Calcium gluconate monohydrate Manufacturer, Supplier, Exporter

Order number	Packaging	Quantity	Price
AC28233	Double PE Sack	25 kg	inquire

Product information
Grade	Ph Eur,BP,USP,FCC,E 578
Synonyms	D-Gluconic acid calcium salt monohydrate
Hill Formula	C₁₂H₂₂CaO₁₄ * H₂O
HS Code	2918 16 00
EC number	206-075-8
Molar mass	448.40 g/mol
CAS number	66905-23-5

Safety information
Storage class	EW1760000
WGK	10 - 13 Other liquids and solids
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.

Transport information
Declaration (transport by sea) IMDG-Code	No Dangerous Good
Declaration (transport by air) IATA-DGR	No Dangerous Good

Calcium gluconate monohydrate

Specifications
Assay (complexometric)	98.5 - 102.0 %
Identity - IR-spectrum	passes test
- TLC	passes test
- Calcium	passes test
Appearance	white or almost white, crystalline powder
Appearance of solution (20 g/l, water)	passes test
pH (50 g/l; water)	6.0 - 8.0
Chloride (Cl)	200 ppm
Sulfate (SO₄)	100 ppm
Oxalate (C₂O₄)	100 ppm
Phosphate (PO₄)	100 ppm
Heavy metals (as Pb)	10 ppm
As (Arsenic)	3 ppm
Cu (Copper)	25 ppm
Fe (Iron)	5 ppm
Pb (Lead)	2 ppm
Zn (Zinc)	25 ppm
Magnesium and alkali metals	0.4 %
Organic substances and boric acid	passes test
Residual solvents (Ph.Eur./USP/ICH)	excluded by manufacturing process
Organic volatile impurities (USP/NF)	conforms
Reducing substances (USP)	1.0 %
Sucrose and reducing sugars	passes test
Loss on drying (105 C, 16 h)	2.0 %
Microbiological test - Total aerobic microbial count (TAMC)	1000 CFU/g
- Total combined yeasts/moulds count (TYMC)	100 CFU/g
- Bile-tolerant gram-negative bacteria (absent in 1 g)	passes test
- Candida albicans (absent in 1 g)	passes test
- Escherichia coli (absent in 1 g)	passes test
- Pseudomonas aeruginosa .br (absent in 1 g)	passes test
- Salmonella (absent in 10 g)	passes test
- Staphylococcus aureus .br (absent in 1 g)	passes test
Residues of metal catalysts or metal reagents acc.to EMEA/CHMP/SWP/4446/2000 are not likely to be present. This product is not intended for use in preparing injectable dosage forms.

Toxicological data
LD 50 oral	LD50 rat > 5000 mg/kg