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Caffeine sodium benzoate gf. Quantitative chemical analysis of a substance

1. Russian name of the drug.

sodium benzoate

Sodium benzoic acid

Sodium salt of benzoic acid

sodium benzoate

2. Latin name of the drug.

Natrium benzoicum

3. Chemical formula with molar mass

Molar mass 144,11

4. Appearance

White crystalline powder, odorless or with a very slight odor, sweetish-salty taste.

5. Physical and chemical properties

Density: 1.44 g/cm3

Solubility.

Easily soluble in water, hardly soluble in alcohol.

Transparency and color of the solution.

A solution of 1 g of the drug in 10 ml of freshly boiled and cooled water should be transparent and colorless.

alkalinity and acidity.

A few drops of phenolphthalein solution are added to the resulting solution; the solution should remain colorless. A pink color should appear from the addition of no more than 0.75 ml of 0.05 N. sodium hydroxide solution.

0.15 g of the preparation is dissolved in 14 ml of water, 1 ml of diluted nitric acid is added and filtered. 10 ml of the filtrate must pass the chloride test (no more than 0.02% in the preparation).

1.5 g of the preparation is dissolved in 25 ml of water, 5 ml of diluted hydrochloric acid are added and filtered. 10 ml of the solution must pass the sulfate test (not more than 0.02% in the preparation).

10 ml of the same filtrate must pass the test for heavy metals (no more than 0.001% in the preparation).

Weight loss on drying.

About 1.5 g of the drug (accurately weighed) is dried at 100-105 to constant weight. Weight loss should not exceed 3%.

Humidity: no more than 2%.

Note. Sodium benzoate for the preparation of injection solutions must additionally pass an iron test: a solution of 0.4 g of the drug in 10 ml of water must withstand the iron test (no more than 0.0075% in the drug).

6. Methods of obtaining

Sodium benzoate is obtained by the reaction of the interaction of benzoic acid with a solution of sodium hydroxide or sodium carbonate:

a) with sodium hydroxide:

sodium benzoate chemical analysis

b) with sodium carbonate:

2+ Na 2 CO 3 2 + H 2 O + CO 2

7. Qualitative analysis

The drug gives a characteristic reaction to benzoates and reaction B to sodium.

Qualitative reaction to benzoates:

To 2 ml of a neutral solution of benzoate (0.01-0.02 g of benzoate ion) add 0.2 ml of ferric chloride solution; a pinkish-yellow precipitate is formed.

6C 6 H 5 COONa + 2FeCl 3 + 10H 2 O (C 6 H 5 COO) 3 Fe Fe(OH) 3 7H 2 O + 6NaCl + 3C 6 H 5 COOH

Qualitative reaction to sodium ions:

a) Dry reaction. Sodium salt added to a colorless flame turns it yellow.

b) With zinccuranyl acetate: (yellow crystalline precipitate)

Na + + Zn [(UO 2) 3 (CH 3 COO) 8] +CH 3 COOH + 9H 2 O = NaZn [(UO 2) 3 (CH 3 COO) 9] 9H 2 O + H +

c) With a solution of picric acid (yellow crystalline precipitate)

C 6 H 2 (NO 2) 3 OH + Na + > C 6 H 2 (NO 2) 3 ONa + H +

Method for determining authenticity according to the State Pharmacopoeia X:

0.25 g of the drug is dissolved in 5 ml of water, 1 ml of nitric acid is added, the precipitated white crystals are filtered off, washed with water and dried in a desiccator over sulfuric acid until a constant weight is reached. The temperature of the resulting benzoic acid is 120-124.5°C.

Reaction scheme:

C 6 H 5 COONa + HNO 3 C 6 H 5 COOH + NaNO 3

8. Quantitative analysis

About 1.5 g of the drug (accurately weighed) is dissolved in 20 ml of water in a flask with a ground stopper with a capacity of 250 ml, 45 ml of ether, 3-4 drops of a mixed indicator (1 ml of methyl orange solution and 1 ml of methylene blue solution) are added and titrated 0.5 n. hydrochloric acid solution until a lilac color appears in the aqueous layer. Shake the flask well at the end of the titration.

1 ml 0.5 n. hydrochloric acid solution corresponds to 0.07205 g of sodium benzoate, which, in terms of dry matter, should be at least 99.0%.

