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B Protocol bij de Europese Overeenkomst betreffende de uitwisseling van geneesmiddelen van menselijke oorsprong, zoals gewijzigd

Chemical tests

1 Oxidisable matter

To 20 ml of the extract in an Erlenmeyer flask of borosilicate glass add 20 ml of 2 millimole potassium permanganate solution per litre and 1.0 ml of 1 mole sulphuric acid per litre and boil the mixture for 3 minutes. Cool the solution rapidly and add 0.1 g of potassium iodide and 5 drops of starch solution. Titrate with a solution containing 10 millimole sodium thiosulphate per litre. At the same time carry out a blank titration. The difference in the volume of thiosulphate used in the two titrations does not exceed 2.00 ml a solution containing 10 millimole sodium thiosulphate per litre.

2 Chloride

The extract complies with a suitable limit test for chloride equivalent to not more than 11.2 µmole chloride per litre.

3 Ammonia

The extract complies with a suitable limit test for ammonia equivalent to not more than 120 µmole NHs per litre.

4 Phosphoric Acid - Phosphate

The extract complies with the limit test for phosphate.

Limit test for phosphate

Evaporate 25 ml of the extract almost to dryness in a Kjeldahl flask, cool the residue, add 2 drops sulphuric acid and 1 ml nitric acid, heat the mixture until white fumes appear, then cool. Add 1 drop of perchloric acid and heat gently for half an hour. Cool the residue and add water to 25 ml. Transfer 10 ml of the solution to a 25 ml titration flask, add 8 ml ammonium molybdate-sulphuric acid solution and 2 ml of freshly prepared solution of ascorbic acid, having a concentration of 100 g/I. Heat on a water bath at 50° C for thirty minutes, cool and dilute the mixture to 25 ml. The green or blue colour of the solution is not more intense than that obtained by treating 25 ml of the blank solution in the same manner.

5 Acidity or alkalinity

10 ml of the extract is not coloured red on the addition of 2 drops of phenolphthalein solution and requires not more than 0.4 ml solution containing 10 millimole sodium hydroxide per litre to produce a red colour. After removal of the colour by the addition of 0.08 ml solution containing 10 millimole hydrochloric acid per litre, the addition of 5 drops of methyl red solution produces a red or orange-red colour.

6 Residue on evaporation

Evaporate 100 ml of the extract to dryness on a water bath and dry at 105° C to constant weight. The residue weighs not more than 5.0 mg.

7 Clarity and colour

The extract when viewed through a thickness of 5 cm is clear and colourless when compared with the blank.

8 Taste and smell

The extract compared with the blank is odourless and tasteless.

9 Special elements

The extract complies with suitable limit tests for

(i) any of the following elements: arsenic, chromium, copper, lead, silicon, silver and tin, equivalent to 1 µg/g

(ii) cadmium, equivalent to 0.1µg/g

10 Residue on ignition

1.0 g of the plastics material when ignited to constant weight leaves not more than 1 mg of residue.

11 Heavy metals

Dissolve the residue on ignition in the minimum quantity of a solution of 2 mole hydrochloric acid per litre, heating if necessary. Carry out a suitable limit test for heavy metals. The plastics material complies with a limit not exceeding 5 microgrammes per gramme as calculated as Pb.

Regeling
Protocol bij de Europese Overeenkomst betreffende de uitwisseling van geneesmiddelen van menselijke oorsprong, zoals gewijzigd
Soort
Verdrag
Geldend vanaf
19-04-1982
BWB-id
BWBV0002901
Versie
1982-04-19_0

In de hele regeling · Officiële tekst op wetten.overheid.nl