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PHR1342

Supelco

Sucralose

Pharmaceutical Secondary Standard; Certified Reference Material

Synonym(s):
1,6-Dichloro-1,6-dideoxy-β-D-fructofuranosyl-4-chloro-4-deoxy-α-D-galactopyranoside, E955, Trichlorosucrose, Sucralose
Empirical Formula (Hill Notation):
C12H19Cl3O8
CAS Number:
Molecular Weight:
397.63
Beilstein:
3654410
MDL number:
PubChem Substance ID:
NACRES:
NA.24

Quality Level

grade

certified reference material
pharmaceutical secondary standard

CofA

current certificate can be downloaded

technique(s)

HPLC: suitable
gas chromatography (GC): suitable

application(s)

pharmaceutical (small molecule)

format

neat

pharmacopeia traceability

traceable to PhEur Y0001344
traceable to USP 1623626

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

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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

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

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.

Storage Class Code

11 - Combustible Solids

WGK

WGK 2

Flash Point(F)

Not applicable

Flash Point(C)

Not applicable

Certificate of Analysis

Certificate of Origin

Evaluating the taste masking effectiveness of various flavors in a stable formulated pediatric suspension and solution using the [TM="Astree"] electronic tongue
Campbell GA, et al.
Powder Technology, 224(25), 109-123 (2012)
Physicochemical and microbiological stabilities of a sweetened and calorie-free metformin extemporaneous formulation for pediatrics
Alemon-Medina R, et al.
Latin American Journal of Pharmacy, 31(25), 1253-1260 (2012)
Comprehensive analysis of pharmaceutical products using simultaneous mixed-mode (ion-exchange/reversed-phase) and hydrophilic interaction liquid chromatography
Kazarian AA, et al.
Journal of Separation Science, 37(16), 2138-2144 (2014)
Analysis of sucralose and other sweeteners in water and beverage samples by liquid chromatography/time-of-flight mass spectrometry
Ferrer I and Thurman EM
Journal of Chromatography A, 1217(25), 4127-4134 (2010)
Sucralose--an overview of the toxicity data.
H C Grice et al.
Food and chemical toxicology : an international journal published for the British Industrial Biological Research Association, 38 Suppl 2, S1-S6 (2000-07-07)

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