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103669 Glycine

Ph Eur,BP,ChP,JP,USP

Glycine: MSDS (material safety data sheet) o SDS, certificato d’analisi (CoA) e certificato di qualità (CoQ), dossier, brochure e altri documenti disponibili.

Sinonimi: 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
103669
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Replacement Information

Tabella delle specifiche principali

CAS #EC NumberHill FormulaChemical FormulaMolar MassGrade Value
56-40-6200-272-2C₂H₅NO₂H₂NCH₂COOH75.07 g/molPh Eur,BP,ChP,JP,USP

Products

Numero di catalogoConfezionamento Qtà/conf
1036691000 Bottiglia di plastica 1 kg
1036695000 Bottiglia di plastica 5 kg
1036699012 Recip. in plastica 12 kg
1036699025 Carton fibra 25 kg
1036699500 Big Bag 500 kg
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
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 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
Global Trade Item Number
Numero di catalogo GTIN
1036691000 04054839404696
1036695000 04054839404702
1036699012 04054839404818
1036699025 04054839404825
1036699500 04054839404832

Documentation

Material Qualification Dossier

TitoloVersione
5.0

Quality Management Dossier (Open Access)

Title

Operational Excellence Dossier

Title

Glycine MSDS

Titolo

Scheda di sicurezza (MSDS) 

Glycine Certificati d'Analisi

N° Catalogo ConfezionamentoSpecificaNumero di lotto
1036691000 Bottiglia di plasticaSpecifiche (pdf)
1036695000 Bottiglia di plasticaSpecifiche (pdf)
1036699012 Recip. in plasticaSpecifiche (pdf)
1036699025 Carton fibraSpecifiche (pdf)
1036699500 Big BagSpecifiche (pdf)

Certificati

Titolo

Brochure

Titolo
Brochure
Granulated materials

Informazioni tecniche

Titolo
Application of Dry Granulation to Facilitate Raw Material Handling

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Categorie

Biopharmaceutical Manufacturing > Formulation > Liquid Dosage > Ingredients - Liquid
Small Molecule Pharmaceuticals > Formulation > Liquid Dosage Form > Ingredients - Liquid
Small Molecule Pharmaceuticals > Formulation > Liquid Dosage Form > Materie prime farmaceutiche granulari
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