Sucralose Excipient | Uses, Suppliers, and Specifications
Sucralose is an artificial sweetener approved for use in pharmaceutical products. It is corresponds to 1,6-Dichloro-1,6-dideoxy-beta-D-fructofuranosyl 4-chloro-4-deoxy-alpha-D-galactopyranoside (chemical formula CC12H19Cl3O8). Sucralose is 600 times sweeter than sucrose and is supplied as a white to off-white coloured, free-flowing, crystalline powder.
Synonyms and Trade Names: Sucralose; 1′,4′,6′-trichloro-Galactosucrose; 4,1′,6′-Trichloro-4,l’,6′-Trideoxy-galacto-sucrose; E955; TGS; Splenda®; SucraPlus®
Uses and Applications: Artificial Sweetener
Sucralose is a synthetic nonnutritive, zero-calorie artificial sweetener approved for use in food and pharmaceutical products. It corresponds to 1,6-Dichloro-1,6-dideoxy-beta-D-fructofuranosyl 4-chloro-4-deoxy-alpha-D-galactopyranoside (chemical formula CC12H19Cl3O8) which is also described as 4,1′,6′-trichlorogalactosucrose (TGS). It was approved for use as a tabletop sweetener by the FDA in 1998 and fully authorised for use in food products in 2005.
Sucralose is synthesised from sucrose by partial replacement of the OH groups with chlorine. As a result, Sucralose is structurally a substituted disaccharide, the difference being that 3 chlorine atoms have replaced 3 hydroxyl groups. However, although sucralose contains chlorine atoms and can be described as a chlorinated carbohydrate, it is not in the class of substances called chlorinated hydrocarbons. On the other hand, the presence of the multiple hydroxyl groups in sucralose makes it, like sugar, a hydrophilic, rather than a lipophilic compound. The considerable water solubility of sucralose (>25% at 22°C) and relatively poor lipid solubility can therefore be expected.
Chemical Structure & Identifiers
|Chemical Name||1,6-Dichloro-1,6-dideoxy- p-D-fructofuranosyI-4-chlor o-4-deoxy-a-D-galactopyranoside|
|CAS Registration Number||[56038-13-2]|
|UNII Code (FDA)||96K6UQ3ZD4|
Sucralose is approved for use as an excipient and is listed in all the major pharmacopoeia. It was approved by the FDA in April 1998 for use as a tabletop sweetener and as an additive in food products and is now accepted for use in many other countries worldwide. A specification for sucralose is contained in the Food Chemicals Codex (FCC). It is currently listed in the FDA IIG database.
|Appearance||White to off white crystalline powder|
|pH ((10% aqueous solution at 20 oC||5-6|
|Bulk density||0.35 g/ml|
|Tapped density||1.62 g/ml|
|True density||1.63 g/ml|
|Melting point||130 OC (anhydrous crystalline grade)|
|Particle size distribution||Micronised grades d90 <10 µm|
|Partition confident||0.51 (octanol-water)|
|Refraction index||1.33 – 1.37|
|Solubility||Sucralose is freely soluble in water and ethanol (95%). It is insoluble in mineral oil|
|Specific rotation||+84.0o to +87.5 o (1% w/v aqueous solution}|
|Viscosity (10% solution)||0.5-4.0 cSt|
|Identification||A, B, C||A, B|
|Optical rotation||1.431 – 1.433|
|Impurities H & I||n/a||specified|
|Residue on ignition||≤0.7%||specified|
|Limit of hydrolysis products||specified||n/a|
|Limit of methanol||≤0.1%||n/a|
Key: n/a Specification is not listed
*All claims with respect to conformity are subject to our Terms and Conditions. No express or implied warranty is made for specific properties or fitness for any particular application or purpose.
Applications in Pharmaceutical Formulations or Technology
Sucralose has grown to become one of the most commonly used artificial sweeteners today. It is currently used as an intense sweetener in drinks, foods, pharmaceuticals and cosmetic products. Sucralose has a smooth and rounded sweetness with sweetening power approximately 300-1000 times that of sucrose. It has no aftertaste or nutritional value, is non-cariogenic, does not promote dental caries, and produces no glycemic response. For this reason, it is widely used in sugar-replacement applications. Typical usage levels range between 0.03 and 0.24%.
