Zinc Chloride Injection
DEFINITION
Zinc Chloride Injection is a sterile solution of Zinc Chloride in Water for Injection. It contains NLT 90.0% and NMT 110.0% of the labeled amount of zinc (Zn).
IDENTIFICATION
• A.
The Sample solution, prepared as directed in the Assay, exhibits an absorption maximum at 213.8 nm, when determined as directed in the Assay.
ASSAY
• Procedure
[Note—The Standard solutions and the Sample solution may be diluted quantitatively with water, if necessary, to obtain solutions of suitable concentrations adaptable to the linear or working range of the instrument. ]
Sodium chloride solution:
0.9 mg/mL of sodium chloride in water
Standard stock solution A:
10 mg/mL of zinc in water prepared as follows. Transfer 3.11 g of zinc oxide to a 250-mL volumetric flask. Add 80 mL of 1 N sulfuric acid, warm to dissolve, and cool. Dilute with water to volume.
Standard stock solution B:
125 µg/mL of zinc in water from Standard stock solution A
Standard solution A:
Transfer 2.0 mL of Standard stock solution B and 5 mL of Sodium chloride solution into a 500-mL volumetric flask, and dilute with water (0.50 µg/mL of zinc).
Standard solution B:
Transfer 3.0 mL of Standard stock solution B and 5 mL of Sodium chloride solution into a 500-mL volumetric flask, and dilute with water (0.75 µg/mL of zinc).
Standard solution C:
Transfer 4.0 mL of Standard stock solution B and 5 mL of Sodium chloride solution into a 500-mL volumetric flask, and dilute with water (1.0 µg/mL of zinc).
Sample solution:
Transfer a volume of Injection, equivalent to 5 mg of zinc, to a 500-mL volumetric flask. Dilute with water to volume. Transfer 10.0 mL of this solution to a 100-mL volumetric flask. From the labeled amount of sodium chloride, if any, in the Injection, calculate the amount, in mg, of sodium chloride in the 10.0-mL portion, and add a sufficient amount of Sodium chloride solution to bring the total sodium chloride content of the 100-mL volumetric flask to 0.9 mg. Dilute with water to volume.
Blank:
Water
Instrumental conditions
Mode:
Atomic absorption spectrophotometry
Analytical wavelength:
Zinc emission line at 213.8 nm
Lamp:
Zinc hollow-cathode
Flame:
Air–acetylene
Analysis
Samples:
Standard solutions and Sample solution
Plot the absorbances of the Standard solutions versus concentration, in µg/mL, of zinc, and draw the straight line best fitting the three plotted points. From the graph so obtained, determine the concentration, in µg/mL, of zinc in the Sample solution.
Calculate the percentage of the labeled amount of zinc (Zn) in the portion of Injection taken:
Result = (CO/CU) × 100
| CO | = | = concentration of zinc in the Sample solution as determined from the standard curve (observed concentration, µg/mL) |
| CU | = | = nominal concentration of the Sample solution, based on the label claim of the Injection and the dilution factor (calculated concentration, µg/mL) |
Acceptance criteria:
90.0%–110.0%
IMPURITIES
• Particulate Matter in Injections 
788
:
Meets the requirements for small-volume injections
788:
Meets the requirements for small-volume injections
SPECIFIC TESTS
• Bacterial Endotoxins Test 85:
It contains NMT 25.0 USP Endotoxin Units/mg of zinc.
85:
It contains NMT 25.0 USP Endotoxin Units/mg of zinc.
• pH 791:
1.5–2.5
791:
1.5–2.5
• Other Requirements:
It meets the requirements in Injections 1.
1.
ADDITIONAL REQUIREMENTS
• Packaging and Storage:
Preserve in single-dose or multiple-dose containers, preferably of Type I or Type II glass.
• Labeling:
Label the Injection to indicate that it is to be diluted with Water for Injection or other suitable fluid to appropriate strength before administration.
• USP Reference Standards 11
11
USP Endotoxin RS
Auxiliary Information—
Please check for your question in the FAQs before contacting USP.
| Topic/Question | Contact | Expert Committee |
|---|---|---|
| Monograph | Feiwen Mao, M.S.
Senior Scientific Liaison 1-301-816-8320 |
(SM32010) Monographs - Small Molecules 3 |
| 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 5070
Pharmacopeial Forum: Volume No. 32(5) Page 1473