The ICH guidelines for residual solvents in pharmaceutical related compounds are
ID: 474786 • Letter: T
Question
The ICH guidelines for residual solvents in pharmaceutical related compounds are strictly obeyed.
(a) Residual ethanol has a limit of 5000 ppm. Convert this limit to mass %.
(b) Residual acetone has a limit of 800 ppm. If you have 3.00 g of pharmaceutical compound, then what is the maximum acetone amount can you tolerated in a) g and b) mg?
(c) You dissolved 1.245 g of an unknown compound in a 100 mL volumetric flask and detected the acetone concentration to be 0.00321 mg/mL. What is the concentration of acetone in ppm?
Explanation / Answer
a)ppm = parts per million
100 × 10000 = 1 million
Therefore ,1 = 10000 ppm
5000ppm = 0.5
b) 800 ppm = 0.08%
Therefore , 0.08% in 3 gram of acetone =( 3g/100%)×0.08% =0.0024g
1g = 1×10^6 microgram
0.0024g = 0.0024 ×10^6 microgram = 2400 microgram
1g = 1 × 10^3 mg
Therefore, 0.0024g = 0.0024 × 10^3 mg= 2.4 mg
c) The acetone concentration = 0.00321 mg/ml
Therefore, total amount of acetone present in 100ml = 100×0.00321 = 0.321mg
The compound dissolved = 1.245 g = 0.001245Kg
Therefore ppm of acetone =(0.321mg/0.001245Kg)× 1Kg = 257.83ppm
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