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137036 di-Sodium hydrogen phosphate dihydrate

Overview

Replacement Information

Key Specifications Table

CAS #EC NumberHill FormulaChemical FormulaMolar MassGrade Value
10028-24-7231-448-7HNa₂O₄P * 2 H₂ONa₂HPO₄ * 2 H₂O177.99 g/molPh Eur,BP,USP

Pricing & Availability

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1370360001
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      Fibre case 3 x 1 kg
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      1370361000
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          Plastic bottle 1 kg
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          1370365000
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              Plastic bottle 5 kg
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              1370369012
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                  Bucket, plastic 12 kg
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                  1370369029
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                      Double PE Sack 25 kg
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                      Description
                      Catalogue Number137036
                      SynonymsSodium monohydrogen phosphate, Sodium phosphate dibasic
                      Descriptiondi-Sodium hydrogen phosphate dihydrate
                      References
                      Product Information
                      CAS number10028-24-7
                      EC number231-448-7
                      GradePh Eur,BP,USP
                      Hill FormulaHNa₂O₄P * 2 H₂O
                      Chemical formulaNa₂HPO₄ * 2 H₂O
                      Molar Mass177.99 g/mol
                      HS Code2835 22 00
                      Quality LevelMQ500
                      Applications
                      Biological Information
                      Physicochemical Information
                      Density2.1 g/cm3 (20 °C)
                      Melting Point92.5 °C Elimination of water of crystallisation
                      pH value9.0 - 9.4 (50 g/l, H₂O, 20 °C)
                      Bulk density850 - 1000 kg/m3
                      Solubility93 g/l
                      Dimensions
                      Materials Information
                      Toxicological Information
                      LD 50 oralLD50 Rat > 2000 mg/kg
                      Safety Information according to GHS
                      Storage class10 - 13 Other liquids and solids
                      WGKWGK 1 slightly hazardous to water
                      Disposal14
                      Inorganic salts: Container I. Neutral solutions of the these salts: Container D. Before placing in Container D, check the pH with pH-Universal indicator strips (Item No. 109535).
                      Safety Information
                      Product Usage Statements
                      Storage and Shipping Information
                      StorageStore at +2°C to +30°C.
                      Packaging Information
                      Transport Information
                      Supplemental Information
                      Specifications
                      Assay (calculated on dried substance according to Ph Eur)98.0 - 101.0 %
                      Assay (calculated on dried substance according to USP)98.0 - 100.5 %
                      Identitypasses test
                      Appearance of solutionpasses test
                      In water insoluble matter≤ 0.3 %
                      pH-value (5 %; water)8.9 - 9.2
                      Chloride (Cl)≤ 0.005 %
                      Sulfate (SO₄)≤ 0.02 %
                      As (Arsenic)≤ 0.0002 %
                      Fe (Iron)≤ 0.001 %
                      Sodium dihydrogen phosphate (NaH₂PO₄)≤ 1.7 %
                      Residual solvents (ICH Q3C)excluded by manufacturing process
                      Substances reducing potassium permanganate (as O)passes test
                      Loss on drying (130 °C)19.5 - 21.0 %
                      Endotoxins≤ 2.5 I.U./g
                      Total aerobic microbial count≤ 1E+02 CFU/g
                      Total yeast and mould count≤ 1E+02 CFU/g
                      DNases (Exo- and endonucleases) (not detectable)passes test
                      RNases (not detectable)passes test
                      Proteases (not detectable)passes test
                      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

                      Documentation

                      Material Qualification Dossier

                      TitleLot Number
                      2.0

                      Quality Management Dossier

                      Title

                      Operational Excellence Dossier

                      Title

                      di-Sodium hydrogen phosphate dihydrate SDS

                      Title

                      Safety Data Sheet (SDS) 

                      di-Sodium hydrogen phosphate dihydrate Certificates of Analysis

                      Product Number PackagingSpecificationLot Number
                      1370360001 Fibre casePDF Specification Document
                      1370361000 Plastic bottlePDF Specification Document
                      1370365000 Plastic bottlePDF Specification Document
                      1370369012 Bucket, plasticPDF Specification Document
                      1370369029 Double PE SackPDF Specification Document

                      Certificates

                      Title
                      Halal Certificate for 137036 di-Sodium phosphate dihydrate suitable for the biopharmaceutical production EMPROVE® bio Ph Eur,BP,USP