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100419 Parteck® M 200 (Mannitol)

Overview

Replacement Information

Key Spec Table

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

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1004192500
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                                              Description
                                              Catalogue Number100419
                                              References
                                              Product Information
                                              CAS number69-65-8
                                              EC number200-711-8
                                              GradePh Eur,BP,ChP,JP,USP,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 Point166 - 168 °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 Rat 13500 mg/kg
                                              Safety Information according to GHS
                                              RTECSOP2060000
                                              Storage class10 - 13 Other liquids and solids
                                              WGKWGK 1 slightly hazardous to water
                                              Disposal3
                                              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
                                              StorageStore at +2°C to +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
                                              Identity (IR-spectrum)passes test
                                              Identity (wet chemistry)passes test
                                              Appearance of solution (13 %; water)passes test
                                              Free acidpasses test
                                              pH-value (10 %; water)4.5 - 7.5
                                              Melting point166 - 169
                                              Spec. rotation (α 25/D; 1 %; molybdate complex, calc. on anhydrous substance)137 - 145 °
                                              Conductivity (25°C) (20 %; water)≤ 20
                                              Arsenic (As)≤ 2
                                              Ni (Nickel) (#)≤ 1
                                              Pb (Lead)≤ 0.5
                                              Chloride (Cl)≤ 0.003 %
                                              Sulfate (SO₄)≤ 0.01 %
                                              Heavy metals (as Pb)≤ 5 ppm
                                              Oxalate (C₂O₄)≤ 0.02 %
                                              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 %
                                              Residual solvents (ICH Q3C)excluded by manufacturing process
                                              Related substances (HPLC) (Sum of all impurities)≤ 2.0 %
                                              Reducing sugars after hydrolysis/total sugar (as glucose)≤ 1
                                              Reducing sugars (as glucose)≤ 0.05
                                              Sulfated ash≤ 0.1
                                              Loss on Drying (105 °C)≤ 0.30 %
                                              Water≤ 0.5 %
                                              Particle size (< 53 µm)≤ 15 %
                                              Particle size (> 500 µm)≤ 15 %
                                              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, ChP, JP, USP, E 421
                                              Conforms to the purity criteria on food additives according to the current European Commission Regulation.
                                              Global Trade Item Number
                                              Catalogue Number GTIN
                                              1004192500 04022536958125
                                              1004199025 04027269146825
                                              1004199050 04022536696652
                                              CO1E1004192500 0
                                              CO1E1004199025 04061839008823
                                              CO1E1004199050 04061839008830
                                              CO1H1004199025 0
                                              CO1H1004199050 0
                                              CO1I1004192500 0
                                              CO1I1004199025 0
                                              CO1I1004199050 04061839802421

                                              Documentation

                                              Material Qualification Dossier

                                              TitleVersion
                                              9.0

                                              Quality Management Dossier (Open Access)

                                              Title

                                              Operational Excellence Dossier

                                              Title

                                              Parteck® M 200 (Mannitol) SDS

                                              Title

                                              Safety Data Sheet (SDS) 

                                              Parteck® M 200 (Mannitol) Certificates of Analysis

                                              Product Number PackagingSpecificationLot Number
                                              1004192500 Plastic bottlePDF Specification Document
                                              1004199025 Fibre cartonPDF Specification Document
                                              1004199050 Fibre cartonPDF Specification Document
                                              CO1E1004192500 PDF Specification Document
                                              CO1E1004199025 PDF Specification Document
                                              CO1E1004199050 PDF Specification Document
                                              CO1H1004199025 PDF Specification Document
                                              CO1H1004199050 PDF Specification Document
                                              CO1I1004192500 PDF Specification Document
                                              CO1I1004199025 PDF Specification Document
                                              CO1I1004199050 PDF Specification Document

                                              Certificates

                                              Title