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100590 Glycine cryst.

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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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              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
              1.00590.1000 04027269222741
              1.00590.5000 04027269222758
              1.00590.9025 04027269222765

              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
              1.00590.1000 Plastic bottlePDF Specification Document
              1.00590.5000 Plastic bottlePDF Specification Document
              1.00590.9025 PDF 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