TBS/CDC 16(6640 ) P3  
 
©TBS 20 20 – All rights reserved                                                                                   First Edition 2020  
 
  
                                DRAFT TANZANIA STANDARD  
 
 
 
Sterilized compound sodium lactate intravenous infusion (Ringer s-lactate 
solution  forinjection)  
 
 
 
 
 
 
 
 
                              
 
 
 
 
 
TANZANIA BUREAU OF STANDARDS  
 TBS/CDC 16(6640 ) P3  
 
©TBS 20 20 – All rights reserved                                                                                   First Edition 2020  
 
 0 Foreword  
 
This Draft T anzania 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 valu e 
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 20 20 – All rights reserved                                                                                   First Edition 2020  
 
  
1 Scope  
  
This Draft Tanzania  standard covers chemical and b iological requirements for a solution of sodium chloride ,  
potassium chloride, calcium chloride and sodium lactate in water for in jections that have been  
manufactured an d packed into suitable containers, sealed and sterilized . It also specifies the requi red 
marking .  
2 Normative references  
The following referenced documents are indispensable for the application of this document . For  
dated references , only the ed ition ci ted applies . For undated references, the latest ed ition 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 an d 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 operatio n 
 
3.3  
certified  
reagent for wh ich a certificate of analys is stat ing the pe rcentage pur ity is ava ilable  
3.4  
product  
compound sod ium lactate intravenous infusion (Ringer -lactate so lution fo r injection ) that is filled, sealed a nd ste rilized in 
the final conta iner 
3.5 
Clean  
free from dirt, marks, stains and any other contaminants  
 
  TBS/CDC 16(6640 ) P3  
 
©TBS 20 20 – All rights reserved                                                                                   First Edition 2020  
 
 4 Requirements  
4.1 Freedom from visible suspended matter and sediment  
When exam ined in acco rdance wi th 5.2, the product shall be c lear and co lorless , without odour or taste .  
4.2 Fill volume  
4.2.1  The maximum nom inal fill volume of a conta iner shall not exceed 1 L .  
4.2.2  When deter mined in accordance with 5 .3, the volume of the conte nts of each conta iner shall not be less than the nominal 
volume and shall not exceed :  
a) 115 % for containe rs with a nom inal volume o f < 50 mL; and  
b) 110 % for containers w ith a nom inal volume of ≥ 50 mL .  
4.3 pH value  
When determined in accordance w ith 5 .4, the pH value of a product that complies with th e USP  
requirements for "Lactated Ringer 's injection" shall be between 6 .0 and 7.5 and a p roduc t that  
complies with the BP requirements for "Ringer-lactate solut ion for inject ion" 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 p roduct shal l give a pos itive reaction fo r chlorides.  
4.4.2 Potassium  
When tested in accordance with 5 .6.2.3.1, the p roduct sol ution (see 5 .6.2.2.5(a)) shall give a reading for abso rbance at 
the emiss ion wavelengt h for potass ium.  
4.4.3 Sodium  
When tested in acco rdance w ith 5.6.2.3.2, the product solution (see 5 .6.2.2.5(b)) shall give a read ing fo r abso rbance a t the 
emission wavelength for sod ium.  
4.4.4 Calcium  
When tested in accordance w ith 5.6.2.3.3, the p roduct solut ion (see 5.6.2.2.5(c)) shall give a reading for absorbance at the 
emission wavelength for calc ium.  
4.4.5 Lactate  
When tested in accordance w ith 5.6 .3, the retent ion time of the lactate pea k in th e ch romatogram of  
the product sha ll correspond to that of the standard preparat ion.  
4.5 Concentration of dissolved substances  
When tested in accordance w ith the methods g iven in column 6 of table 1 , the concent ration o f the  
dissolved substances shall comply with the limits given in column 2 and column 3 of tab le 1 for  
products that comply w ith the USP requirements for "Lactated R inger's inject ion", and co lumn 4 and  
column 5 of table 1 for products that comply with the BP requirements for "Ringer -lactate solut ion  
for injection", as required (see annex  A).  TBS/CDC 16(6640 ) P3  
 
