TBS/CDC 16(6642 ) P3 
 
 
 ©TBS 20 20 – All rights reserved                                                                                   First Edition 2020  
 
 
  
 
 
                          DRAFT TANZANIA STANDARD  
 
 
 
Sterilized sodium chloride and dextrose intravenous infusion  
 
 
 
 
 
 
 
 
 
 
 
 
TANZANIA BUREAU OF STANDARDS  
 
 TBS/CDC 16(6642 ) P3 
 
 
 ©TBS 20 20 – All rights reserved                                                                                   First Edition 2020  
 
 
 0 Foreword  
 
This Draft Tanzania Standard is being prepared by the Pharmaceuticals Technical Co mmittee, 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 Standa rd SANS 59 9:2009  Sterilized  Sodium chloride and  Dextrose intravenous infusion , 
                         published by  South Africa Bureau of Standards.   
  
For the purpose of deciding whether a particular requirement of this draft Tanzania Standard is compli ed 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(6642 ) P3 
 
 
 ©TBS 20 20 – All rights reserved                                                                                   First Edition 2020  
 
 
  
 
1 Scope  
  
This Draft Tanzania  standard covers  chemical and biological requirem ents for a solution of sodium chloride and 
dextrose in water for inject ions that has been manufactured and packed  into suitable conta iners, sealed and sterilized . 
It also specifies the required marking .  
2 Normative references  
The following referenced doc uments are indispensable for the application of this document . For  
dated references , only the edition cited applies . For undated references , the latest ed ition of the  
referenced document (including any amendments) applies . 
2.1 Standards  
ISO 15747, Plast ics 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 Sta tes Pharmacopeia (USP) .  
 
3 Definitions  
For the purposes of th is document , the follow ing definit ions apply .  
3.1  
acceptable  
acceptable to the authority admin istering this standard , or to the part ies conclud ing the purchase  
contract , as relevant  
3.2  
batch  
that quantity of the product that is homogenous , filled and sealed in conta iners, and ste rilized in the  
same cycle of operations  
3.3  
certified  
reagent for wh ich a cert ificate of analys is stat ing the percentage purity is ava ilable  
3.4  
product  
sodium chloride and dextrose intravenous infusion that is filled , sealed and ster ilized in the final  
container  
3.5 
Clean 
free from dirt, marks, stains and any other contaminants  TBS/CDC 16(6642 ) P3 
 
 
 ©TBS 20 20 – 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 color less,. Solut ions conta ining 200 g or  
more of dextrose per l itre shall not be more than faintly straw -colored .  
4.2 Fill volume  
4.2.1  The maximum nominal fill volume of a containe r shall not exceed 1 L .  
4.2.2  When determined in accordance with 5 .3, the volume of the contents of each conta iner shall  
not be less than the nominal volume and not more than 110 % of the nominal volume .  
4.3 pH Value   
When determined in accordance with 5.4 , the pH value of the product shall be between 3 .5 and 6 .5.  
4.4 Identification  
4.4.1 Dextrose  
When tested in accordance with 5.5.1, the product shall g ive a positive react ion for dextrose .  
4.4.2 Sodium  
When tested in accordance with 5 .5.2, the p recipitate  formed shall comply with the solub ility tests in 5.5.2.2 that 
indicate the presence of sod ium.  
4.4.3 Chlor ides  
When tested in accordance w ith 5.5.3 , the product shall g ive a pos itive react ion for chlor ides.  
4.5 5 -Hydroxymethylfurfural and related subst ances  
When tested in accordance with 5 .6, the absorbance of the diluted product solution shall not e xceed 0 .25.  
4.6 Dextrose content  
When determined in accordance with 5 .7, the dextrose (C6H1206) content of the product shall be between 95 .0 % and 
105.0 % of the concentration stated on the container or on the label .  
4.7 Sodium chloride content  
When determ ined in accordance wi th 5.8. the sod ium chlor ide (NaC!) conten t shall be be tween 95 .0 % and 105 .0 % of the 
concentra tion stated on the conta iner o r on the labe l.  
4.8 Particulate matter (sub -visible particles )  
When tested in accordance w ith 5.9 , the number of part icles w ith a d iarneter ≥ 10 µrn and ≥ 25 µrn, respectively , shall 
comp ly with the lim its for small volume injections and large volume injections, as relevant .  
4.9 Sterility  
When tested in accordance w ith 5.10, there shall be no s igns of m icrobial gro wth.  TBS/CDC 16(6642 ) P3 
 
 
 ©TBS 20 20 – All rights reserved                                                                                   First Edition 2020  
 
