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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.

Pharmacopoeial Compliance: USP-NF; Ph.Eur; B.P; J.P; I.P; FCC

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

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SPLENDA® Micronised - Tate & Lyle

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SPLENDA® Granular - Tate & Lyle

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Sucralose Mirconised Pharma Grade - Nuitang

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Sucralose Granular Pharma Grade - Nuitang

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Description

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]
Empirical Formula C12H19Cl3O
EC Number 259-952-2
UNII Code (FDA) 96K6UQ3ZD4

Regulatory Status

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.

Physicochemical Properties

Form Solid, powder
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

Pharmacopeoeal Specifications

USP-NF Ph.Eur
Official name Sucralose Sucralose
Authorised use Excipient Excipient
Definition specified specified
Identification A, B, C A, B
Optical rotation 1.431 – 1.433
Impurities H & I n/a specified
Related substances specified specified
Sulfated ash n/a ≤0.7%
Residue on ignition ≤0.7% specified
Limit of hydrolysis products specified n/a
Limit of methanol ≤0.1% n/a
Water ≤2.0% ≤2.0%
Assay 98.0-102.0% 98.0-102.0%
Labelling n/a 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

Tate & Lyle Inc

  • SPLENDA® Sucralose Micronised
  • SPLENDA® Sucralose Granular

Niutang (Natong Changhai Food Additive Co.)

  • Sucralose Micronised
  • Sucralose Granular

Anhui Jinhe 

  • Sucralose

Additional Resources (Downloads)

References and Literature Used

[1] A.M. Bertorelli, J.V. Czarnowski-Hill, Review of present and future use of nonnutritive sweeteners, The Diabetes Educator, 16 (1990) 415-420.

[2] 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).

[3] M. Kroger, K. Meister, R. Kava, Low‐calorie sweeteners and other sugar substitutes: a review of the safety issues, Comprehensive Reviews in Food Science and Food Safety, 5 (2006) 35-47.

[4] A. Mortensen, Sweeteners permitted in the European Union: safety aspects, Scandinavian Journal of Food and Nutrition, 50 (2006) 104-116.

[5] 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.

[6] V.L. Grotz, I.C. Munro, An overview of the safety of sucralose, Regulatory Toxicology and Pharmacology, 55 (2009) 1-5.

[7] A.B. Rodero, L. de Souza Rodero, R. Azoubel, Toxicity of Sucralose in Humans: A Review, International Journal of Morphology, 27 (2009).

[8] 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.

[9] K. Woertz, C. Tissen, P. Kleinebudde, J. Breitkreutz, Taste sensing systems (electronic tongues) for pharmaceutical applications, International journal of pharmaceutics, 417 (2011) 256-271.

[10] 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.

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