©TBS 20 20 – 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 chlor ide (KCI),       
sodium ch loride (NaCI) , and       
calcium ch loride dihydrate       
(CaCI2 .2H2O)       
Potassium chloride (KCI) :       
Expressed as potass ium (K)  14.2  17.3  0.019  0.022  5.6.2.3.1  
Expressed as KC Ia  27.0  33.0  0.038  0.042   
Sodium chloride (NaCI) and       
sodium lactate (C 3H5Na0 3):       
Expressed as sodiumb (Na)  285.0  315.0  0.27  0.32  5.6.2.3.2  
Calcium chloride dihydrate :       
Expressed  as Ca lcium (Ca)  4.90  6.00  -  -  5.6.2.3.3  
Expressed as CaC l2·2H20c 18.0  22.0  0.025  0.029   
Sodium lactate (C 3H5Na0 3 ):       
Expressed as lactate  231.0  261.0  0.23  0.28  5.6.3  
(C3H503)       
Expressed as C 3H5Na0 3d 290.0  330.0  -  -   
a  The factor to convert K to KC I is 1.9067.      
b  The facto r to convert NaCI to Na is 0 .3934.      
c  The fac tor to conver t Ca to CaC12·2H20 is 3.6681.     
0  The factor to co nvert C3Hs03 to C3HsNa03 is 1.244.     
4.6 Particulate matter (sub -visible p articles)  
When tested in accordance with 5.7 , the number of particles w ith a d iarnete r ≥ 10 µrn and ≥ 25 µrn, respectively , shall 
comply with the l imits for smal l volume injections and large vo lume injections g iven in the USP , as relevant .  
4.7 Sterility  
When tested in accordance with 5 .8, there shall be no s igns of m icrobial growth .  
4.8 B acterial endotoxins  
When tested in accordance with 5 .9, the p roduct shall not contain more than 0 .5 endotox in un its per  
millilitre according to USP requirements and 0 .25 endotoxin un its per m illilitre acco rding to BP  
requirements .  
 TBS/CDC 16(6640 ) P3  
 
©TBS 20 20 – All rights reserved                                                                                   First Edition 2020  
 
 5 Inspection and met hods of test  
5.1 General  
Unless otherw ise specified , only use water that compl ies 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 anne x B for the qual ity ve rification of ster ilized compou nd sod ium lactate intravenous infus ion  
(Ringer -lactate solution for in jection ). 
5.2 Inspection  
5.2.1  Gently invert the con tainer and examine , without magn ification, for any v isible s igns of  
suspended matter or sed iment .  
5.2.2 Check for compliance with 4 .1.  
5.3 Fill volume  
5.3.1  Transfer , as completely as poss ible, the contents of a container into a graduated measuring  
cylinder of a size able to conta in at least 110 % of the nom inal volume of the container .  
5.3.2  Record  the volume of l iquid in the measuring cy linder.  
5.3.3  Determine the average f ill volume of at least three containers .  
5.3.4  Check for compliance with 4 .2.  
5.4 pH value   
5.4.1  Determ ine the pH value in accordance with the relevant procedure desc ribed 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(HN0 3) = 2 mol /L  
Dilute 12 .6 mL of concentrated nitric acid (d at 25 °C = 1.42) to 100 .0 mL w ith water .  
5.5.1.2  Silver nitrate solution , 4.25 g/100mL  
Dissolve 4 .25 g of silver nitrate (AgN0 3) in water and dilute to 100 .0 mL w ith water . Ensure that the  
silver nitrate solution is clear before use and, and filter if necessary . Store protected from l ight.  
5.5.2 Proce dure  
5.5.2.1  Transfer 2 mL of the product into a 50 mL cen trifuge tube .  
5.5.2.2  Add one drop of the nitric acid solution and 0 .4 mL of the silver n itrate solut ion. Shake and  
allow to stand. A curdled wh ite precip itate is formed.  
5.5.2.3  Centr ifuge the tube with the contents . Wash the precipitate th ree times with 1 mL of water .  
Carry out this operation rapidly in subdued l ight, disregard ing the fact that the supernatant might not  
become perfectly clear .  
5.5.2.4  Suspend the precip itate in 2 mL of water  and add 1 .5 mL o f concentrated ammon ia. The  
precipitate dissolves easily with the exception of a few large part icles, which d issolve s lowly.  TBS/CDC 16(6640 ) P3  
 
©TBS 20 20 – All rights reserved                                                                                   First Edition 2020  
 
