A Review of the Role of FTIR, NMR, and Raman Spectroscopy in Drug Product Characterisation

Kiran Kumar Byram; Chirag Patel; Sagar Patel; Shravan Kumar Muthyam

doi:10.37022/jpmhs.v9i2.192

Authors

Kiran Kumar Byram Department of Chemistry, Acharya Nagarjuna University, NH 16, Nagarjuna Nagar, Guntur, Andhra Pradesh 522510
Chirag Patel Senior Scientist, Department of AR&D, Amneal Pharmaceuticals, 49 Colonial Drive, Piscataway, New Jersey 08854
Sagar Patel Research Scientist II, Department of AR&D, Amneal Pharmaceuticals, 49 Colonial Drive, Piscataway, New Jersey 08854
Shravan Kumar Muthyam Lead Scientist, Quality Control, New England Avenue, Piscataway, NJ, 08854.

DOI:

https://doi.org/10.37022/jpmhs.v9i2.192

Keywords:

FTIR spectroscopy, NMR spectroscopy, Raman spectroscopy, drug product characterisation, polymorphism, impurity profiling, pharmaceutical analysis

Abstract

Drug product characterisation is a critical aspect of pharmaceutical development, ensuring the quality, safety, and efficacy of finished dosage forms. Spectroscopic techniques play a vital role in this process by providing rapid, reliable, and non-destructive analysis of drug substances and formulations. Among these, Fourier Transform Infrared (FTIR), Nuclear Magnetic Resonance (NMR), and Raman spectroscopy are widely employed due to their complementary analytical capabilities. FTIR is primarily used for functional group identification and compatibility studies, while NMR offers detailed structural elucidation and impurity profiling at the molecular level. Raman spectroscopy, with its minimal interference from water and suitability for in situ analysis, is particularly useful for polymorphic characterisation and real-time monitoring. These techniques collectively support critical applications such as structural confirmation, detection of degradation products, polymorphism analysis, and drug–excipient interaction studies. Their combined use enhances analytical accuracy and provides comprehensive insight into pharmaceutical systems. With ongoing advancements in instrumentation, chemometrics, and process analytical technology, spectroscopic methods are expected to play an increasingly significant role in modern pharmaceutical analysis and quality control.

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References

ICH Q2(R1). Validation of Analytical Procedures: Text and Methodology. International Council for Harmonisation, 2005.

ICH Q6A. Specifications: Test Procedures and Acceptance Criteria for New Drug Substances and Products. ICH, 1999.

ICH Q1A(R2). Stability Testing of New Drug Substances and Products. ICH, 2003.

Silverstein RM, Webster FX, Kiemle DJ. Spectrometric Identification of Organic Compounds. 7th ed., Wiley, 2005.

Pavia DL, Lampman GM, Kriz GS. Introduction to Spectroscopy. 5th ed., Cengage Learning, 2015.

Mukuntha Kumar M, Rao SV, Abbulu K, Narayana BV, Sukumar I. Simultaneous Estimation of Telmisartan and Chlorthalidone in Tablet Dosage Form by Using Reversed Phase High Performance Liquid Chromatographic Method. American Journal of Pharm Tech Research. 2014;4(5):696-710.

De Bleye C, Sacré PY, Netchacovitch L, et al. Raman spectroscopy for pharmaceutical analysis. TrAC Trends Anal Chem. 2012;35:131–143.

Pavia DL, Lampman GM, Kriz GS, Vyvyan JR. Introduction to Spectroscopy. 5th ed., Cengage Learning, 2015.

Silverstein RM, Webster FX, Kiemle DJ. Spectrometric Identification of Organic Compounds. 7th ed., Wiley, 2005.

Stuart B. Infrared Spectroscopy: Fundamentals and Applications. Wiley, 2004.

Claridge TDW. High-Resolution NMR Techniques in Organic Chemistry. 3rd ed. Oxford: Elsevier; 2016.

Keeler J. Understanding NMR Spectroscopy. 2nd ed. Chichester: Wiley; 2010.

Smith E, Dent G. Modern Raman Spectroscopy: A Practical Approach. Chichester: Wiley; 2005.

Pavia DL, Lampman GM, Kriz GS, Vyvyan JR. Introduction to Spectroscopy. 5th ed. Boston: Cengage Learning; 2015.

Stuart B. Infrared Spectroscopy: Fundamentals and Applications. Chichester: Wiley; 2004.

De Bleye C, Sacré PY, Netchacovitch L, et al. Raman spectroscopy for pharmaceutical analysis. TrAC Trends Anal Chem. 2012; 35:131–143.

Workman J Jr, Weyer L. Practical Guide to Interpretive Near-Infrared Spectroscopy. Boca Raton: CRC Press; 2008.

Griffiths PR, de Haseth JA. Fourier Transform Infrared Spectrometry. 2nd ed. Hoboken: Wiley; 2007.

Lambert JB, Gronert S, Shurvell HF, Lightner DA. Organic Structural Spectroscopy. 2nd ed. Upper Saddle River: Prentice Hall; 2010.

Long DA. The Raman Effect: A Unified Treatment of the Theory of Raman Scattering by Molecules. Chichester: Wiley; 2002.

Brittain HG. Polymorphism in Pharmaceutical Solids. 2nd ed. New York: Informa Healthcare; 2009.

P. Erukulla, P.V. Narasimha Raju, K.T. Kumar Reddy, V.R. Singamaneni, A. Pathak, S. Kumar Yadav, M. Sandeep Kumar,A.A. Mohathasim Billah. Emerging Analytical Techniques for Detection of Environmental Pollutants: A Review. Adv. J.Chem. A, 2026, 9(6), 962-996.

R. Hechhu, K. Krishnan, V. Singamaneni, P.V.N. Raju, P. Erukulla, K.V. Kandimalla, R.H. Babu, N. Vidiyala, GC-MS-Based Phytochemical Analysis, In-depth ADMET Screening and Molecular Docking Targeting EGFR for Anticancer Potential, Chem. Methodol., 2026, 10(5) 465-488

S.M. Bairagi, J.G. Wagh, A.R. Thanage, P. Venkata Narasimha Raju, P. Erukulla, K. Vamsi Kandimalla, A. Manukonda, R. Hari Babu. Green Extraction, Antioxidant, and Hepatoprotective Evaluation of Calotropis procera Leaf Extract. Asian Journal of Green Chemistry, 10 (3) 2026, 430-449.

Hancock BC, Zografi G. Characteristics and significance of the amorphous state in pharmaceutical systems. J Pharm Sci. 1997;86(1):1–12.

Crowley MM, Zhang F, Repka MA, Thumma S, Upadhye SB, Kumar Battu S, et al. pharmaceutical applications of hot-melt extrusion. Pharm Dev Technol. 2007;12(1):21–30.

PV B, Konda RK, M RTR. Validated Rp-hplc method for simultaneous estimation of cabotegravir and rilpivirine in tablet dosage form. IJPDA [Internet]. 2025Aug.27 [cited 2026Apr.26];13(3):23-3.

K S, Konatham TKR. Formulation And Evaluation of Ibuprofen and Chlorzoxazone Suspension Using Natural and Synthetic Suspending Agents. World Journal of Current Medical and Pharmaceutical Research. 2026 Feb 23;33–8.

Murali KR, Venkata NB, Shyamala P, Srinivasu K, Dantuluri HR. A validated rp-hplc method for impurity profiling of sodium nitroprusside in injection dosage form. International Journal of Applied Pharmaceutics. 2021;13:160-9.