MERCK 106522.2500 Sodium -(S)- lactace- solution Emprove

Key Spec Table

Grade Value
Ph Eur,BP,USP

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Description
Catalogue Number	106522

Product Information
Grade	Ph Eur,BP,USP
HS Code	2918 11 00
Structure formula Image
Quality Level	MQ500

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 hazardous to water
Disposal	3Relatively 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 +15°C to +25°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 (in present substance)	6.5 - 9.0
Chloride (Cl)#	≤ 50 ppm
Sulfate (SO₄) (Ph Eur)#	≤ 100 ppm
Sulfate (SO₄) (USP)	passes test
Al (Aluminium)	≤ 0.1 ppm
Fe (Iron)#	≤ 10 ppm
K (Potassium)	≤ 100 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 sucrose (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 lactateElemental 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, USP
#calculated on sodium lactateElemental 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, USP