 5.5.2.5 Check for compl iance w ith 4.4.1.  
5.6 Concentration of dissolved substances  
5.6.1 Total chloride conten t  
5.6.1 .1 Reagents   
5.6.1.1.1 Silver nitrate solution , c(AgNO3) = 0.1 mo l/L  
Dissolve 17 .0 g of s ilver n itrate (AgNO3) in wate r and d ilute to 1 L w ith wa ter. Standard ize aga inst  
certified sodium chlor ide and store protected f rom light.  
NOTE 1 Comme rcially ava ilable concentrated volumetric solution can be used prov ided the diluted sol ution i s standardized b efore use .  
NOTE 2 The methods for standa rdizatio n given in the USP o r in the BP can be u sed.  
5.6.1.1.2  Potassium chromate solution , 5 g/100 mL  
Disso lve 5 g of potassium chromate (K 2Cr0 4) in water and d ilute to 100 .0 mL with water . Potassium  
chromate produces a red precipitate w ith silver n itrate in neutra l solutions.  
5.6.1 .2 Procedure   
5.6.1.2.1  Transfer a volume of the product that contains approx imately 0 .1 g of sod ium chlor ide into  
a con ical flask and add about 1 mL of the potass ium chromate so lution.  
5.6.1.2.2  Titrate w ith the standard ized s ilver nitrate solution to a reddish -brown  endpoint.  
5.6.1.2.3 Calculate the total chlor ide co ntent (Clc) in the product , expressed as c hloride  
in mg/ 100 mL , using the following fo rmula:  
Clc  = t x M x 35.453 x100  
                      V 
where  
                    Clc is the total ch loride co ntent;  
                     t    is the volume of the standa rdized silver nitrate solu tion used in the t itration, in millilitres ;  
                    M is the molarity of the standa rdized s ilver n itrate so lution;  
                      V is the volume of p roduc t used for the test , in mi llilitres; and  
                   35.453  is the atomic mass of chlo ride ion.  
5.6.1.2.4  Check for compliance w ith 4.5.  
 
NOTE Alternat ive t est methods su ch as potentiometry ca n be also used to determin e the total chl oride  
content of t he produc t provided these methods give equ ivalent results.  
 
 
 
 TBS/CDC 16(6640 ) P3  
 
©TBS 20 20 – All rights reserved                                                                                   First Edition 2020  
 
 5.6.2 Potassium, sodium and calcium content  
5.6.2.1 Apparatus  
Atom ic absorption spectrophotometer , equipped with sodium , potass ium and calc ium hollow -  
cathode lamps and an a ir-acetylene flame .  
5.6.2.2 Solutions  
5.6.2.2.1 Lanthanum chlorid e solut ion  
Transfe r 17.7 g of lanthanum chlor ide (LaCI3(7)H20) into a 200 mL volumet ric flask. Add 100 m L of  
water and carefully add 50 mL of hydrochlor ic ac id and m ix. Allow to coo l and d ilute to 200 .0 mL  
with water .  
5.6.2.2.2  Standard stock solutions   
NOTE Comme rcially available s tandard stock solutions can be used .  
Prepa re the following standar d stock solut ions:  
a) Potassium standard stock solution , 1 000 µg/mL K  
Dissolve 381 .4 mg of ce rtified potass ium chlor ide (KCI), previously dried at 105 °C for 2 h , in  
50 mL of water . Transfe r into a 200 mL volumetr ic flask and d ilute to 200 ,0 mL w ith water and  
mix. This solution conta ins 1 000 µg/mL of potass ium.  
b) Sodium standard stock solution , 1 000 µg/mL Na  
Dissolve 508 .4 mg of cer tified sodium chlor ide (NaCI ), previously dr ied at 105 °C for 2 h , in  
50 mL of water . Transfer into a 200 mL volumetr ic flask and d ilute to 200 ,0 mL with wa ter and  
mix. This solu tion conta ins 1 000 µg/mL of sodium.  
c) Calcium standard stock solution , 1 000 µg/mL Ca  
Transfe r 499 .5 mg of cert ified calc ium ca rbonate (CaC0 3) into a 200 mL volumet ric flask with  
10 mL water . Carefully add 5 mL of 10 % (volume frac tion) of hydrochlor ic ac id. Swirl to d issolve  
the calcium carbonate and d ilute to 200 ,0 mL w ith water . This solution  conta ins 1 000 µg/mL of  
calcium .  
5.6.2.2.3 Standard working solutions  
Prepare the fol lowing s tandard wo rking solutions from the sta ndard stoc k solutions:  
a) Potassium standard working solution , 50 µg/mL K  
Transfer 5 .0 mL of the potass ium standard sto ck solu tion into a 100 mL vo lumetric flask and  
dilute to 100 .0 mL w ith wate r and m ix. This work ing standard solution conta ins 50 µg/mL of  
potassium .  
b) Sodium standard working solution , 50 µg/mL Na  
Transfer 5 .0 mL of the sodium standa rd stock so lution into a 100 mL vo lumetric flask and d ilute  
to 100 .0 mL w ith water and m ix. This working sta ndard solution conta ins 50 µg/mL o f sodium.  
c) Calcium standard working solution , 100 µg/mL Ca  
Transfer 10.0 mL of the ca lcium standa rd stock so lution into a 100 mL volumetric flas k and d ilute  
to 100 .0 mL w ith wate r and m ix. This working standard solu tion conta ins 100 µg/mL of calcium .  
 TBS/CDC 16(6640 ) P3  
 
