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TBS/CDC 16(6640) P3

©TBS 2020 All rights reserved

First Edition 2020

DRAFT TANZANIA STANDARD

Sterilized compound sodium lactate intravenous infusion (Ringers-lactate solution forinjection)

TANZANIA BUREAU OF STANDARDS

TBS/CDC 16(6640) P3

©TBS 2020 All rights reserved First Edition 2020

0 Foreword

This Draft Tanzania Standard is being prepared by the Pharmaceuticals Technical Committee, under the supervision of

Chemicals Divisional Standards Committee and it is in accordance with the procedures of the Bureau. This Draft Tanzania Standard has been prepared with assistance drawn from;

South Africa Standard SANS 597:2014 Sterilized compound sodium lactate intravenous infusion (Ringer-lactate

solution for injection), published by South Africa Bureau of standards (SABS)

For the purpose of deciding whether a particular requirement of this draft Tanzania Standard is complied with, the final value

observed or calculated, expressing the result of a test or analysis, shall be rounded off in accordance with TZS 4.

TBS/CDC 16(6640) P3

©TBS 2020 All rights reserved First Edition 2020

1 Scope

This Draft Tanzania standard covers chemical and biological requirements for a solution of sodium chloride,

potassium chloride, calcium chloride and sodium lactate in water for injections that have been

manufactured and packed into suitable containers, sealed and sterilized. It also specifies the required

marking.

2 Normative references

The following referenced documents are indispensable for the application of this document. For

dated references, only the edition cited applies. For undated references, the latest edition of the

referenced document (including any amendments) applies.

2.1 Standards

ISO 15747, Plastics containers for intravenous injection. TZS 59 Water for analytical laboratory use - Specification and test methods. TZS 773 Marking and labeling of pharmaceutical products-Specification

2.2 Other publications

British Pharmacopoeia (BP).

United States Pharmacopoeia (USP).

3 Definitions

For the purposes of this document, the following definitions apply. 3.1 acceptable

acceptable to the authority administering this standard, or to the parties concluding the purchase contract, as relevant

3.2 batch

that quantity of the product that is homogenous, filled and sealed into containers, and sterilized in the same cycle

of operation 3.3 certified reagent for which a certificate of analysis stating the percentage purity is available 3.4 product

compound sodium lactate intravenous infusion (Ringer-lactate solution for injection) that is filled, sealed and sterilized in

the final container 3.5 Clean free from dirt, marks, stains and any other contaminants

TBS/CDC 16(6640) P3

©TBS 2020 All rights reserved First Edition 2020

4 Requirements

4.1 Freedom from visible suspended matter and sediment

When examined in accordance with 5.2, the product shall be clear and colorless, without odour or taste.

4.2 Fill volume

4.2.1 The maximum nominal fill volume of a container shall not exceed 1 L.

4.2.2 When determined in accordance with 5.3, the volume of the contents of each container shall not be less than the nominal

volume and shall not exceed: a) 115 % for containers with a nominal volume of < 50 mL; and b) 110 % for containers with a nominal volume of 50 mL.

4.3 pH value

When determined in accordance with 5.4, the pH value of a product that complies with the USP

requirements for "Lactated Ringer's injection" shall be between 6.0 and 7.5 and a product that

complies with the BP requirements for "Ringer-lactate solution for injection" shall be between 5.0

and 7.0 (see table 1).

4.4 Identification

4.4.1 Chlorides

When tested in accordance with 5.5, the product shall give a positive reaction for chlorides.

4.4.2 Potassium

When tested in accordance with 5.6.2.3.1, the product solution (see 5.6.2.2.5(a)) shall give a reading for absorbance at

the emission wavelength for potassium.

4.4.3 Sodium

When tested in accordance with 5.6.2.3.2, the product solution (see 5.6.2.2.5(b)) shall give a reading for absorbance at the

emission wavelength for sodium.

4.4.4 Calcium

When tested in accordance with 5.6.2.3.3, the product solution (see 5.6.2.2.5(c)) shall give a reading for absorbance at the

emission wavelength for calcium.

4.4.5 Lactate

When tested in accordance with 5.6.3, the retention time of the lactate peak in the chromatogram of

the product shall correspond to that of the standard preparation.

4.5 Concentration of dissolved substances

When tested in accordance with the methods given in column 6 of table 1, the concentration of the

dissolved substances shall comply with the limits given in column 2 and column 3 of table 1 for

products that comply with the USP requirements for "Lactated Ringer's injection", and column 4 and

column 5 of table 1 for products that comply with the BP requirements for "Ringer-lactate solution

for injection", as required (see annex A).

