Appearance (Colour)
White crystalline
Appearance (Form)
Free flowing, fine powder
Solubility
10% aq. solution is completely soluble
Clarity of solution
10% w/v aqueous solution is clear and colourless
pH (25°C)
(10% aq.) 4.00 - 6.00
Residue on ignition
Max 0.03%
Chloride (CI)
Max 0.005%
Sulphate (SO4)
Max 0.005%
Heavy Metals (Pb)
Max 0.0001%
Dextrose
Passes test
Sucrose
Passes test
Acidity
Max. 0.25 ml
Nitrogen Compounds (N)
Max. 0.02%
Water (KF)
4.8 - 5.4%
Absorbance (A) of 1% aq. solution in a 1cm cell v/s H2O
@210 - 220 nm...max. 0.25
@270 - 300 nm...max. 0.07
Sterility (Bacterial count)
No growth is observed after 14 days for bacteria at 30-35°C and for fungi at 20-25°C
Cultural Response
Cultural response observed after an incubation at 35 ± 2°C for 18 - 24 hours by preparing Phenol Red Broth Base (14517) using 0.5% of Lactose monohydrate, Sterile (Gamma Irradiated)
Organism
Enterobacter aerogenes ATCC 13048
Inoculum (cfu) 10-100
Growth: Good, Acid: + , Gas production: +
Organism
Escherichia coli ATCC 25922
Inoculum (cfu) 10-100
Growth: Good, Acid: + , Gas production: +
Organism
Proteous vulgaris ATCC 13315
Inoculum (cfu) 10-100
Growth: Good, Acid: -- , Gas production: --
Organism
Salmonella typhimurium ATCC 14028
Inoculum (cfu) 10-100
Growth: Good, Acid: -- , Gas production: --
Organism
Pseudomonas aeruginosa ATCC 27853
Inoculum (cfu) 10-100
Growth: Good, Acid: -- , Gas production: --
Applications
Lactose monohydrate, Sterile (Gamma Irradiated) is used for Media Fill Runs in dry injectable in pharmaceutical industry.
