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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

Products

Catalogue NumberPackaging Qty/Pack
1005900001 Fibre case 3 x 1 kg
1005901000 Plastic bottle 1 kg
1005905000 Plastic bottle 5 kg
1005909012 Bucket, plastic 12 kg
1005909025 25 kg
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
1005900001 04027269300494
1005901000 04027269222741
1005905000 04027269222758
1005909012 04027269260668
1005909025 04027269222765

Documentation

Material Qualification Dossier

TitleVersion
3.0

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
1005900001 Fibre casePDF Specification Document
1005901000 Plastic bottlePDF Specification Document
1005905000 Plastic bottlePDF Specification Document
1005909012 Bucket, plasticPDF Specification Document
1005909025 PDF 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 > 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