TBS/CDC 16(6640) P3

©TBS 2020 All rights reserved First Edition 2020

Table 1 - Concentration of dissolved substances

1 2 3 4 5 6

USP requirements BP requirements

Dissolved substances

concentration concentration Test mg/100 mL g/100 mL method min. max. min. max. Total chlorides (CI) present 368.0 408.0 0.37 0.42 5.6.1 expressed as: potassium chloride (KCI), sodium chloride (NaCI), and calcium chloride dihydrate (CaCI2 .2H2O)

Potassium chloride (KCI):

Expressed as potassium (K) 14.2 17.3 0.019 0.022 5.6.2.3.1

Expressed as KCIa 27.0 33.0 0.038 0.042

Sodium chloride (NaCI) and

sodium lactate (C3H5Na03): Expressed as sodiumb (Na) 285.0 315.0 0.27 0.32 5.6.2.3.2

Calcium chloride dihydrate:

Expressed as Calcium (Ca) 4.90 6.00 - - 5.6.2.3.3 Expressed as CaCl2·2H20c 18.0 22.0 0.025 0.029

Sodium lactate (C3H5Na03 ):

Expressed as lactate 231.0 261.0 0.23 0.28 5.6.3 (C3H503)

Expressed as C3H5Na03d 290.0 330.0 - -

a The factor to convert K to KCI is 1.9067. b The factor to convert NaCI to Na is 0.3934. c The factor to convert Ca to CaC12·2H20 is 3.6681.

0 The factor to convert C3Hs03 to C3HsNa03 is 1.244.

4.6 Particulate matter (sub-visible particles)

When tested in accordance with 5.7, the number of particles with a diarneter 10 µrn and 25 µrn, respectively, shall

comply with the limits for small volume injections and large volume injections given in the USP, as relevant.

4.7 Sterility

When tested in accordance with 5.8, there shall be no signs of microbial growth.

4.8 Bacterial endotoxins

When tested in accordance with 5.9, the product shall not contain more than 0.5 endotoxin units per

millilitre according to USP requirements and 0.25 endotoxin units per millilitre according to BP

requirements.

TBS/CDC 16(6640) P3

©TBS 2020 All rights reserved First Edition 2020

5 Inspection and methods of test

5.1 General

Unless otherwise specified, only use water that complies with the requirements for grade 3 water as

given in TZS 59, and reagents of analytical reagent grade or of the purest grade available.

NOTE See annex B for the quality verification of sterilized compound sodium lactate intravenous infusion

(Ringer-lactate solution for injection).

5.2 Inspection

5.2.1 Gently invert the container and examine, without magnification, for any visible signs of

suspended matter or sediment.

5.2.2 Check for compliance with 4.1.

5.3 Fill volume

5.3.1 Transfer, as completely as possible, the contents of a container into a graduated measuring

cylinder of a size able to contain at least 110 % of the nominal volume of the container.

5.3.2 Record the volume of liquid in the measuring cylinder.

5.3.3 Determine the average fill volume of at least three containers.

5.3.4 Check for compliance with 4.2.

5.4 pH value

5.4.1 Determine the pH value in accordance with the relevant procedure described in the current

USP or BP.

5.4.2 Check for compliance with 4.3.

5.5 Identification of chlorides

5.5.1 Reagents

5.5.1.1 Nitric acid solution, c(HN03) = 2 mol/L

Dilute 12.6 mL of concentrated nitric acid (d at 25°C = 1.42) to 100.0 mL with water.

5.5.1.2 Silver nitrate solution, 4.25 g/100mL

Dissolve 4.25 g of silver nitrate (AgN03) in water and dilute to 100.0 mL with water. Ensure that the

silver nitrate solution is clear before use and, and filter if necessary. Store protected from light.

5.5.2 Procedure

5.5.2.1 Transfer 2 mL of the product into a 50 mL centrifuge tube.

5.5.2.2 Add one drop of the nitric acid solution and 0.4 mL of the silver nitrate solution. Shake and

allow to stand. A curdled white precipitate is formed.

5.5.2.3 Centrifuge the tube with the contents. Wash the precipitate three times with 1 mL of water.

Carry out this operation rapidly in subdued light, disregarding the fact that the supernatant might not

become perfectly clear.

5.5.2.4 Suspend the precipitate in 2 mL of water and add 1.5 mL of concentrated ammonia. The

precipitate dissolves easily with the exception of a few large particles, which dissolve slowly.

TBS/CDC 16(6640) P3

©TBS 2020 All rights reserved First Edition 2020

5.5.2.5 Check for compliance with 4.4.1.

5.6 Concentration of dissolved substances

5.6.1 Total chloride content

5.6.1.1 Reagents

5.6.1.1.1 Silver nitrate solution, c(AgNO3) = 0.1 mol/L

Dissolve 17.0 g of silver nitrate (AgNO3) in water and dilute to 1 L with water. Standardize against

certified sodium chloride and store protected from light.

