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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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                                              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
                                              1005909012 04027269260668
                                              1005909025 04027269222765
                                              CO1E1005901000 04061839008892
                                              CO1E1005905000 04061839008908
                                              CO1E1005909012 0
                                              CO1E1005909025 04061839008915
                                              CO1I1005901000 04061839010772
                                              CO1I1005909012 0
                                              CO1I1005909025 04061839010789

                                              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
                                              1005909012 Bucket, plasticPDF Specification Document
                                              1005909025 PDF Specification Document
                                              CO1E1005901000 PDF Specification Document
                                              CO1E1005905000 PDF Specification Document
                                              CO1E1005909012 PDF Specification Document
                                              CO1E1005909025 PDF Specification Document
                                              CO1I1005901000 PDF Specification Document
                                              CO1I1005909012 PDF Specification Document
                                              CO1I1005909025 PDF Specification Document

                                              Certificates

                                              Title

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                                              Categories

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                                              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