9. Application

1. Preparation: Sodium benzoate

Pharmacological group: secretolytics and stimulants of the motor function of the respiratory tract.

As an expectorant - alone (per se) and as part of combined preparations. When taken orally, it enhances the secretion of the mucous membrane of the respiratory tract.

2. Drug: Caffeine-sodium benzoate

Pharmacological group: respiratory stimulants, psychostimulants

Diseases accompanied by depression of the central nervous system, functions of the cardiovascular and respiratory systems (including drug poisoning, infectious diseases), spasms of cerebral vessels (including migraine), decreased mental and physical performance, drowsiness, enuresis in children, respiratory disorders (periodic breathing, idiopathic apnea) in newborns (including premature babies).

10. Storage conditions

In a well-closed container, in a dry, dark place.

Lab #5

Analysis of Purine Derivatives

Caffeine-sodium benzoate (Coffeinum - natrii benzoas)

Conclusion: the drug meets the requirements of the Global Fund in terms of its physical properties.

Authenticity:

Caffeine-sodium benzoate

UV spectrometry

With general alkaloid precipitation reagents. With a 0.1% solution of tannin, a white precipitate is formed, which is soluble in an excess of the reagent.

0.5 g of the drug is dissolved in 3 ml. water, add 1 ml. sodium hydroxide solution, 10 ml. chloroform and shake for 1-2 minutes. The chloroform layer is filtered through an anhydrous sodium sulfate filter and the chloroform is evaporated on a water bath. The remainder gives the authenticity reaction to caffeine:

To 10 mg. The preparation in a porcelain cup is added with 10 ml of hydrochloric acid and 0.5 ml of hydrogen peroxide and evaporated to dryness on a water bath. Add 1 drop of ammonia - the precipitate acquires a purple-red color, which disappears when 2-3 drops of sodium hydroxide solution are added.

Murexide test for caffeine

Reaction to benzoate. To 2 ml neutral solution of benzoate (0.01-0.02 g benzoate ion) add 0.2 ml ferric chloride solution; a pinkish-yellow precipitate is formed.

Sodium salt added to a colorless flame turns it yellow.

Transparency and color of the solution. Solution of 0.5 g of the drug in 10 ml water should be clear and colorless

alkalinity or acidity. 0.25 g of the drug is dissolved in 5 ml freshly boiled and cooled water and add a few drops of phenolphthalein solution. The solution should not turn pink. A pink color should appear from the addition of no more than 0.15 ml of 0.05 N. sodium hydroxide solution.

organic impurities. 0.3 g of the drug is dissolved in 3 ml of concentrated sulfuric acid. The color of the solution should not be more intense than standard No. 5a.

chlorides. 0.1 g of the drug is dissolved in 5 ml of water, 5 ml are added alcohol. The resulting solution must withstand the test for chlorides (no more than 0.02% in the preparation).

sulfates. 0.5 g of the drug is dissolved in 5 ml of water, 5 ml are added alcohol. The resulting solution must pass the sulfate test (no more than 0.02% in the formulation).

Heavy metals. 0.5 g of the drug is dissolved in 10 ml of water. The resulting solution must pass the test for heavy metals (no more than 0.001% in the preparation).

Weight loss on drying. About 0.5 g of the drug (accurately weighed) is dried at 80° to constant weight. Weight loss should not exceed 5%.

Quantitative determination of caffeine-sodium benzoate by kofein.

About 0.1 g of the powder is dissolved in 10 ml of water in a 50 ml volumetric flask, 2 ml of diluted sulfuric acid, 8 ml of 0.1 mol / l iodine solution are added, the volume is adjusted to the mark with water and mixed. After settling for 15 min, the solution is quickly filtered through a layer of cotton wool into a dry flask, covering the funnel with a watch glass. The first 10 ml of the filtrate are discarded. Transfer 25 ml of the filtrate into a flask and titrate the excess iodine with 0.1 mol/l sodium thiosulfate solution until it becomes colorless (indicator - starch).

In parallel, a control experiment is carried out by titrating the iodine solution after filtration (A ml).

