standard test procedure dextrose injection

Product Name : standard test procedure dextrose 5% injection
Label Claim : 5 %
1.0 OBJECTIVE
1.1 The objective of this STP is to define the Test procedure for ELECTROLITE “G” WITH 5% dextrose injection.
2.0 SCOPE
2.1 This STP is applicable for Test procedure ELECTROLITE “G” WITH 5% DEXTROSE INJECTION quality control department
3.0 RESPONSIBILITY
3.1 QC-chemist-Quality control- To follow the STP for ELECTROLITE “G” WITH 5% DEXTROSE INJECTION..
3.2 Head- Quality Control – Training on SOP.
3.3 ACCOUNTABILITY
3.3.1 Head – Quality Control

4.0 ENVIRONMENT, HEALTH AND SAFETY
As per procedure
5.0 PROCEDURE
5.1 Multiple Electrolytes and Dextrose Injection Type V Multiple Electrolytes and Dextrose Injection Type V is a sterile solution of Dextrose and suitable

salts in Water for Injections to provide sodium, potassium, calcium, magnesium, acetate, citrate and chloride ions. It may contain Hydrochloric Acid or Sodium Hydroxide used for adjusting the pH.
5.2 Description.
5.2.1 A clear, colourless or faintly straw-coloured solution.
5.3 Identification
5.3.1 A. To 1 ml add 0.05 ml of potassium cupri-tartrate solution; the solution remains blue and clear. Heat to boiling, a copious red precipitate is formed.
5.3.2 B. 20 ml gives the reactions of acetates, chlorides phosphates, sodium salts, potassium salts and magnesium salts
5.4 pH
5.4.1 3.0 to 7.0.
5.5 5-Hydroxymethylfurfural and Related substances.
5.5.1 Dilute a volume containing 1.0 g of Dextrose to 500.0 ml with water and measure the absorbance of the resulting solution at the maximum at

