AFDC 05(6095 ) P3 
 
 
                  
DRAFT TANZANIA STANDARD  
 
 
 
 
 
 
Sucralose — Specification  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
                                    TANZANIA BUREAU OF STANDARDS                                                                                                                       
AFDC 05( 6095 )P3 
 
 Sucralose — Specification  
 
0.  Foreword  
 
Sucralose,(1, 6-Dichloro -1,6-dideoxy -β-D-fructofuranosyl -4-chloro -4-deoxy -alpha -D-galactopyranoside) is a 
non-nutritive  artificial sweetener, approximately 650 times sweeter than sucrose (table sugar), twice as sweet 
as saccharin, and four times as sweet as aspartame. I t has an acceptable daily intake (ADI) of 15 mg/kg body 
weight.  
 
Consumption of sucralose has increased as result of the growing trends to consume low calorie foods with 
less impact on blood glucose than sucrose. It also has no effect on tooth decay and is  commonly found in oral 
health products. It possesses the following sweetener characteristics: non -nutritive , insipid and stability at high 
temperatures and in acidic medium. Its characteristics are preserved, even during pasteurisation, sterilisation 
and cooking at high temperatures. In addition, it cannot be hydrolysed during digestion or metabolism due to 
the high stability of its carbon -chlorine bonds and it does not interact chemically with other foods.   
 
Sucralose -based products are found in a broad range of lower -calorie foods, including, fizzy drinks, chewing 
gum, baking mixes, breakfast cereals and salad dressings.  
 
This standard has  been formulated to provide the necessary guidelines to manufacturers, traders and 
consumers of sucralose and sucral ose-based products and, for purposes of conformity assessment.  
 
In preparation of this draft Tanzania standard assistance was drawn from India standard ( IS 15969:2013 ) 
Specification for sucralose.  
 
In reporting the result of a test or analysis made in acco rdance with the Tanzania standard, if the final value 
observed or calculated is to be rounded off, it shall b e done in accordance with TZS 4.  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
                                                                                                                        
AFDC 05( 6095 )P3 
 
  
1 Scope  
This Draft Tanzania Standard specifies requirements, methods of sampling and test for food grade sucralose.  
 
2 Normative references  
The following referenced documents are referred to in the text in such a way that some or all their content 
constitutes requirements of this document. For dated references, only the editio n cited applies. For undated 
references, the latest edition of the referenced document (including any amendments) applies.  
AOAC 972.25, Lead in food. Atomic absorption spectrophotometric method  
AOAC 973.34, Cadmium in food by atomic absorption spectroscopy  (AAS)  
TZS 116, General standard for the labelling of food additives when sold as such  
CAC/GL 50 – General guidelines on sampling  
The Weights and Measures (Sales and Labelling of goods) Rules, 2007  
TZS 4, Rounding off numerical value  
TZS 538, Labelling of pre-packaged foods — General requirements  
 
3 Terms and definitions  
For the purposes of this document, the following terms and definitions apply.  
3.1 artificial/non -nutritive sweetener  is artificial substance that has a similar taste to sugar other than sugar 
used to sweeten food or drink.  
 
3.2 food grade material a material, made of substances which are safe and suitable for their intended use 
and which will not impart any toxic substance or undesirable odour or flavour to the product.  
4 Requirements  
4.1 General requirements  
Sucralose  shall be, fr ee from off odors,  foreign matter and adulterants  
Sucralose shall be presented as a white to off -white, practically odourless crystalline powder. It shall be freely 
soluble in water, methanol and ethanol, and sli ghtly soluble in ethyl acetate.  
 
4.2 Infrared Absorption  
The infrared spectrum of a potassium bromide dispersion of a sucralose sample shall correspond with the 
reference infrared spectrum for sucralose . 
 
 
 
 
 
 
 
                                                                                                                        
AFDC 05( 6095 )P3 
 
  
4.3 Thin Layer Chromatography  
The main spot  in the test solution shall have the same retardation factor ( Rf) as that of the main spot of 
Standard Solution A obtained in the test for other chlorinated disaccharides (see Annex B) when tested using 
thin layer chromatography.  
 
4.3 Specific requirements  
When tested in accordance with the specified or annexed methods, sucralose shall conform to the 
requirements in Table 1.  
 
