Descriptions - Q3C(R5): Impurities: Guideline For Residual Solvents

Equations

Equation 1

Concentration (ppm) equals 1000 times PDE divided by dose.

Equation 2

PDE equals NOEL multiplied by weight adjustment, divided by F1 multiplied by F2 multiplied by F3 multiplied by F4 multiplied by F5.

Equation 3

S equals kM to the power of zero decimal six seven.

Equation 4

PDE equals fifty decimal seven mg kg to the power of negative one, day to the power of negative one multiplied by fifty kg, divided by twelve multiplied by ten multiplied by five multiplied by one multiplied by one equals four decimal two two mg day to the power of negative one.

Equation 5

n divided by V equals P divided by RT equals three hundred multiplied by 10 to the power of negative 6 atm multiplied by one five three eight four zero mg mol to the power of negative one, divided by zero decimal zero eight two L atm K to the power of negative one mol to the power of negative one multiplied by two hundred and ninety eight K equals forty six decimal one five mg divided by twenty four decimal four five L equals one decimal eight nine mg/L.

Equation 6

Two hundred ppm equals two hundred multiplied by seventy two decimal one zero divided by twenty four decimal four five equals five hundred and eighty nine decimal eight mg per m to the power of three equals zero decimal five nine mg per L.

For continuous dosing equals zero decimal five nine multiplied by 6 multiplied by five divided by twenty four multiplied by seven equals zero decimal one zero five mg per L.

Daily dose equals zero decimal one zero five multiplied by two hundred and ninety divided by zero decimal four two five equals seventy one decimal six five mg per kg.

PDE equals seventy one decimal six five multiplied by fifty divided by five multiplied by ten multiplied by one multiplied by ten multiplied by one equals seven decimal one six five mg per day equals seven decimal two mg per day.

Limit equals seven decimal two multiplied by one thousand divided by ten equals seven hundred and twenty ppm.

Equation 7

One hundred and fifty ppm equals one hundred and fifty multiplied by ninety nine decimal one three divided by twenty four decimal four five equals six hundred and eight decimal one six mg per m to the power of three equals zero decimal six zero eight mg per L.

For continuous dosing equals zero decimal six zero eight multiplied by six divided by twenty four equals zero decimal one five two mg per L.

Daily dose equals zero decimal one five two multiplied two hundred and ninety divided by zero decimal three three equals one hundred and thirty three decimal five eight mg per kg.

PDE equals one hundred and thirty three decimal five eight multiplied by fifty divided by five multiplied by ten multiplied by one multiplied by five multiplied by five equals five decimal three mg per day.

Limit equals five decimal three multiplied by one thousand divided by ten equals five hundred and thirty ppm.

Equation 8

Two hundred and fifty ppm equals two hundred and fifty multiplied by one hundred and twenty decimal one nine divided by twenty four decimal four five equals one thousand two hundred and twenty nine mg per m to the power of three equals one decimal two three mg per L.

Equation 9

For continuous dosing equals one decimal two three multiplied by six multiplied by five divided by twenty four multiplied by seven equals zero decimal two two mg per L

Equation 10

Daily dose equals zero decimal two two mg l to the power of negative one multiplied by two hundred and ninety l day to the power of negative one divided by zero decimal four two five kg equals one hundred and fifty mg per kg per day.

Equation 11

PDE equals one hundred and fifty multiplied by fifty divided by five multiplied by ten multiplied by one multiplied by ten multiplied by ten equals one decimal five zero mg per day.

Equation 12

Limit equals one decimal five multiplied by one thousand divided by ten equals one hundred and fifty ppm.

Equation 13

One hundred and twenty five ppm equals one hundred and twenty five multiplied by one hundred and twenty decimal one nine divided by twenty four decimal four five equals six hundred and fourteen mg per m to the power of three equals zero decimal six one mg per l.

Equation 14

For continuous dosing equals zero decimal six one multiplied by six multiplied by five divided by twenty four multiplied by seven equals zero decimal one one mg per l.

Equation 15

Daily dose equals zero decimal one one mg l to the power of negative one multiplied by forty three l day to the power of negative one equals zero decimal zero two eight kg equals one hundred and sixty nine mg per kg per day.

Equation 16

PDE equals one hundred and sixty nine multiplied by fifty divided my twelve multiplied by ten multiplied by one multiplied by ten multiplied by ten equals zero decimal seven zero mg per day.

Equation 17

Limit equals zero decimal seven multiplied by one thousand divided by ten equals seventy ppm.