 
 4.10 Bacterial endotoxins  
When tested in accordance w ith 5.11, the product shall not co ntain mo re than 10.0 USP Endo toxin Un its per gram of  
dextrose .  
5 Inspection and methods of test  
5.1 General   
Unless otherwise spec ified, only use water that compl ies with the requ irements for grade 3 water as given in TZS 59 , 
and reagents of analyt ical reagent grade o r of the pu rest grade a vailable.  
5.2 Inspection  
5.2.1  Gently invert the container and exam ine, without magnif ication, for any v isible s igns of suspended matter or 
sedimen t (see A .3).  
5.2.2 Check fo r comp liance w ith 4.1.  
5.3 Fill volume  
5.3.1  Transfe r, as completely as poss ible, the conten ts of a co ntainer into a g radua ted meas uring cylinder of a size 
able to con tain at leas t 110 % of the nom inal vo lume of the conta iner.  
5.3.2 Record the volume of liquid in the measu ring cylinde r.  
5.3.3  Determ ine the ave rage f ill volume of a t least th ree conta iners.  
5.3.4  Chec k for compl iance w ith 4.2.  
5.4 pH value  
5.4.1  Dilute the p roduct w ith wa ter for injections o r grade 3 water that comp lies with TZS 59 , if necessary , to conta in not more 
than 5 g o f dextrose pe r 100 mL.  
5.4.2  Determine the pH va lue in accorda nce with the relevan t procedu re desc ribed in the current BP .  
5.4.3  Check for compl iance w ith 4.3.  
5.5 Identification  
5.5.1 Dextrose  
5.5.1.1 Reagents  
5.5.1 .1.1 Solution A  
Dissolve 3 .5 g of cup ric sulfate (CuS0 4.5H20) in wate r and d ilute to 50.0 mL with wa ter.  
5.5.1.1.2 Solution B  
Dissolve 17 .3 g of crystal line potass ium sodium ta rtrate (KNaC 4H406.4H20) and 5 g of sod ium hydroxide in water and dilute to 
50.0 mL with water .  
5.5.1.1.3 Cupric -tartaric solution  TBS/CDC 16(6642 ) P3 
 
 
 ©TBS 20 20 – All rights reserved                                                                                   First Edition 2020  
 
 
 Mix equal volumes of solution A  and solut ion B immediately before use .  
5.5.1.2 Procedure  
5.5.1.2.1 Heat 5 mL of the cupr ic-tartaric solut ion in a test tube . Add a few d rops of the p roduct and heat again if necessa ry.  
5.5.1.2.2 A cop ius red precipitate ind icates the presence of dextro se.  
5.5.1.2.3 Check for compliance wi th 4.4.1.  
5.5.2  Sodium   
5.5.2.1 Reagents  
5.5.2.1.1 Absolute ethanol  
Analyt ical reagent grade of comme rce that conta ins not less than 99 .5 % of ethanol (C2H6O) (volume fract ion).  
5.5.2.1.2  Methoxyphenylacetic  reagen t  
Dissolve 2 .7 g of metho xyphenylacetic ac id in 6 mL of tetramethylammon ium hydroxide solution and add 20 mL of absolute 
ethanol . Store in a polyethylene con tainer.  
5.5.2 .1.3 Ammonia solution , 5 M  
Dilute 37 .5 mL of concentrated ammonia (about 13 .5 M) to 100.0 mL with wa ter.  
5.5.2.1.4 Ammonium carbonate solution , 15.8 g/100 mL  
Dissolve 7 .9 g of ammonium carbona te in water and d ilute to 50.0 mL w ith water.  
5.5.2.2 Procedure  
5.5.2.2.1  Add 1.5 mL of the metho xyphenylacet ic reagent to 0 .5 mL o f the p roduc t in a test tube and cool in ice wate r 
for 30 m in. A volum inous wh ite prec ipitate is formed.  
5.5.2.2.2  Place the test tube in water at 20 °C and stir for 5 min . The precip itate does not disappear .  
5.5.2.2.3 Add 1 mL of the ammon ia solution . The precipitat e dissolves completely .  
5.5.2.2.4  Add 1 mL of the ammonium carbonate solution . No precipitate is formed .  
5.5.2.2.5  Check for compliance with 4 .4.2.  
NOTE Alternat ive methods for the identifi cation of sodium can be used provided they g ive equivalent results.  
5.5.3 Chlorides  
5.5.3.1 Reagents  
5.5.3.1.1 Nitric acid solution , concentration 2 mol/L  
Dilute 12 .6 mL of concentrated nitric acid (density  at 25 °C = 1.42) to 100 .0 mL w ith water .  
5.5.3.1.2 Silver nitrate solution , 4.25 g/100 mL  
Dissolve 4 .25 g o f silver nitrate (AgN0 3) in water and dilute to 100 .0 mL with water . Ensure that the silver nitrate solution is clear 
before use , and f ilter if necessary. Store protected from l ight.  TBS/CDC 16(6642 ) P3 
 