Table 1 — Requirements for Sucralose  
 
S/N Parameter  Requirement  Method of test  
    
i Assay (purity), percent by mass (dry basis)  98 – 102 Annex C  
    
ii Moisture , percent by mass, Max  2 ISO 760  
    
iii Sulphated ash, percent by mass, Max  0.7 Annex D  
    
iv Triphenylphosphine oxide, mg/kg, Max  150 Annex E  
    
v Methanol, percent by mass, Max  0.1 Annex F  
    
vi Chlorinated disaccharides  To pass  Annex A  
    
vii Chlorinated monosaccharides  To pass  Annex B  
    
 
5.Hygiene  
 
5.1 Food grade sucralose  shall be prepared and packaged in premises built and maintained under hygienic 
condition in accordance with TZS 109.  
  
5.2   Food grade sucralose shall be free from pathogenic organisms.  
 
 
                                                                                                                        
AFDC 05( 6095 )P3 
 
  
 
6 Contaminants  
When tested following  AOAC 972.25, the heavy metal contamination expressed as Lead (Pb) shall not 
exceed 1 mg/kg.  
7. Sampling  
 
Representative samples of the product shall be  drawn in accordance with CAC/GL 50.  
 
8. Packaging, marking and labelling.  
8.1 The product shall be securely packaged in containers made of food grade materials conforming to TZS 
539. The packages shall preserve the quality of the product, prevent entry of  light and preclude contamination 
from the external environment.  
8.2 Marking and labelling  
8.2.1 In addition to the requirements of TZS 538 and TZS 116, the product label shall be legibly and indelibly 
labelled with the following:  
a) Name of the product as  sucralose  with the words ‘Food Grade’;  
b) Name and physical address of the manufacturer/distributor;  
c) Net weight in metric units;  
d) Batch/lot number;  
e) Directions for storage;  
f) Date of manufacture; and the  
g) Expiry date.  
h) Instruction for use refer to CODEXSTAN 107  
i) Statutory warnings (For industrial use)  
 
8.2.2 The language on the label shall be “Kiswahili” or Kiswahili and English. A second language may be used 
depending on the designated market.  
8.2.3        The packages of the buns may also b e marked with the TBS certification mark.  
NOTE - The TBS Standards Mark of Quality may be used by the manufacturers only under license from TBS. 
Particulars of conditions under which the licenses are granted, may be obtained from TBS  
 
 
 
 
 
 
 
 
                                                                                                                        
AFDC 05( 6095 )P3 
 
  
 
 
 
 
 
 
 
Anne x A 
(normative)  
Determination of chlorinated disaccharides  
 
B-1 REQUIREMENTS  
- TLC Plates — Reverse phase thin layer chromatography plates coated with 0.2 mm layer of silica gel  
absorbent (for example, Whatman LKC18).  
 
B-2 REAGENTS  
a) Mobile phase — Mix 7 volumes of a 5.0% w/v aqueous solution of sodium chloride and 3 volumes of  
acetonitrile.  
 
b) Spray reagent — Use 15% v/v solution of concentrated sulphuric acid in methanol.  
 
c) Standard solutions — Dissolve 1.0 g of sucralose reference standard in 10 ml of methanol (Solution  
A). Dilute 0.5 ml of Solution A with methanol to 100 ml (Solution B).  
 
d) Test solution — Dissolve 1.0 g of sample in 10 ml of methanol.  
 
B-3 PROCEDURE  
Apply 5 μl each of solution A, solution B and test solution to the bottom of the chromat ographic plate. Place 
the plate in a suitable chromatography chamber containing freshly prepared mobile phase and allow the 
solvent front to ascend 15 cm. Remove the plate from the chamber, allow it to dry and spray with spray 
reagent. Heat the plate in an  oven at 125 °C for 10 min.  
 
The sample is said to have passed the test when the main spot in the test solution has the same Rf value as 
the main in solution A and no other spot in the test solution is more intense than the 0.5 percent spot in 
solution B.  
 
 
 
 
 
                                                                                                                        
AFDC 05( 6095 )P3 
 
  
 
Annex B  
(normative)  
Test for chlorinated monosaccharides  
 
C-1 REQUIREMENTS  
- TLC plates — Thin layer chromatography plates coated with 0.25 mm thickness of silica gel 60 or  
equivalent.  
 
C-2 REAGENTS  
- Spray reagent — Dissolve 1.23 g p -anisidine  and 1.66 g phthalic acid in 100 ml methanol. Store the  
solution in darkness and refrigerate to prevent it from becoming decolourised. Discard if solution 
becomes discoloured.  
 
NOTE — p-anisidine is toxic by skin absorption and inhalation and should be use d with due caution.  
 
- Standard solution A — Dissolve 10.0  ± 0.001g of mannitol in 40 ml of distilled water in a 100 ml  
volumetric flask. Dilute to volume using the water.  
 