Safety and Precautions
Sucralose is an approved food additive that is generally regarded as a nontoxic and nonirritant substance. It is approved in several countries for use in food and pharmaceutical products. Upon ingestion, sucralose is not absorbed and is excreted in the faeces. Sucralose has been evaluated by the European Union (EU) Scientific Committee on Food (SCF) and an acceptable daily intake (ADI) of 15 mg/kg body weight (bw) established in 1991 and 2000 by the joint FAO/WHO Expert Committee on Food Additives (JECFA) and by the SCF, respectively.
Toxicology: LD50 (rat, oral): > 10 g/kg
Stability and Storage Conditions
Sucralose is a relatively stable excipient. It is most stable at pH 5-6. In aqueous solution (at low pH (< 3) or at high temperatures (< 35 °C), Sucralose can hydrolyse to produce 4-chloro-4-deoxygalactose and 1,6-dichloro-l,6-dideoxyfructose. When added to food products, Sucralose stays stable for extended time periods, even at low pH.
Sucralose should be stored in a well-closed container in a cool, dry place, at a temperature not exceeding 250C. At elevated temperatures, sucralose may discolour, and eventually degrade.
When handling Sucralose, observance of established SEHQ protocols appropriate to the circumstances and quantity of material processed.
Sustainability and Environmental Impact
A sustainability score for Sucralose has not been provided.
Manufacturers & Suppliers
Additional Resources (Downloads)
References and Literature Used
 J.F.W.E.C.o.F. Additives, World Health Organization & Food and Agriculture Organization of the United Nations. (1991). Evaluation of certain food additives and contaminants : Thirty-Seventh Report of the Joint FAO/WHO Expert Committee on Food Additives [Meeting held in Geneva from 5 to 14 June 1990], (1991).
 J.Y. Zheng, M.P. Keeney, Taste masking analysis in pharmaceutical formulation development using an electronic tongue, International Journal of Pharmaceutics, 310 (2006) 118-124.
 S.D. Anton, C.K. Martin, H. Han, S. Coulon, W.T. Cefalu, P. Geiselman, D.A. Williamson, Effects of stevia, aspartame, and sucrose on food intake, satiety, and postprandial glucose and insulin levels, Appetite, 55 (2010) 37-43.
 K. Woertz, C. Tissen, P. Kleinebudde, J. Breitkreutz, Taste sensing systems (electronic tongues) for pharmaceutical applications, International journal of pharmaceutics, 417 (2011) 256-271.
 J. Walsh, A. Cram, K. Woertz, J. Breitkreutz, G. Winzenburg, R. Turner, C. Tuleu, I. Playing hide and seek with poorly tasting paediatric medicines: do not forget the excipients, Advanced Drug Delivery Reviews, 73 (2014) 14-33.
PharmaCentral.com may on occasion publish user-generated content. Any information provided on our platform is for general informational and educational purposes only. All information is provided in good faith to enable collaboration and sharing of know-how among our community of users. Authors who submit content retain copyright to it.
PharmaCentral.com does not make any representation or warranty of any kind regarding its accuracy, adequacy, or legality. Any references to particular product names, brands, descriptions, formats, styles, corporate entities, tests, applications, technologies, uses, standardisations, medical conditions, and treatments are for illustration purposes and should not be considered complete or binding. All respective intellectual property, such as trademarks and logos, are properties of their owners
Fair Use Copyright Disclaimer
Under Section 107 of the Copyright Act 1976, allowance is made for ‘Fair Use’ for purposes such as criticism, comment, news, reporting, scholarship, education, and research.
Fair use is a use permitted by copyright statute that might otherwise be infringing.
Some information contained on PharmaCentral.com may contain copyrighted material, the use of which may not have been specifically authorised by the respective copyright owners. Some material is made available to help explain and relay complex phenomena, formulae, physical and chemical constants, and other concepts that are scientifically incontestable but relevant to the use of products, and/or to illustrate, transmit, and teach pharmaceutical science principles. Some material is published to support research and user education, and for the public good.