Packaging and storage— Preserve in tight, light-resistant containers.

USP Reference standards 11— USP Isoniazid RS.

Identification— A volume of Oral Solution equivalent to about 50 mg of isoniazid meets the requirements of Identification test B under Isoniazid.

Residual solvents 467: meets the requirements.

Assay— Transfer an accurately measured volume of Oral Solution, equivalent to about 100 mg of isoniazid, to a 100-mL beaker. Add 50 mL of a mixture of 1 part of potassium bromide in 10 parts of dilute hydrochloric acid (1 in 6), and proceed as directed under Nitrite Titration 451, beginning with “cool to 15.” Each mL of 0.1 M sodium nitrite is equivalent to 13.71 mg of isoniazid (C6H7N3O).

Expert Committee : (MDAA05) Monograph Development-Antivirals and Antimicrobials

USP29–NF24 Page 1190

Phone Number : 1-301-816-8394