1 ml of 0.1 mol/l iodine solution corresponds to 0.004855 g of anhydrous caffeine. The content of caffeine-sodium benzoate (X) in grams is calculated by the formula:

where P is the average weight of the powder, g; 2.564 - conversion factor for caffeine-sodium benzoate with a content of 38 - 40% caffeine in the preparation.

iodometry method. It is based on the formation of a precipitate of caffeine periodide in an acidic medium, which is filtered off and an excess of iodine is determined in the filtrate.

Dana LF:

Caffeine-sodium benzoate 0.05 g

Sugar 0.1 g

Conclusion:

Storage: formerly List B, in a well-closed container.

Application: CNS stimulant, cardiotonic agent.

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Educational and research work of a student

Quantitative chemical analysis of a substance. sodium benzoate

Completed:

student of group 5201 KSMU

Mamedova S.N.

Checked by: Bukhovets A.V.

Kazan, 2014

Content

I. Analysis of the drug "Sodium benzoate"
II. Quantitative analysis of the drug "Sodium Benzoate" by direct acidimetry with a solution of 0.05 N. of hydrochloric acid
III. Protocol for performing a titrimetric analysis of a sodium benzoate preparation by direct acidimetry with a solution of 0.05 N. hydrochloric acid in the presence of ether
References

I. Analysis of the drug "Sodium benzoate"

1. RussianNamemedicinalfacilities.

sodium benzoate

Sodium benzoic acid

Sodium salt of benzoic acid

sodium benzoate

2. latinNamemedicinalfacilities.

Natrii benzoas

Natrium benzoicum

3. ChemicalformulaWithindicatingmolarmasses

C 6 H 5 COONa

Molarweight 144,11

4. Externalview

White crystalline powder, odorless or with a very slight odor, sweetish-salty taste.

5. PhysicalAndchemicalproperties

Density: 1.44 g/cm3

Solubility.

Easily soluble in water, hardly soluble in alcohol.

TransparencyAndchromaticitysolution.

A solution of 1 g of the drug in 10 ml of freshly boiled and cooled water should be transparent and colorless.

AlkalinityAndacidity.

A few drops of phenolphthalein solution are added to the resulting solution; the solution should remain colorless. A pink color should appear from the addition of no more than 0.75 ml of 0.05 N. sodium hydroxide solution.

Contentchlorides.

0.15 g of the preparation is dissolved in 14 ml of water, 1 ml of diluted nitric acid is added and filtered. 10 ml of the filtrate must pass the chloride test (no more than 0.02% in the preparation).

Contentsulfates.

1.5 g of the preparation is dissolved in 25 ml of water, 5 ml of diluted hydrochloric acid are added and filtered. 10 ml of the solution must pass the sulfate test (not more than 0.02% in the preparation).

Contentheavymetals.

10 ml of the same filtrate must pass the test for heavy metals (no more than 0.001% in the preparation).

A lossVweightatdrying.

About 1.5 g of the drug (accurately weighed) is dried at 100-105 to constant weight. Weight loss should not exceed 3%.

Humidity: no more than 2%.

Note . Sodium benzoate for the preparation of injection solutions must additionally pass an iron test: a solution of 0.4 g of the drug in 10 ml of water must withstand the iron test (no more than 0.0075% in the drug).

6. Waysreceiving

Sodium benzoate is obtained by the reaction of the interaction of benzoic acid with a solution of sodium hydroxide or sodium carbonate:

a) with sodium hydroxide:

sodium benzoate chemical analysis

b) with sodium carbonate:

2+ Na 2 CO 3 2 + H 2 O + CO 2

7. Qualitativeanalysis

The drug gives a characteristic reaction to benzoates and reaction B to sodium.

qualityreactiononbenzoates:

To 2 ml of a neutral solution of benzoate (0.01-0.02 g of benzoate ion) add 0.2 ml of ferric chloride solution; a pinkish-yellow precipitate is formed.

