111597 SAFCParteck® SI 400 LEX (Sorbitol)

suitable for use as excipient EMPROVE® exp Ph Eur,BP,NF,JP

Parteck® SI 400 LEX (Sorbitol) 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

Synonyms: D-Glucitol

EC Number: 200-061-5 Molar Mass: 182.17 g/mol CAS #: 50-70-4 Grade: Ph Eur,BP,NF,JP Hill Formula: C₆H₁₄O₆

Overview

Replacement Information

Key Specifications Table

CAS #	EC Number	Hill Formula	Molar Mass	Grade Value
50-70-4	200-061-5	C₆H₁₄O₆	182.17 g/mol	Ph Eur,BP,NF,JP

Pricing & Availability

Catalog Number	Availability	Packaging	Qty/Pack	Price	Quantity
1115979012	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	Plastic drum	12 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
1115979023	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	Plastic drum	25 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
1115979024	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	Plastic drum	25 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
1.11597.9027	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	25 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	111597
Synonyms	D-Glucitol

References

Product Information
CAS number	50-70-4
EC number	200-061-5
Grade	Ph Eur,BP,NF,JP
Hill Formula	C₆H₁₄O₆
Molar Mass	182.17 g/mol
HS Code	2905 44 91
Structure formula Image

Applications

Biological Information

Physicochemical Information
Density	1.49 g/cm3 (20 °C)
Flash point	>100 °C
Ignition temperature	420 °C
Melting Point	94 - 96 °C
pH value	6 - 7 (100 g/l, H₂O, 20 °C)
Bulk density	450 kg/m3
Solubility	2350 g/l

Dimensions

Materials Information

Toxicological Information
LD 50 oral	LD50 Rat 15900 mg/kg

Safety Information according to GHS
RTECS	LZ4290000
Storage class	10 - 13 Other liquids and solids
WGK	NWG not water endangering
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	Storage temperature: no restrictions.

Packaging Information

Transport Information
Declaration (railroad and road) ADR, RID	Kein Gefahrgut
Declaration (transport by air) IATA-DGR	No Dangerous Good
Declaration (transport by sea) IMDG-Code	No Dangerous Good

Supplemental Information

Specifications
Assay (HPLC, calc.on anhydrous substance)	97.0 - 100.5 %
Identity	passes test
pH-value (10 %; water)	3.5 - 7.0
Appearance of solution (25 %; water)	passes test
Spec. rotation (α20/D, 10 %, borate complex, calc. on anhydrous substance)	+4.0 - +7.0 °
Conductivity (25°C) (20 %; water)	≤ 20
Chloride (Cl)	≤ 0.002 %
Sulfate (SO₄)	≤ 0.006 %
Heavy metals (as Pb)	≤ 5 ppm
As (Arsenic)	≤ 1.0 ppm
Ni (Nickel) (#)	≤ 1 ppm
Pb (Lead)	≤ 0.5 ppm
Related substances (HPLC, EP) (Major impurity (Mannitol))	≤ 2.0 %
Related substances (HPLC, EP) (Sum of all impurities)	≤ 3.0 %
Reducing sugars after hydrolysis/total sugar (as glucose)	≤ 0.8
Reducing sugars (as glucose)	≤ 0.11 %
Sulfated ash	≤ 0.02 %
Loss on drying	≤ 2.0 %
Water	≤ 1.5 %
Residual solvents (ICH Q3C)	excluded by manufacturing process
Microbiological test	passes test
Colony count (aerobic bacteria (TAMC))	≤ 10²
Colony count (Yeasts and moulds (TYMC))	≤ 10²
Salmonella spp.	in 10g Substance not detectable
E.coli	in 1g substance not detectable
Pseudomonas aeruginosa	in 1g substance not detectable
Staphylococcus aureus	in 1g substance not detectable
Candida albicans	In 1g substance not detectable
Endotoxins	≤ 1
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., BP, NF, JP

Documentation

Material Qualification Dossier

Title
EMPROVE® Material Qualification Dossier - 111597

Quality Management Dossier

Title
Parteck® SI 400 LEX (Sorbitol) suitable for use as excipient EMPROVE® exp Ph Eur,BP,NF,JP

Operational Excellence Dossier

Title
Parteck® SI 400 LEX (Sorbitol) suitable for use as excipient EMPROVE® exp Ph Eur,BP,NF,JP

Parteck® SI 400 LEX (Sorbitol) SDS

Title
Safety Data Sheet (SDS)

Parteck® SI 400 LEX (Sorbitol) Certificates of Analysis

Product Number	Packaging	Specification	Lot Number
1115979012	Plastic drum	PDF Specification Document	Enter Lot Number
1115979023	Plastic drum	PDF Specification Document	Enter Lot Number
1115979024	Plastic drum	PDF Specification Document	Enter Lot Number
1.11597.9027	Fibre carton	PDF Specification Document	Enter Lot Number

Certificates

Title
Aflatoxin Certificate for 111597 Parteck® SI 400 LEX (Sorbitol) suitable for use as excipient EMPROVE® exp Ph Eur,BP,NF,JP
BSE/TSE Certificate for 111597 Parteck® SI 400 LEX (Sorbitol) suitable for use as excipient EMPROVE® exp Ph Eur,BP,NF,JP
GMO Certificate for 111597 Parteck® SI 400 LEX (Sorbitol) suitable for use as excipient EMPROVE® exp Ph Eur,BP,NF,JP
Halal Certificate for 111597 Parteck® SI 400 LEX (Sorbitol) EMPROVE®
Kosher Certificate 111597 Parteck® 400 LEX (Sorbitol) suitable for use as excipient EMPROVE® exp Ph Eur,BP,NF,JP