 
 ©TBS 20 20 – All rights reserved                                                                                   First Edition 2020  
 
 
 5.5.3.2 Procedure  
5.5.3.2.1  Transfer 2 mL of the product into a 50 mL c entrifuge tube.  
5.5.3.2.2  Add one drop of the n itric acid solution and 0 .4 mL of the silver nitrate sol ution. Shake and allow to stand. A curdled 
white precipitate is formed.  
5.5.3.2.3  Centrifuge the tube with the contents. Wash the precipitate three tim es with 1 mL of water . Carry out this operation 
rapidly in subdued light , disregarding the fact that the supernatant might not become pe rfectly clear .  
5.5.3.2.4  Suspend the precipitate in 2 mL of water and add 1 .5 mL of concentrated ammonia. The precipita te dissolves easily 
with the except ion of a few large particles , which dissolve slowly .  
5.5.3.2.5  Check for compl iance with 4 .4.3.  
5.6 5 -Hydroxymethylfurfural and related substances  
5.6.1  Dilute a volume of the product containing 1 .0 g of dextrose (C6H1206) to 500 mL with wate r.  
5.6.2  Measure the absorbance of this solut ion at the max imum at approx imately 284 nm in a 1 cm cell w ith water in the  
reference cell.  
5.6.3 Check for compliance w ith 4.5.  
5.7 Dextrose content  
5.7.1 Apparatus  
Polarimeter , capable of g iving readings to the nearest 0 .01°.  
5.7.2 Reagent  
Ammonia solution , 5 M  
Dilute 37 .5 ml of concentrated ammon ia (about 13 .5 M) to 100 .0 ml with water .  
5.7.3 Procedure  
5.7.3.1  Pipette a volume of the produc t containing 2 g to 5 g of dextrose i nto a 100 .0 ml volumetric flask .  
5.7.3.2 Add 0 .2 ml of the ammon ia solution and d ilute to 100 .0 ml with water . Mix well and leave  
for 30 min .  
5.7.3.3  Determine the optical rotation (R) at (20 ± 0 .5) °C in a 200 mm tube wi th the polar imeter  
using sodium  light.  
 
 
 
 
 
 TBS/CDC 16(6642 ) P3 
 
 
 ©TBS 20 20 – All rights reserved                                                                                   First Edition 2020  
 
 
 5.7.3.4  Calculate the dextrose content (D) of the product , in g/100 ml , using the following formula  
D = R  X  0.9477  X  100  
                  V 
where  
                                   R is the observed optical rotation , in degrees ;  
                                   V is the volume of the product used for the test , in millilitres .  
The observed rotation mult iplied by 0 .9477 represents the mass of dextrose (C6H1206), in grams , in the volume (V ) used for the 
test.  
5.7.3.5  Check for compl iance with 4.6.  
5.8 Sodium chloride content  
5.8.1 Reagents  
5.8.1.1 Silver nitrate solution , concentration 0.1 mol /L  
Dissolve 17 .0 g of silver nitrate (AgN0 3) in water and dilute to 1 L with water . Standardize against cert ified sodium  chloride and 
store protected from l ight.  
NOTE 1 Commerc ially available concentrated volumetric solution  can also be u sed provided t he diluted solut ions a re 
standardized before use.  
NOTE 2 The methods fo r standardization given in the USP o r in the BP can be us ed.  
5.8.1.2 P otassium chromate solution , 5 g/100 ml  
Dissolve 5 g of potass ium chromate (K 2Cr0 4) in water and dilute to 100 .0 ml w ith wate r. Potass ium chromate produces a red 
precipitate w ith silver nitrate in neutral solutions.  
 5.8.2 Procedure  
5.8.2.1  Transfer a vol ume of the product that contains approx imately 0 .1 g of sodium chloride into a conical flask and add 
about 1 mL of the potassium chromate solution .  
5.8.2.2 Titrate with the standardized silver nitrate solution to a reddish -brown endpoint.  
5.8.2.3 Calcula te the sodium chloride content (S) in the product , in g/100 mL, using the following  
formula  
           S =   t x M x 58.44 x 100  
                         V x  1 000  
Where    
              t    is the volume of silver nitrate used in the titration , in mi llilitres;  
             M   is the molarity of the standardized silver nitrate solution;  
             58.44  is the molecular mass of the sodium chloride  (NaCl);  TBS/CDC 16(6642 ) P3 
 
 
 ©TBS 20 20 – All rights reserved                                                                                   First Edition 2020  
 
