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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 benzoate

2. Latin name of the drug.

Natrium benzoicum

3. Chemical formula indicating molar mass

Molar mass 144,11

4. Appearance

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

5. Physical and chemical properties

Density: 1.44 g/cm3

Solubility.

Easily soluble in water, difficultly 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 adding no more than 0.75 ml of 0.05 N. caustic soda solution.

0.15 g of the drug 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 test for chlorides (no more than 0.02% in the drug).

1.5 g of the drug is dissolved in 25 ml of water, 5 ml of diluted hydrochloric acid is added and filtered. 10 ml of the solution must pass the test for sulfates (no more than 0.02% in the drug).

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

Weight loss during drying.

About 1.5 g of the drug (exactly 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 a test for iron: a solution of 0.4 g of the drug in 10 ml of water must pass the test for iron (no more than 0.0075% in the drug).

6. Methods of obtaining

Sodium benzoate is obtained by the reaction 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 benzoate solution (0.01-0.02 g of benzoate ion) add 0.2 ml of ferric oxide 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 zinc acetate: (a yellow crystalline precipitate forms)

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 (a yellow crystalline precipitate forms)

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

Methodology for determining authenticity according to State Pharmacopoeia X:

0.25 g of the drug is dissolved in 5 ml of water, 1 ml of nitric acid is added, the separated white crystals are filtered off, washed with water and dried in a desiccator over sulfuric acid until a constant weight is achieved. 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 (exactly weighed) is dissolved in 20 ml of water in a flask with a ground stopper with a capacity of 250 ml, add 45 ml of ether, 3-4 drops of a mixed indicator (1 ml of methyl orange solution and 1 ml of methylene blue solution) and titrate 0.5 n. with a solution of hydrochloric acid until a lilac color appears in the aqueous layer. At the end of the titration, the contents of the flask are shaken well.

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

9. Application

1. Drug: Sodium benzoate

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

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

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), cerebral vascular spasms (including migraine), decreased mental and physical performance, drowsiness, enuresis in children, breathing disorders (periodic breathing, idiopathic apnea) in newborns (including premature infants).

10. Storage conditions

In a well-closed container, in a dry place, protected from light.

Laboratory work No. 5

Analysis of purine derivatives

Caffeine-sodium benzoate (Coffeinum – natrii benzoas)

Conclusion: the drug meets the requirements of the Global Fund in 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, soluble in 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 a filter with anhydrous sodium sulfate and the chloroform is evaporated in a water bath. The remainder gives the authenticity reaction to caffeine:

To 10 mg. Add 10 ml of hydrochloric acid and 0.5 ml of hydrogen peroxide to the preparation in a porcelain cup and evaporate to dryness in 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. K 2 ml neutral benzoate solution (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 transparent 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 adding no more than 0.15 ml of 0.05 N. caustic soda 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, add 5 ml alcohol The resulting solution must pass 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, add 5 ml alcohol The resulting solution must pass the test for sulfates (no more than 0.02% in the preparation).

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

Quantitative determination of caffeine-sodium benzoate by kOpheine.

About 0.1 g of powder is dissolved in 10 ml of water in a 50 ml volumetric flask, 2 ml of diluted sulfuric acid and 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 minutes, 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 filtrate is discarded. Transfer 25 ml of the filtrate into a flask and titrate the excess iodine with 0.1 mol/l sodium thiosulfate solution until discolored (indicator - starch).

At the same time, 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 using the formula:

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

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

Dana LF:

Caffeine sodium benzoate 0.05 g

Sugar 0.1 g

Conclusion:

Storage: former list B, in a well-closed container.

Application: CNS stimulant, cardiotonic.

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Student research work

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 using 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 benzoate

2. LatinNamemedicinalfacilities.

sodium benzoas

Natrium benzoicum

3. ChemicalformulaWithindicatingmolarmasses

C6H5COONa

Molarweight 144,11

4. Externalview

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

5. PhysicalAndchemicalproperties

Density: 1.44 g/cm 3

Solubility.

Easily soluble in water, difficultly 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 adding no more than 0.75 ml of 0.05 N. caustic soda solution.

Contentchlorides.

0.15 g of the drug 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 test for chlorides (no more than 0.02% in the drug).

Contentsulfates.

