Mass Balance in Pharmaceutical Stress Testing: A Review of Principles and Practical Applications

International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). Stability Testing of New Drug Substances and Products, Q1A(R2). ICH. 2003.

World Health Organization Annex 6: Guidelines on submission of documentation for a multisource (generic) finished pharmaceutical product: Quality part. WHO Technical Report Series No 986. 2014.

Guideline for obtainment of the degradation profile, and identification and qualification of degradation products in drugs, Guideline No. 04/2015 – Version 1. In: ANVISA, editor. Brazilian Ministry of Health National Health Surveillance Agency 2015.

Baertschi SW, Pack BW, HoaglundHyzer CS, Nussbaum MA. Assessing mass balance in pharmaceutical drug products: New insights into an old topic. TrAC, Trends Anal Chem. 2013;49:126–36. https://doi.org/10.1016/j.trac.2013.06.006.

Article  CAS  Google Scholar 

Nussbaum MA, Kaerner, A, Jansen, PJ, Baertschi SW. Role of “mass balance” in pharmaceutical stress testing. In: Baertschi SW, Alsante KM, Reed RA, editors. Pharmaceutical Stress Testing: Predicting Drug Degradation, 2nd ed: Informa Healthcare, London, UK; 2011. p. 233–53.

Baertschi SW. Analytical methodologies for discovering and profiling degradation-related impurities. TrAC, Trends Anal Chem. 2006;25(8):758–67. https://doi.org/10.1016/j.trac.2006.05.012.

Article  CAS  Google Scholar 

Singh S, Junwal M, Modhe G, Tiwari H, Kurmi M, Parashar N, et al. Forced degradation studies to assess the stability of drugs and products. TrAC, Trends Anal Chem. 2013;49:71–88. https://doi.org/10.1016/j.trac.2013.05.006.

Article  CAS  Google Scholar 

Baertschi SW, Reynolds, DW, Jansen PJ, Alsante KM, Smith WK. Introduction, Stress testing: A predictive tool, and Stress testing: Analytical considerations. In: Baertschi SW A, KM, Reed RA, editor. Pharmaceutical Stress Testing: Predicting Drug Degradation. 210. 2 ed: Informa Healthcare; 2011.

Zelesky T, Baertschi SW, Foti C, Allain LR, Hostyn S, Franca JR, et al. Pharmaceutical Forced Degradation (Stress Testing) Endpoints: A Scientific Rationale and Industry Perspective. J Pharm Sci. 2023;112(12):2948–64. https://doi.org/10.1016/j.xphs.2023.09.003.

Article  CAS  PubMed  Google Scholar 

Pascal Marillier NA, Steven W. Baertschi, John M. Campbell, Zongyun Huang*. Liquid Chromatographic Peak Purity Assessments in Forced Degradation Studies - an Industry Perspective LCGC International. 2024;1(1):22–31.

Gorog S. The sacred cow: the questionable role of assay methods in characterising the quality of bulk pharmaceuticals. J Pharm Biomed Anal. 2005;36(5):931–7. https://doi.org/10.1016/j.jpba.2004.06.025.

Article  CAS  PubMed  Google Scholar 

Food and Drug Administration; International Conference on Harmonisation; Stability Testing of New Drug Substances and Products; Guideline; Availability; Notice. 59 Fed. Reg.; 1994. p. 23380.

International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). Validation of Analytical Procedures: Text and Methodology Q2(R1). ICH; 2005.

Zhang K, Kurita KL, Venkatramani C, Russell D. Seeking universal detectors for analytical characterizations. J Pharm Biomed Anal. 2019;162:192–204. https://doi.org/10.1016/j.jpba.2018.09.029.

Article  CAS  PubMed  Google Scholar 

Nefliu M, Zelesky T, Jansen P, Sluggett GW, Foti C, Baertschi SW, et al. Artifacts Generated During Azoalkane Peroxy Radical Oxidative Stress Testing of Pharmaceuticals Containing Primary and Secondary Amines. J Pharm Sci. 2015;104(12):4287–98. https://doi.org/10.1002/jps.24667.

Article  CAS  PubMed  Google Scholar 

Campbell JM, Grinias K, Facchine K, Igne B, Clawson J, Peterson J, et al. Analysis of unstable degradation impurities of a benzodiazepine and their quantification without isolation using multiple linear regression. J Pharm Biomed Anal. 2019;167:1–6. https://doi.org/10.1016/j.jpba.2019.01.028.

Article  CAS  PubMed  Google Scholar 

Campbell JM, Lee M, Clawson J, Kennedy-Gabb S, Bethune S, Janiga A, et al. The Degradation Chemistry of GSK2879552: Salt Selection and Microenvironmental pH Modulation to Stabilize a Cyclopropyl Amine. J Pharm Sci. 2019;108(9):2858–64. https://doi.org/10.1016/j.xphs.2019.04.026.

Article  CAS  PubMed  Google Scholar 

De Spiegeleer BM, D’Hondt M, Vangheluwe E, Vandercruyssen K, De Spiegeleer BV, Jansen H, et al. Relative response factor determination of beta-artemether degradants by a dry heat stress approach. J Pharm Biomed Anal. 2012;70:111–6. https://doi.org/10.1016/j.jpba.2012.06.002.

Article  CAS  PubMed  Google Scholar 

Nussbaum MA, Baertschi SW, Jansen PJ. Determination of relative UV response factors for HPLC by use of a chemiluminescent nitrogen-specific detector. J Pharm Biomed Anal. 2002;27(6):983–93. https://doi.org/10.1016/s0731-7085(01)00545-3.