6C 6 H 5 COONa + 2FeCl 3 + 10H 2 O (C 6 H 5 COO) 3 Fe Fe(OH) 3 7H 2 O + 6NaCl + 3C 6 H 5 COOH

qualityreactiononionssodium:

a) Dry reaction. Sodium salt added to a colorless flame turns it yellow.

b) With zinccuranyl acetate: (yellow crystalline precipitate)

Na + + Zn [(UO 2) 3 (CH 3 COO) 8] +CH 3 COOH + 9H 2 O = NaZn [(UO 2) 3 (CH 3 COO) 9] 9H 2 O + H +

c) With a solution of picric acid (yellow crystalline precipitate)

C 6 H 2 (NO 2) 3 OH + Na + > C 6 H 2 (NO 2) 3 ONa + H +

Methodologydefinitionsauthenticityaccording toStatePharmacopoeiaX:

Schemereactions:

C 6 H 5 COONa + HNO 3 C 6 H 5 COOH + NaNO 3

8. Quantitativeanalysis

1 ml 0.5 n. hydrochloric acid solution corresponds to 0.07205 g of sodium benzoate, which, in terms of dry matter, should be at least 99.0%.

9. Application

1 . A drug: sodium benzoate

Pharmacologicalgroup: secretolytics and stimulants of the motor function of the respiratory tract.

As an expectorant - alone (per se) and as part of combined preparations. When taken orally, it enhances the secretion of the mucous membrane of the respiratory tract.

2 . A drug: Caffeine-sodium benzoate

Pharmacologicalgroup: respiratory stimulants, psychostimulants

10. Conditionsstorage

In a well-closed container, in a dry, dark place.

II. Quantitative analysis of the drug "Sodium Benzoate" by direct acidimetry with a solution of 0.05 N. of hydrochloric acid

1 . Essencemethod.

The chosen method for quantitative analysis of the sodium benzoate preparation is direct acidometric titration and belongs to the methods of acid-base titration.

Acid-basetitration- titrimetric methods for determining the concentration of acids or bases, based on the neutralization reaction: H 3 O + + OH? \u003d 2H 2 O. Titration with an alkali solution is called alkalimetry, and titration with an acid solution is called acidimetry. In the quantitative determination of acids - alkalimetry - the working solution is a solution of a strong acid (usually HCl or H 2 SO 4). In the quantitative determination of alkali - acidimetry - the working solution is an alkali solution of NaOH or KOH. It is impossible to prepare a titrated acid solution from concentrated acid.

If you titrate a solution of any acid with an alkali solution, the H + ions of the acid are bound by OH ions - and the concentration of H + ions gradually decreases, and the pH of the solution increases. At a certain pH value, the equivalence point is reached and the titration must be completed. When an alkali solution is titrated with an acid solution, OH - ions bind, their concentration in the solution decreases, and the concentration of H + ions increases and the pH of the solution decreases. However, the pH value at the equivalence point does not always have the same value, it depends on the nature of the reacting acid and base.

2 . titrant,standardizationtitrant.

In the chosen titration procedure, the titrant is 0.05 N. HCl solution.

It is impossible to prepare a titrant according to an exact sample, because hydrochloric acid is volatile. A solution of approximately the desired concentration is prepared and standardization is carried out according to the installation substances: sodium tetraborate (borax) - Na 2 B 4 O 7 10H 2 O, anhydrous sodium carbonate - Na 2 CO 3, etc.

Cookingsolutiontitrantapproximatelynecessaryconcentration:

a) calculate the mass of the substance to prepare the solution,

b) weigh the substance on an analytical balance,

c) the weighed substance is dissolved in a volumetric flask,

d) calculate the exact concentration of the solution,

e) calculate the correction factor.

Cookingsolutioninstallationsubstances:

The solution of the adjusting substance is prepared in the same way as the preparation of the titrant solution by accurately weighing it.

Requirements,presentedToinstallationsubstances:

a) the composition of the substance must correspond to the formula,

b) the substance must be pure,

c) the substance must be highly soluble in water,

d) the substance must be stable during storage both in pure form and in solution,

e) the adjusting agent must react with the titrant quickly and in stereochemical amounts (according to the reaction equation).

e) no side reactions should occur in the solution,

g) the adjusting agent must have a larger molar mass equivalent (less weighing error),

h) it should be possible to select an indicator.

i) standardization - the process of finding the exact concentration of a solution.

