4. REAGENTS - DrugFuture

1 EUROPEAN PHARMACOPOEIA REAGENTS 01/2011:40000 : about : about 4. REAGENTS bp : about 103 C. Additional information for REAGENTS that can only be fully Acetaldehyde. C2H4O. (Mr ). 1000200. [75-07-0]. Ethanal. identified by a trademark or whose availability is limited may Clear, colourless flammable liquid, miscible with water and with be found in the KNOWLEDGE database on the EDQM website. ethanol (96 per cent). This information is given only to make it easier to obtain : about such REAGENTS and this does not suggest in any way that the : about mentioned suppliers are especially recommended or certified bp : about 21 C.

2 By the European Pharmacopoeia Commission or the Council of Europe. It is therefore acceptable to use REAGENTS from Acetaldehyde ammonia trimer trihydrate. C6H15N3,3H2O. another source provided that they comply with the standards (Mr ). 1133500. [58052-80-5]. 2,4,6-Trimethylhexahydro-1, of the Pharmacopoeia. 3,5-triazine trihydrate. mp : 95 C to 97 C. 01/2011:40100 Acetic acid, anhydrous. C2H4O2. (Mr ). 1000300. [64-19-7]. Content : minimum per cent m/m of C2H4O2. REAGENTS , STANDARD Colourless liquid or white or almost white, shining, fern-like SOLUTIONS, BUFFER SOLUTIONS crystals, miscible with or very soluble in water, in ethanol (96 per cent), in glycerol (85 per cent), and in most fatty and Where the name of substance or a solution is followed by the essential oils.

3 Letter R (the whole in italics), this indicates a reagent included : to in the following list. The specifications given for REAGENTS do not necessarily guarantee their quality for use in medicines. bp : 117 C to 119 C. Within the description of each reagent there is a seven-figure A 100 g/L solution is strongly acid ( ). reference code in italics (for example, 1002501). This number, A 5 g/L solution neutralised with dilute ammonia R2 gives which will remain unchanged for a given reagent during reaction (b) of acetates ( ).

4 Subsequent revisions of the list, is used for identification Freezing point ( ) : minimum C. purposes by the Secretariat, and users of the Pharmacopoeia Water ( ) : maximum per cent. If the water content may also find it useful, for example in the management of is more than per cent it may be adjusted by adding the reagent stocks. The description may also include a CAS number calculated amount of acetic anhydride R. (Chemical Abstract Service Registry Number) recognisable by its typical format, for example 9002-93-1.

5 Storage: protected from light. Some of the REAGENTS included in the list are toxic and are to Acetic acid, glacial. C2H4O2. (Mr ). 1000400. [64-19-7]. be handled in conformity with good quality control laboratory See Acetic acid, glacial (0590). practice. REAGENTS in aqueous solution are prepared using water R. Acetic acid. 1000401. Where a reagent solution is described using an expression such Content : 290 g/L to 310 g/L of C2H4O2 (Mr ). as hydrochloric acid (10 g/L HCl) , the solution is prepared by Dilute 30 g of glacial acetic acid R to 100 mL with water R.

6 An appropriate dilution with water R of a more concentrated reagent solution specified in this chapter. Reagent solutions Acetic acid, dilute. 1000402. used in the limit tests for barium, calcium and sulfates are Content : 115 g/L to 125 g/L of C2H4O2 (Mr ). prepared using distilled water R. Where the name of the solvent Dilute 12 g of glacial acetic acid R to 100 mL with water R. is not stated, an aqueous solution is intended. The REAGENTS and reagent solutions are to be stored in Acetic anhydride. C4H6O3. (Mr ).

7 1000500. [108-24-7]. well-closed containers. The labelling should comply with the Content : minimum per cent m/m of C4H6O3. relevant national legislation and international agreements. Clear, colourless liquid. bp : 136 C to 142 C. 01/2011:40101 Assay. Dissolve g in mL of 1 M sodium hydroxide in a ground-glass-stoppered flask and boil under a reflux condenser for 1 h. Titrate with 1 M hydrochloric acid, using REAGENTS mL of phenolphthalein solution R as indicator. Calculate Acacia. 1000100. the number of millilitres of 1 M sodium hydroxide required for 1 g (n1).

8 Dissolve g in 20 mL of cyclohexane R in a See Acacia (0307). ground-glass-stoppered flask, cool in ice and add a cold mixture Acacia solution. 1000101. of 10 mL of aniline R and 20 mL of cyclohexane R. Boil the Dissolve 100 g of acacia R in 1000 mL of water R. Stir with mixture under a reflux condenser for 1 h, add mL of 1 M. a mechanical stirrer for 2 h. Centrifuge at about 2000 g for sodium hydroxide and shake vigorously. Titrate with 1 M. 30 min to obtain a clear solution. hydrochloric acid, using mL of phenolphthalein solution R.

9 As indicator. Calculate the number of millilitres of 1 M sodium Storage: in polyethylene containers of about 250 mL hydroxide required for 1 g (n2). Calculate the percentage of capacity at a temperature of 0 C to 20 C. C4H6O3 from the following expression : Acebutolol hydrochloride. 1148900. [34381-68-5]. See Acebutolol hydrochloride (0871). Acetal. C6H14O2. (Mr ). 1112300. [105-57-7]. Acetaldehyde Acetic anhydride solution R1. 1000501. diethyl acetal. 1,1-Diethoxyethane. Dissolve mL of acetic anhydride R in anhydrous Clear, colourless, volatile liquid, miscible with water and with pyridine R and dilute to mL with the same solvent.

10 Ethanol (96 per cent). Storage: protected from light and air. General Notices (1) apply to all monographs and other texts 379. REAGENTS EUROPEAN PHARMACOPOEIA Acetic anhydride - sulfuric acid solution. 1000502. Acetyl chloride. C2H3 ClO. (Mr ). 1000800. [75-36-5]. Carefully mix 5 mL of acetic anhydride R with 5 mL of Clear, colourless liquid, flammable, decomposes in contact with sulfuric acid R. Add dropwise and with cooling to 50 mL of water and with ethanol (96 per cent), miscible with ethylene anhydrous ethanol R.