1.5 g of the drug is dissolved in 25 ml of water, 5 ml of diluted hydrochloric acid is added and filtered. 10 ml of the solution must pass the test for sulfates (no more than 0.02% in the drug).

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 (exactly 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 a test for iron: a solution of 0.4 g of the drug in 10 ml of water must pass the test for iron (no more than 0.0075% in the drug).

6. Methodsreceiving

Sodium benzoate is obtained by the reaction 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.

High qualityreactiononbenzoates:

To 2 ml of a neutral benzoate solution (0.01-0.02 g of benzoate ion) add 0.2 ml of ferric oxide 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

High qualityreactiononionssodium:

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

b) With zinc acetate: (a yellow crystalline precipitate forms)

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 (a yellow crystalline precipitate forms)

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 must be at least 99.0%.

9. Application

1 . A drug: Sodium benzoate

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

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

2 . A drug: Caffeine sodium benzoate

Pharmacologicalgroup: respiratory stimulants, psychostimulants

10. Conditionsstorage

In a well-closed container, in a dry place, protected from light.

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 conducting a 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? = 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 NaOH or KOH. It is impossible to prepare a titrated acid solution from concentrated acid.

If a solution of any acid is titrated 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 titrating an alkali solution 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 have the same value in all cases; 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.

The titrant cannot be prepared using an exact sample, because hydrochloric acid is volatile. A solution of approximately the required concentration is prepared and standardization is carried out according to the setting substances: sodium tetraborate (borax) - Na 2 B 4 O 7 10H 2 O, anhydrous sodium carbonate - Na 2 CO 3, etc.

Preparationsolutiontitrantapproximatelynecessaryconcentrations:

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.

Preparationsolutioninstallationsubstances:

The solution of the setting substance is prepared in the same way as preparing a titrant solution using an accurate weighing.

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 establishing substance must react with the titrant quickly and in stereochemical quantities (according to the reaction equation).

f) no side reactions should occur in the solution,

g) the installation substance must have a larger equivalent molar mass (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 a 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 an accurately known volume. In the second case, a solution containing a carefully weighed amount of the substance is titrated with a solution of the primary standard. Substances that can be considered as good primary standards must have a number of important properties: have a high degree of purity, be resistant to atmospheric influences, have low hygroscopicity and low tendency to weather, be easily accessible, and have a sufficiently high equivalent mass. Few substances satisfy these requirements, so the number of primary standards is very limited.

Primary standard- standardization for precise weighing

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

SoHowsaltacidflying,standardsolutionherCancookonlybystandardizationByinstallationsubstance.

1 ) Preparationprimarystandard - solutioncarbonatesodium.

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

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

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

Place a dry funnel into a clean 100 cm3 volumetric flask and transfer a portion of sodium carbonate, thoroughly washing the watch glass and funnel with a small amount of distilled water from the wash. 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. Add distilled water to the flask to the mark. The addition of water is completed using a pipette, adding water drop by drop, holding the flask so that the mark is at eye level. Having prepared the solution, mix it thoroughly, closing the flask with a stopper. Calculate the concentration and titer of the prepared sodium carbonate solution using the formulas:

2 ) Preparation200 cm3approximately0,05 Msolutionsaltacids.

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 a 200 cm3 solution containing 0.05 mol HCl in 1 dm3. For further calculations, measure the density of a concentrated acid solution using a hydrometer. The hydrochloric acid solution is poured into a dry cylinder and

immerse the hydrometer in it. The 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 . Using the table, find the percentage concentration of the acid and calculate the volume of the solution that contains the required amount of hydrochloric acid. ~ 150 cm 3 of distilled water is poured into a beaker with a volume of 250-300 cm 3. The calculated volume of the initial HCl solution is measured with a cylinder, poured into a beaker with water and added to the required volume, corresponding to 200 cm 3. The prepared solution is thoroughly mixed. The hydrochloric acid solution is ready for standardization.

3 ) StandardizationsolutionsaltacidsapproximatelynecessaryconcentrationsBycarbonatesodium.

Standardization of a hydrochloric acid solution is carried out using a primary standard of sodium carbonate, prepared by precise weighing. When titrating, use the indicator methyl orange.

