1. Prepare a composite specimen of

1. Prepare a composite specimen of a sufficient number of dosage units to provide the amount of specimen called for in the Assay in the individual monograph plus the amoun required for the special Procedure for content uniformity in the monograph by finely powdering tablets or mixing the contents of capsules or oral solutions, suspensions, emulsions, gels, or solids in single-unit containers to obtain a homogeneous mixture. If a homogeneous mixture cannot be obtained in this manner, use suitable solvents or other procedures to prepare a solution containing all of the drug substance, and use appropriate aliquot portions of this solution for the specified procedures.

2. Assay separate, accurately measured portions of the composite specimen of capsules o tablets or suspensions or inhalations or solids in single-unit containers, both (a) as directed in the Assay, and (b) using the special Procedure for content uniformity in the monograph.

3. Calculate the weight of drug substance equivalent to 1 average dosage unit, by (a) usin the results obtained by the Assay procedure, and by (b) using the results obtained by th special procedure.

4. Calculate the correction factor, F, by the formula:

F = W/P

in which W is the weight of drug substance equivalent to 1 average dosage unit obtaine by the Assay procedure, and P is the weight of drug substance equivalent to 1 average dosage unit obtained by the special procedure. If













is greater than 10, the use of a correction factor is not valid.

5. The correction factor is to be applied only if F is not less than 1.030 nor greater than 1.100, or not less than 0.900 nor greater than 0.970. If F is between 0.970 and 1.030, n correction is required.

6. If F lies between 1.030 and 1.100, or between 0.900 and 0.970, calculate the weight of drug substance in each dosage unit by multiplying each of the weights found using the special procedure by F.

Uncoated, Coated, or Molded Tablets, Capsules, Oral Solutions in Single-Unit Containers, Oral Suspensions or Oral Emulsions or Oral Gels in Single-Unit Containers, and Solids (including Sterile Solids) in Single-Unit Containers— Assay 10 units individually as directed in the Assay in the individual monograph, unless otherwise specified in the Procedure for content uniformity in th individual monograph. Calculate the acceptance value as directed below.

For oral solutions, oral suspensions, oral emulsions, or oral gels in single-unit containers, condu the Assay on the amount of well-mixed material that drains from an individual container in not more than 5 seconds, or for highly viscous products, conduct the Assay on the amount of well-mixed material that is obtained by quantitatively removing the contents from an individual container, and express the results as the delivered dose.