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                    DRAFT TANZANIA STANDARD  
TBS/CDC 16(6639) P 3 
 
 
       Sterilized dextrose intravenous infusion  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
TANZANIA BUREAU OF STANDARDS  
  
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Foreword  
 
This Draft Tanzania Standard is being prepared by the Pharmaceuticals Technica l 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 598:2008  Sterilized 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 complied with, the 
final value observed or cal culated, expressing the result of a test or analysis, shall be rounded off in accordance 
with TZS 4.  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
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Sterilized dextrose intravenous infusion  
 
1 Scope  
This Draft Tanzania  standar d cover s chemical and biological requ irements for a solut ion of de xtrose in 
waterfo rinjections that has been manufactured and packed into suitable conta iners, sealed and ste rilized. 
2 Normative references  
The follow ing referenced documents are indispensable for the appl ication of th is doc ument . For  
dated references , only the ed ition c ited applies. For undated references , the latest ed ition of the  
referenced document (includ ing any amendments ) applies.  
2.1 Standards  
ISO 15747, Plastics containers for intravenous injection.   
TZS 59 , Water for anal ytical labor atory u se - Specif ication and te st methods .  
TZS 773 Marking and labeling of pharmaceutical products -Specification  
2.2 Other publications  
British Pharmacopoeia (BP).  
United States Pharmacope ia (USP).  
3.Terms and  Definit ions  
For the purpos es of th is docum ent, the following d efinitions app ly.  
3.1  
acceptable  
acceptable to the author ity adm inister ing th is standard , or to the part ies c oncluding the pu rchase  
contract , as relevant   
3.2  
batch  
that quant ity of the product that is homogenous , filled and sealed in conta iners, and ste rilized in the  
same cycle of ope rations  
3.3  
product  
dextrose intravenous infusion that is filled, sealed and ster ilized in the final container  
  
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  3.4 
Clean  
free from dirt, marks, stains and an y other contaminants  
 
