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Handbook of Solvents - George Wypych - ChemTech - Ventech!

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996 Michel Bauer, Christine Barthélémy<br />

pyridine, tetrahydr<strong>of</strong>uran and dimethyl sulphoxide. Parsons and Col 39 have performed a<br />

search for trace impurities in solvents commonly used for gas chromatographic analysis <strong>of</strong><br />

environmental samples.<br />

14.21.1.5.3 Quality <strong>of</strong> solvents used in titrimetry<br />

For titrimetric determinations performed in an aqueous medium it is highly recommended<br />

to use distilled water and to perform a blank determination if necessary.<br />

For determinations performed in non aqueous media, the solvents should be as anhydrous<br />

as possible and, <strong>of</strong> course, inert to the titrant and the substance. Their purity should be<br />

such that they do not contain impurities which could react with the substance to be analyzed.<br />

A blank titration should be performed if necessary.<br />

14.21.1.6 Conclusions<br />

Far from being inert and not affecting the molecules dissolved in it, the solvent can affect<br />

the behavior <strong>of</strong> the solute in different ways. This chapter has aimed to support the idea that it<br />

is important for the chemist and the pharmacist to control the quality <strong>of</strong> the solvents used in<br />

the different areas <strong>of</strong> pharmaceutical activity. As we have tried to show, many pitfalls can<br />

be avoided during the development <strong>of</strong> a drug if a thorough investigation <strong>of</strong> the quality <strong>of</strong> the<br />

solvents used is carried out.<br />

References<br />

1 C. Reichardt, <strong>Solvents</strong> and solvents effect in organic chemistry, 2nd edition, 1998,<br />

VCH Verlagsgesellschaft mbH.<br />

2 G.A. Stephenson, E.G. Groleau, R.L. Kleemann, W. Xu and D.R. Rigsbee, J. Pharm. Sci., 87, 536 (1998).<br />

3 A. Picot, Le bon usage des solvants, Information Toxicologique n° 3, Unité de prévention du risque<br />

chimique - CNRS (France) (1995).<br />

4 ICH Harmonised Tripartite Guideline, Impurities: Guideline for Residual <strong>Solvents</strong>.<br />

5 M. Gachon, STP Pharma Pratiques 1, 531 (1991).<br />

6 Carbomer Monograph - Eur. Ph. Addendum 2000, p 494.<br />

7 J.A. Riddik and W.B. Bungler, Organic <strong>Solvents</strong>, Wiley Intersciences, New-York, 1970, pp 552-571.<br />

8 G.P.J. Ravissot, STP Pharma Pratiques, 9, 3 (1999).<br />

9 See Reference 1 p 427.<br />

10 M. Debaert, STP Pharma Pratiques, 1, 253 (1991).<br />

11 A.M. Guyot-Hermann, STP Pharma Pratiques, 1, 258 (1991).<br />

12 D. Chulia, M. Deleuil, Y. Pourcelot, Powder Technology and Pharmaceutical Processes, Elsevier,<br />

Amsterdam, 1994.<br />

13 J.L. Burdett and M.T. Rodgers, J. Am. Chem. Soc., 86, 2105 (1964).<br />

14 M.T. Rodgers and J.L. Burdett, Can. J. Chem., 43, 1516 (1965).<br />

15 J. Haleblian and W. McCrone, J. Pharm. Sci., 58, 911 (1969).<br />

16 P. York, Int. J. Pharm., 14, 1 (1983).<br />

17 S. Khoshkhoo and J. Anwar, J. Phys. D.; Appl. Phys., 26, B90 (1993).<br />

18 J. Shyh-Ming, Diss. Abst. Int., 57 (10), 6402-B (1997).<br />

19 W. Beckmann and W.H. OTTO, Chem. E. Res. Des., 74, 750 (1996).<br />

20 N. Rodriguez-Hornedo and D. Murphy, J. Pharm. Sci., 88, 651 (1999).<br />

21 R. David and D. Giron in Powder Technology and Pharmaceutical Processes, <strong>Handbook</strong> <strong>of</strong> Powder<br />

Technology, Elsevier Sciences, Ed., Amsterdam 1994, pp 193-241.<br />

22 A.S. Myerson, S.M. Jang, J. Cryst. Growth, 156, 459 (1995).<br />

23 A.H.L. Chow, D.J.W. Grant, Int. J. Pharm., 42, 123 (1988).<br />

24 C. Lefebvre-Ringard, A.M. Guyot-Hermann, R. Bouché et J. Ringard, STP Pharma Pratiques, 6, 228 (1990).<br />

25 D.C. Messer, L.T. Taylor, W.N. Moore and W.E. Weiser, Ther. Drug Monit., 15, 581 (1993).<br />

26 M. Perrut, Information Chimie, 321, 166 (1990).<br />

27 R.R. Pfeiffer, K.S. Yang and M.A. Tucker, J. Pharm. Sci., 59, 1809 (1970).<br />

28 R. Hüttenrauch, Pharm. Ind., 45, 435 (1983).<br />

29 D.S. Bindra, T.D. William and V.J. Stella, Pharm. Res., 11, 1060 (1994).

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