Isoniazid Oral Solution
(Monograph under this new title—to become official June 1,2005)
(Current monograph title is Isoniazid Syrup)
»Isoniazid Oral Solution contains,in each 100mL,not less than 0.93g and not more than 1.10g of isoniazid (C6H7N3O).
Packaging and storage— Preserve in tight,light-resistant containers.
Identification— Avolume of Oral Solution equivalent to about 50mg of isoniazid meets the requirements of Identificationtest Bunder Isoniazid.
Assay— Transfer an accurately measured volume of Oral Solution,equivalent to about 100mg of isoniazid,to a 100-mLbeaker.Add 50mLof a mixture of 1part of potassium bromide in 10parts of dilute hydrochloric acid (1in 6),and proceed as directed under Nitrite Titration á451ñ,beginning with “cool to 15.”Each mLof 0.1Msodium nitrite is equivalent to 13.71mg of isoniazid (C6H7N3O).
(Official June 1,2005)
Auxiliary Information— Staff Liaison:Behnam Davani,Ph.D.,MBA,Senior Scientist
Expert Committee:(PA7)Pharmaceutical Analysis 7
USP28–NF23Page 1075
Pharmacopeial Forum:Volume No.28(2)Page 311
Phone Number:1-301-816-8394