MilliporeSigma

Sucralose.

Profiles of drug substances, excipients, and related methodology (2013-05-15)
Omar A A AlDeeb, Hoda Mahgoub, Nagwa H Foda
ABSTRACT

Sucralose is a nonnutritive, zero-calorie artificial sweetener. It is a chlorinated sugar substitute that is about 600 times as sweet as sucrose. It is produced from sucrose when three chlorine atoms replace three hydroxyl groups. It is consumed as tablets (Blendy) by diabetic and obese patients. It is also used as an excipient in drug manufacturing. Unlike other artificial sweeteners, it is stable when heated and can, therefore, be used in baked and fried foods. The FDA approved sucralose in 1998. This review presents a comprehensive profile for sucralose including physical, analytical, and ADME profiles and methods of its synthesis. Spectral data for X-ray powder diffraction and DSC of sucralose are recorded and presented. The authors also recorded FT-IR, (1)H- and (13)C NMR, and ESI-MS spectra. Interpretation with detailed spectral assignments is provided. The analytical profile of sucralose covered the compendial methods, spectroscopic, and different chromatographic analytical techniques. The ADME profile covered all absorption, distribution, metabolism, and elimination data in addition to pharmacokinetics and pharmacological effects of sucralose. Some nutritional aspects for sucralose in obesity and diabetes are also presented. Both chemical and microbiological synthesis schemes for sucralose are reviewed and included.

MATERIALS
Product Number
Brand
Product Description

Sigma-Aldrich
Sucralose, ≥98.0% (HPLC)
Sigma-Aldrich
Sucrose, puriss., meets analytical specification of Ph. Eur., BP, NF
Supelco
Sucrose, analytical standard, for enzymatic assay kit SCA20
Sigma-Aldrich
Sucrose, ≥99.5% (GC), Grade II, suitable for plant cell culture
Sigma-Aldrich
Sucrose, ≥99% (GC), Grade I, suitable for plant cell culture
Sigma-Aldrich
Sucrose, meets USP testing specifications
Sigma-Aldrich
Sucrose, ≥99.5% (GC), BioReagent, suitable for cell culture, suitable for insect cell culture
Sigma-Aldrich
Sucrose, ≥99.5% (GC), BioXtra
Sigma-Aldrich
Sucrose, for molecular biology, ≥99.5% (GC)
Sigma-Aldrich
Sucrose, ACS reagent
Sigma-Aldrich
Sucrose, ≥99.5% (GC)
Sigma-Aldrich
Sucrose, ≥99.5% (GC)
Supelco
Sucrose, Pharmaceutical Secondary Standard; Certified Reference Material
Sucralose, European Pharmacopoeia (EP) Reference Standard
Sucrose, European Pharmacopoeia (EP) Reference Standard
Supelco
Sucralose, Pharmaceutical Secondary Standard; Certified Reference Material
USP
Sucralose, United States Pharmacopeia (USP) Reference Standard
Sigma-Aldrich
Sucrose, BioUltra, for molecular biology, ≥99.5% (HPLC)
Millipore
Sucrose, suitable for microbiology, ACS reagent, ≥99.0%
Supelco
Sucralose, analytical standard