N.D. Admin. Code 33-44-01-49

Current through Supplement No. 394, October, 2024

Section 33-44-01-49 - Standards for solvents compliance testing

1. A batch fails solvent testing if the presence of one of the following solvents, at a minimum, is above the action level listed in the published International Conference on Harmonization of Technical Requirements for Pharmaceuticals for Human Use guidance for industry Impurities: Residual Solvents Q3C(R6) in effect as of January 1, 2018:

a. 1,4-Dioxane.

b. 2-Butanol.

c. 2-Ethoxyethanol.

d. 2-Propanol (IPA).

e. Acetone.

f. Acetonitrile.

g. Benzene.

h. Cumene.

i. Cyclohexane.

j. Dichloromethane.

k. Ethyl acetate.

l. Ethyl ether.

m. Ethylene glycol.

n. Heptane.

o. Hexanes.

p. Isopropyl acetate.

q. Methanol.

r. Pentanes.

s. Tetrahydrofuran.

t. Toluene.

u. Xylenes.

2. In addition to subsection 1, a batch fails solvent testing if the presence of one of the following solvents exceeds the limits in the following table:

	Parts Per Million (ppm)
Butanes	5,000
Ethylene oxide	50
Propane	5,000

3. A manufacturing facility must receive written approval from the department prior to using any solvent not listed in subsection 1 and subsection 2. The department shall include in the written approval an action level, not to be exceeded, that is to be used as the standard for solvent testing.

4. A manufacturing facility only may use a solvent that is at least ninety-nine percent purity or is food-grade.

5. If the samples do not pass testing standards for solvents, the manufacturing facility shall comply with section 33-44-01-52.

N.D. Admin Code 33-44-01-49

Adopted by Administrative Rules Supplement 368, April 2018, effective 4/1/2018.

General Authority: NDCC 19-24.1-36

Law Implemented: NDCC 19-24.1-36