 
4 Requirements  
4.1 Freedom from visible suspended matter and sediment  
When examined in accordance with 5 .2, the product shall be clear and colourless . Solut ions conta ining 200 
g or more of dextrose per litre shall not be more than faintly straw -coloured .  
4.2 Fill volume  
4.2.1 The maximum nominal f ill volume of a conta iner shall not exceed 1 L .  
4.2.2 When dete rmined in accordance with 5.3 , the volume of the contents o f each conta iner shall not be  
less than the nom inal volume and n ot more than 110 % of the nominal volume.  
4.3 pH Value  
When determined in accordance w ith 5.4, the pH value of the product shall be be tween 3 .5 and 6 .5. 
4.4 Identification of dextrose  
When tested in accordance with 5 .5, the p roduct shall g ive a positive  reaction fo r dextro se 
4.5 5 -Hydroxymethylfurfural and related substances  
When tested in accordance w ith 5.6, the abso rbance of the d iluted produc t solution shall not exceed  
0.25.  
4.6 Dextrose content  
When determined in accordance with 5 .7, the dextros e (C6H1206) content of t he product shall be between 
95.0 % and 105 .0 % of the concentrat ion stated on the conta iner or on the labe l.  
4.7 Particulate matter (sub-visible particles)  
When tested in accordance with 5 .8, the n umber of pa rticles w ith a diamete r ≥ 10 µm  and ≥ 25 µm,  
respect ively, shall comply with the l imits for small vo lume inject ions and la rge volume injections, as  
relevant .  
4.8 Sterility  
When tested in accordance w ith 5.9, there shall be no s igns of m icrobial growth .  
4.9 Bacterial endoto xins  
When tested in accordance w ith 5.10, the product shall not con tain mo re than 0.5 USP Endo toxin  
Units per m illilitre for infusions conta ining less than 5 % of dex trose a nd not more tha n 10.0 USP  
Endotoxin Un its pe r gram for infusions conta ining betw een 5 % and 70 % of dextrose. 
5. Inspection  and method s of test  
5.1 General  
Unless otherwise specified , only use wate r that complies with the requi rements fo r grade 3 water as  
given in TZS 59 , and reagents of analytical reagent grade or of the purest gr ade available .  
5.2 Inspection  
5.2.1 Gently invert the container and examine , without magnificat ion, for any v isible signs of   
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 suspended matter or sediment (see A .3).  
5.2.2 Check for compl iance with 4 .1.  
5.3 Fill volume  
5.3.1 Transfer , as completely as  possible , the contents of a conta iner into a g raduated measu ring  
cylinder of a size able to contain at least 110 % of the nom inal volume of the conta iner.  
5.3.2 Record the volume of liquid in the measuring cylinder .  
5.3.3 Determine the average f ill volume of at least three containers .  
5.3.4 Check for compl iance with 4 .2. 
 5.4 pH value  
5.4.1 Dilute the product with water for injections or grade 3 water that compl ies w ith TZS 59 , if  
necessary , to contain not mo re than 5 g of dextrose per 100 mL .  
5.4.2  Determine the pH value in accordance w ith the relevant procedure descr ibed in the current  
BP.  
5.4.3 Check for compliance w ith 4.3.  
5.5 Identification of dextrose  
5.5.1 Reagents  
5.5.1.1 Solution A  
Dissolve 3 .5 g of cupr ic sulfate (CuSO 4.5H 2O) in wate r and di lute to 50 .0 mL with water .  
5.5.1.2 Solution B  
Dissolve 17 ,3 g of crystalline potassium sodium tartrate (KNaC 4H40s-4H20) and 5 g of sod ium  
hydrox ide in water and d ilute to 50 ,0 mL w ith water .  
5.5.1.3 Cupric -tartaric solution  
Mix equal volumes of solut ion A and solut ion B immediately befo re use . 
5.5.2 Procedure  
5.5.2.1 Heat 5 mL of the cupric -tartaric solution in a test tube. Add a few drops of the product and  
heat again if necessary .  
5.5.2.2  A copius red precipitate ind icates the presence of  dextrose.  
5.5.2.3  Check for compliance with 4 .4.  
5.6 5 -Hydroxymethylfurfural and related substances  
5.6.1  Dilute a volume of the product conta ining 1.0 g o f dextrose (C6H1206) to 250 .0 mL w ith wate r.  
5.6.2  Measure the absorbance of th is solut ion at th e max imum at app roximately 284 nm in a 1 cm  
cell with water in the reference cell.  
5.6.3  Check for compliance with 4.5 .  
5.7 Dextrose content  
5.7.1 Apparatus   
Polarimeter , capable of giv ing readings to the nearest 0 .01°.  
5.7.2  Reagent  
Ammonia solution , 5 M  
Dilute 37 .5 mL of concent rated ammonia (about 13 .5 M) to 100 ,0 mL w ith water .  
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  5.7.3  Procedure   
5.7.3.1  Pipette a volume of the product con taining 2 g to 5 g of dextrose into a 100.0 mL volumetr ic  
flask.  
5.7.3.2  Add 0 .2 mL of the ammonia solu tion and d ilute to 100 .0 mL w ith wa ter. Mix we ll and leave  
for 30 min .  
5.7.3.3  Determine the optical rotation (R) at (20 ± 0.5) °C in a 200 mm tube w ith the po larimete r  
using sodium l ight.  
5.7.3.4  Calculate the dextrose content (D) of the product , in g/100m L, using the follow ing fo rmula  
D= R x 0.9477 x 100  
                  V 
where  
R is the obse rved optical rotat ion, in degrees ;  
V is the volume of the product used for the test, in millilitres.  
The observed rotat ion multiplied by 0 .9477 represents the ma ss of dextrose (C6H12O6), in grams , in  
the volume ( \I) used for the test.  
5.7.3.5 Check fo r compliance w ith 4.6 .  
5.8 Particulate matter (sub -visible particles)  
5.8.1 Use the method under "Light obscuration particle count test" given in the USP .  
5.8.2 Check for compliance with 4.7 .  
5.9 Sterility  
5.9.1 Use the method under "Ster ility tests " given in the USP.  
5.9.2 Check for compliance w ith 4.8.  
5.10 Bacterial endotoxins  
5.10.1 Use the method under "Bacterial endotoxins test " given in the USP.  
5.10. 2 Check for compliance with 4 .9.  
6 Packing and marking   
6.1 Packing  
6.1.1  Containers  
6.1.1.1  The product shall be  packed  in acceptable , clean , single -dose , colorless containers that  
shall not affect or be affected by the contents .  
6.1.1.2  Glass contai ners shall be transparent and shall be of type I or type II glass as descr ibed  
under "Glass conta iners for pharmaceutical use " in the BP . Plast ics containe rs sha ll comply w ith the  
requirements of  ISO 15747 .  
6.1.1.3  Containers shall be hermetically close d by means of su itable closu res that shall no t affect  
or be affected by the contents of the conta iner.  
6.1.2  Primary Packages    
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 An acceptable number of containers of the same batch identif ication shall be packed together in a  
package of su itable des ign that is sufficiently rob ust to protect the contents du ring normal handl ing,  
transportation and storage .  
6.1.3  Secondary and tertiary packages  
An acceptable number of packages of the same batch identification shall be packed in a secondary and/or 
tertiary  pack age respectively that is suff iciently robust to protect the contents dur ing normal ha ndling, 
transpo rtation and sto rage.  
6.2 Marking  
Marking shall be done in accordance with TZS 773  
 
