103669 Glycine

103669
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      Overview

      Replacement Information

      Key Specifications Table

      CAS #EC NumberHill FormulaChemical FormulaMolar MassGrade Value
      56-40-6 200-272-2 C₂H₅NO₂ H₂NCH₂COOH 75.06 g/mol Ph.Eur.,BP,JP,USP

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      1036691000
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          Plastic bottle 1 kg
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          1036695000
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              Plastic bottle 5 kg
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              1036699012
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                  Bucket, plastic 12 kg
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                  1036699025
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                      Fibre carton 25 kg
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                      1036699500
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                          Big Bag 500 kg
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                          Description
                          Catalogue Number103669
                          SynonymsGly, Aminoacetic acid, Aminoethanoic acid
                          References
                          Product Information
                          CAS number56-40-6
                          EC number200-272-2
                          GradePh.Eur.,BP,JP,USP
                          Hill FormulaC₂H₅NO₂
                          Chemical formulaH₂NCH₂COOH
                          Molar Mass75.06 g/mol
                          HS Code2922 49 85
                          Applications
                          Biological Information
                          Physicochemical Information
                          Density1.161 g/cm3 (20 °C)
                          Melting Point233 °C
                          pH value5.9 - 6.4 (50 g/l, H₂O, 20 °C)
                          Vapor pressure0.0000171 Pa (25 °C)
                          Bulk density920 kg/m3
                          Solubility250 g/l
                          Dimensions
                          Materials Information
                          Toxicological Information
                          Safety Information according to GHS
                          RTECSMB7600000
                          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 +5°C to +30°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 (perchloric acid titration, calculated on dried substance)98.5 - 101.0 %
                          Identity (IR-spectrum)passes test
                          Appearancewhite to almost white granules
                          Appearance of solution (100 g/l, CO₂-free water)clear and colorless and not more intense in color than reference solution Y₇
                          pH (50 g/l CO₂-free water)5.9 - 6.4
                          Chloride (Cl)≤ 70 ppm
                          Sulfate (SO₄)≤ 65 ppm
                          Heavy metals (as Pb)≤ 10 ppm
                          As (Arsenic)≤ 2 ppm
                          Hydrolyzable substancespasses test
                          Related substances (TLC)passes test
                          Ninhydrin-positive substances (LC) (any ninhydrin-positive impurity)≤ 0.10 %
                          Ninhydrin-positive substances (LC) (ammonium (570 nm))≤ 0.02 %
                          Ninhydrin-positive substances (LC) (total impurities)≤ 1.0 %
                          Related substances (HPLC) (Impurity B)≤ 0.10 %
                          Related substances (HPLC) (Impurity H)≤ 0.10 %
                          Related substances (HPLC) (Impurity I)≤ 0.10 %
                          Related substances (HPLC) (unspecified impurities)≤ 0.10 %
                          Related substances (HPLC) (Sum of all impurities)≤ 0.2 %
                          Related compounds (HPLC) (Glycine anhydride)≤ 0.10 %
                          Related compounds (HPLC) (Iminodiacetic acid)≤ 0.10 %
                          Related compounds (HPLC) (Diglycine)≤ 0.10 %
                          Related compounds (HPLC) (Triglycine)≤ 0.10 %
                          Related compounds (HPLC) (Hexamethylenetetramine)≤ 0.10 %
                          Related compounds (HPLC) (Total impurities)≤ 1.0 %
                          Methanol (HS-GC)≤ 3000 ppm
                          Other residual solvents (ICH Q3C)excluded by manufacturing process
                          Loss on drying (105 °C, 2 h)≤ 0.2 %
                          Sulfated ash (600 °C)≤ 0.1 %
                          Bacterial endotoxins≤ 2.0 I.U./g
                          Total aerobic microbial count (TAMC)≤ 10 CFU/g
                          Total combined yeasts/moulds count (TYMC)≤ 10 CFU/g
                          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, JP, USP

                          Documentation

                          Material Qualification Dossier

                          Title

                          Quality Management Dossier

                          Title

                          Operational Excellence Dossier

                          Title

                          Glycine SDS

                          Title

                          Safety Data Sheet (SDS) 

                          Glycine Certificates of Analysis

                          Product Number PackagingSpecificationLot Number
                          1036691000 Plastic bottlePDF Specification Document
                          1036695000 Plastic bottlePDF Specification Document
                          1036699012 Bucket, plasticPDF Specification Document
                          1036699025 Fibre cartonPDF Specification Document
                          1036699500 Big BagPDF Specification Document

                          Certificates

                          Title

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                          Categories

                          Biopharmaceutical Manufacturing > Formulation > Liquid Dosage > Ingredients - Liquid
                          Small Molecule Pharmaceuticals > Formulation > Liquid Dosage Form > pH Adjustments and Isotonizers
                          Small Molecule Pharmaceuticals > Formulation > Liquid Dosage Form > Surfactants and Stabilizers
                          Biopharmaceutical Manufacturing > Formulation > Liquid Dosage > Surfactants and Stabilizers
                          Small Molecule Pharmaceuticals > Formulation > Liquid Dosage Form > Ingredients - Liquid
                          Biopharmaceutical Manufacturing > Formulation > Liquid Dosage > pH Adjustments and Isotonizers
                          Small Molecule Pharmaceuticals > Formulation > Liquid Dosage Form > Granulated Glycine