Reference

1. Impurities in New Drug Substances Q3a (R2), Geneva, Switzerland: International Conference On Harmonisation of Technical Requirements For Registration Of Pharmaceuticals For Human Use, 2006. https://www.ich.org/page/quality-guidelines. Accessed December 04, 2022.
2. Guidance for Industry ANDAs: Impurities in Drug Substances, Silver Spring, Maryland, USA: U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER), 2009. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/andas-impurities-drug-substances. Accessed December 04, 2022.
3. Impurities in new drug products q3b (r2), Geneva, Switzerland: International conference on Harmonisation of technical requirements for registration of pharmaceuticals for human use, 2006. https://www.ich.org/page/quality-guidelines. Accessed December 04, 2022.
4. Guidance for Industry ANDAs: Impurities in Drug Products, Silver Spring, Maryland, USA: U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER), 2010. https://www.fda.gov/files/drugs/published/ANDAs--Impurities-in-Drug-Products.pdf. Accessed December 04, 2022.
5. Establishing Impurity Acceptance Criteria As Part of Specifications for NDAs, ANDAs, and BLAs Based on Clinical Relevance, Silver Spring, Maryland, USA: Manual Of Policies And Procedures, Center For Drug Evaluation And Research, 2020. https://www.fda.gov/media/124859/download. Accessed December 04, 2022.
6. Scott WR., Nina SC., Minhi M. Control Streategy Expectations in Early Clinical Phase Synthetic  Oncology Programs: Two Global Regulatory Case Studies.  Org. Process Res. Dev 2020;.24: 96-100.
7. Typical Fda Comments On Impurity Profiling In Ctd/Cep/Dmf Submissions, Pune, India: Perfect Pharmaceutical Consultants Pvt. Ltd, 2012. https://www.perfectdossier.com/pdf/Typical L FDA Comments on Impurity Profiling........pdf. Accessed December 04, 2022.
8. USP, ?1220? Analytical Procedure Life Cycle, General chapter of USP, Pharmacopeial forum PF-46(5), 2020.
9. Sandra B., Alka J.M. H., Dragana M. P, and Marija K.M. Determination of pKa values of active pharmaceutical ingredients. Trends Anal. Chem, 2007;.26:1043-1061.
10. E. Jime´nez-Lozano, I. Marque´s, D. Barro´n, J.L. Beltra´n, J. Barbosa. Determination of pKa values of quinolones from mobility and spectroscopic data obtained by capillary electrophoresis and a diode array detector. Anal. Chim. Acta. 2002; 464:37-45.
11. J. Barbosa, R. Berge´s, I. Toro, V. Sanz-Nebot. Protonation equilibria of quinolone antibacterials in acetonitrile-water mobile phases used in LC. Talanta. 1997; 44:1271-1283.
12. A.I. Drakopoulos, P.C. Ioannou. Spectrofluorimetric study of the acid–base equilibria and complexation behavior of the fluoroquinolone antibiotics ofloxacin, norfloxacin, ciprofloxacin and pefloxacin in aqueous solution.  Anal. Chim. Acta. 1997; 354:197-204.
13. USP, ?1236? Solubility Measurements, General chapter of USP, Pharmacopeial forum PF-46(5), 2020.
14. Naveen C., Madan LA., Deepak P. A review of drug isomerism and its significance. Int. j. appl. basic med. 2013;3:16-18.
15. Budesonide Delayed Release Capsules. United States Pharmacopoeia- PF 45 (5), US Pharmacopoeial convention: Rockville, 2019.
16. Olanzapine Tablets. United States Pharmacopoeia-46, National Formulary 41, US Pharmacopoeial convention: Rockville, 2023.
17. Olanzapine Orally Disintegrating Tablets. United States Pharmacopoeia-46, National Formulary 41, US Pharmacopoeial convention: Rockville, 2023.
18. Guidance for Industry ANDAs: Pharmaceutical Solid Polymorphism, Silver Spring, Maryland, USA: U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER), 2007. https://www.fda.gov/regulatory-information/search-fda-guidance documents/andaspharmaceutical-solid-polymorphism-chemistry-manufacturing and-controls-information. Accessed December 04, 2022.
19. Callow RK, Kennard O. Polymorphism Of Cortisone Acetate. J Pharm Pharmacol. 1961; 13:723–733.
20. Levi G, Procknal JA. Dissolution Rate Studies on Methylprednisolone Polymorphs. J Pharm Sci. 1964; 53:656-658.
21. Kimura K, Hirayama F, Uekama K. Characterization of tolbutamide polymorphs (burger's forms II and IV) and polymorphic transition behavior. J Pharm sci. 1999; 88:85-391.
22. De Villiers MM, Watt VJG, Lotter AP. Kinetic study of the solid-state photolytic degradation of two polymorphic forms of furosemide. Int J Pharm. 1992; 88:275–283.
23. Matsuda R, Akazawa R, Teraoka M, Otsuka R. Pharmaceutical Evaluation of Carbamazepine Modifications: Comparative Study for Photostability of Carbamazepine Polymorphs by using Fourier-transformed Reflection-absorption Infrared Spectroscopy and Colorimetric Measurement. J Pharm Phamacol. 1994; 46:162–167.
24. Otsuka M, Onoe M, Matsuda Y. Physicochemical Stability of Phenobarbital Polymorphs at Various Levels of Humidity and Temperature. Pharm Res. 1993; 10:577–582.