©TBS 20 20 – All rights reserved                                                                                   First Edition 2020  
 
 5.6.2 .2.4 Standard reference solutions  
Prepa re the standard refe rence so lutions from the standard work ing so lutions as fo llows:  
a) Add 5 mL lanthanum ch loride solu tion to each of the five 100 mL vo lumetric flasks.  
b) Dilute the bla nk solution to 100 .0 mL w ith wate r and m ix.  
c) Add the volumes g iven in column 2 , column 3 and column 4 o f table 2 of t he potass ium, sodium,  
and calc ium standard wo rking so lutions , respect ively, to eac h of the remaining four volumetric  
flasks .  
d) Dilute to 100.0 mL with wa ter and m ix.  
Table 2 - Preparation of standard reference  solutions  
 
1  2  3  4  5  6  
  Volume of working standard solutions ad ded  Final concentration in  
  reference standard solution  
Flask  50 µg/mL K  50 µg/mL Na  100 µg/mL Ca  K and Na  Ca  
  solution  solution  solution    
  mL  mL  mL  µg/mL  µg/mL  
1  1  1  1  0.5  1.0  
2  2  2  2  1.0  2.0  
3  3  3  3  1.5  3.0  
4  4  4  4  2.0  4.0  
NOTE  The co ncentrations of the standa rd solutions and the samp le solutions may be modified to fit the linear  
or wo rking range of the atomic absorp tion spec trophotome ter.    
5.6.2.2.5 Product solutions  
Prepare the following prod uct solutions by d iluting the product as follows :  
a) Product solution for the determination of the potassium content  
Transfer 5 .0 mL of the product , (V), into a 50 mL volumetr ic flask and d ilute to 50 .0 mL w ith water  
and mix . Transfe r 5.0 mL of th is sol ution into a 50 mL volumetr ic flask t hat conta ins 2.5 mL of the  
lanthanum chlor ide solut ion. Dilute to 50 .0 mL w ith water and mix . Use th is solut ion for the  
determinat ion of the potass ium content .  
b) Product solution for the determination of the sodium  conten t  
Transfer 2 .0 mL of the product , (V), into a 200 mL volumetr ic flask and d ilute to 200 .0 mL w ith  
water and mix . Transfer 2 .0 mL of th is solution into a 50 mL volumetric flask that contains 2 .5 mL  
of the lanthanum chlor ide solution . Dilute to 50 .0 mL with wa ter and mix . Use this solut ion for the  
determ ination of the sod ium content .  
c) Product solution for the determination of the calcium content  
Transfer 2 .0 mL of the p roduct , (V), into a 50 mL volumetr ic flask that conta ins 2 .5 mL of the  
lanthanum ch loride so lution. Dilute to 50 .0 mL with water and m ix. Use this so lution for the  
determinat ion of the calc ium conten t.  
 
 TBS/CDC 16(6640 ) P3  
 
©TBS 20 20 – All rights reserved                                                                                   First Edition 2020  
 
