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100590 Glycine cryst.

Overview

Replacement Information

Key Specifications Table

CAS #EC NumberHill FormulaChemical FormulaMolar MassGrade Value
56-40-6 200-272-2 C₂H₅NO₂ H₂NCH₂COOH 75.06 g/mol Ph Eur,BP,ChP,JP,USP

Pricing & Availability

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1005900001
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      1005901000
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          1005905000
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              1005909012
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                  Bucket, plastic 12 kg
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                  1005909025
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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 Mass75.06 g/mol
                      HS Code2922 49 85
                      Structure formula ImageStructure formula Image
                      Quality LevelMQ500
                      Applications
                      Biological Information
                      Physicochemical Information
                      Density1.161 g/cm3 (20 °C)
                      Melting Point233 °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

                      Documentation

                      Material Qualification Dossier

                      Title

                      Quality Management Dossier

                      Title

                      Operational Excellence Dossier

                      Title

                      Glycine cryst. SDS

                      Title

                      Safety Data Sheet (SDS) 

                      Glycine cryst. Certificates of Analysis

                      Product Number PackagingSpecificationLot Number
                      1005900001 Fibre casePDF Specification Document
                      1005901000 Plastic bottlePDF Specification Document
                      1005905000 Plastic bottlePDF Specification Document
                      1005909012 Bucket, plasticPDF Specification Document
                      1005909025 Fibre cartonPDF Specification Document

                      Certificates

                      Title

                      Related Products & Applications

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                      Categories

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