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105988 SAFCD(-)-Mannitol

fine powder EMPROVE® ESSENTIAL Ph Eur,BP,USP,JP,FCC,E 421

D(-)-Mannitol 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

CAS #: 69-65-8 EC Number: 200-711-8 Molar Mass: 182.17 g/mol Hill Formula: C₆H₁₄O₆ Grade: Ph Eur,BP,USP,JP,FCC,E 421

Recommended Products

Overview

Replacement Information

Key Spec Table

CAS #	EC Number	Hill Formula	Molar Mass	Grade Value
69-65-8	200-711-8	C₆H₁₄O₆	182.17 g/mol	Ph Eur,BP,USP,JP,FCC,E 421

Products

Catalogue Number	Packaging	Qty/Pack
1059881000	Plastic bottle	1 kg	Add To Favorites Add To Favorites Added To My Favorites
1059889024	Double PE Sack	20 kg	Add To Favorites Add To Favorites Added To My Favorites

Description
Catalogue Number	105988

References

Product Information
CAS number	69-65-8
EC number	200-711-8
Grade	Ph Eur,BP,USP,JP,FCC,E 421
Hill Formula	C₆H₁₄O₆
Molar Mass	182.17 g/mol
HS Code	2905 43 00
Structure formula Image
Quality Level	MQ500

Applications

Biological Information

Physicochemical Information
Boiling point	290 - 295 °C (4 hPa)
Density	1.52 g/cm3 (20 °C)
Ignition temperature	410 °C
Melting Point	164 - 169 °C
pH value	5.0 - 6.5 (182 g/l, H₂O, 25 °C)
Bulk density	400 - 500 kg/m3
Solubility	213 g/l

Dimensions

Materials Information

Toxicological Information
LD 50 oral	LD50 Rat 13500 mg/kg

Safety Information according to GHS
RTECS	OP2060000
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 dried substance)	98.0 - 101.0 %
Identity (NIR)	passes test
Appearance of solution (10 %; water)	passes test
pH-value (10 %; water)	4.5 - 7.5
Melting point	165 - 169
Conductivity (25°C) (20 %; water)	≤ 20
Heavy metals (as Pb)	≤ 5 ppm
Ni (Nickel) (#)	≤ 1 ppm
Pb (Lead)	≤ 0.5 ppm
Related substances (HPLC) (Sorbitol (Impurity A))	≤ 2.0 %
Related substances (HPLC) (Sum of Maltitol and Isomalt (Impurities B and C))	≤ 2.0
Related substances (HPLC) (Major unspecified impurity)	≤ 0.10 %
Related substances (HPLC) (Sum of all impurities)	≤ 2.0 %
Reducing sugars (as glucose)	≤ 0.05
Reducing sugars after hydrolysis/total sugar (as glucose)	≤ 1
Sulfated ash	≤ 0.1
Water	≤ 0.5 %
Loss on Drying (105 °C)	≤ 0.30 %
Particle size (> 150 µm)	≤ 2 %
Residual solvents (ICH Q3C)	excluded by manufacturing process
Microbiological test	passes test
Colony count (aerobic bacteria (TAMC))	≤ 10³
Colony count (Yeasts and moulds (TYMC))	≤ 10²
Salmonella spp.	in 10g Substance not detectable
E.coli	in 1g Substance not detectable
Staphylococcus aureus	in 1g Substance not detectable
Pseudomonas aeruginosa	in 1g Substance not detectable
Candida albicans	In 1g Substance not detectable
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, USP, JP, FCC, E 421 Conforms to the purity criteria on food additives according to the current European Commission Regulation.

Global Trade Item Number
Catalogue Number	GTIN
1059881000	04022536961385
1059889024	04022536934037

Documentation

Material Qualification Dossier

Title	Version
Material Qualification Dossier	8.0

Quality Management Dossier (Open Access)

Title
Quality Management Dossier

Operational Excellence Dossier

Title
Operational Excellence Dossier

D(-)-Mannitol SDS

Title
Safety Data Sheet (SDS)

D(-)-Mannitol Certificates of Analysis

Product Number	Packaging	Specification	Lot Number
1059881000	Plastic bottle	PDF Specification Document	Enter Lot Number
1059889024	Double PE Sack	PDF Specification Document	Enter Lot Number

Certificates

Title
BSE/TSE Certificate for 105988 D(-)-Mannitol fine powder EMPROVE® ESSENTIAL Ph Eur,BP,USP,JP,FCC,E 421
GMO Certificate for 105988 D(-)-Mannitol fine powder EMPROVE® ESSENTIAL Ph Eur,BP,USP,JP,FCC,E 421
Halal Certificate for 105988 D(-)-Mannitol fine powder EMPROVE® ESSENTIAL Ph Eur,BP,USP,JP,FCC,E 421
Kosher Certificate for 105988 D(-)-Mannitol fine powder EMPROVE® ESSENTIAL Ph Eur,BP,USP,JP,FCC,E 421

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105988 SAFCD(-)-Mannitol

fine powder EMPROVE® ESSENTIAL Ph Eur,BP,USP,JP,FCC,E 421

Recommended Products

Overview

Key Spec Table

Products

Documentation

Material Qualification Dossier

Quality Management Dossier (Open Access)

Operational Excellence Dossier

D(-)-Mannitol SDS

D(-)-Mannitol Certificates of Analysis

Certificates

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