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103669 Glycine

Overview

Replacement Information

Key Specifications Table

CAS #EC NumberHill FormulaChemical FormulaMolar MassGrade Value
56-40-6200-272-2C₂H₅NO₂H₂NCH₂COOH75.07 g/molPh Eur,BP,ChP,JP,USP

Pricing & Availability

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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,ChP,JP,USP
                      Hill FormulaC₂H₅NO₂
                      Chemical formulaH₂NCH₂COOH
                      Molar Mass75.07 g/mol
                      HS Code2922 49 10
                      Quality LevelMQ500
                      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 +2°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)99.0 - 101.0 %
                      Identity (IR-spectrum)passes test
                      Identity (TLC)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
                      Transmittance of solution (50 g/l, water)≥ 98.0 %
                      pH (50 g/l CO₂-free water)5.9 - 6.4
                      Acidity (50g/l, water)5.6 - 6.6
                      Chloride (Cl)≤ 70 ppm
                      Sulfate (SO₄)≤ 60 ppm
                      Heavy metals (as Pb)≤ 10 ppm
                      As (Arsenic)≤ 1 ppm
                      Fe (Iron)≤ 10 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 %
                      Sum of impurities (Ph Eur)≤ 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 %
                      Sum of impurities (USP)≤ 1.0 %
                      Methanol (HS-GC)≤ 3000 ppm
                      Other residual solvents (ICH Q3C)excluded by manufacturing process
                      Sulfated ash (600 °C)≤ 0.1 %
                      Loss on drying (105 °C, 2 h)≤ 0.2 %
                      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, ChP, JP, USP
                      Global Trade Item Number
                      Catalog Number GTIN
                      1036691000 04054839404696
                      1036695000 04054839404702
                      1036699012 04054839404818
                      1036699025 04054839404825
                      1036699500 04054839404832

                      Documentation

                      Material Qualification Dossier

                      TitleVersion
                      4.0

                      Quality Management Dossier (Open Access)

                      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

                      Brochure

                      Title
                      Brochure
                      Granulated materials

                      Technical Info

                      Title
                      Application of Dry Granulation to Facilitate Raw Material Handling

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                      Categories

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