Sulfadiazine Tablets
DEFINITION
Sulfadiazine Tablets contain NLT 95.0% and NMT 105.0% of the labeled quantity of C10H10N4O2S.
IDENTIFICATION
• B. Melting Range or Temperature, Class Ia 
741
741
Sample solution:
Equivalent to 100 mg/mL of sulfadiazine from finely powdered Tablets in chloroform
Analysis:
Transfer the Sample solution to a small filter. Wash with 5 mL of chloroform, and discard the filtrate. Triturate the residue with 10 mL of 6 N ammonium hydroxide for 5 min, add 10 mL of water, and filter. Warm the filtrate until most of the ammonia is expelled, cool, and add 6 N acetic acid until the reaction is distinctly acid: a precipitate of sulfadiazine is formed. Collect the precipitate on a filter, wash it with cold water, and dry at 105
for 1 h.
for 1 h.
Acceptance criteria:
The sulfadiazine melts at 250–254.
–254.
ASSAY
• Procedure
Mobile phase:
Acetonitrile, glacial acetic acid, and water (12:1:87)
Standard solution:
1 mg/mL of USP Sulfadiazine RS in 0.025 N sodium hydroxide
Sample solution:
1 mg/mL of sulfadiazine from powdered Tablets in 0.025 N sodium hydroxide. [Note—Weigh NLT 20 Tablets, shake the solution for 30 min, and centrifuge, if necessary. ]
Chromatographic system
Mode:
LC
Detector:
UV 254 nm
Column:
4-mm × 30-cm; packing L1
Flow rate:
2 mL/min
Injection size:
10 µL
System suitability
Sample:
Standard solution
Suitability requirements
Tailing factor:
NMT 1.5 for sulfadiazine
Relative standard deviation:
NMT 2.0% (five replicate injections)
Analysis
Samples:
Standard solution and Sample solution
Calculate the percentage of C10H10N4O2S in the portion of Tablets taken:
Result = (rU/rS) × (CS/CU) × 100
| rU | = | = peak response from the Sample solution |
| rS | = | = peak response from the Standard solution |
| CS | = | = concentration of USP Sulfadiazine RS in the Standard solution (mg/mL) |
| CU | = | = nominal concentration of sulfadiazine in the Sample solution (mg/mL) |
Acceptance criteria:
95.0%–105.0%
PERFORMANCE TESTS
• Dissolution 711
711
Medium:
0.1 N hydrochloric acid; 900 mL
Apparatus 2:
75 rpm
Time:
90 min
Detector:
UV, 242 nm
Analysis:
Determine the quantity of C10H10N4O2S dissolved by using UV absorption on filtered portions of the solution under test, in comparison with a Standard solution having a known concentration of USP Sulfadiazine RS in the same medium. Use Medium as the blank and cells with a path length of 0.1 cm.
Tolerances:
NLT 70% (Q) of the labeled amount of C10H10N4O2S is dissolved.
• Uniformity of Dosage Units 905:
Meet the requirements
905:
Meet the requirements
ADDITIONAL REQUIREMENTS
• Packaging and Storage:
Preserve in well-closed, light-resistant containers.
• USP Reference Standards 11
11
USP Sulfadiazine RS 
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Auxiliary Information—
Please check for your question in the FAQs before contacting USP.
| Topic/Question | Contact | Expert Committee |
|---|---|---|
| Monograph | Leonel M. Santos, Ph.D.
Senior Scientific Liaison 1-301-816-8168 |
(SM12010) Monographs - Small Molecules 1 |
| 711 |
Margareth R.C. Marques, Ph.D.
Senior Scientific Liaison 1-301-816-8106 |
(GCDF2010) General Chapters - Dosage Forms |
| Reference Standards | RS Technical Services 1-301-816-8129 rstech@usp.org |
USP35–NF30 Page 4707
Pharmacopeial Forum: Volume No. 35(3) Page 577