25. Hamarapurkar P.D, Abhijeet N.P. HPLC Method for the Determination of Emtricitabine and Related Degradation Substances. J. Chromatogr. Sci. 2013; 51:419–424.
26. R. Snyder, Joseph J. Kirkland, Joseph L. Glajch. Practical HPLC Method Development, Lloyd, John Wiley & Sons, Inc.: New Jersey, 1997.
27. Ahuja S., Rasmussen H. HPLC Method Development For Pharmaceuticals, , Academic Press: London, 2007
28. Agrahari V., Bajpai M., Nanda S. Essential Concepts of Mobile Phase Selection for Reversed Phase HPLC Research. J. Pharm. and Tech. 2013; 6:459–464.
29. A Guide to HPLC and LC-MS Buffer Selection, Scotland: Advanced Chromatography Technologies, 2008. https://www.hplc.eu/Downloads/ACE_Guide_BufferSelection.pdf. Accessed December 05, 2022.
30. Back to Basics: The Role of pH in Retention and Selectivity, Europe: LCGC solutions for separation scientists, 2017. https://www.chromatographyonline.com/view/back-basics-role-ph-retention-and-selectivity-0. Accessed December 05, 2022.
31. USP, ?621? Chromatography, General chapter of USP, Pharmacopeial forum PF-46(5), 2022.
32. Reviewer Guidance Validation of Chromatographic Methods, Silver Spring, Maryland, USA: U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER), 1994. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/reviewer-guidance-validation-chromatographic-methods. Accessed December 05, 2022.
33. Horwitz Equation As Quality Benchmark In Iso/Iec 17025 Testing Laboratory, Mexico: Bufete de ingenieros industrials, 2007. https://bii.mx/documentos/horwitzCf11.pdf. Accessed December 05, 2022.
34. Key Factors in Sample Diluent Selection for HPLC Assays of Active Pharmaceutical Ingredients, North America: LCGC solutions for separation scientists, 2005. https://www.chromatographyonline.com/view/key-factors-sample-diluent-selection-hplc-assays-active-pharmaceutical-ingredients. Accessed December 05, 2022.
35. USP, ?1226? Verification Of Compendial Procedures, General chapter of USP, Pharmacopeial forum PF-46(5), 2022.
36. Filtration Approaches to Sample Preparation and Cleanup, USA: Agilent Technologies. https://www.agilent.com/cs/library/eseminars/Public/Sample Prep and Filtration How to Select the Right Options for the Modern Analytical World.pdf. Accessed December 05, 2022.
37. Syringe Filter Selection, Canada: Chromatographic Specialties Inc., https://www.crawfordscientific.com/media/wysiwyg/Technical/Tech-Pages/Crawford-Scientific-Syringe-Filter-Selection-Guide/Syringe-filters-A2-poster.pdf. Accessed December 05, 2022.
38. Validation of Analytical Procedures Q2 (R2), Geneva, Switzerland: International Conference On Harmonisation of Technical Requirements For Registration of Pharmaceuticals For Human Use, 2022. https://www.ich.org/page/quality-guidelines. Accessed December 05, 2022.
39. How To Approach A Forced Degradation Study, Berlin, Germany: SGS, 2011. https://www.sgsgroup.at/~/media/Global/Documents/Technical Documents/SGS-LSS-Forced Degradation-EN-11.pdf. Accessed December 05, 2022.
40. Trivikram R., Pandey IP. Forced degradation studies for Drug Substances and Drug Products- Scientific and Regulatory Considerations.  J. Pharm. Sci. & Res. 2015; 7:238–241.
41. Manish S., Manoharan M. Forced Degradation Study an Essential Approach to Develop Stability Indicating Method.  J Chromatogr. Sep. Tech. 2017; 8:1–3.
42. Krishna G.R., Ekta T.P., Anvesha G.V. Stability And Degradation Kinetic Study Of Bilastine In Solution State by RP-HPLC Method.  J. drug deliv. Ther. 2021; 11:48–56.
43. Oxidation of Drugs during Drug Product Development: Problems and Solutions, Basel, Switzerland: MDPI, 2022. https://www.researchgate.net/publication/358224398_Oxidation_of_Drugs_during_Drug_Product_Development_Problems_and_Solutions. Accessed December 05, 2022.
44. Stability Testing Of New Drug Substances And Products Q1A (R2), Geneva, Switzerland: International Conference on Harmonisation of Technical Requirements For Registration of Pharmaceuticals For Human Use, 2003. https://www.ich.org/page/quality-guidelines. Accessed December 05, 2022.
45. F E M O'Brien. The Control of Humidity by Saturated Salt Solutions.  J. Sci. Instrum. 1948;25:73–76.
46. Stability Testing:  Photostability Testing of New Drug Substances And Products Q1B, Geneva, Switzerland: International Conference on Harmonisation of Technical Requirements For Registration of Pharmaceuticals For Human Use, 1996. https://www.ich.org/page/quality-guidelines. Accessed December 05, 2022.
47. Review on Mass Balance, Pune, Maharashtra: Veeprho Pharmaceuticals, 2020. https://veeprho.com/review-on-mass-balance/. Accessed December 05, 2022.
48. Christina S.R., Tony S.B., Scott A.G. Risk-Based Analytical Method Transfer: Application to Large Multi-Product Transfers.  Anal. Chem. 2010; 82:5936