 5.6.2.3 Procedure  
5.6.2.3.1 Determination of the potassium content  
Proceed to dete rmine the po tassium co ntent of the product  by atom ic absor ption as follows:  
a) Set the atom ic absorpt ion spec tropho tomete r for maximum abso rbance at a wave length of abou t 766 nm.  
b) Adjust the instrument to ze ro absorbance with the blank sol ution.  
c)Adjust the instrument to max imum abso rbance w ith the most concent rated standard reference so lution .  
d) Read and reco rd the absorbances of the othe r standard reference solut ions and the product solut ion (see 
5.6.2.2.5(a)).  
e) Plot the absorbance versus the concentrat ion of potass ium, in micrograms p er millilitre, of the standard 
reference so lutions. Draw the line best fitt ing the plot ted po ints.  
f) Determ ine the concentrat ion of potass ium (a), in mi crograms pe r millilitre, in the diluted prod uct so lution (see 
5.6.2.2.5(a)) from the g raph so obtained . 
g) Calculate the potass ium conten t (Kc)of the prod uct, in mg /100 mL , using the fol lowing formula  
Kc =   a    x     50     x     50       x    100  
        1 000       V             5  
where  
 Kc  is the potass ium content ;  
 a  is the concentrat ion of p otass ium determined from the graph , in micrograms per  
                                              millilitre; and  
 V  is the volume of product used for the initial d ilution , in millilitres.  
h) Check for compl iance w ith 4.4.2 and 4 .5.  
5.6.2.3.2 Determ ination of the sodium content  
Proceed to determ ine the sod ium co ntent of the prod uct by ato mic abso rption as follows:  
a) Carry out the p rocedu re in 5.6.2.3.1, but set the atomic absorpt ion spec tropho tometer for a maximum 
absorbance a t a wavelength of abo ut 589 nm .  
b) Determine the concentration of sodium (b), in micrograms per m illilitre, in the d iluted product solution (see 
5.6.2.2.5(b)) from the g raph so obta ined.  
c) Calculate the sodium content  (Na c)of the produc t, in mg/100 mL , using the following formula  
 
Nac   =       b       x       200    x    50     x        100  
             1 000              V            2  
where  
 Nac  is the sod ium content ;  
 b  is the co ncentration of sod ium de termined f rom the graph , in micrograms per  
                                              millilitre; and  
 V  is the volume of produc t used for the initial dilution , in millilitres.  TBS/CDC 16(6640 ) P3  
 
©TBS 20 20 – All rights reserved                                                                                   First Edition 2020  
 
 d) Check for comp liance w ith 4.4.3 and 4.5.  
5.6.2.3.3  Determination of the calcium content  
Proceed to determine the calc ium content of the pr oduct by atomic absorption as fo llows:  
Carry out the procedure in 5 .6.2.3.1, but set the atomic absorption spectrophotometer for a  
maximum absorbance at a wavelength of about 422 .7 nm .  
Determine the concentration of calcium (c), in m icrograms per mill ilitre, in the d iluted product  
solut ion (see 5 .6.2.2.5(c)) from the graph so obtained .  
Calculate the calcium content (Cac) of the product , in mg/100 mL , using the follow ing formula  
 
Cac =    c       x        50     x     100  
          1 000             V 
where  
                                Cac     is the calcium content ;  
                                 c      is the concentration of calc ium determined from the graph , in micrograms pe  millilitre ; 
and  
 
                                    V is the vol ume of product used for the initial dilution , in millilitres .  
d) Check for compliance with 4 .4.4 and 4 .5.  
NOTE 1 When the potassium chloride  (KClc )content  and the calc ium dihydrate content (CaCl 2.2H20) has been dete rmined , the sodium 
chloride  (Na c) conte nt of the product , in mg/100 mL, can be calcu lated from the total chlor ide (Clc) content using the follow ing formula:  
NaClc =(Clc -(KClc x 0.4755) -(CaCl 2.2H2Oc x 0.4823)) x 1.648  
where  
 
NaClc  
Clc  
KClc  
 
 
 
CaCl 2.2H 2Oc  
is the sodium chloride content ;  
is the total chloride content , in mg/100 mL (see 
5.6.1 .2.3);  
is the potass ium chlor ide content , in mg /100 mL ; 
and  
is the calc ium d ihydrate content , in mg /100 
mL 
 
NOTE 2 Alternat ive test methods can be used fo r the identif ication of potass ium, sodium an d ca lcium  
provided these methods g ive equ ivalent results .  
NOTE 3 Alternat ive test methods can be used to dete rmine the potass ium, sodium and calc ium content  
provided these methods g ive equ ivalent results . The c once ntrations of the sta ndard reference solutions and  
the product solutions may have to be adjusted to be w ithin the optimum wor king range o f the instrument used .  
NOTE 4 A titrimetr ic method for the determ ination of the calc ium chloride content is given in the BP.  
 
