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LC2812 Gelatin

(sheets) suitable for use as excipient EMPROVE exp Ph Eur,BP,NF

 

Order number Packaging Quantity Price €
AC29812 Fibre case 1 kg Inquire

 

Product information
Grade Ph Eur,BP,NF
HS Code 3503 00 10
EC number 232-554-6
CAS number 9000-70-8

 

Chemical and physical data
Solubility (20 °C) (swelling)
pH value 3.8 – 7.6 (10 g/l, H2O, 25 °C)

 

Safety information
Storage class 10 – 13 Other liquids and solids
WGK NWG not 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.

 

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
Identity
– A: coloring (Ph. Eur.)
passes test
– B: gelatinizing property (Ph. Eur.) passes test
– C: turbidity (NF) passes test
– D: precipitate (NF) passes test
Appearance Colorless to yellowish-brownish, faint transparent plats.
Odor and water-insoluble substances passes test
pH (10 g/l, CO2-free water) 3.8 – 7.6
Conductivity (1.0 %, 30 °C) ≤ 1 mS/cm
Sulfur dioxide (SO2) ≤ 40 ppm
Heavy metals (as Pb) ≤ 10 ppm
As (Arsenic) ≤ 0.8 ppm
Cr (Chromium) ≤ 10.0 ppm
Fe (Iron) ≤ 30.0 ppm
Zn (Zinc) ≤ 30.0 ppm
Peroxide (as H2O2) ≤ 10 ppm
Residual solvents (Ph. Eur./USP/ICH) excluded by manufacturing process
Bloom value (about 200) 160 – 240
Ash (550 °C) ≤ 2.0 %
Loss on drying (105 °C) ≤ 15.0 %
plats about 70 * 225 * 0.1 mm
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