179 related articles for article (PubMed ID: 36241213)
1. 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]
2. 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]
3. 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]
4. Recommendation of Single Time Point Leachables Testing for Lyophilized Biotechnology Products Stored in Rubber Stoppered Glass Vial Systems.
Gallegos A; Liu J; Ronk M; Qi L; Li K; Semin D; Nashed-Samuel Y
J Pharm Sci; 2022 Jun; 111(6):1599-1604. PubMed ID: 35257694
[TBL] [Abstract][Full Text] [Related]
5. 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]
6. 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]
7. 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]
8. 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]
9. 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]
10. A Holistic Approach of Extractables and Leachables Assessment of Rubber Stoppered Glass Vial Systems for Biotechnology Products.
Qi L; Liu J; Ronk M; Gallegos A; Fujimori K; Luo Y; Li K; Lee H; Nashed-Samuel Y
J Pharm Sci; 2021 Nov; 110(11):3580-3593. PubMed ID: 34324943
[TBL] [Abstract][Full Text] [Related]
11. Method for determination of elemental impurities in metronidazole benzoate using inductively coupled plasma mass spectrometry.
Tian M; Zhang H; Fan H; Yin M; Wang W; Shi C
Eur J Mass Spectrom (Chichester); 2024 Feb; 30(1):60-64. PubMed ID: 37926973
[TBL] [Abstract][Full Text] [Related]
12. Creating a Holistic Extractables and Leachables (E&L) Program for Biotechnology Products.
Li K; Rogers G; Nashed-Samuel Y; Lee H; Mire-Sluis A; Cherney B; Forster R; Yeh P; Markovic I
PDA J Pharm Sci Technol; 2015; 69(5):590-619. PubMed ID: 26429108
[TBL] [Abstract][Full Text] [Related]
13. 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]
14. 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]
15. Flow injection combined with ICP-MS for accurate high throughput analysis of elemental impurities in pharmaceutical products according to USP <232>/<233>.
Fischer L; Zipfel B; Koellensperger G; Kovac J; Bilz S; Kunkel A; Venzago C; Hann S
J Pharm Biomed Anal; 2014 Jul; 95():121-9. PubMed ID: 24667566
[TBL] [Abstract][Full Text] [Related]
16. Elemental impurities determination in bromhexine hydrochloride injections.
Xu S; Zhang L; Bai Q; Wang L; Chen X
J Pharm Biomed Anal; 2023 May; 229():115379. PubMed ID: 37011549
[TBL] [Abstract][Full Text] [Related]
17. 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]
18. Determination of arsenic, cadmium, mercury, lead and nickel as elemental impurities in atorvastatin calcium by inductively coupled mass spectrometer.
Pal AK; Sundararajan R
Eur J Mass Spectrom (Chichester); 2022 Feb; 28(1-2):3-11. PubMed ID: 35656753
[TBL] [Abstract][Full Text] [Related]
19. 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]
20. Materials in Manufacturing and Packaging Systems as Sources of Elemental Impurities in Packaged Drug Products: A Literature Review.
Jenke DR; Stults CL; Paskiet DM; Ball DJ; Nagao LM
PDA J Pharm Sci Technol; 2015 1/2; 69(1):1-48. PubMed ID: 25691713
[TBL] [Abstract][Full Text] [Related]
[Next] [New Search]