Article  CAS  PubMed  Google Scholar 

Baertschi SW. Revisiting old topics: New insights into the concept of ‘mass balance’ in drug products. USP Convention; June 28–29, 2017; Rockville, MD2017.

Olsen BA, Argentine MD. Investigation of response factor ruggedness for the determination of drug impurities using high-performance liquid chromatography with ultraviolet detection. J Chromatogr A. 1997;762(1–2):227–33. https://doi.org/10.1016/s0021-9673(96)00678-4.

Article  CAS  PubMed  Google Scholar 

Vas G, Alquier L, Maryanoff CA, Cohen J, Reed G. Investigation of mass-balance issue in e-beam sterilized paclitaxel eluting coronary stents by SPME/GC-MS. J Pharm Biomed Anal. 2008;48(3):568–72. https://doi.org/10.1016/j.jpba.2008.05.031.

Article  CAS  PubMed  Google Scholar 

Oyler AR, Armstrong BL, Dunphy R, Alquier L, Maryanoff CA, Cohen JH, et al. Mass balance in rapamycin autoxidation. J Pharm Biomed Anal. 2008;48(5):1368–74. https://doi.org/10.1016/j.jpba.2008.09.030.

Article  CAS  PubMed  Google Scholar 

Korner A. Uncovering Deficiencies in Mass Balance Using HPLC with Chemiluminescence Nitrogen-Specific Detection. LCGC North Am. 2002;20(4):364–73.

Google Scholar 

Lukulay P, Hokanson G. Reconciling Mass Balance in Forced Degradation Studies. Pharmaceutical Technology. 2005;29(10).

Zhang B, Li X, Yan B. Advances in HPLC detection–towards universal detection. Anal Bioanal Chem. 2008;390(1):299–301. https://doi.org/10.1007/s00216-007-1633-0.

Article  CAS  PubMed  Google Scholar 

Schulz K, Oberdieck U, Backensfeld T, Weitschies W. Changes in recovery due to drug product matrix ageing as a source of mass imbalances. J Pharm Biomed Anal. 2013;74:117–25. https://doi.org/10.1016/j.jpba.2012.10.014.

Article  CAS  PubMed  Google Scholar 

Panagopoulos Abrahamsson D, Park JS, Singh RR, Sirota M, Woodruff TJ. Applications of Machine Learning to In Silico Quantification of Chemicals without Analytical Standards. J Chem Inf Model. 2020;60(6):2718–27. https://doi.org/10.1021/acs.jcim.9b01096.

Article  CAS  PubMed  Google Scholar 

Liu S, Yao S, Zhang H, Hu C. Determination of Relative Response Factors of Cefazolin Impurities by Quantitative NMR. AAPS PharmSciTech. 2017;18(6):1895–900. https://doi.org/10.1208/s12249-016-0654-4.

Article  CAS  PubMed  Google Scholar 

Webster GK, Marsden I, Pommerening CA, Tyrakowski CM, Tobias B. Determination of relative response factors for chromatographic investigations using NMR spectrometry. J Pharm Biomed Anal. 2009;49(5):1261–5. https://doi.org/10.1016/j.jpba.2009.02.027.

Article  CAS  PubMed  Google Scholar 

Sun P, Wang X, Alquier L, Maryanoff CA. Determination of relative response factors of impurities in paclitaxel with high performance liquid chromatography equipped with ultraviolet and charged aerosol detectors. J Chromatogr A. 2008;1177(1):87–91. https://doi.org/10.1016/j.chroma.2007.11.035.

Article  CAS  PubMed  Google Scholar 

Mayhew JW, Gideon LT, Ericksen B, Hlavaty JJ, Yeh SM, Chavdarian CG, et al. Development of a gel permeation chromatographic assay to achieve mass balance in cellulose acetate phthalate stability studies. J Pharm Biomed Anal. 2009;49(2):240–6. https://doi.org/10.1016/j.jpba.2008.10.039.

Article  CAS  PubMed  Google Scholar 

Priestner AA. Use of radiolabelled drug substance to investigate mass balance during validation of a high-performance liquid chromatography method for impurities. Anal Proc. 1993;30(9):374–7. https://doi.org/10.1039/ap9933000374.

Article  CAS  Google Scholar 

Gorecki T, Lynen F, Szucs R, Sandra P. Universal response in liquid chromatography using charged aerosol detection. Anal Chem. 2006;78(9):3186–92. https://doi.org/10.1021/ac060078j.

Article  CAS  PubMed  Google Scholar 

Foley DA, Wang J, Maranzano B, Zell MT, Marquez BL, Xiang Y, et al. Online NMR and HPLC as a reaction monitoring platform for pharmaceutical process development. Anal Chem. 2013;85(19):8928–32. https://doi.org/10.1021/ac402382d.

Article  CAS  PubMed  Google Scholar 

Jordi MA, Rowland K, Liu W, Cao X, Zong J, Ren Y, et al. Reducing relative response factor variation using a multidetector approach for extractables and leachables (E&L) analysis to mitigate the need for uncertainty factors. J Pharm Biomed Anal. 2020;186:113334. https://doi.org/10.1016/j.jpba.2020.113334.

Article  CAS  PubMed  Google Scholar 

Hong P, Phoebe AD, Jones MD. Study of relative response factors and mass balance in forced degradation studies with liquid chromatography/photo-diode array detector/evaporative light scattering detector/mass spectrometry system. J Chromatogr A. 2

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