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100590 Glycine cryst.

EMPROVE® EXPERT Ph Eur,BP,ChP,JP,USP

Glycine cryst. 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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100590
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Overview

Replacement Information

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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      1005905000
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          Description
          Catalogue Number100590
          SynonymsGly, Aminoacetic acid, Aminoethanoic acid
          DescriptionGlycine cryst.
          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
          Structure formula ImageStructure formula Image
          Quality LevelMQ500
          Applications
          Biological Information
          Physicochemical Information
          Density1.161 g/cm3 (20 °C)
          Melting Point>233 °C (decomposition)
          pH value5.9 - 6.4 (50 g/l, H₂O, 20 °C)
          Vapor pressure0.0000171 Pa (25 °C)
          Bulk density920 kg/m3
          Solubility250 g/l soluble
          Dimensions
          Materials Information
          Toxicological Information
          LD 50 oralLD50 Rat 7930 mg/kg
          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, crystalline powder
          Appearance of solution (100 g/l, CO₂-free water)clear and colorless and not more intense in color than reference solution Y₇
          Acidity (50g/l, water)5.6 - 6.6
          pH (50 g/l CO₂-free water)5.9 - 6.4
          Transmittance of solution (50 g/l, water)≥ 98.0 %
          Chloride (Cl)≤ 70 ppm
          Sulfate (SO₄)≤ 60 ppm
          Fe (Iron)≤ 10 ppm
          Heavy metals (as Pb)≤ 10 ppm
          As (Arsenic)≤ 1 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
          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, ChP, JP, USP
          Global Trade Item Number
          Catalogue Number GTIN
          1005901000 04027269222741
          1005905000 04027269222758

          Documentation

          Material Qualification Dossier

          TitleVersion
          5.0

          Quality Management Dossier (Open Access)

          Title

          Operational Excellence Dossier

          Title

          Glycine cryst. SDS

          Title

          Safety Data Sheet (SDS) 

          Glycine cryst. Certificates of Analysis

          Product Number PackagingSpecificationLot Number
          1005901000 Plastic bottlePDF Specification Document
          1005905000 Plastic bottlePDF Specification Document

          Certificates

          Title

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          Categories

          Biopharmaceutical Manufacturing > Formulation > Liquid Dosage > Ingredients - Liquid
          Small Molecule Pharmaceuticals > Formulation > Liquid Dosage Form > Ingredients - Liquid
          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