NOTE 1 Commercially available concentrated volumetric solution can be used provided the diluted solution is standardized before use.

NOTE 2 The methods for standardization given in the USP or in the BP can be used.

5.6.1.1.2 Potassium chromate solution, 5 g/100 mL

Dissolve 5 g of potassium chromate (K2Cr04) in water and dilute to 100.0 mL with water. Potassium

chromate produces a red precipitate with silver nitrate in neutral solutions.

5.6.1.2 Procedure

5.6.1.2.1 Transfer a volume of the product that contains approximately 0.1 g of sodium chloride into

a conical flask and add about 1 mL of the potassium chromate solution.

5.6.1.2.2 Titrate with the standardized silver nitrate solution to a reddish-brown endpoint.

5.6.1.2.3 Calculate the total chloride content (Clc) in the product, expressed as chloride

in mg/100 mL, using the following formula:

Clc = t x M x 35.453 x100

V where

Clc is the total chloride content;

t is the volume of the standardized silver nitrate solution used in the titration, in millilitres;

M is the molarity of the standardized silver nitrate solution; V is the volume of product used for the test, in millilitres; and

35.453 is the atomic mass of chloride ion.

5.6.1.2.4 Check for compliance with 4.5.

NOTE Alternative test methods such as potentiometry can be also used to determine the total chloride

content of the product provided these methods give equivalent results.

TBS/CDC 16(6640) P3

©TBS 2020 All rights reserved First Edition 2020

5.6.2 Potassium, sodium and calcium content

5.6.2.1 Apparatus

Atomic absorption spectrophotometer, equipped with sodium, potassium and calcium hollow- cathode lamps and an air-acetylene flame.

5.6.2.2 Solutions

5.6.2.2.1 Lanthanum chloride solution

Transfer 17.7 g of lanthanum chloride (LaCI3(7)H20) into a 200 mL volumetric flask. Add 100 mL of

water and carefully add 50 mL of hydrochloric acid and mix. Allow to cool and dilute to 200.0 mL

with water.

5.6.2.2.2 Standard stock solutions

NOTE Commercially available standard stock solutions can be used.

Prepare the following standard stock solutions:

a) Potassium standard stock solution, 1 000 µg/mL K

Dissolve 381.4 mg of certified potassium chloride (KCI), previously dried at 105°C for 2 h, in

50 mL of water. Transfer into a 200 mL volumetric flask and dilute to 200,0 mL with water and

mix. This solution contains 1 000 µg/mL of potassium. b) Sodium standard stock solution, 1 000 µg/mL Na

Dissolve 508.4 mg of certified sodium chloride (NaCI), previously dried at 105°C for 2 h, in

50 mL of water. Transfer into a 200 mL volumetric flask and dilute to 200,0 mL with water and

mix. This solution contains 1 000 µg/mL of sodium. c) Calcium standard stock solution, 1 000 µg/mL Ca

Transfer 499.5 mg of certified calcium carbonate (CaC03) into a 200 mL volumetric flask with

10 mL water. Carefully add 5 mL of 10 % (volume fraction) of hydrochloric acid. Swirl to dissolve

the calcium carbonate and dilute to 200,0 mL with water. This solution contains 1 000 µg/mL of

calcium.

5.6.2.2.3 Standard working solutions

Prepare the following standard working solutions from the standard stock solutions: a) Potassium standard working solution, 50 µg/mL K

Transfer 5.0 mL of the potassium standard stock solution into a 100 mL volumetric flask and

dilute to 100.0 mL with water and mix. This working standard solution contains 50 µg/mL of

potassium. b) Sodium standard working solution, 50 µg/mL Na

Transfer 5.0 mL of the sodium standard stock solution into a 100 mL volumetric flask and dilute

to 100.0 mL with water and mix. This working standard solution contains 50 µg/mL of sodium. c) Calcium standard working solution, 100 µg/mL Ca

Transfer 10.0 mL of the calcium standard stock solution into a 100 mL volumetric flask and dilute

to 100.0 mL with water and mix. This working standard solution contains 100 µg/mL of calcium.

TBS/CDC 16(6640) P3

©TBS 2020 All rights reserved First Edition 2020

5.6.2.2.4 Standard reference solutions

Prepare the standard reference solutions from the standard working solutions as follows: a) Add 5 mL lanthanum chloride solution to each of the five 100 mL volumetric flasks. b) Dilute the blank solution to 100.0 mL with water and mix.

c) Add the volumes given in column 2, column 3 and column 4 of table 2 of the potassium, sodium,

and calcium standard working solutions, respectively, to each of the remaining four volumetric flasks. d) Dilute to 100.0 mL with water and mix. Table 2 - Preparation of standard reference solutions

1 2 3 4 5 6

Volume of working standard solutions added Final concentration inquotesdbs_dbs6.pdfusesText_11

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