 
 
 TBS/CDC 1 6(6639 )P2  
 
 
©TBS 20 20 – All rights reserved                                                                                                  First Edition 2020  
 Annex A  
(normative)  
Sampling and compliance with this standar d  
A.1 Sampling  
A.1.1 General  
The following sampling procedure shall be applied in determining whether a  batch  submitted for  
inspection and testing complies with the relevant requirements of this standard . The sample so  
drawn shall be deemed to represe nt 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 th is standard  
A.1.2.2  
Batch  
that quant ity of the product that is homogenous , filled and sealed in conta iners, and st erilized in the  
same cycle of ope rations  
A.2 Sample for testing  
A.2.1 Chemical tests  
From the batch  take, at random , enough containers to obtain a volume of at least 200 mL .  
A.2.2 Sterility test  
From the batch  take, at random , 20 containers .  
A.2.3 B acterial endotoxin test  
From the batch  take, at random , enough conta iners to obta in a volume of at least 100 mL .  
A.3 Compliance with this standard  
The batch  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 w ith A.2, no defect ive is found .  
 
 
 
 
 
 
 
 
 
 
 
 
 TBS/CDC 1 6(6639 )P2  
 
 
©TBS 20 20 – All rights reserved                                                                                                  First Edition 2020  
  
 
 
Annex B  
(Informative)  
Quality verification of sterilized dextrose intravenous infusion  
When a purchaser requires ongoing verification of the quality of ster ilized dextrose intravenous  
infusion , it is suggested that , instead of concentrating solely on evaluation of the final product , he  
also direct h is attention to the manufacturer 's qual ity system . In th is connect ion it should be noted  
that TZS 501  and TZS 1967  cover the provisions of an integrated quality system.  
 
 
 
 
 
 
 
 
 TBS/CDC 1 6(6639 )P2  
 
 
©TBS 20 20 – All rights reserved                                                                                                  First Edition 2020  
 Bibliography  
TZS501 /ISO 9001 , Quality management systems - Requirements.  
TZS 1967/ISO 13485 , Medical devices - Quality managemen t systems - Requirements for  
regulatory purposes .  
 
 
 
 
 
 
 
 TBS/CDC 1 6(6639 )P2  
 
 
©TBS 20 20 – All rights reserved                                                                                                  First Edition 2020  
  
 
 
 TBS/CDC 1 6(6639 )P2  
 
 
©TBS 20 20 – All rights reserved                                                                                                  First Edition 2020  
  
 
  
 
 
 
 TBS/CDC 1 6(6639 )P2  
 
 
©TBS 20 20 – All rights reserved                                                                                                  First Edition 2020  
 TBS/CDC 1 6(6639 )P2  
 
 
©TBS 20 20 – All rights reserved                                                                                                  First Edition 2020  
  
 
 
 TBS/CDC 1 6(6639 )P2  
 
 
©TBS 20 20 – All rights reserved                                                                                                  First Edition 2020