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100590 Glycine cryst.

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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1005901000
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      Plastic bottle 1 kg
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      1005905000
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          1005909025
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              25 kg
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              1005909026
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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
                  1005909025 04027269222765
                  1005909026 04027269237578

                  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
                  1005909025 PDF Specification Document
                  1005909026 Fibre cartonPDF 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