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103669 Glycine

Ph Eur,BP,ChP,JP,USP

Glycine : FDS (Fiches de données de sécurité), certificats d’analyse (CoA) et de qualité (CoQ), dossiers, brochures et autres documents disponibles.

Synonymes: 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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Tableau de caractéristiques principal

CAS #EC NumberHill FormulaChemical FormulaMolar MassGrade Value
56-40-6200-272-2C₂H₅NO₂H₂NCH₂COOH75.07 g/molPh Eur,BP,ChP,JP,USP
Description
Catalogue Number103669
SynonymsGly, Aminoacetic acid, Aminoethanoic acid
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
Quality LevelMQ500
Applications
Biological Information
Physicochemical Information
Density1.161 g/cm3 (20 °C)
Melting Point233 °C
pH value5.9 - 6.4 (50 g/l, H₂O, 20 °C)
Vapor pressure0.0000171 Pa (25 °C)
Bulk density920 kg/m3
Solubility250 g/l
Dimensions
Materials Information
Toxicological Information
Safety Information according to GHS
RTECSMB7600000
Safety Information
Product Usage Statements
Storage and Shipping Information
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 granules
Appearance of solution (100 g/l, CO₂-free water)clear and colorless and not more intense in color than reference solution Y₇
Transmittance of solution (50 g/l, water)≥ 98.0 %
pH (50 g/l CO₂-free water)5.9 - 6.4
Acidity (50g/l, water)5.6 - 6.6
Chloride (Cl)≤ 70 ppm
Sulfate (SO₄)≤ 60 ppm
Heavy metals (as Pb)≤ 10 ppm
As (Arsenic)≤ 1 ppm
Fe (Iron)≤ 10 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
Sulfated ash (600 °C)≤ 0.1 %
Loss on drying (105 °C, 2 h)≤ 0.2 %
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

TitreVersion
7.0

Quality Management Dossier (Open Access)

Title

Operational Excellence Dossier

Title

Glycine FDS

Titre

Fiche de données de sécurité des matériaux (FDS) 

Glycine Certificats d'analyse

Référence ConditionnementNuméro de lot
103669

Certificats

Titre

Brochure

Titre
Brochure
Granulated materials

Informations techniques

Titre
Application of Dry Granulation to Facilitate Raw Material Handling

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Produits associés classés par : Application Facete

Surfactants and Stabilizers

Produits associés classés par : Brand Facete

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Catégories

Biopharmaceutical Manufacturing > Formulation > Liquid Dosage > Ingredients - Liquid
Small Molecule Pharmaceuticals > Formulation > Liquid Dosage Form > Ingredients - Liquid
Small Molecule Pharmaceuticals > Formulation > Liquid Dosage Form > Matières premières pharmaceutiques en granules
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