EUROPEAN PHARMACOPOEIA 70
Potassium bromide
Potassium carbonate
EUROPEAN PHARMACOPOEIA 7.0
Acid value: maximum 3.0.
Add 1 ml. of phenotphthalein solution R to 50 mL of solution S and titrate with 0.05M potassium hydroxide until the pink colour persists for 15 L Calculate the acid value from the expression:
2.805V 2
V- number of millilitTes of 005Mpotassium hydroxide used.
Ester value [2.5.2): 90 per cent to 110 per cent of the value stated on the label
Saponify 1 00 g in d mixture of 25.0 mL of 0.5 M alcoholic potassium hydroxide and 250 mL of water R [2.5.6]. Heavy metal* [2 4 8): maximum 10 ppm. 1.0 g complies with test D- Prepare the reference solution using 1 mL of lead standard solution (10 ppm Pb) r.
Lou on drying [2232) maximum 5.0 per cent, determined on 1000 g by drying in an oven at 105 °C for 3 h.
Sulfated ash [2.4.14): maximum 1.0 per cent, determined on 10 g.
The (allowing test concerning the pharmacotechnological properties may be carried out depending on the intended formulation. It is not a mandatory requirement Infrared absorption spectrum (22.24). The determination of the spectrum and comparison with a suitable sample is useful far ensuring suitable functionality-related properties. The intensities of the absorption maxima at 1720 cm'1 and 1260 cm"1 are inversely proportional to the degree of hydrolysis.
LABELLING The label states:
- the viscosity for a 40 g/L solution,
— the ester value
01/2008:1139 corrected 7.0
POTASSIUM ACETATE
Kalii acetas
C,H,KO, Af, 98.
I127-Q8-21
DEFINITION
Content: 99.0 per cent to 101.0 per cent (dried substancel. CHARACTERS
Appearance: white or almost white, crystalline powder or colourless crystals, deliquescent
Solubility: very soluble in water, freely soluble in ethanol (96 per cent).
IDENTIFICATION
A It gives reaction (a) of acetates {2.3.1). R. It gives reaction (a) of potassium [2.3.1).
TESTS
Solution S. Dissolve 100 g in distilled water R and dilute to 100 mL with the same solvent
Appearance of solution. Solution S is clear (2.2.1\ and colourless (222, Method II). pH 12.2.31: 7.5 to 9.0.
Dissolve 1 0 g in carbon dioxide-free water R and dilute to 20 mL with the same solvent.
Reducing substances Dilute 10 mL of solution S to 100 mL
with water R. Add 5 mL of dilute sulfuric acid R and 0.5 mL of
a 0.32 g/L solution of potassium permanganate R. Mix and
boil gently for 5 min. The solution remains pink.
Chlorides (2.4.4): maximum 200 ppm
Dilute 2.5 mL of solution S to 15 mL with water R.
Sulfates 124 13) maximum 200 ppm.
Dilute 7.5 mL of solution S to 15 mL with distilled water R
Aluminium (2.4.17): maximum 1 ppm, if intended for use in the
manufacture of peritoneal dialysis solutions, haemofiltration
solutions or hemodialysis solutions.
Pre scribed solution Dissolve 2.0 g in 50 mL of water R and
add 5 mL of acetate buffer solution pH 6.0 R
Reference solution. Mix 1 mL of aluminium standard solution
(2 ppm Al) R, 5 mL of acetate buffer solution pH 6.0 R and
49 mL of water R.
Blank solution. Mix 5 mL of acetate buffer solution pH 6.0 R
and 50 mL of water R.
Iron (2.4.9): maximum 20 ppm.
Dilute 5 mL of solution S^to 10 mL with water R.
Sodium: maximum 0.5 per cent
Atomic emission spectrometry (2.2.22, Method If)
Test solution. Dissolve LOO g in water R and dilute to 100.0 mL
with the same solvenL
Reference solutions. Prepare the reference solutions using
sodium standard solution (200ppm XaiR, diluted as necessary
with water R.
Wavelength \ 589 nm.
Heavy metals (2.4.3): maximum 4 ppm.
Dissolve 5.0 g in water R and dilute to 20 mL with the same
solvenL 12 ml of the solution complies with test A Prepare the
reference solution using lead standard solution (1 ppm Pb) R.
Loss on drying (22.32). maximum 3.0 per cent, determined on 1.000 g by drying in an oven at 105 DC
ASSAY
Dissolve 80.0 mg in 20 mL of anhydrous acetic acid R. Add
0 2 mL of naphtholbenzein solution R. Titrate with 0.1 M perchloric acid. Carry out a blank titration.
1 mL of 0.1 M perchloric acid is equivalent to 9.81 mg ofCjHjKOj.
STORAGE
In an airtight container.
01/200B:01S.4 corrected 6.0
POTASSIUM BROMIDE
Kalii bromidům
KBr M, 119 0
[77584)2-3]
DEFINITION
Content: 98 0 per cent to 100.5 per cent (dried substance) CHARACTERS
Appearance: white or almost white, crystalline powder or colourless crystals.
Solubility: freely soluble in water and in glycerol, slightly soluble in alcohol.
IDENTIFICATION
4- It gives reaction (a) of bromides (2.3.1).
& Solution S (see Tests) gives the reactions of potassium
(2.3.1).
General Notices (1) apply to alt monographs and other texts
Solution S. Dissolve 10.0 g in carbon dioxide-free water R prepared from distilled water R and dilute to 100 mL with the same solvenL
Appearance of solution. Solution S is clear (2.2.1) and colourless (2.2.2, Method II).