about 284 nm; absorbance at about 284 nm, not more than 0.25
5.6 Bacterial endotoxins
5.6.1 Not more than 0.5 Endotoxin Unitper ml.
5.7 Other tests.
5.7.1 Comply with the tests stated under Parenteral Preparations (Injections).
5.8 Assay.
5.8.1 For sodium – Dilute suitably with water and determine by Method A for flame photometry or by Method A for atomic absorption spectrophotometry (2.4.2), measuring at 589 nm and using sodium solution FP or sodium solution AAS respectively, suitably diluted with water for the standard solutions.
5.8.2 For calcium – Dilute suitably with water and determine by Method A for flame photometry or by Method A for atomic absorption spectrophotometry (2.4.2), measuring at 422.7 nm and using calcium solution FP or calcium solution AAS respectively, suitably diluted with water for the standard solution
5.8.3 For magnesium – To 50.0 ml add 50 ml of water and 5 ml of strong ammonia-ammonium chloride solution and titrate with 0.005 M disodium edetate using 50 mg of eriochrome black T mixture as indicator. Carry out a blank titration using 17.5 mg of CaC12.2H20 dissolved in 50 ml of distilled water, add 5.0 ml of ammonia-ammonium chloride solution and dilute to 250 ml with water. Calculate the content of magnesium with the volume obtained by subtracting the volume of EDTA required for calcium from the consumption of 0.005 M EDTA in the titration of magnesium. Carry out a blank titration using 17.5 mg of CaCl 2.2H20 dissolved in 50 ml of distilled water, add 5.0 ml of ammonia-ammonium chloride solution and dilute to 250 ml with water. Calculate the content of magnesium with the volume obtained by subtracting the volume of EDTA required for calcium from the consumption of 0.005 M EDTA in the titration of magnesium. 1 ml of 0.005 M disodium edetate is equivalent to 0.1215 mg
of Mg.
5.8.4 For acetate – Determine by liquid chromatography Test solution. Dilute a measured volume of the preparation under examination quantitatively with water to obtain a solution containing about 0.12 per cent w/v of Sodium Acetate. Reference solution. Dissolve a weighed quantity of sodium acetate in water to obtain a solution having a known concentration of about 0.12 per cent w/v of sodium acetate. Chromatographic system – a stainless steel column 30 cm 7.8 mm, packed with strong cation-exchange resin consisting of sulphonated cross-linked styrene-divinylbenzene copolymer in the hydrogen form (7 m) and a guard column 4 cm 7.8 mm packed with the same column material, – column. Temperature 60°, – mobile phase: 0.1 M sulphuric acid, flow rate: 0.8 ml per minute, spectrophotometer set at 210 nm, – injection volume: 20 pl. Inject the reference solution. The test is not valid unless the tailing factor is not more than 2.0 and the relative standard deviation for replicate injections is not more than 2.0 per cent. Inject the reference solution and the test solution. Calculate the content of acetate in the preparation under examination.
5.8.5 For citrate – Determine by liquid chromatography (2.4.14). Test solution. Preparation under examination. Reference solution. Dissolve a weighed quantity of anhydrous sodium citrate, previously dried at 180° for 18 hours, in water to obtain a stock solution having a known concentration of about 10 mg per ml. Dilute measured volumes of this solution quantitatively with water to obtain three solutions having known concentrations of about 0.5, 1.0 and 2.0 mg, respectively of anhydrous sodium citrate per ml.Chromatographic system- a stainless steel column 30 cm 7.8 mm, packed with strong cation-exchange resin consisting of sulphonated cross-linked styrene-divinylbenzene copolymer in the hydrogen form (7 m) and a guard column 4 cm 7.8 nun packed with the same column material, – column. temperature 60 C,
– mobile phase: 0.1 M sulphuric acid, flow rate: 0.8 ml per minute, – spectrophotometer set at 210 nm, – injection volume: 20 pl. Inject the reference solution containing 1.0 mg of anhydrous sodium citrate per ml. The test is not valid unless the tailing factor is not more than 1.5 and the relative standard deviation for replicate injections is not more than 2.0 per cent. Inject the test solution and all the three preparations of reference solution and measure the responses for the major peak. Plot the responses of all the three preparations of reference solution versus concentration, in mg of anhydrous sodium citrate per ml, and draw the straight line best fitting the three plotted points. From the graph so obtained, calculate the content of citrate in mg equivalent to anhydrous sodium citrate per litre of the preparation under examination.
5.8.6 For total potassium – Dilute suitably with water and determine by Method A for flame photometry (2.4.4), or by Method A for atomic absorption spectrophotometry (2.4.2),measuring at 767 nm and using potassium solution FP or potassium solution AAS respectively, suitably diluted with water for the standard solutions.
5.8.7 For ammonium – Transfer a measured volume of the preparation under examination, containing about 63 mg of ammonium, to a 500-ml Kjeldahl flask, dilute to 200 ml with Ater, mix and add 50 ml of 40 per cent w/v solution of sodium hydroxide. Connect the flask immediately to a well-cooled condenser through a distillation trap. Let the delivery tube from the condenser dip into 40 ml of a 4.0 per cent w/v solution
of boric acid contained in a suitable receiver. Heat to boiling and distil about 200 ml. Cool the liquid in the receiver, if necessary, and titrate with 0.05 M sulphuric acid using methyl red solution as indicator. Carry out a blank titration. 1 ml of 0.05 M sulphuric acid is equivalent to 1.804 mg ofammonium, NH4.
5.8.8 For total chloride – To 20.0 ml add 30 ml of water, 50.0 ml of 0.1 M silver nitrate and 2 ml of nitric acid. Filter, wash the precipitate with water slightly acidified with nitric acid and titrate the excess of silver nitrate with 0.1 M ammonium thiocyanate using ferric ammonium sulphate solution as indicator until a reddish yellow colour is produced. Carry out a blank titration.1 ml of 0.1 M silVer nitrate is equivalent to 0.003545 g of total chloride, calculated as Cl.
5.8.9 For dextrose – To a measured volume containing 2 g to 5 g of Dextrose, add 0.2 ml of 5 M ammonia and sufficient water to produce 100.0 ml. Mix well, allow to stand for
30 minutes and determine the optical rotation in a 2-dm tube The observed rotation in degrees multiplied by 0.9477 represents the weight, in g, of dextrose, in the volume taken for assay.
5.8.10 Storage.
5.8.10.1 Store in single dose containers at a temperature not
exceeding 30c.

5.8.11 Limit Of Assay-
5.8.11.1 Multiple Electrolytes and Dextrose Injection Type V contains
not less than 90.0 per cent and not more than 110.0 per cent of
the stated amounts of sodium, Na, potassium, K and not less
than 90.0 per cent and not more than 120.0 per cent of the
stated amount of chloride, Cl. It also contains not less than
90.0 per cent and not more than 110.0 per cent of the stated
amount of dextrose, C6H1206. It contains no antimicrobial agent.
5.8.12 Labeling
5.8.12.1 The label states (1) the content of each electrolyte in terms of millimoles in a given volume; (2) the amount of each

ingredient in 100 ml; (3) the total osmolar concentration in mOsmol per litre; (4) that the preparation should not be used if it contains visible particles.
6.0 HISTORY

STP NO.	REASON FOR CHANGE	REVISION NUMBER	CHANGE CONTROL NUMBER	EFFECTIVE DATE
	New STP	00	NA

standard test procedure dextrose injection

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