Pertussis Immune Globulin
(per tus' is i mune' glob' ue lin).
» Pertussis Immune Globulin conforms to the regulations of the FDA concerning biologics (see Biologics 
1041
). It is a sterile, nonpyrogenic solution of globulins derived from the blood plasma of adult human donors who have been immunized with pertussis vaccine such that each 1.25 mL contains not less than the amount of immune globulin to be equivalent to 25 mL of human hyperimmune serum. It may contain 0.3 M glycine as a stabilizing agent, and it contains a suitable preservative.
1041). It is a sterile, nonpyrogenic solution of globulins derived from the blood plasma of adult human donors who have been immunized with pertussis vaccine such that each 1.25 mL contains not less than the amount of immune globulin to be equivalent to 25 mL of human hyperimmune serum. It may contain 0.3 M glycine as a stabilizing agent, and it contains a suitable preservative.
Packaging and storage—
Preserve at a temperature between 2
and 8.
and 8.
Expiration date—
The expiration date is not later than 3 years after date of issue from manufacturer's cold storage (5, 3 years).
, 3 years).
Labeling—
Label it to state that it is not intended for intravenous injection.
Auxiliary Information—
Please check for your question in the FAQs before contacting USP.
| Topic/Question | Contact | Expert Committee |
|---|---|---|
| Monograph | Fouad Atouf, Ph.D.
Senior Scientific Liaison 1-301-816-8365 |
(BIO22010) Monographs - Biologics and Biotechnology 2 |
USP35–NF30 Page 4277