MERCK 100590 Glycine cryst. suitable for use as excipient EMPROVE exp Ph.Eur.,BP,JP,USP
MERCK

MERCK 100590 Glycine cryst. suitable for use as excipient EMPROVE exp Ph.Eur.,BP,JP,USP

5.889,62 TL
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KİMYASAL ÜRÜNLER
Stok Kodu
M.100590.1000
Fiyat
135,62 EUR + KDV
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Description
Catalogue Number 100590
Synonyms Gly, Aminoacetic acid, Aminoethanoic acid
Description Glycine cryst.
Product Information
CAS number 56-40-6
EC number 200-272-2
Grade Ph.Eur.,BP,JP,USP
Hill Formula C₂H₅NO₂
Chemical formula H₂NCH₂COOH
Molar Mass 75.06 g/mol
HS Code 2922 49 85
Structure formula Image
Physicochemical Information
Density 1.161 g/cm3 (20 °C)
Melting Point 233 °C (decomposition)
pH value 5.9 - 6.4 (50 g/l, H₂O, 20 °C)
Vapor pressure 0.0000171 Pa (25 °C)
Bulk density 920 kg/m3
Solubility 250 g/l soluble
Toxicological Information
LD 50 oral LD50 Rat 7930 mg/kg
Safety Information according to GHS
RTECS MB7600000
Storage class 10 - 13 Other liquids and solids
WGK WGK 1 slightly water endangering
Disposal 3
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.
Storage and Shipping Information
Storage Store at +5°C to +30°C.
Transport Information
Declaration (railroad and road) ADR, RID Kein Gefahrgut
Declaration (transport by air) IATA-DGR No Dangerous Good
Declaration (transport by sea) IMDG-Code No Dangerous Good
Specifications
Assay (perchloric acid titration, calculated on dried substance) 98.5 - 101.0 %
Identity (IR-spectrum) passes test
Appearance white 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
pH (50 g/l CO₂-free water) 5.9 - 6.4
Chloride (Cl) ≤ 70 ppm
Sulphate (SO₄) ≤ 65 ppm
Heavy metals (as Pb) ≤ 10 ppm
As (Arsenic) ≤ 2 ppm
Hydrolyzable substances passes 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 %
Related substances (HPLC) (Sum of all impurities) ≤ 0.2 %
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 ≤ 3.0 I.U./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, JP, USP
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MERCK 100590 Glycine cryst. suitable for use as excipient EMPROVE exp Ph.Eur.,BP,JP,USP M.100590.1000
MERCK 100590 Glycine cryst. suitable for use as excipient EMPROVE exp Ph.Eur.,BP,JP,USP

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