Packaging and storage— Preserve in tight containers at a temperature that is 5 or more below the melting range stated in the labeling.

Labeling— The labeling includes the nominal melting temperature, which is between 27 and 44.

Melting range, Class II 741: the melting temperature does not differ by more than 2 from the nominal value given under Labeling.

Acid value 401: not more than 1.0.

Hydroxyl value 401: not more than 70.

Iodine value 401: not more than 7.0.

Saponification value 401: between 215 and 255.

Unsaponifiable matter 401: not more than 3.0%.

Alkaline impurities— Dissolve 2.0 g in a mixture of 1.5 mL of alcohol and 3.0 mL of ether. Add 0.05 mL of bromophenol blue TS, and titrate with 0.01 N hydrochloric acid to a yellow endpoint: not more than 0.15 mL of 0.01 N hydrochloric acid is required.

Residue on ignition 281: not more than 0.05%.

Residual solvents 467: meets the requirements.

Expert Committee : (EM105) Excipient Monographs 1

USP29–NF24 Page 3334

Phone Number : 1-301-816-8262