The accuracy with which the concentration of the standardized titrant is known limits the accuracy of the method as a whole, so special attention is paid to the preparation of standard solutions. The concentration of standard solutions is determined either directly (if the substance itself is the primary standard), or indirectly, if the substance does not meet the requirements for primary standards. In the first case, a carefully weighed amount of the substance is taken and diluted to a precisely known volume. In the second case, a solution containing a carefully weighed amount of a substance is titrated with a solution of a primary standard. Substances that can be considered good primary standards should have a number of important properties: high purity, weather resistance, low hygroscopicity and low weathering, readily available, and sufficiently high equivalent weight. Only a few substances meet these requirements, so the number of primary standards is very limited.

Primary standard- standardization for precise weighting

Secondary standard- standardization according to the adjusting substance (solution of the adjusting substance).

SoHowhydrochloricacidflying,standardsolutionherCancookonlythroughstandardizationByinstallationsubstance.

1 ) Cookingprimarystandard - solutioncarbonatesodium.

Calculate the amount of Na2CO3 required to prepare 100 cm3 of a 0.1 M solution, given that the molar mass of sodium carbonate equivalent in the reaction with hydrochloric acid is 53 g/mol:

m (Na2CO3) \u003d C (1 / 2Na2CO3) V (Na2CO3) M (1 / 2Na2CO3) \u003d 0.1 mol / dm3 0.1 dm3 53 g / mol \u003d 0.53 g.

Therefore, to prepare 100 cm3 of a 0.1M (1/2 Na2CO3) Na2CO3 solution, 0.53 g is required. Sodium carbonate is weighed on a watch glass. It is difficult to weigh an accurately calculated mass, therefore, the required amount of salt is weighed on technical scales, and then the mass of the sample is determined on an analytical balance with an accuracy of 0.0002 g.

A dry funnel is placed in a clean 100 cm3 volumetric flask and a weighed amount of sodium carbonate is transferred, thoroughly washing the watch glass and funnel with a small amount of distilled water from the wash bottle. The volume of water in the flask should not be more than 2/3. Stir the contents of the flask until the salt is completely dissolved. Fill the flask with distilled water up to the mark. The addition of water is completed with a pipette, adding water drop by drop, holding the flask so that the mark is at eye level. After preparing the solution, mix it thoroughly by closing the flask with a stopper. Calculate the concentration and titer of the prepared sodium carbonate solution according to the formulas:

2 ) Cooking200 cm3approximately0,05 Msolutionhydrochloricacids.

A solution of hydrochloric acid of a given concentration is prepared from a more concentrated solution by dilution. Calculate the amount of anhydrous acid required to prepare 200 cm3 of a solution containing 0.05 mol of HCl in 1 dm 3 . For further calculations, the density of a concentrated acid solution is measured using a hydrometer. Hydrochloric acid solution is poured into a dry cylinder and

immerse a hydrometer in it. Reading on the hydrometer scale is carried out along the lower meniscus from top to bottom with an accuracy of 0.001 g/cm 3 . According to the table, the percentage concentration of the acid is found and the volume of the solution containing the required amount of hydrochloric acid is calculated. In a beaker with a volume of 250-300 cm 3 pour ~ 150 cm 3 of distilled water. The cylinder measures the calculated volume of the initial solution of Hcl, poured into a beaker with water and topped up to the desired volume, corresponding to 200 cm 3 . The prepared solution is thoroughly mixed. The hydrochloric acid solution is ready for standardization.

3 ) StandardizationsolutionhydrochloricacidsapproximatelynecessaryconcentrationBycarbonatesodium.

Standardization of the hydrochloric acid solution is carried out using a primary standard of sodium carbonate, prepared according to an accurate sample. Titration uses methyl orange as an indicator.

A thoroughly washed burette is rinsed twice with small portions of the prepared hydrochloric acid solution. Using a funnel, fill the burette with acid so that the lower edge of the meniscus of the liquid is slightly above the zero division. Then fill the burette spout with acid solution, displacing air bubbles from the connecting hose. After removing the funnel, release the acid from the burette in such a way that the lower edge of the meniscus is at the level of the zero division of the burette scale.

A clean 10.00 ml pipette is rinsed with sodium carbonate solution. 10.00 cm3 of Na2CO3 solution is pipetted into the titration flask and 1-2 drops of methyl orange indicator are added. In another conical flask, a "witness" solution is prepared.

3 . Conditionsholdingtitration.

