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103669 Glycine

granulated EMPROVE® EXPERT Ph Eur,BP,ChP,JP,USP

Glycine MSDS (material safety data sheet) or SDS, CoA and CoQ, dossiers, brochures and other available documents.

Synonyms: Gly, Aminoacetic acid, Aminoethanoic acid

CAS #: 56-40-6 EC Number: 200-272-2 Molar Mass: 75.07 g/mol Chemical Formula: H₂NCH₂COOH Hill Formula: C₂H₅NO₂ Grade: Ph Eur,BP,ChP,JP,USP
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103669
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Key Spec Table

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

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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
      Catalogue Number GTIN
      1.03669.1000 04054839404696

      Documentation

      Material Qualification Dossier

      TitleVersion
      5.0

      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
      1.03669.1000 Plastic bottlePDF 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