100895 SAFCSucralose granular

EMPROVE® ESSENTIAL Ph Eur,NF,JPE

Sucralose granular MSDS (material safety data sheet) or SDS, CoA and CoQ, dossiers, brochures and other available documents.

Quality Management Dossier
Operational Excellence Dossier
SDS
CoA
Certificates
Material Qualification Dossier

EC Number: 259-952-2 CAS #: 56038-13-2 Hill Formula: C₁₂H₁₉Cl₃O₈ Molar Mass: 397.63 g/mol Grade: Ph Eur,NF,JPE

Recommended Products

Overview

Replacement Information

Key Specifications Table

CAS #	EC Number	Hill Formula	Molar Mass	Grade Value
56038-13-2	259-952-2	C₁₂H₁₉Cl₃O₈	397.63 g/mol	Ph Eur,NF,JPE

Pricing & Availability

Catalog Number	Availability	Packaging	Qty/Pack	Price	Quantity
1008950010	Retrieving availability... — Limited Availability Stocked Discontinued Limited Quantities Available Available Login to See Inventory Stocked Limited Availability Stocked Remaining : Will advise Remaining : Will advise Will advise Contact Customer Service Contact Customer Service Contact Customer Service Contact Customer Service	Glass bottle	10 g	Retrieving price... Price could not be retrieved Minimum Quantity needs to be mulitiple of Upon Order Completion More Information You Saved () — Request Pricing Login to See Your Pricing	Check Availability —	Add To Favorites Add To Favorites Added To My Favorites
1008951000	Retrieving availability... — Limited Availability Stocked Discontinued Limited Quantities Available Available Login to See Inventory Stocked Limited Availability Stocked Remaining : Will advise Remaining : Will advise Will advise Contact Customer Service Contact Customer Service Contact Customer Service Contact Customer Service	Fibre case	1 kg	Retrieving price... Price could not be retrieved Minimum Quantity needs to be mulitiple of Upon Order Completion More Information You Saved () — Request Pricing Login to See Your Pricing	Check Availability —	Add To Favorites Add To Favorites Added To My Favorites
1008951001	Retrieving availability... — Limited Availability Stocked Discontinued Limited Quantities Available Available Login to See Inventory Stocked Limited Availability Stocked Remaining : Will advise Remaining : Will advise Will advise Contact Customer Service Contact Customer Service Contact Customer Service Contact Customer Service	Fibre case	1 kg	Retrieving price... Price could not be retrieved Minimum Quantity needs to be mulitiple of Upon Order Completion More Information You Saved () — Request Pricing Login to See Your Pricing	Check Availability —	Add To Favorites Add To Favorites Added To My Favorites
1008959010	Retrieving availability... — Limited Availability Stocked Discontinued Limited Quantities Available Available Login to See Inventory Stocked Limited Availability Stocked Remaining : Will advise Remaining : Will advise Will advise Contact Customer Service Contact Customer Service Contact Customer Service Contact Customer Service	Fibre carton	10 kg	Retrieving price... Price could not be retrieved Minimum Quantity needs to be mulitiple of Upon Order Completion More Information You Saved () — Request Pricing Login to See Your Pricing	Check Availability —	Add To Favorites Add To Favorites Added To My Favorites
1008959011	Retrieving availability... — Limited Availability Stocked Discontinued Limited Quantities Available Available Login to See Inventory Stocked Limited Availability Stocked Remaining : Will advise Remaining : Will advise Will advise Contact Customer Service Contact Customer Service Contact Customer Service Contact Customer Service	Fibre carton	10 kg	Retrieving price... Price could not be retrieved Minimum Quantity needs to be mulitiple of Upon Order Completion More Information You Saved () — Request Pricing Login to See Your Pricing	Check Availability —	Add To Favorites Add To Favorites Added To My Favorites

Description
Catalogue Number	100895

References

Product Information
CAS number	56038-13-2
EC number	259-952-2
Grade	Ph Eur,NF,JPE
Hill Formula	C₁₂H₁₉Cl₃O₈
Molar Mass	397.63 g/mol
HS Code	2932 14 00
Structure formula Image
Quality Level	MQ500

Applications

Biological Information

Physicochemical Information
Density	1.62 g/cm3 (20 °C) Not applicable
Melting Point	114.5 °C (decomposition)
pH value	6 - 8 (100 g/l, H₂O, 20 °C)
Solubility	300 g/l

Dimensions

Materials Information

Toxicological Information
LD 50 oral	LD50 Rat > 10000 mg/kg

Safety Information according to GHS
RTECS	LW5440140
Storage class	11 Combustible Solids
WGK	WGK 2 obviously hazardous to water
Disposal	3 Relatively unreactive organic reagents should be collected in container A. If halogenated, they should be collected in container B. For solid residues use container C.