The State Pharmacopoeia X recommends titration of the sodium benzoate preparation in the presence of ether.

4 . Definitionultimatepointstitration.

The end point of the titration is determined visually by the change in color of the indicator present in the titrated solution.

In the chosen method, when the equivalence point is reached, the color of the mixed indicator (1 ml of methyl orange + 1 ml of methylene blue) changes color from green to lilac.

5 . Application.

Analysisdrug " sodiumbenzoate" .

Methodology: about 1.6 g of the drug (accurately weighed) is transferred into a 25 ml volumetric flask, dissolved in freshly boiled and cooled water, adjusted to the mark. Take 10 ml of the resulting solution for titration with a measuring pipette, add 18 ml of ether, 2 drops of a mixed indicator (1 ml of methyl orange solution and 1 ml of methylene blue solution) and titrate with 0.5 N hydrochloric acid until a lilac color appears in the aqueous layer. Shake the flask well at the end of the titration. The content in the preparation must be at least 99.9% in terms of dry matter (weight loss on drying - 2.5%).

M (C 7 H 5 NaO 2) = 144.11

III. Protocol for performing a titrimetric analysis of a sodium benzoate preparation by direct acidimetry with a solution of 0.05 N. hydrochloric acid in the presence of ether

Accurateweighthingespowderbenzoatesodium: m= 1.6003 g

Schemereactions:

M (C 7 H 5 NaO 2) = 144.11, f equiv. =1

M eq. (C 7 H 5 NaO 2) = 144.11

Volumespenttitrant:

V 1 \u003d 7.82 ml

V 2 \u003d 7.80 ml

V 3 \u003d 7.84 ml

V cf. = 7.82 ml

TitersolutionhydrochloricacidsBybenzoatesodium:

= = = 0,0072

CalculationpercentagecontentbenzoatesodiumVpreparation:

w = = = 88.04%

WITHtaking into accountlossesweightatdrying:

88%*102,5% = 90,24%

BystandardmasssharebenzoatesodiumVpreparationmusthesitateVwithin99,0% - 103, 0% .

Conclusion: in terms of the percentage of sodium benzoate, the analyzed drug does not meet the requirements of the State Pharmacopoeia of the Russian Federation.

References

1. State Pharmacopoeia of the USSR. - 10th ed. - M.: Publishing house "Medicine", 1968.

2. Kharitonov Yu.Ya. Analytical chemistry. Analytics: in 2 books. - 2nd ed. - M.: Higher school, 2003.

3. Belikov V.G. Pharmaceutical chemistry. At 2 o'clock: Educational. allowance - M.: MEDpress-inform, 2007 - 624 p.

4. Arzamastsev A.P. Pharmaceutical chemistry: Proc. allowance - M.: GEOTAR-MED, 2004 - 640 p.

5. Guide to laboratory studies in analytical chemistry. Qualitative analysis. Abdullina S.G., Schukin V.A. - Kazan, 2007.

6. Encyclopedic Dictionary of Brockhaus and Efron: In 86 volumes (82 volumes and 4 additional). - St. Petersburg, 1890-1907.

7. State Pharmacopoeia of the Russian Federation / Publishing House "Scientific Center for Expertise of Medicinal Products", 2008. - 704 pp.: ill.

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Authenticity.

Caffeine-sodium benzoate

Coffeinum natrio-benzoicum

Receipt. The interaction of aqueous solutions of sodium benzoate and caffeine, the resulting solution is evaporated to form a dry powder.

1. reactions to caffeine after isolation with alkali and chloroform.

2. Reaction to the benzoate ion with iron trichloride produces a flesh-colored precipitate.

3. the drug gives reactions characteristic of the sodium ion.

1. determination of caffeine by the iodometric method after its precipitation from the preparation with acid in the form of a caffeine base, the caffeine content should be 38 - 40% in terms of dry matter.

An accurate sample of the drug is dissolved in water, diluted sulfuric acid and 0.1 M iodine solution are added, after settling for 15 minutes, the solution is filtered and the excess iodine in the filtrate is titrated with 0.1 M sodium thiosulfate solution, at the end of titration, starch solution is added.

