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111597 SAFC山梨醇

EMPROVE® EXPERT Ph Eur,BP,NF,JP

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

Material Qualification Dossier
Quality Management Dossier (Open Access)
Operational Excellence Dossier
SDS
CoA
Certificates

Synonyms: D-Glucitol

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

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Overview

Replacement Information

Key Spec 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

Products

Catalogue Number	Packaging	Qty/Pack
1.11597.1003	塑膠瓶	1 kg	Add To Favorites Add To Favorites Added To My Favorites
1.11597.9012	塑膠滾桶	12 kg	Add To Favorites Add To Favorites Added To My Favorites
1.11597.9024	塑膠滾桶	25 kg	Add To Favorites Add To Favorites Added To My Favorites
1.11597.9028	纖維紙箱	25 kg	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
Quality Level	MQ500

Applications

Biological Information

Physicochemical Information
Density	1.49 g/cm3 (20 °C)
Ignition temperature	420 °C
Melting Point	98 - 100 °C
pH value	5.0 - 7 (182 g/l, H₂O, 25 °C)
Vapor pressure	<0.1 hPa (25 °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	WGK 1 slightly 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 +2°C to +25°C.

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 %
Ni (Nickel) (#)	≤ 1 ppm
Related substances (HPLC, Ph. Eur.) (major impurity)	≤ 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
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

Global Trade Item Number
Catalogue Number	GTIN
1.11597.1003	04027269171643
1.11597.9012	04027269138134
1.11597.9024	04027269170844
1.11597.9028	04022536936468

Documentation

Material Qualification Dossier

Title	Version
Material Qualification Dossier	11.0

Quality Management Dossier (Open Access)

Title
Quality Management Dossier

Operational Excellence Dossier

Title
Operational Excellence Dossier

山梨醇 MSDS

Title
Safety Data Sheet (SDS)

山梨醇 Certificates of Analysis

Product Number	Packaging	Specification	Lot Number
1.11597.1003	塑膠瓶	PDF Specification Document	Enter Lot Number
1.11597.9012	塑膠滾桶	PDF Specification Document	Enter Lot Number
1.11597.9024	塑膠滾桶	PDF Specification Document	Enter Lot Number
1.11597.9028	纖維紙箱	PDF Specification Document	Enter Lot Number

Certificates

Title
Aflatoxin Certificate for 111597 Parteck® SI 400 LEX (Sorbitol) EMPROVE® EXPERT Ph Eur,BP,NF,JP
BSE/TSE Certificate for 111597 Parteck® SI 400 LEX (Sorbitol) EMPROVE® EXPERT Ph Eur,BP,NF,JP
GMO Certificate for 111597 Parteck® SI 400 LEX (Sorbitol) EMPROVE® EXPERT Ph Eur,BP,NF,JP
Halal Certificate for 111597 Parteck® SI 400 LEX (Sorbitol) EMPROVE® EXPERT Ph Eur,BP,NF,JP
Kosher Certificate for 111597 Parteck® SI 400 LEX (Sorbitol) EMPROVE® EXPERT Ph Eur,BP,NF,JP
Supply Chain Information for 111597 Parteck® SI 400 LEX (Sorbitol) EMPROVE® EXPERT Ph Eur,BP,NF,JP

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