 TBS/CDC 16(6640 ) P3  
 
©TBS 20 20 – All rights reserved                                                                                   First Edition 2020  
 
 5.6.3 Lac tate c ontent  
5.6.3. 1 Use the method for l iquid chromatography g iven in the monograph .  
5.6.3.2  Check for compl iance with 4 .4.5 and 4 .5.  
5.7 Particulate m atter (sub-visible particles)  
5.7.1  Use the method "Light obscuration particle count test " under part iculate matter in inject ions  
given in the pharmacopoeia .  
5.7.2 Check for compliance with 4 .6.  
5.8 Sterility  
5.8.1  Use the method under "Sterility tests " given in the pharmacopoeia .  
5.8.2  Check for compliance with 4 .7.  
5.9 Bacterial endotoxins  
5.9.1  Use the method unde r "Bacterial endotoxins test" given in the pharmacopoeia .  
5.9.2  Check for compliance with 4 .8.  
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 no t 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 g lass as described under "Glass  
containers for pharmaceutical use " in the pharmacopoe ia. Plast ics containers shall comply with the req uirements of 
ISO15747  
6.1.1.3  Containers shall be hermetically closed by means of suitable closures that shall not affect or be affected by the 
contents of the container .  
6.1.1.4  Plastics containers in the form of bags shall be supplied sealed individuall y in over -pouches that shall protect 
the contents during normal handling , transportation and storage .  
6.1.2  Primary  Packages  
An acceptable number of containers of the same batch identification shall be packed togethe r in packages of suitable 
design that is suff iciently robust to protect the contents during normal handl ing, transportation and storage .  
6.1.3 Secondary and tertiary packages   
An acceptable number of packages of the same batch identificat ion 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(6640 ) P3  
 
©TBS 20 20 – All rights reserved                                                                                   First Edition 2020  
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 TBS/CDC 16(6640 ) P3  
 
©TBS 20 20 – All rights reserved                                                                                   First Edition 2020  
 
 Annex A  
(normative ) 
Notes to purchasers  
Each order or contract sha ll specify wheth er the R inger-lactate (Hartmann 's) intravenous so lution ordered shall 
comply w ith the requ irements of 4 .5.  
                                                 
 
 
 
 
 
 
 
 
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©TBS 20 20 – All rights reserved                                                                                   First Edition 2020  
 
                                                  Annex B  
                                                              (informat ive) 
Quality verification of sterilized compound sodium lactate intravenous infusion 
(Ringer -lactate solution for injection)  
When a purchaser requires ongoing ver ification of the qua lity of sterilized compound sod ium lactate intravenous 
infus ion (Ringer -lactate solution for inject ion), it is suggested that , instead of concentrating so lely on evaluation of 
the final product , he also directs h is attent ion to the manufacturer 's quality system . In this connection it should be 
noted that TZS 50 1 and TZS 1967  cover the prov isions of an integrated quality system .  
 
 
 
 
 
 
 
 TBS/CDC 16(6640 ) P3  
 
©TBS 20 20 – All rights reserved                                                                                   First Edition 2020  
 
 Bibliography  
TZS 50 1/IS0 9001 , Quality management systems - Requireme nts.  
TZS 1967 /IS0 13485 , Medical de vices - Qualit y management syste ms - Requ irements for re gulatory purposes .  
 
 
 
 
 
 
 
  
 
 
 TBS/CDC 16(6640 ) P3  
 
©TBS 20 20 – All rights reserved                                                                                   First Edition 2020  
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 TBS/CDC 16(6640 ) P3  
 
©TBS 20 20 – All rights reserved                                                                                   First Edition 2020  
 
  TBS/CDC 16(6640 ) P3  
 
©TBS 20 20 – All rights reserved                                                                                   First Edition 2020  
 
  
 
 
 TBS/CDC 16(6640 ) P3  
 
©TBS 20 20 – All rights reserved                                                                                   First Edition 2020  
 
  
 
 
 TBS/CDC 16(6640 ) P3  
 
©TBS 20 20 – All rights reserved                                                                                   First Edition 2020  
 
 TBS/CDC 16(6640 ) P3  
 
©TBS 20 20 – All rights reserved                                                                                   First Edition 2020  
 
  
 
  
 
 
 TBS/CDC 16(6640 ) P3  
 
©TBS 20 20 – All rights reserved                                                                                   First Edition 2020  
 
 TBS/CDC 16(6640 ) P3  
 
©TBS 20 20 – All rights reserved                                                                                   First Edition 2020  
 
  
 
 TBS/CDC 16(6640 ) P3  
 
©TBS 20 20 – All rights reserved                                                                                   First Edition 2020  
 
  
 TBS/CDC 16(6640 ) P3  
 
©TBS 20 20 – All rights reserved                                                                                   First Edition 2020  
 
 TBS/CDC 16(6640 ) P3  
 
©TBS 20 20 – All rights reserved                                                                                   First Edition 2020