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105988 D(-)-Manitol

jemný prášok EMPROVE® ESSENTIAL Ph Eur,BP,USP,JP,FCC,E 421

D(-)-Manitol MSDS (material safety data sheet) or SDS, CoA and CoQ, dossiers, brochures and other available documents.
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
105988
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Overview

Replacement Information

Key Spec Table

CAS #EC NumberHill FormulaMolar MassGrade Value
69-65-8200-711-8C₆H₁₄O₆182.17 g/molPh Eur,BP,USP,JP,FCC,E 421

Products

Catalogue NumberPackaging Qty/Pack
1059881000 Plastová flaša 1 kg
1059889024 Dvojité PE vrecko 20 kg
Description
Catalogue Number105988
References
Product Information
CAS number69-65-8
EC number200-711-8
GradePh Eur,BP,USP,JP,FCC,E 421
Hill FormulaC₆H₁₄O₆
Molar Mass182.17 g/mol
HS Code2905 43 00
Structure formula ImageStructure formula Image
Quality LevelMQ500
Applications
Biological Information
Physicochemical Information
Boiling point290 - 295 °C (4 hPa)
Density1.52 g/cm3 (20 °C)
Ignition temperature410 °C
Melting Point164 - 169 °C
pH value5.0 - 6.5 (182 g/l, H₂O, 25 °C)
Bulk density400 - 500 kg/m3
Solubility213 g/l
Dimensions
Materials Information
Toxicological Information
LD 50 oralLD50 Potkan 13500 mg/kg
Safety Information according to GHS
RTECSOP2060000
Storage class10 - 13 Iné kvapaliny a tuhé látky
WGKWGK 1 mierne ohrozujúce vody
Disposal3
Relatívne nereaktívne organické reagencie je potrebné zhromaždovať v nádobe A. Ak sú halogénované, je potrebné ich zhromaždovať v nádobe B. Pre tuhé zvyšky použite nádobu C.
Safety Information
Product Usage Statements
Storage and Shipping Information
StorageSkladujte pri +2°C až +25°C.
Packaging Information
Transport Information
Declaration (railroad and road) ADR, RIDKein Gefahrgut
Declaration (transport by air) IATA-DGRNo Dangerous Good
Declaration (transport by sea) IMDG-CodeNo 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 point165 - 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 testpasses test
Colony count (aerobic bacteria (TAMC))≤ 10³
Colony count (Yeasts and moulds (TYMC))≤ 10²
Salmonella spp.in 10g Substance not detectable
E.coliin 1g Substance not detectable
Staphylococcus aureusin 1g Substance not detectable
Pseudomonas aeruginosain 1g Substance not detectable
Candida albicansIn 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

TitleVersion
8.0

Quality Management Dossier (Open Access)

Title

Operational Excellence Dossier

Title

D(-)-Manitol MSDS

Title

Safety Data Sheet (SDS) 

D(-)-Manitol Certificates of Analysis

Product Number PackagingSpecificationLot Number
1059881000 Plastová flašaPDF Specification Document
1059889024 Dvojité PE vreckoPDF Specification Document

Certificates

Title

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Categories

Biopharmaceutical Manufacturing > Formulation > Liquid Dosage > Surfactants and Stabilizers
Small Molecule Pharmaceuticals > Formulation > Solid Dosage Form > Binders and Fillers
Biopharmaceutical Manufacturing > Formulation > Liquid Dosage > Tonicity Agents
Small Molecule Pharmaceuticals > Formulation > Liquid Dosage Form > Tonicity Agents
Small Molecule Pharmaceuticals > Formulation > Liquid Dosage Form > Surfactants and Stabilizers