4.1.2. Standard solutions for limit tests EUROPEAN PHARMACOPOEIA 5.5

Factor Xa solution, bovine R1. 1037302.

Reconstitute as directed by the manufacturer and diluteto 1.4 nkat/ml with tris(hydroxymethyl)aminomethaneEDTA buffer solution pH 8.4 R.

Lanatoside C. C49H76O2. (Mr 985). 1163300. [17575-22-3].3β-[(β-D-Glucopyranosyl-(1→4)-3-O-acetyl-2,6-dideoxy-β-D-ribo-hexopyranosyl-(1→4)-2,6-dideoxy-β-D-ribo-hexopyranosyl-(1→4)-2,6-dideoxy-β-D-ribo-hexopyranosyl)oxy]-12β,14-dihydroxy-5β-card-20(22)-enolide.Long flat prisms obtained after recrystallisation in ethanol(96 per cent).

Freely soluble in pyridine and in dioxane.

Luteolin-7-glucoside. C21H20O11. (Mr 448.4).1163400. [5373-11-5]. 2-(3,4-Dihydroxyphenyl)-7-(β-D-glucopyranosyloxy)-5-hydroxy-4H-1-benzopyran-4-one.

Yellow powder.

Absorbance (2.2.25). A solution in methanol R showsabsorption maxima at 255 nm, 267 nm, 290 nm and 350 nm.

mp: about 247 °C.

Petroleum, light. 1063100. [8032-32-4]. Petroleumether 50-70 °C.

A clear, colourless, flammable liquid without fluorescence,practically insoluble in water, miscible with ethanol (96 percent).

: 0.661 to 0.664.

Distillation range (2.2.11) : 50 °C to 70 °C.

Petroleum, light R1. 1063101. Petroleum ether 40-60 °C.

Complies with the requirements prescribed for lightpetroleum R, with the following modifications.

: 0.630 to 0.656.

Distillation range (2.2.11) : 40 °C to 60 °C.

It does not become cloudy at 0 °C.

Petroleum, light R2. 1063102. Petroleum ether 30-40 °C.

Complies with the requirements prescribed for lightpetroleum R, with the following modifications.

: 0.620 to 0.630.

Distillation range (2.2.11) : 30 °C to 40 °C.

It does not become cloudy at 0 °C.

Petroleum, light R3. 1063103. Petroleumether 100-120 °C.

Complies with the requirements prescribed for lightpetroleum R, with the following modifications.

: about 0.720.

Distillation range (2.2.11) : 100 °C to 120 °C.

Water (2.5.12) : maximum 0.03 per cent.

Potassium iodobismuthate solution. 1070600.

Potassium iodobismuthate solution R5. 1070606.

To 0.85 g of bismuth subnitrate R add 10 ml of glacialacetic acid R and gently heat until completely dissolved.Add 40 ml of water R and allow to cool. To 5 ml of thissolution, add 5 ml of a 400 g/l solution of potassiumiodide R, 20 ml of glacial acetic acid R and 70 ml ofwater R.

Protopine hydrochloride. C20H20ClNO5. (Mr 389.8).1163500. [6164-47-2].5-Methyl-4,6,7,14-tetrahydrobis[1,3]benzodioxolo[4,5-c:5′,6′-g]azecin-13(5H)-one hydrochloride.

Salicylaldehyde. C7H6O2. (Mr 122.1). 1075400. [90-02-8].2-Hydroxybenzaldehyde.A clear, colourless, oily liquid.

: about 1.167.: about 1.574.

bp : about 196 °C.mp: about 7 °C.

Swertiamarin. C16H22O10. (Mr 374.3). 1163600.[17388-39-5]. Swertiamaroside. (4R,5R,6S)-5-Ethenyl-6-(β-D-glucopyranosyloxy)-4a-hydroxy-4,4a,5,6-tetrahydro-1H,3H-pyrano[3,4-c]pyran-1-one.

Thrombin, human. 1090100.

Thrombin solution, human R1. 1090102.Reconstitute human thrombin R as directed by themanufacturer and dilute to 2.5 IU/ml with phosphatebuffer solution pH 6.5 R.

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4.1.2. STANDARD SOLUTIONS FORLIMIT TESTSSodium standard solution (1000 ppm Na). 5005700.Dissolve a quantity of anhydrous sodium carbonate Requivalent to 2.305 g of Na2CO3 in a mixture of 25 ml ofwater R and 25 ml of nitric acid R and dilute to 1000.0 mlwith water R.

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4.1.3. BUFFER SOLUTIONSPhosphate buffer solution pH 6.5. 4012800.Dissolve 2.75 g of sodium dihydrogen phosphate R and4.5 g of sodium chloride R in 500 ml of water R. Adjust thepH (2.2.3) with phosphate buffer solution pH 8.5 R.

Tris-sodium acetate buffer solution pH 7.4. 4012900.Dissolve 6.3 g of tris(hydroxymethyl)aminomethane R and4.9 g of anhydrous sodium acetate R in 900 ml of water R.Adjust to pH 7.4 (2.2.3) with sulphuric acid R and dilute to1000 ml with water R.

Tris-sodium acetate-sodium chloride buffer solutionpH 7.4. 4013000.Dissolve 30.0 g of tris(hydroxymethyl)aminomethane R,14.5 g of anhydrous sodium acetate R and 14.6 g of sodiumchloride R in 900 ml of water R. Add 0.50 g of bovinealbumin R. Adjust to pH 7.4 (2.2.3) with sulphuric acid Rand dilute to 1000 ml with water R.

Tris-sodium acetate buffer solution pH 8.0. 4013100.Dissolve 6.3 g of tris(hydroxymethyl)aminomethane R and4.9 g of anhydrous sodium acetate R in 900 ml of water R.Adjust to pH 8.0 (2.2.3) with sulphuric acid R and dilute to1000 ml with water R.

4126 See the information section on general monographs (cover pages)

EUROPEAN PHARMACOPOEIA 5.5 4.2.2. Volumetric solutions

Tris-sodium acetate-sodium chloride buffer solutionpH 8.0. 4013200.Dissolve 30.0 g of tris(hydroxymethyl)aminomethane R,14.5 g of anhydrous sodium acetate R and 14.6 g of sodiumchloride R in 900 ml of water R. Add 0.50 g of bovinealbumin R. Adjust to pH 8.0 (2.2.3) with sulphuric acid Rand dilute to 1000 ml with water R.

Phosphate buffer solution pH 8.5. 4013300.Dissolve 3.5 g of dipotassium hydrogen phosphate R and4.5 g of sodium chloride R in 500 ml of water R. Adjustthe pH (2.2.3) with a mixture of equal volumes of dilutephosphoric acid R and water R.

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4.2.2. VOLUMETRIC SOLUTIONS0.02 M Perchloric acid. 3009900.Dilute 20.0 ml of 0.1 M perchloric acid to 100.0 ml withanhydrous acetic acid R.

General Notices (1) apply to all monographs and other texts 4127