| Parameter |
Test Method |
Specification |
Unit |
Organoleptic test |
| Appearance |
|
Food additive, Aspartame is a Non-Nutrive artificial sweetener based on two amino acids. It is metabolized like a food protein. Aspartame is a white or almost white odourless crystalline substance having a seeet tast, slightly hygroscopic, appronimately 200 times as sweet as sucrose. Aspartame provides a clean sugar-like sweetness, without any bitter or metallic aftertaste. |
| Colour |
visual |
white |
|
| Flavor and taste |
organoleptic |
Approx. 200 times as sweet as sucrose. Clean sugar-like sweetness without aftertaste. |
| Odour |
organoleptic |
odoless |
|
Physical parameter |
| Form |
|
crystalline powder |
| Conductivity |
conductometric
(0.8 g/100 mL) |
≤ 30 |
μS/cm |
| Loss on drying |
gravimetric |
≤ 4,5 |
% |
| pH value |
potentiometric |
(1g per 125g H2O) 4,5 – 6,0 |
| Specific Optical Rotation |
polarimetric |
[αD20] +14.5 – +16.5 |
° |
| Bulk density |
volumetric |
0,45 – 0,65 |
kg/L |
| Solubility |
|
Slightly soluble in water and ethanol |
| Transmittance |
photometric
(1-cm cell, 430nm) |
(1g in 100g 2N HCl) ≥ 95 |
% |
Identity |
| Assay |
titrimetric |
(dry) 98 – 102 |
% |
Impurities |
| Impurity |
GC |
5-Benzyl-3,6-dioxo-2-piperazineacetic acid ≤ 1,5 |
% |
Elemental Impurities |
| Arsenic (As) |
acc. to manufacturer |
≤ 3 |
ppm |
| Lead (Pb) |
acc. to manufacturer |
≤ 1 |
ppm |
Microbiological data |
| Escherichia Coli. |
acc. to manufacturer |
Negative |
/g |
| Salmonella |
acc. to manufacturer |
Negative |
/25 g |
| Total Plate Count |
acc. to manufacturer |
≤ 250 |
CFU/g |
| Yeast and Mould |
acc. to manufacturer |
≤ 100 |
CFU/g |
Particle size distribution |
| Particles |
sieve analyses |
< 150 µm ≤ 50 |
% |
| Particles |
sieve analyses |
< 75 µm ≤ 100 |
% |
| Particles |
sieve analyses |
> 300 µm ≤ 1 |
% |
Regulatory information:
Allergens statement:
Mandatory note: "Contains a source of phenylalanine"
BSE/TSE statement:
The product is a highly purified, high intensity Non-Nutritive dipeptide artificial sweetener and does not contain any components derived from beef or has been in contact with any parts of animals origin during manufacturing, storage or distribution. The product is therefore free of BSE/TSE and fully complies with the Regulation (EC) No. 999/2001 of the European parliament and of the council of 22 May 2001, and with the Note for Guidance reference EMA/410/01 rev.3.
Elemental Impurities:
The manufacturer confirms that the product is evaluated according to ICH guideline Q3D and that no Elements are identified to be a potential impurities in it.
GMO statement:
The raw materials or any components used for the production of this product are not of animal or plant origin. During manufacturing or storage the final product has not been in contact with any parts of animal or plant origin.
Supplemental information:
Released by manufacturer:
2018-01-01
Shelf life:
5 years under recommended storage conditions
Derivation:
produced by a chemical synthesis process from Amino Acids, L-Aspartic acid and L-Phenylalanine
Note:
Not subject to authorization, labelling or traceability according to Regulations (EC) No 1829/2003 and No 1830/2003, does not require allergen labelling according to Regulation (EU) No 1169/2011
Storage conditions:
Original (unopened) packaging in a dry place (15-30°C; 35-75% relative humidity) protected against odours and pests
Complies with monographie:
E 951
Regional origin:
EU
Usage:
Food additive, Sweetener
Version of manufacturer:
2
Conclusion:
European Pharmacopoeia (EP), U.S. Pharmacopeia/National Formulary (USP/NF), Japanese Pharmacopoeia for Excipients (JPE), Commission Regulation (EU) No 231/2012, Food Chemicals Codex (FCC), Joint FAO/WHO Expert Committee on Food Additives (JECFA) and Japanese Standards for Food Additives (JSfA) have set purity criteria for this substance (Heavy metals (as. Lead), Arsenic (As) and Lead (Pb)). Therefore this product fully complies with this requirement.
Product is produced in compliance with applicable European Food Law (e.g. Regulation (EC) No 178/2002, Regulation (EU) No 231/2012). According to the manufacturer the product also meets Ph. Eur. And FAO/WHO Specifications