The 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 liquid meniscus is slightly above the zero mark. Then fill the burette spout with the acid solution, displacing air bubbles from the connecting hose. After removing the funnel, release the acid from the burette so that the lower edge of the meniscus is at the level of the zero division of the burette scale.

A clean 10.00 cm3 pipette is rinsed with sodium carbonate solution. Pipette 10.00 cm3 of Na2CO3 solution into the titration flask and add 1-2 drops of methyl orange indicator. A “witness” solution is prepared in another conical flask.

3 . Conditionscarrying outtitration.

State Pharmacopoeia X recommends titrating 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 (exactly weighed) is transferred to a 25 ml volumetric flask, dissolved in freshly boiled and cooled water, and adjusted to the mark. Using a measuring pipette, take 10 ml of the resulting solution for titration, 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 solution until a lilac color appears in the aqueous layer. At the end of the titration, the contents of the flask are shaken well. The content in the preparation must be at least 99.9% in terms of dry matter (weight loss upon drying is 2.5%).

M (C 7 H 5 NaO 2) = 144.11

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

Accurateweightweightspowderbenzoatesodium: m= 1.6003 g

Schemereactions:

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

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

Volumespenttitrant:

V 1 = 7.82 ml

V 2 = 7.80 ml

V 3 = 7.84 ml

V avg. = 7.82 ml

TitersolutionsaltacidsBybenzoatesodium:

= = = 0,0072

CalculationpercentagecontentbenzoatesodiumVdrug:

ы = = = 88.04%

WITHtaking into accountlossesweightatdrying:

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

BystandardmassivesharebenzoatesodiumVdrugmusthesitateVwithin99,0% - 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. manual - M.: MEDpress-inform, 2007 - 624 p.

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

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

6. Encyclopedic Dictionary of Brockhaus and Efron: In 86 volumes (82 volumes and 4 additional ones). - 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 until a dry powder is formed.

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

2. The reaction of benzoate ion with iron trichloride forms a flesh-colored precipitate.

3. the drug gives reactions characteristic of sodium ion.

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

An exact weighed portion of the drug is dissolved in water, diluted sulfuric acid and a 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 a 0.1 M sodium thiosulfate solution, and at the end of the titration a starch solution is added.

I 2 + 2Na 2 S 2 O 3 = 2NaI + Na 2 S 4 O 6

UC=1/4; back titration formula

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

An exact weighed portion of the drug is dissolved in water, ether and a mixed indicator (methyl orange and methylene blue) are added and titrated with 0.5 M hydrochloric acid until the water layer turns lilac.

Sodium benzoate should be 58 - 62%.

Storage. in a well-closed container.

Application. Central nervous system stimulant, cardiotonic.

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

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

172. Coffeenum

1,3,7-Trimethylxanthine

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

M.v. 194.19 (anhydrous)

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

Solubility. Slowly soluble in water (1:60), easily soluble in hot water and chloroform, slightly 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 with a 0.1% tannin solution; 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; There should be no sediment or turbidity. When adding a few drops of diluted hydrochloric acid, a brown precipitate is formed, 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 adding 5 drops of thymolphthalein solution to a cooled solution, no blue color should appear. The latter should appear when adding no more than 0.1 ml 0.05 n. caustic soda solution.

Foreign alkaloids. 10 ml solution of the drug (1: 100) should not produce cloudiness after adding a few drops of Mayer's reagent.

Organic impurities. 0.3 G drugs must dissolve in 3 ml concentrated sulfuric acid, as well as 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 to 25 ml and filtered through a filter previously washed with hot water. 10 ml This filtrate must pass the chloride test (not more than 0.01% in the preparation).

Sulfates. 10 ml the same filtrate must pass the test for sulfates (not more than 0.05% in the preparation).

Weight loss during drying. About 0.5 G The drug (accurately weighed) is dried at 80° to constant weight. Weight loss should not exceed 8.5% for caffeine monohydrate and 0.5% for caffeine anhydrous.

Sulfated ash and heavy metals. Sulfated ash from 0.5 G the preparation should not exceed 0.1% and must pass the test for heavy metals (no more than 0.001% in the preparation).

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

At the same time, a control experiment is carried out.

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

Storage. List B. In a well-closed container.

Highest single oral dose 0.3 G.

Highest daily oral dose 1.0 G.