I 2 + 2Na 2 S 2 O 3 \u003d 2NaI + Na 2 S 4 O 6

UCH=1/4; back titration formula

2. In another sample, the amount of sodium benzoate is determined by the neutralization method. The titration is carried out in the presence of ether, which removes the benzoic acid that is released.

An accurate sample of the drug is dissolved in water, ether, a mixed indicator (methyl orange and methylene blue) are added and titrated with 0.5 M hydrochloric acid until a lilac color of the aqueous layer appears.

Sodium benzoate should be 58 - 62%.

Storage. in a well sealed container.

Application. CNS stimulant, cardiotonic agent.

Release forms. Solutions for injections 10, 20%, tablets 0.1; 0.2.

Cm. Educational and methodological manual for intra-pharmacy control: concentrated solution of caffeine-sodium benzoate 10%; solutions for internal use - a solution of sodium bromide and caffeine-sodium benzoate; infusion of herb adonis, caffeine-sodium benzoate and sodium bromide; intra-pharmacy preparation and packaging (mixture) composition: infusion of valerian rhizomes and roots, caffeine-sodium benzoate, magnesium sulfate, sodium bromide, peppermint tincture.

172. coffinum

1,3,7-Trimethylxanthine

C 8 H 10 N 4 0 2 * H 2 0 M. c. 212.21

M. v. 194.19 (anhydrous)

Description. White silky needle-shaped crystals or white crystalline powder, odorless, bitter taste. It vanishes in air, sublimates when heated.

Solubility. Slowly soluble in water (1:60), freely soluble in hot water and chloroform, sparingly soluble in alcohol, very slightly soluble in ether.

Authenticity. 0.01 G the drug is placed in a porcelain cup, 10 drops of diluted hydrochloric acid, 10 drops of perhydrol are added and evaporated to dryness in a water bath. The residue is moistened with 1-2 drops of ammonia solution; a purple-red color appears.

0,01 G the drug is dissolved in 10 ml water. K 5 ml the resulting solution is added dropwise 0.1% solution of tannin; a white precipitate is formed, soluble in excess of the reagent.

0,05 G the drug is dissolved in 5 ml hot water, cool, add 10 drops of 0.1 N. iodine solution; no sediment or turbidity should appear. When a few drops of dilute hydrochloric acid are added, a brown precipitate is formed, which is soluble in excess alkali.

Melting point 234-237° (after drying at 80° to constant weight).

acidity or alkalinity. 0.2 G the drug is dissolved in 10 ml freshly boiled hot water. When 5 drops of thymolphthalein solution are added to the cooled solution, no blue color should appear. The latter should appear when adding no more than 0.1 ml 0.05 n. sodium hydroxide solution.

foreign alkaloids. 10 ml a solution of the drug (1: 100) should not give turbidity from the addition of a few drops of Mayer's reagent.

organic impurities. 0.3 G drugs must dissolve in 3 ml concentrated sulfuric acid, as well as in 3 ml concentrated nitric acid to form clear, colorless solutions.

Chlorides. 0.5 G the drug is shaken with 2 ml hot water, dilute with water up to 25 ml and filtered through a filter previously washed with hot water. 10 ml of this filtrate must pass the chloride test (not more than 0.01% in the formulation).

sulfates. 10 ml of the same filtrate must pass the sulfate test (not more than 0.05% in the formulation).

Weight loss on drying. About 0.5 G the drug (exact weighing) is dried at 80 ° to constant weight. Weight loss should not exceed 8.5% for caffeine monohydrate and 0.5% for caffeine anhydrous.

Sulphated ash and heavy metals. Sulphated ash from 0.5 G the preparation should not exceed 0.1% and must pass the test for heavy metals (not more than 0.001% in the preparation).

Quantitation. About 0.15 g pre-dried at 80 ° to a constant weight of the drug (accurately weighed) is dissolved in 10 ml acetic anhydride when heated in a water bath, add 20 ml benzene, 5 drops of crystal violet and titrated with 0.1 N. perchloric acid solution until a yellow color is obtained.

In parallel, conduct a control experiment.

1 ml 0.1 N perchloric acid solution corresponds to 0.01942 G C 8 H 10 N 4 O 2 , which should be at least 99.0% in the dried preparation.

Storage. List B. In a well sealed container.

The highest single dose inside 0.3 G.

The highest daily dose inside 1.0 G.