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103669 Glicyna

granulowana EMPROVE® EXPERT Ph Eur,BP,ChP,JP,USP

Glicyna MSDS (material safety data sheet) or SDS, CoA and CoQ, dossiers, brochures and other available documents.

Synonyms: 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

Tabela kluczowych gatunków

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

Products

Numer katalogowyOpakowanie Ilość/opak.
1036691000 Butelka plastikowa 1 kg
1036695000 Butelka plastikowa 5 kg
1036699012 Kubel plastikowy 12 kg
1036699025 Pudlo tekturowe 25 kg
1036699500 Duza torba 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 Inne substancje ciekłe i stałe
WGKWGK 1 lekkie zanieczyszczenie wody
Disposal3
Względnie niereaktywne odczynniki organiczne należy zbierać w Kategorii A. Odczynniki chlorowcowane należy umieszczać w Kategorii B. Do pozostałości stałych stosować Kategorię C.
Safety Information
Product Usage Statements
Storage and Shipping Information
StoragePrzechowywać w +2°C do +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
Numer katalogowy GTIN
1036691000 04054839404696
1036695000 04054839404702
1036699012 04054839404818
1036699025 04054839404825
1036699500 04054839404832

Documentation

Emprove Dossier

TitleVersion
5.0

Quality Management Dossier (Open Access)

Title

Operational Excellence Dossier

Title

Glicyna MSDS

Title

Safety Data Sheet (SDS) 

Glicyna Certificates of Analysis

Numer katalogowy OpakowanieSpecyfikacjaNumer partii
1036691000 Butelka plastikowaDokument ze specyfikacją, w formacie PDF
1036695000 Butelka plastikowaDokument ze specyfikacją, w formacie PDF
1036699012 Kubel plastikowyDokument ze specyfikacją, w formacie PDF
1036699025 Pudlo tekturoweDokument ze specyfikacją, w formacie PDF
1036699500 Duza torbaDokument ze specyfikacją, w formacie PDF

Certificates

Title

Brochure

Title
Brochure
Granulated materials

Technical Info

Title
Application of Dry Granulation to Facilitate Raw Material Handling

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Kategorie

Biopharmaceutical Manufacturing > Formulation > Liquid Dosage > Ingredients - Liquid
Small Molecule Pharmaceuticals > Formulation > Liquid Dosage Form > Ingredients - Liquid
Small Molecule Pharmaceuticals > Formulation > Liquid Dosage Form > Granulated Pharmaceutical Raw Materials
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