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LC1110 Bole white

powder low bacterial content, for internal use, suitable for use as excipient exp Ph Eur,BP

 

Order number Packaging Quantity Price €
AC28110 Fibre carton 25 kg inquire

 

Product information
Grade Ph Eur,BP
HS Code 2507 00 20
EC number 310-194-1
CAS number 1332-58-7

 

Chemical and physical data
Solubility (20 °C) insoluble
Density 2.6 g/cm3 (20 °C)
Bulk density 470 kg/m3
pH value 6 – 7 (50 g/l, H2O) (slurry)

 

Safety information
RTECS GF1670500
Storage class 10 – 13 Other liquids and solids
WGK NWG not water endangering
Disposal 14
Inorganic salts: Container I. Neutral solutions of the these salts: Container D. Before placing in Container D, check the pH with pH-Universal indicator strips (Item No. 109535).

 

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

 

Specifications
Identity passes test
Substances soluble in hydrochloric acid ≤ 1 %
Acidic or alkaline impurities passes test
Chloride (Cl) ≤ 0.0250 %
Sulphate (SO4) ≤ 0.1 %
Heavy metals (as lead) ≤ 0.0025 %
Ca (Calcium) ≤ 0.0250 %
Organic impurities passes test
Adsorption power passes test
Loss on ignition (600 °C) ≤ 15 %
Lumps passes test
Microbiological purity
– Total aerobic microbial count (TAMC)
≤ 1E+03 CFU/g
– Total yeast and mould count (TYMC) ≤ 1E+02 CFU/g
– Bile tolerant Gram negative Bacteria (absent in 1 g) conforms
– Escherichia coli (absent in 1 g) conforms
– Pseudomonas aeruginosa (absent in 1 g) conforms
– Staphylococcus aureus (absent in 1 g) conforms
– Candida albicans (absent in 1 g) conforms
– Salmonella ssp (absent in 10 g) conforms
Swelling power passes test
Residual solvents (Ph. Eur./ICH) Excluded by production process
Residues of metal catalysts or metal reagents acc. to EMEA/C HMP/SWP/4446/2000 are not likely to be present.
conforms to Ph Eur, BP