PHR1342

Sucralose

Pharmaceutical Secondary Standard; Certified Reference Material

• Synonym(s): Sucralose, 1,6-Dichloro-1,6-dideoxy-β-D-fructofuranosyl-4-chloro-4-deoxy-α-D-galactopyranoside, E955, Trichlorosucrose
• Empirical Formula (Hill Notation): C₁₂H₁₉Cl₃O₈
• CAS Number: 56038-13-2
• Molecular Weight: 397.63
• Beilstein/REAXYS Number: 3654410
• MDL number: MFCD03648615
• UNSPSC Code: 41116107
• PubChem Substance ID: 329823327
• NACRES: NA.24

Properties

• grade: certified reference material; pharmaceutical secondary standard
• Quality Level: 300
• agency: traceable to Ph. Eur. Y0001344; traceable to USP 1623626
• API family: sucralose
• CofA: current certificate can be downloaded
• technique(s): HPLC: suitable; gas chromatography (GC): suitable
• application(s): pharmaceutical (small molecule)
• format: neat
• storage temp.: 2-8°C
• SMILES string: OC[C@H]1O[C@H](O[C@]2(CCl)O[C@H](CCl)[C@@H](O)[C@@H]2O)[C@H](O)[C@@H](O)[C@H]1Cl
• InChI: 1S/C12H19Cl3O8/c13-1-4-7(17)10(20)12(3-14,22-4)23-11-9(19)8(18)6(15)5(2-16)21-11/h4-11,16-20H,1-3H2/t4-,5-,6+,7-,8+,9-,10+,11-,12+/m1/s1
• InChI key: BAQAVOSOZGMPRM-QBMZZYIRSA-N

Description

General description

Certified pharmaceutical secondary standards for application in quality control provide pharma laboratories and manufacturers with a convenient and cost-effective alternative to pharmacopeia primary standards.
Sucralose is a polar, chlorinated sugar synthesized from saccharose precursor. It is widely used as a sweetener in a number of food and beverage products.

Application

Sucralose may be used as a pharmaceutical reference standard for the determination of the analyte in pharmaceutical formulations by various chromatography techniques.

These Secondary Standards are qualified as Certified Reference Materials. These are suitable for use in several analytical applications including but not limited to pharma release testing, pharma method development for qualitative and quantitative analyses, food and beverage quality control testing, and other calibration requirements.

Biochem/physiol Actions

A synthetic sweet tastant detectable by humans. Activates T1R2/T1R3 sweet taste receptors on enteroendocrine cells and elicits increased hormonal secretion of glucagon-like peptide-1 and glucose-dependent insulinotrophic peptide.

Analysis Note

These secondary standards offer multi-traceability to the USP, EP (PhEur) and BP primary standards, where they are available.

Other Notes

This Certified Reference Material (CRM) is produced and certified in accordance with ISO 17034 and ISO/IEC 17025. All information regarding the use of this CRM can be found on the certificate of analysis.

Footnote

To see an example of a Certificate of Analysis for this material enter LRAA1094 in the slot below. This is an example certificate only and may not be the lot that you receive.

Safety Information

• wgk_germany: WGK 2
• flash_point_f: Not applicable
• flash_point_c: Not applicable