- Standard solution B — Dissolve 10 g of mannitol and 40 mg of fructose (Analytical grade) in 25 ml 
of water in a 100 ml volumetric flask and make up to volume with the water.  
 
- Sample solution — Dissolve 2.5 g of sample in 5 ml of methanol in a 10 ml volumetric flask and  
make up to volume with methanol.  
 
C-3 PROCEDURE  
Spot 5 μl of each of  standard solutions A and B onto the TLC plate, applying the solution slowly in 1 μl 
aliquots and allowing the plate to dry between applications. Spot 5 μl of the sample solution onto the plate in a 
similar manner. The three spots should be of similar size . Spray the plate with the spray reagent and heat at 
100 ± 2 °C for 15 minutes. Immediately after heating, view the plate against a dark background.  
 
The sample shall have passed the test when the spot from the sample solution is not more coloured than the  
spot from solution B (equivalent to a limit of 0.1% maximum total chlorinated monosaccharides).  
 
Darkening of the mannitol spot from standard solution A indicates that the plate has been held too long in the 
oven, and a second plate should be prepared.  
 
 
 
 
 
                                                                                                                        
AFDC 05( 6095 )P3 
 
 Annex C  
(normative)  
 
Assay of sucralose  
 
D-1 CHROMATOGRAPHIC SYSTEM  
Fit a high -pressure liquid chromatograph, operated at room temperature, with a radial compression module 
containing a 10 cm 5 μm  C18 reverse phase column. The mobile phase is maintained at a pressure and flow 
rate (typically 1.5 ml/min) capable of giving the required elution time (see D -5). An ultraviolet detector that 
monitors absorption at 190 nm, or a refractive index detector i s used.  
D-2 MOBILE PHASE  
Add 150 ml of acetonitrile (HPLC grade, far UV, filtered through a 0.45 μm millipore filter or equivalent) to 850 
ml of water (glass distilled, filtered through a 0.45 μm millipore filter or equivalent). Mix and degas thoroughly.  
D-3 STANDARD SOLUTION  
Weigh accurately about 250 mg of sucralose reference standard into a 25 ml volumetric flask. Dissolve and 
make up to volume using the mobile phase. Filter the solution through a 0.45 μm millipore filter or equivalent. 
Record the weigh t of reference standard as Ws.  
D-4 TEST SOLUTION  
Weigh accurately about 250 mg of sample into a 25 ml volumetric flask. Dissolve and make up to volume 
using the mobile phase. Filter the solution through a 0.45 μm millipore filter or equivalent. Record the weight 
of sample as Wt.  
D-5 SYSTEM SUITABILITY TEST  
Inject duplicate 20 μl portions of standard solution into the chromatograph. The retention time of the sucralose 
should be approximately 9 min. The co -efficient of variation (100 x standard deviation divi ded by mean peak 
area) for the peak areas should not exceed 2 percent.  
NOTE — The retention time quoted is appropriate for a 10 cm 5 μm Rad -Pak C18 column. If a column of a 
different make or length is used it may be necessary to adjust the proportion of ac etonitrile in the eluent to 
obtain the required retention time.  
D-6 PROCEDURE  
Analyse the test solution under the conditions described above, making duplicate 20 μl injections, and 
calculate the mean peak area. Calculate the percentage purity from the rela tive peak areas of the test (At) and 
standard solutions (As) per the following formula:  
 
Purity, percent = At  x Ws  x 100  
    As  x Wt 
 
Calculate the percentage purity on a water -free and methanol -free basis using the values obtained in the tests 
for water and methanol.                                                                                                                         
AFDC 05( 6095 )P3 
 
  
Annex D  
(normative)  
 
Determination of sulphated ash  
 
E-1 REAGENT  
 
- Concentrated sulphuric acid (A.R. grade)  
 
E-2 APPARATUS  
 
-Crucible  
-Desiccator  
-Hot plate  
-Furnace  
-Weigh balance  
 
 
E-3 PROCEDURE  
Weigh accurately about 2 g of product in a tared crucible. Ignite, gently at first, until the material is thoroughly 
charred, cool, moisten the residue with 1 ml of sulphuric acid and ignite gently till the carbon is completely 
consumed. Cool the crucible in a desiccator and weigh.  
NOTE — Carry out the ignition in a place protected from air currents and use as low a temperature as 
possible to effect the combustion of carbon.  
 
E-4 CALCULATION  
 
 
Sulphated ash, percent by mass =  
 
wher e,  
W
1 
 
W 2  
 
X 100                                                                                                                         
AFDC 05( 6095 )P3 
 
 W1 = mass in grams of the residue; and  
 
W2 = mass in grams of the product tested.  
 