Safety Information

Product Usage Statements

Storage and Shipping Information
Storage	Store at +15°C to +25°C.

Packaging Information

Transport Information
Declaration (railroad and road) ADR, RID	Kein Gefahrgut
Declaration (transport by air) IATA-DGR	UN 1845 , 9,
Declaration (transport by sea) IMDG-Code	UN 1845 , 9,

Supplemental Information

Specifications
Assay (HPLC, calc. on anhydrous substance)	98.0 - 102.0 %
Assay (calc. on anhydrous substance) (JPE)	98.0 - 102.0 %
Appearance of substance (description)	granular powder
Appearance of substance (color)	almost white
Identity (HPLC)	conforms
Identity (TLC)	conforms
Identity (IR)	conforms
Identity (Spec. rotation (Ph Eur))	conforms
Spec. Rotation [α²0/D (calc. on anhydrous substance) (Ph Eur/JPE)	+84.0 - +87.5 °
Spec. rotation α20/D (calc. on anhydrous substance) (NF)	+84.0 - +87.5 °
Appearance of solution (10 %, water)	conforms
pH-Test	Decrease of 1 pH unit max.
Heavy metals (as Pb)	≤ 0.0010 %
Methanol	≤ 0.1 %
Cyclohexane	≤ 3880 ppm
N,N-Dimethylformamide	≤ 880 ppm
Acetic acid	≤ 5000 ppm
Ethyl acetate	≤ 5000 ppm
Other residual solvents (ICH Q3C)	excluded by production process
Hydrolysis products	≤ 0.1 %
Impurities H and I	≤ 0.1 %
Monosaccharide-Chloride (as Fructose)	≤ 0.16 %
Related substances (Ph Eur)	≤ 0.5 %
Related substances (NF)	≤ 0.5 %
Other Disaccharide-Chlorides	≤ 0.5 %
Triphenylphosphine oxide	≤ 150 ppm
Residue on ignition	≤ 0.7 %
Water (according to Karl Fischer)	≤ 2.0 %
Particle Size (d90)	≥ 80 µm
Microbiological purity (Total aerobic microbial count (TAMC))	≤ 1E+03 CFU/g
Microbiological purity (Total yeast and mould count (TYMC))	≤ 1E+02 CFU/g
Bile tolerant Gram negative Bacteria (absent in 1 g)	conforms
Escherichia coli (absent in 1 g)	conforms
Pseudomonas aeruginosa (absent in 1 g)	conforms
Staphylococcus aureus (absent in 1 g)	conforms
Candida albicans (absent in 1 g)	conforms
Salmonella ssp (absent in 10 g)	conforms
Elemental impurity specifications have been set considering ICH Q3D (Guideline for Elemental Impurities). Class 1-3 elements are not likely to be present above the ICH Q3D option 1 limit, unless specified and indicated (*).
Corresponds to Ph Eur, NF, JPE

Documentation

Material Qualification Dossier

Title
EMPROVE® Material Qualification Dossier - 100895

Quality Management Dossier

Title
Sucralose granular EMPROVE® ESSENTIAL Ph Eur,NF,JPE

Operational Excellence Dossier

Title
Sucralose granular EMPROVE® ESSENTIAL Ph Eur,NF,JPE

Sucralose granular SDS

Title
Safety Data Sheet (SDS)

Sucralose granular Certificates of Analysis

Product Number	Packaging	Specification	Lot Number
1008950010	Glass bottle	PDF Specification Document	Enter Lot Number
1008951000	Fibre case	PDF Specification Document	Enter Lot Number
1008951001	Fibre case	PDF Specification Document	Enter Lot Number
1008959010	Fibre carton	PDF Specification Document	Enter Lot Number
1008959011	Fibre carton	PDF Specification Document	Enter Lot Number

Certificates

Title
Aflatoxin Certificate for 100895 Sucralose granular EMPROVE® ESSENTIAL Ph Eur,NF,JPE
BSE/TSE Certificate for 100895 Sucralose granular EMPROVE® ESSENTIAL Ph Eur,NF,JPE
GMO Certificate for 100895 Sucralose granular EMPROVE® ESSENTIAL Ph Eur,NF,JPE
Halal Certificate for 100895 Sucralose granular suitable for use as excipient EMPROVE® exp Ph Eur,NF
Kosher Certificate 100895 Sucralose granular suitable for use as excipient EMPROVE® exp Ph Eur,NF