MERCK 106522 Sodium-(S)-lactate-solution about 50% suitable for use as exipient EMPROVE® exp Ph Eur,BP,USP

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Stok Kodu
106522.2500
Kategori
Havale
5.314,68 TL (%5,00 havale indirimi)
* 597,02 TL den başlayan taksitlerle!!
5.594,40 TL KDV DAHİL
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Description
Catalogue Number 106522
Product Information
Grade Ph Eur,BP,USP
HS Code 2918 11 00
Structure formula Image
Physicochemical Information
Boiling point 109 °C (1013 hPa)
Density 1.263 g/cm3 (20 °C)
pH value 6.5 - 9.0 (H₂O)
Safety Information according to GHS
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*) 50.0 - 51.0 %
Assay (Stereochemical purity of sodium(S)-lactate) ≥ 95.0 %
Identity (Sodium) passes test
Identity (Lactat) passes test
Appearance of solution Clear and not more intense in color than reference solution BY₇
pH (for the substance to be examined) 6.5 - 9.0
Chlorid (Cl)* ≤ 50 ppm
Sulfate (SO₄) (Ph. Eur.*) ≤ 100 ppm
Sulphate (SO₄) (USP) passes test
Heavy metals (as Pb)* ≤ 10 ppm
Al (Aluminium) ≤ 0.1 ppm
As (Arsenic)* ≤ 3 ppm
Ba (Barium) passes test
Fe (Iron)* ≤ 10 ppm
Hg (Mercury) ≤ 1 ppm
Pb (Lead) ≤ 5 ppm
Oxalate and Phosphate (Ph. Eur.) passes test
Citrate, Oxalate, Phosphate or Tartrate (USP) passes test
Methanol and Methyl Esters ≤ 250 ppm
Reducing sugars and saccharose (Ph. Eur.) passes test
Sugar (USP) passes test
Methanol* ≤ 50 ppm
Residual solvents (ICH Q3C) excluded by manufacturing process
Total aerobic microbial count (TAMC) ≤ 100 CFU/ml
Total combined yeasts/moulds count (TYMC) ≤ 10 CFU/ml
Bile-tolerant gram-negative bacteria (absent in 1 ml) passes test
Candida albicans (absent in 1 ml) passes test
Escherichia coli (absent in 1 ml) passes test
Pseudomonas aeruginosa (absent in 1 ml) passes test
Salmonella (absent in 10 ml) passes test
Staphylococcus aureus (absent in 1 ml) passes test
Endotoxins < 5
*calculated on sodium lactate
Residues of metal catalysts or metal reagents acc. to EMEA/CHMP/SWP/4446/2000
are not likely to be present.
Corresponds to Ph. Eur., BP, USP
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MERCK 106522 Sodium-(S)-lactate-solution about 50% suitable for use as exipient EMPROVE® exp Ph Eur,BP,USP

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