Regulatory and Analytical Aspects of Residual Solvents in Ayurvedic Formulations - A Recent Update

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Residual solvents are potentially undesirable substances in herbal formulations when present above the permissible limits given by ICH guidelines in 1997 and they must be regulated properly in order to avoid their deleterious health effects. The present paper provides a recent update on the regulations for residual solvents, different Pharmacopoeial guidelines and analytical techniques available for the screening of residual solvents
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Analytical Techniques; Herbal Formulations; Residual Solvents

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European Pharmacopoeia: European Directorate for the Quality of Medicines & HealthCare (EDQM). Guide for the elaboration of monographs on herbal drugs and herbal drug preparations, 2007.

Harnischfeger G. Standardisation and quality control of medicinal plants and their products 2005.

Mukherjee PK. Quality Control of Herbal Drugs. Bussiness Horizons 2002: 380.

ICH Harmonised Tripartite Guideline on Impurities in New Drug Substances (ICH Q3AR), International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use, 1997.

Reflection paper on ethanol content in herbal medicinal products and traditional herbal medicinal products used in children. Committee on herbal medicinal products (HMPC); European Medicines Agency, 2010.

A. Roy, S. Nyarady, M. Matchett. Genotoxic and non-genotoxic impurities in pharmaceuticals-Current regulations, status and trend. Chimica Oggi / Chemistry today, 2009, 27, 19-23.

Residual Solvents: FDA/ Regulatory Perspective. PDA/USP Residual Solvents Conference, Jan 2007.

Analysis of herbal medicines and healthcare products-Application Compendium.

Guidance for Industry, Q3C Impurities: Residual Solvents. U.S. Food and Drug Administration, 1997.

K. Grodowska, A. Parczewski. Analytical methods for residual solvent determination in pharmaceutical products. Acta Poloniae Pharmaceutica - Drug Research, 2010, 67, 13-26.

S.B. Puranik, P.N.S. Pai, G.K. Rao. Organic Volatile Impurities in P.harmaceuticals. Indian Journal of Pharmaceutical Sciences, 2007, 69(3), 352-359.

Organic Volatile Impurities. General Notices and Requirements: Applying to Standards, Tests, Assays, and Other Specifications of the United States Pharmacopeia. Chapter 467; 2007.

Understanding the Revisions to USP Monograph: Residual Solvents; Phenomenex Inc: 1-16.

A.M. Dwiwedi. Residual Solvent Analysis in Pharmaceuticals. Pharmaceutical Technology, 2002, 42-46.

Residual solvents controls: European Pharmacopoeia perspective. PDA/USP Joint Meeting, Maryland, Irish medicines board, 18th Jan 2007.

Residual Solvents Test. Japanese Pharmacopoeia 2002; XIV.

B. Hymer. Residual solvent testing: A review of gas-chromatographic and alternative techniques. Pharmaceutical Research, 2003, 20, 337-344.

C. Witschi, E. Doelker. Residual solvents in pharmaceutical products: acceptable limits, influences on physicochemical properties, analytical methods and documented values. Eur J Pharm Biopharm, 1997, 43(3),215–242.

D.G. Westmorland, G.R. Rhodes. Analytical techniques for trace organic compounds II: Detectors for gas chromatography. Pure & Applied Chemistry, 1989, 61(6), 1147–1160.

I.D. Smith, D.G. Waters. Determination of residual solvent levels in bulk pharmaceuticals by capillary gas chromatography. Analyst 1991, 116 (12), 1327–1331.

C.C. Camarasu, M. Meqei-Szuts,et al., Residual solvents in pharmaceutical products by GC-HS and GC-MS-SPME. J Pharm Biomed Anal, 1998, 18, 623–638.

P.R. Battu, M.S. Reddy. Residual Solvents Determination by HS-GC with Flame Ionization Detector in Omeprazole Pharmaceutical formulations. International Journal of Pharm Tech Research 2009; 1 (2): 230-234.

Wampler TP, Bowe WA, Levy EJ. Dynamic headspace analysis of residual volatiles in pharmaceuticals. J Chromatogra Sci 1985; 23(2): 64–67.

Vitenberg AG, Kostkina MI. Gas chromatographic head space analysis on capillary columns. J Anal Chem 1998; 43:253– 261.

Camarasu CC. Head Space SPME Method Development for the Analysis of Volatile Polar Residual solvents by GC-MS. J Pharm Biomed Anal 2000; 23:197.

Residual solvent analysis with 2D GC. LC-GC north America-solutions for separation scientists 2008; 26(1).

Deng C, Yao N, Wang B, Zhang X. Development of microwave-assisted extraction followed by headspace single-drop micro-extraction for fast determination of paeonol in traditional Chinese medicines. J Chromatogr A 2006; 1103:15-21.

Cole J, Phillips E, Conoley M. Analysis of residual solvents in pharmaceuticals using vacuum fast analysis by static headspace GC/MS. Thermo Electron Corporation.

Puranik SB, Pai PNS, Rao GK. Determination of organic volatile impurities in herbal formulations and extracts by capillary gas chromatography. International Journal of Applied Research in Natural Products 2009; 2(1): 32-46.

Pena F, Cárdenas S, Gallego M, Valcarce M. Direct sampling of orujo oil for determining residual hexane by using a chemsensor. JAOCS 2003; 80:613-618.

Hashimoto K, Urakami K, Fujiwara Y, Terada S. Determination of residual solvents in pharmaceuticals by thermal desorption-GC/MS. Anal Sci 2001; 17:645-8.

Nikopour A, Zhou M, Pocci R, Lorenz D. Residual Solvents Screening By Utilization of Headspace - GC/MS. Irvine Pharmaceutical Services, Inc. • 10 Vanderbilt, Irvine, CA 92618.

Mulligan KJ, McCauley H. Factors that influence the determination of residual solvents in pharmaceuticals by automated static headspace sampling coupled to capillary GC-MS. J Chromatogr Sci 1995; 33:49–54.


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