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UNIT

11
Calculations involving "Units",
"ug/mg" and Other measures of
Potency

I.

The potencies of some antibiotics, endocrine products, vitamins, products derived through
biotechnology, and biologics (e.g., vaccines) are based on their activity and are expressed in
terms of units (of activity), in micrograms per milligram (g/mg), or in other standardized terms
of measurement. These measures of potency meet standards approved by the Food and Drug
Administration and are set forth in the United States Pharmacopeia (USP).1 In general, they
conform also to international standards defined by the World Health Organization and termed
International Units (IU).
The potency of antibiotics may also be designated in terms of ug (micrograms) of activity. This
concept originated at a time when reference standards for antibiotics were thought to consist
entirely of single chemical entities and were therefore assigned potencies of 1000 ug/mg. As
newer methods of antibiotic manufacture and purification were developed, however, it was
determined that some highly purified antibiotics had greater than 1000 g of activity per milligram
compared with the original reference standard. Differences in potency were also found when
comparing the chemical base versus the salt form. For example, ampicillin sodium has a potency
equivalent to between 845 and 988 g/mg of its parent compound ampicillin.
Specific examples of the potency of vaccines expressed in terms other than weight are:
● Hepatitis A Vaccine, Inactivated, 1440 EL.U (ELISA units) per 1-mL dose
● Influenza Virus Vaccine, Live (intranasal), 106.5–7.5 FFU (fluorescent focus
units per 0.2 mL dose
● Measles Virus Vaccine, Live NLT 1000 TCID50 (50% tissue culture infectious
dose) in each 0.5-mL dose
● Zoster Vaccine, Live, 19,400 PFU (plaque-forming units) per 0.65-mL dose

Example Calculations of Measures of Activity or Potency


Determinations of the activity or potency of a biologic material considered in this chapter may be
performed through the use of ratio and proportion or dimensional analysis, as demonstrated by
the following examples.
Units of Activity. Calculations involving units of activity are exemplified as follows.
How many milliliters of U-100 insulin should be used to obtain 40 units of insulin?
U-100 insulin contains 100 units/mL Dimensional Analysis

Activity Based on Weight. Calculations involving the determination of activity per unit of
weight are exemplified as follows.
If neomycin sulfate has a potency of 600 ug of neomycin per milligram, how many milligrams of
neomycin sulfate would be equivalent in potency to 1 mg of neomycin?

Dose or Antigen Content of a Biologic Based on Potency. Calculations of the dose or the
antigen content of a biologic product are exemplified as follows.
A biologic contains 50 Lf Units of diphtheria toxoid in each 2.5 mL of product. If a pediatric
patient is to receive 10 Lf Units, how many milliliters of product should be administered?
Group Members: __________________________________
Class Schedule: ___________
Date: ________

WORKSHEET 11:
Chapter 11: Calculations involving "Units", "ug/mg" and Other measures of
Potency

1. Calcitonin is available as an injection containing 200 international units per milliliter.


Adult doses of up to 32 units per kilogram have produced no adverse effects. On this
basis, if a 120-lb. patient were administered 0.75 mL of injection, would adverse effects
be anticipated?

2. Each 0.01 mL of a mumps vaccine contains 400 TCID50 of the mumps virus. If the usual
dose contains 20,000 TCID50, how many milliliters of vaccine should be administered?
3. If a biologic product contains 7.5 Lf Units of diphtheria toxoid per 0.5 mL, how many
flocculating units would be present in a 7.5-mL multiple dose vial?

4. A hepatitis B immune globulin contains 312 international units per milliliter. If the dose
is 0.06 mL/kg for certain at-risk persons, calculate the dose:
a. in units
b. in milliliters for a 132-lb. person.

5 How many milliliters of U-100 insulin zinc suspension should be used to obtain 18 units
of insulin?
6 A physician prescribes 2.5 million units of penicillin G potassium daily for 1 week. If 1
unit of penicillin G potassium equals 0.6 ug, how many tablets, each containing 250mg
will provide the prescribed dosage regimen?

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