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Calcium gluconate monohydrate

Calcium gluconate monohydrate
Calcium gluconate monohydrate
Product Code : LC1233
Product Description
LC1233 Calcium gluconate monohydrate
suitable for use as excipient exp Ph Eur,BP,USP,FCC,E 578

 

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

 

Chemical and physical data
Solubility 30 g/l (20 °C)
Melting point 178 °C
Molar mass 448.40 g/mol
Bulk density 560 kg/m3
pH value 6.4 - 8.0 (50 g/l, H2O, 20 °C)

 

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

 

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

 

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 Â°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.
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