| ≥1 piece |
CHEMICAL ANALYSIS TYPICAL SPECIFICATION
Acidity or alkalinity 0.1 mL 0.4 mL of 0.1 N NaOH (maximum)
Clarity and color @ 400 nm 0.01 0.04 (maximum)
Heavy metals, g/g Less than 5.0 5.0 (maximum)
Loss on drying, % 0.6 1.0 (maximum)
Protein and light-absorbing impurities
at 210-220 nm 0.05 0.25 (maximum)
at 270-300 nm 0.01 0.07 (maximum)
Residue on ignition, % 0.02 0.1 (maximum)
Specific rotation +54.8° to +55.2° +54.4° to +55.9°
Water, % 4.8 to 5.2 4.5 to 5.5
MICROBIOLOGICAL STANDARDS TYPICAL SPECIFICATION
Total aerobic microbial count Less than 10 cfu/g 100 cfu/g (maximum)
Escherichia coli Negative Negative
Total combined molds and Yeasts count Less than 10 cfu/g 50 cfu/g (maximum)
Staphylococcus aureus Negative Negative
Pseudomonas aeruginosa Negative Negative
Salmonella species Negative Negative
POWDER FINENESS (CUMULATIVE) TYPICAL SPECIFICATION
On USS #60 (250 micron) 0.0-0.5 % 2.0 % (maximum)
On USS #140 (106 micron) 30-55 % 20 % (minimum)
On USS #200 (75 micron) 60-80 % 50 % (minimum)
PHYSICAL CHARACTERISTICS TYPICAL SPECIFICATION
Bulk Density 0.58 g/mL 0.50 g/mL (minimum)
Tapped Density 0.67 g/mL 0.60 g/mL (minimum)
% Lactose (d.b.) 99 % (+)
Appearance and Flavor White, crystalline powder, slightly sweet
Microscopic Appearance Spherical particles, ranging in size from 60-120 microns