 
               V     is the volume of product used for the test,  in millilitres  
 
5.8.2.4  Alternatively , the sodium chloride content in the product can be calculated us ing the following factor : 1 mL of 0 .1 mol/L 
silver nitrate solution (AgN0 3) is equ ivalent to 0 .005844 g of sod ium chloride (NaCI) .  
NOTE Alterna tive titr imetric methods or potentiom etric methods can also be used to determine the s odium chloride  content of 
the product .   
5.8.2.5  Check for compliance with 4 .7.  
5.9 Particulate matter (sub -visible particles)  
5.9.1  Use the method under "L ight obscurat ion part icle count test " given in the USP .  
5.9.2  Check for compliance with 4 .8.  
5.10 Sterility  
5.10.1  Use the method under "Ster ility tests " given in the USP .  
5.10.2  Check for compl iance with 4.9 .  
5.11 Bacterial endotoxins  
5.11.1  Use the method under "Bacterial endotoxins test " given  in the USP.  
5.11.2  Check for compliance with 4.10 . 
6 Packing and marking  
6.1 Packing  
6.1.1  Containers  
6.1.1.1  The product shall be dispensed in acceptable, clean, single -dose, colorless containers that shall not affect or be 
affected by the contents.  
6.1.1.2 Glass containers shall be transparent and shall be of type I or type II glass as described under “Glass containers for 
pharmaceutical use” in the BP. Plastics  containers shall comply with the requirements of ISO 15747  
6.1.1.3  Containers shall be herme tically closed by means of suitable closures that shall not affect or be affected by the 
contents of the container.  
 
 
 
6.1.2 Primary Packages  
An acceptable number of conta iners of the same batch identificat ion shal l be packed togethe r in a package of su itable design 
that is suffic iently robust to protect the contents dur ing normal handling , transportat ion and storage .  
6.1.3 Secondary and tertiary packages  TBS/CDC 16(6642 ) P3 
 
 
 ©TBS 20 20 – All rights reserved                                                                                   First Edition 2020  
 
 
 An acceptable number of packages of the same batch identif ication shall be packed in a bulk pack that  is sufficiently  robust to 
protect the contents during normal handl ing, transportat ion and storage .  
6.2 Marking  
Marking shall be in accordance with TZS 773  TBS/CDC 16(6642 ) P3 
 
 
 ©TBS 20 20 – All rights reserved                                                                                   First Edition 2020  
 
 
  
Annex A  
(normat ive) 
Sampling and compliance with this standard  
A.1 Sampling  
A.1.1 General  
The following sampling procedure shall be applied in determining whether a lot subm itted for inspection and testing complies 
with the relevant requirements of this standard. The sample so drawn shall be deemed to represent the lot .  
A.1.2 Definitions  
A.1.2.1  
defective   
sample that fails in one or more respects to comply with the relevant requirements of this standard  
A.1.2.2   
batch  
that quantity of the product that is homogenous , filled and sealed in conta iners, and ste rilized in the  
same cycle of opera tions  
A.2 Sample for testing  
A.2.1 Chemical tests  
From the batch/ lot draw , at random , enough containe rs to obtain a volume of at least 200 mL .  
A.2.2 Sterility test  
From the batch/ lot draw , at random , 20 containers.  
A.2.3 Bacterial endotoxin test  
From the lot draw , at random , enough containe rs to obtain a volume of at least 100 mL .  
A.3 Compliance  with this standard  
The lot shall be deemed to comply with the requirements of this standard if , after inspection (see 5.2) and testing of the samples 
taken  in accordance with A .2, no defect ive is found .  
 
 TBS/CDC 16(6642 ) P3 
 
 
 ©TBS 20 20 – All rights reserved                                                                                   First Edition 2020  
 
 
  
 
 
Annex B  
(informativ e) 
Quality verification of sterilized sodium chloride and dextrose intravenous infusion  
When  a purchaser  requires  ongoing  verification  of the quality  of sterilized  sodiu m chloride  and dextrose intravenous infusion , it 
is suggested that , instead of concentrating solely on evaluat ion of the f inal product , he also directs  his attention to the  
manufacturer's quality system . In this connect ion it should be noted that TZS 501 and TZS 1967  cover the provis ions of an 
integ rated qual ity system . 
 
 
 
 
 
 
 TBS/CDC 16(6642 ) P3 
 
 
 ©TBS 20 20 – All rights reserved                                                                                   First Edition 2020  
 
 
 Bibliography  
TZS 501 /IS0 9001 , Quality management systems - Requirement s.  
TZS 1967 /IS0 13485 , Medical de vices - Quality mana gemen t systems - Requ iremen ts for regulatory purposes .  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 TBS/CDC 16(6642 ) P3 
 
 
 ©TBS 20 20 – All rights reserved                                                                                   First Edition 2020  
 
 
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 ©TBS 20 20 – All rights reserved                                                                                   First Edition 2020  
 
 
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 ©TBS 20 20 – All rights reserved                                                                                   First Edition 2020