development and validation of an ICP-MS method for the determination of elemental impurities in TP-6076 active pharmaceutical ingredient (API) according to USP 〈232〉/〈233〉.
Chahrour O; Malone J; Collins M; Salmon V; Greenan C; Bombardier A; Ma Z; Dunwoody N
J Pharm Biomed Anal; 2017 Oct; 145():84-90. PubMed ID: 28654780
[TBL] [Abstract][Full Text] [Related]
[Next] [New Search]