Annex E  
(normative)  
Test for triphenylphosphine oxide  
 
F-1 APPARATUS  
Chromatographic system — Typically a high-pressure liquid chromatograph, operated at room temperature,  
is fitted with a radial compression module containing a 5 μm C18 Rad -Pak reverse phase column (10 cm x 8 
mm). The mobile phase is maintained at a pressure and flow rate (typically 1.5 ml/min ) capable of giving the 
required elution time. The chromatograph is equipped with a UV detector (220 nm).  
F-2 REAGENTS  
F-2.1 Mobile phase — Add 67 volumes of acetonitrile (HPLC grade, far UV, filtered through a 0.45 μm  
millipore  filter or equivalent) to 33 volumes of water (glass distilled, filtered through a 0.45 μm millipore filter or 
equivalent). Mix and de -gas thoroughly.  
F-2.2 Standard solution — Weigh accurately 100 mg of triphenylphosphine oxide into a 10 ml volumetric  
flask. Dissolve and make up to volume using the mobile phase. Take 1.0 ml of the resulting solution and make 
up to 100 ml with mobile phase. From this solution, prepare a further 100 -fold dilution with mobile phase and 
use this as the standard solution. Filte r through a 0.45 μm millipore filter or equivalent.  
F-2.3 Test solution — Weigh accurately 100 mg of sample into a 10 ml volumetric flask. Dissolve and make  
up to volume with mobile phase. Filter through a 0.45 μm millipore filter or equivalent. Record the  weight of 
sample as Wt mg.  
F-3 PROCEDURE  
Inject duplicate 25 μl portions of the standard and test solutions into the chromatograph. Under the conditions 
stated above the retention time for triphenylphosphine oxide is 6 min. Record the mean peak areas for the 
standard and test solutions as As and At respectively.  
F-4 CALCULATION  
Calculate the concentration of triphenylphosphine oxide (TPPO) in the sample from the following formula:  
 
 
TPPO (mg/kg) =   
 
A 
 t 
A 
s   
 
x  
 
10000  
W 
t   
 
.                                                                                                                        
AFDC 05( 6095 )P3 
 
 Annex F  
(normative)  
 
Test for methanol  
 
G-1 APPARATUS/EQUIPMENT  
 
Use a suitable gas chromatograph equipped with a hydrogen flame ionization detector containing a 2.1 m x 
4.0 mm (id) glass column packed with Porapak PS 80 -100 mesh or equivalent materials.  
G-2 OPERATING CONDITIONS  
The operating conditions may vary dependi ng upon the particular instrument used but a suitable 
chromatogram may be obtained by using the following conditions:  
a) Column temperature: 150 °C (isothermal)  
 
b) Inlet temperature: 200 °C  
 
c) Detector temperature: 250 °C  
 
d) Carrier gas nitrogen: 20 ml/min  
 
G-3 REAGENTS  
G-3.1 Standard solutio n — Using a 2.0 -ml class A volumetric pipette, pipette 2.0 ml of methanol into a 100  
ml volumetric flask, dilute to volume with pyridine, and mix. Transfer 1.0 ml of this solution to a 100 ml 
volumetric flask, dilute to volum e with pyridine, and mix.  
G-3.2 Sample solution — Weigh accurately about 2 g of the sample into a 10 -ml volumetric flask, dilute to  
volume with pyridine , and mix.  
G-4 PROCEDURE  
Inject a 1 μl portion of the standard solution onto a gas chromatography column , obtain the chromatogram, 
and measure the area of the peak produced. The relative standard deviation for replicate injections is not 
more than 2.0 percent. Calculate the mean peak areas for the standard solution. Similarly, inject a 1 μl portion 
of the sa mple solution into the gas chromatograph, and measure the areas of the peaks produced by 
methanol. Calculate the mean peak areas, and determine the methanol concentration using the following 
formula:    AFDC 5 ( 6095 ) P3 
12 
 
DRAFT TANZANIAN STANDARD  
Methanol, percent =  
where  
SA = sample area;  
S 
A x V x C 
S   S   
 A x W 
S  
  S    
 
CS = percentage concentration of methanol in the standard (volume of methanol x dilution factor 
x density of solvent equals 2 x 10–4 x 0.79 x 100);  
 
VS = volume of the sample solution;  
 
AS = standard area; and  
WS = mass in grams of the sample.  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
   AFDC 5 ( 6095 ) P3 
13 
 
DRAFT TANZANIAN STANDARD  
 
Bibliography  
 
[1] IS 15969: 2013, Sucralose, food grade — Specification  
 
[2] JECFA (1993), Sucralose