Aprotinin Injection
» Aprotinin Injection is a sterile solution of Aprotinin in Water for Injection that also contains sodium chloride. One USP Aprotinin Unit is equivalent to 1800 Kallikrein Inhibition Units (K.I.U.). It contains not less than 90.0 percent and not more than 110.0 percent of the potency stated on the label, expressed in Kallikrein Inhibition Units per mL.
Packaging and storage—
Preserve in single-dose containers, store up to 25
, and avoid freezing.
, and avoid freezing.
USP Reference standards 
11
—
USP Aprotinin RS.
USP Aprotinin System Suitability RS.
USP Endotoxin RS.
USP Trypsin Crystallized RS.
11—
USP Aprotinin RS.
USP Aprotinin System Suitability RS.
USP Endotoxin RS.
USP Trypsin Crystallized RS.
Identification—
A:
The retention time of the major peak in the chromatogram of the Test solution corresponds to that in the chromatogram of the Standard solution, as obtained in the test for Limit of N-pyroglutamyl-aprotinin and related compounds under Aprotinin.
B:
The determination of activity by the Assay is based on the specific inhibition of trypsin.
Bacterial endotoxins 85—
It contains not more than 0.14 USP Endotoxin Units per USP Aprotinin Unit.
85—
It contains not more than 0.14 USP Endotoxin Units per USP Aprotinin Unit.
Sterility 71—
It meets the requirements when tested as directed for Membrane Filtration under Test for Sterility of the Product to be Examined.
71—
It meets the requirements when tested as directed for Membrane Filtration under Test for Sterility of the Product to be Examined.
pH 791:
between 4.5 and 6.5.
791:
between 4.5 and 6.5.
Particulate matter 788:
meets the requirements.
788:
meets the requirements.
Sodium chloride content—
Pipet 5.0 mL of Injection into 50 mL of water in a beaker. Add 10 mL of 25% nitric acid. Titrate with 0.1 N silver nitrate VS to a potentiometric endpoint, using a silver combination electrode. Perform a blank determination (see Titrimetry 541), and make any necessary correction. Each mL of 0.1 N silver nitrate is equivalent to 5.844 mg of sodium chloride: between 42.5 mg and 47.5 mg of sodium chloride is found.
541), and make any necessary correction. Each mL of 0.1 N silver nitrate is equivalent to 5.844 mg of sodium chloride: between 42.5 mg and 47.5 mg of sodium chloride is found.
Other requirements—
It meets the requirements under Injections 1 and for Limit of N-pyroglutamyl-aprotinin and related compounds under Aprotinin.
1 and for Limit of N-pyroglutamyl-aprotinin and related compounds under Aprotinin.
Limit of high molecular weight proteins—
Proceed as directed in the test for Limit of high molecular weight proteins under Aprotinin. The sum of all oligomers is not more than 1.5%.
Auxiliary Information—
Please check for your question in the FAQs before contacting USP.
| Topic/Question | Contact | Expert Committee |
| Monograph | Larry N. Callahan, Ph.D.
Senior Scientist 1-301-816-8385 |
(BBPP05) Biologics and Biotechnology - Proteins and Polysaccharides |
| Reference Standards | Lili Wang, Technical Services Scientist 1-301-816-8129 RSTech@usp.org |
|
| 85 |
Radhakrishna S Tirumalai, Ph.D.
Senior Scientist 1-301-816-8339 |
(MSA05) Microbiology and Sterility Assurance |
| 71 |
Radhakrishna S Tirumalai, Ph.D.
Senior Scientist 1-301-816-8339 |
(MSA05) Microbiology and Sterility Assurance |
USP32–NF27 Page 1577
Pharmacopeial Forum: Volume No. 31(3) Page 736