Acidity or alkalinity To 10 mL of solution S add 0.1 mL ol
bromothymolblue solution RI. Not more than 0.5 mLof 0.01 M hydrochloric add or 0.01 Msodium hydroxide is required lo change the colour of the indicator Bromate* To 10 mL of solution S add 1 ml. of starch solution R, 0.1 mL of a 100 g/L solution of potassium iodide R and 0 25 mL of 0 5 M sulfuric acid and allow to stand protected from light for 5 min. No blue or violet colour develops.
Chlorides: maximum 0.6 per cent.
In a conical flask, dissolve 1000 g in 20 mL of dilute nitric acid R. Add 5 mL of strong hydrogen peroxide solution R and heat on a water-bath until the solution is completely decolorised. Wash down the sides of the flask with a Little water R and heat on a water-bath for 15 mm Allow to cool, dilute to 50 mL with water R and add 5.0 mL of 0 1 M stiver nitrate and 1 mL of dibutyi phthalate R. Shake and titrate with 0.1 M ammonium Oiiocyanate. using 5 mL of ferric ammonium sulfate solution R2 as indicator. Not more than 1.7 mL of 0 I Msilver nitrate is used Note the volume of 0.1 M silver nitrate used (see Assay). Carry out a blank test
Iodides. To 5 mL of solution S add 0.15 mL of ferric chloride solution RI and 2 mL of methylene chloride R. Shake and allow to separate. The lower Layer is colourless (2.2.2, Method I)
i (2.4.13): maximum 100 ppm.
01/2008:1557 corrected 6.0
POTASSIUM CARBONATE
Kalii carbonas
15 mL of solution S complies with the limit test for sulfates. Iron (2.4.9): maximum 20 ppm.
5 mL of solution S diluted to 10 mL with water R complies with the limit test for iron.
Magnesium and alkaline-earth metals (2.4 7): maximum 200 ppm, calculated as Ca.
10.0 g complies with the limit test for magnesium and alkaline-earth metals. The volume of 0.07 msodium edetate used does not exceed 5.0 mL.
Heavy metals (2.4 8): maximum 10 ppm
12 mL of solution S complies with limit test A Prepare the standard using lead standard solution (1 ppm Pb) R,
Lass on drying (2.2.32): maximum 1 0 per cent, determined on 1.000 g by drying in an oven at 105 °C for 3 h.
ASSAY
Dissolve 2.000 g in water R and dilute to 100.0 mL with the same solvenL To 10.0 mL of the solution add 50 mL of water R. 5 mL of dilute nitric acid R. 25 0 mL of 01 M silver nitrate and 2 mL of dibutyi phthalate R. Shake. Titrate with 0.1 M ammonium thiocyanate, using 2 mL of ferric ammonium sulfate solution R2as indicator and shaking vigorously towards the end-point.
1 mL of 0.1 M silver nitrate is equivalent to 1190 mg of KBr late the percentage content of KBr from the expression:
- 3.357 b
*   percentage content of KRr and KCl obtained in the
assay and calculated as KBr, -   percentage content of CI in the test for chlorides.
KjCOj mt 138.2
(SS4-0&7]
DEFINITION
Content: 99.0 per cent to 101.0 per cent (dried substance). CHARACTERS
Appearance: white or almost white granular powder, hygroscopic
Solubility: freely soluble in water, practically insoluble in ethanol (96 per cent).
IDENTIFICATION
A. Dissolve 1 g in 10 mL of water R. The solution is strongly alkaline {2.2.4).
B. 2 mL of the solution prepared for identification test A gives the reaction of carbonates and hicaTbonates {23 1)
C. 1 mL of the solution prepared for identification test A gives reaction (b) of potassium (2.3.1).
TESTS
Solution S Dissolve 10.0 g in 25 mL of distilled water R. Slowly add 14 mL of hydrochloric acid R. When the effervescence has ceased, boil for a few minutes. Allow to cool and dilute to 50 mL with distilled water r.
Appearance of solution- Solution 5 is not more opalescent than reference suspension II (2.2.1) and not more intensely coloured than reference solution V„ (2.2.2. Method It).
Chlorides (2 4.4) maximum 100 ppm
Dissolve 0.50 g in 10 mL of water r. Carefully add dropwise 1 mL of nitric acid r. Boil. Cool, add 5 mL of dilute nitric acid r and dilute to 15 mL with water r
Sulfates (2.4.13): maximum 100 ppm.
Dilute 7-50 mL of solution S to 15 mL with distilled water r.
Calcium (2.4.3): maximum 100 ppm
To 5 mL of solution S add 1 mL of concentrated ammonia r. Boil Cool. Dilute to 15 mL with distilled water R
Iron (2.4.9): maximum 10 ppm.
Dilute 5 mL of solution S to 10 mL with water r
Heavy metals (2.4.8): maximum 20 ppm.
Dilute 10 mL of solution 5 to 20 mL with water R. 12 mL of the solution complies with test A. Prepare the reference solution using lead standard solution (2 ppm Pb) r.
Loss on drying (2.2.32): maximum 5.0 per cent, determined on 0.300 g by drying in an oven at 120125 DC for 5 h.
ASSAY
Dissolve 0 500 g in 50 mL of carbon dioxide-free water R. Carry out a potentiometnc titration {2 2 20). using 1 M hydrochloric acid. Read the volume added at the 2nd point of inflexion.
1 mLof 1m hydrochloric acid is equivalent to 69 1 mgof K.CO,. STORAGE
In an airlight container.
See the information section on general monographs (cover pages)