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108219 Tris(hydroxymethyl)aminomethane hydrochloride

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Tris(hydroxymethyl)aminomethane hydrochloride MSDS (material safety data sheet) or SDS, CoA and CoQ, dossiers, brochures and other available documents.

Synonyms: Trometamol, Aminomethylidine trimethanol, 2-Amino-2-hydroxymethyl-1.3-propanediol, TRIS-buffer

CAS #: 1185-53-1 EC Number: 214-684-5 Molar Mass: 157.60 g/mol Chemical Formula: C₄H₁₁NO₃*ClH Hill Formula: C₄H₁₁NO₃˙ ClH
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108219
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Overview

Replacement Information

Key Spec Table

CAS #EC NumberHill FormulaChemical FormulaMolar Mass
1185-53-1214-684-5C₄H₁₁NO₃˙ ClHC₄H₁₁NO₃*ClH157.60 g/mol

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          1.08219.9010
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              Description
              Catalogue Number108219
              SynonymsTrometamol, Aminomethylidine trimethanol, 2-Amino-2-hydroxymethyl-1.3-propanediol, TRIS-buffer
              DescriptionTris(hydroxymethyl)aminomethane hydrochloride
              References
              Product Information
              CAS number1185-53-1
              EC number214-684-5
              Hill FormulaC₄H₁₁NO₃˙ ClH
              Chemical formulaC₄H₁₁NO₃*ClH
              Molar Mass157.60 g/mol
              HS Code2922 19 99
              Structure formula ImageStructure formula Image
              Quality LevelMQ500
              Applications
              Biological Information
              Physicochemical Information
              Density1.28 g/cm3 (20.2 °C)
              Melting Point150.7 °C
              pH value4.2 (100 g/l, H₂O, 20 °C)
              Vapor pressure<0.1 hPa (50 °C)
              Solubility561 g/l soluble
              Dimensions
              Materials Information
              Toxicological Information
              Safety Information according to GHS
              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 +15°C to +25°C.
              Packaging Information
              Transport Information
              Supplemental Information
              Specifications
              Appearancewhite to almost white, crystalline powder
              Assay (alkalimetric, calculated on dried substance)≥ 99.0 %
              Identity (IR-spectrum)conforms
              pH-value (0.5 mol/l, water)3.5 - 5.0
              Melting point147 - 153 °C
              UV-Absorption (230 nm; 10 %; 1 cm; water)≤ 0.1
              UV-Absorption (260 nm; 10 %, 1 cm; water)≤ 0.06
              UV-Absorption (280 nm; 10 %; 1 cm; water)≤ 0.06
              UV-Absorption (300 nm; 10 %; 1 cm; water)≤ 0.02
              UV-Absorption (400 nm; 10 %; 1 cm; water)≤ 0.01
              Residual solvents (ICHQ3C) of class 2 (Methanol)≤ 3000 ppm
              Residual solvents (ICHQ3C) of class 2 (Nitromethane)≤ 50 ppm
              Residual solvents (ICHQ3C) of class 3 (Ethanol)≤ 5000 ppm
              Residual solvents (ICHQ3C) of class 3 (Ethylmethylketon)≤ 5000 ppm
              Other residual solvents (ICH Q3C)excluded by manufacturing process
              Sulfated ash≤ 0.03
              Loss on Drying (105°C)≤ 0.5
              Endotoxins< 2.5
              Total aerobic microbial count≤ 10²
              Total yeast and mould count
              ≤ 10²
              Salmonella spp.
              absent in 10 g
              E.coli
              absent in 1 g
              Staphylococcus aureus
              absent in 1 g
              Pseudomonas aeruginosa
              absent in 1 g
              Candida albicans
              absent in 1 g
              Bile tolerante gram negative bacteria
              absent in 1 g
              DNases (Exo- and endonucleases)
              not detected
              Proteases
              not detected
              RNases
              not detected
              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 (*).
              Total yeast and mould count
              ≤ 10²
              Salmonella spp.
              absent in 10 g
              E.coli
              absent in 1 g
              Staphylococcus aureus
              absent in 1 g
              Pseudomonas aeruginosa
              absent in 1 g
              Candida albicans
              absent in 1 g
              Bile tolerante gram negative bacteria
              absent in 1 g
              DNases (Exo- and endonucleases)
              not detected
              Proteases
              not detected
              RNases
              not detected
              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 (*).
              Global Trade Item Number
              Catalogue Number GTIN
              1.08219.1000 04022536101811
              1.08219.5000 04022536532899
              1.08219.9010 04022536702742

              Documentation

              Material Qualification Dossier

              TitleVersion
              6.0

              Quality Management Dossier (Open Access)

              Title

              Operational Excellence Dossier

              Title

              Tris(hydroxymethyl)aminomethane hydrochloride SDS

              Title

              Safety Data Sheet (SDS) 

              Tris(hydroxymethyl)aminomethane hydrochloride Certificates of Analysis

              Product Number PackagingSpecificationLot Number
              1.08219.1000 Plastic bottlePDF Specification Document
              1.08219.5000 Plastic bottlePDF Specification Document
              1.08219.9010 Plastic drumPDF Specification Document

              Certificates

              Title

              Brochure

              Title
              Emprove bio 新製品トリス塩酸塩-GMP グレード
              Emprove bio 新製品トリス塩酸塩-GMP グレード（評価用3 バッチ製品入り）
              バイオ医薬品製造用製品ガイド