Protamine Sulfate Injection
DEFINITION
Protamine Sulfate Injection is a sterile, isotonic solution of Protamine Sulfate. Each mg of Protamine Sulfate, used in the manufacture of the Injection, neutralizes NLT 100 USP Heparin Units, calculated on the dried basis. It contains NLT 90.0% and NMT 120.0% of the labeled amount of protamine sulfate.
IDENTIFICATION
• Identification Tests—General, Sulfate 
191
:
Meets the requirements
191:
Meets the requirements
ASSAY
• Procedure
Sample solution:
0.15 mg/mL of protamine sulfate in Water for Injection from a measured volume of Injection
Analysis:
[Note—Titrate the Sample solution in duplicate. ] Transfer the same volume of the Sample solution to the analytical cell as used in the Assay for the drug substance. Proceed as directed in the Assay under Protamine Sulfate, using the same concentration of Titrant and the same wavelength as used in the Assay for the drug substance. The concentration of the Sample solution of the drug substance should also be 0.15 mg/mL. Perform the entire Assay in triplicate, and calculate the average of the triplicate determinations. The percentage of the label claim is given as follows:
Result = (v/V) × 100
| v | = | = volume of Titrant added to the Injection Sample solution (mL) |
| V | = | = volume of Titrant added to the drug substance Sample solution (mL) |
Acceptance criteria:
90.0%–120.0%
SPECIFIC TESTS
• Bacterial Endotoxins Test 85:
It contains NMT 7.0 USP Endotoxin Units/mg of protamine sulfate.
85:
It contains NMT 7.0 USP Endotoxin Units/mg of protamine sulfate.
• Other Requirements:
It meets the requirements under Injections 1.
1.
ADDITIONAL REQUIREMENTS
• Packaging and Storage:
Preserve in single-dose containers, preferably of Type I glass. Store at controlled room temperature.
• Labeling:
Label it to indicate the approximate neutralization capacity in USP Heparin Units.
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Auxiliary Information—
Please check for your question in the FAQs before contacting USP.
| Topic/Question | Contact | Expert Committee |
|---|---|---|
| Monograph | Anita Y. Szajek, Ph.D.
Principal Scientific Liaison 1-301-816-8325 |
(BIO12010) Monographs - Biologics and Biotechnology 1 |
| 85 |
Radhakrishna S Tirumalai, Ph.D.
Principal Scientific Liaison 1-301-816-8339 |
(GCM2010) General Chapters - Microbiology |
| Reference Standards | RS Technical Services 1-301-816-8129 rstech@usp.org |
USP35–NF30 Page 4473
Pharmacopeial Forum: Volume No. 36(3) Page 646