Didanosine for Oral Solution
DEFINITION
Didanosine for Oral Solution, when reconstituted as directed in the labeling, yields a 10 mg/mL solution that contains NLT 90.0% and NMT 110.0% of the labeled amount of didanosine (C10H12N4O3).
IDENTIFICATION
• B.
The retention time of the major peak in the Sample solution corresponds to that of the Standard solution, as obtained in the Assay.
ASSAY
• Procedure
Solution A:
0.77 mg/mL of ammonium acetate in water
Mobile phase:
Acetonitrile and Solution A (1:24)
Standard solution:
0.1 mg/mL of USP Didanosine RS in water. [Note—Use this solution within 24 h of preparation. ]
Sample solution:
0.1 mg/mL obtained by diluting the contents of 1 bottle of Didanosine for Oral Solution in water.[Note—Use this solution within 24 h of preparation. ]
Chromatographic system
Mode:
LC
Detector:
UV 254 nm
Analytical column:
4-mm × 25-cm; packing L1
Guard column:
4.6-mm × 20-cm; packing L1
Flow rate:
2 mL/min
Injection size:
20 µL
System suitability
Sample:
Standard solution
Suitability requirements
Retention time:
Between 7 and 11 min
Column efficiency:
NLT 6000 theoretical plates
Relative standard deviation:
NMT 1.5%
Analysis
Samples:
Standard solution and Sample solution
Calculate the percentage of C10H12N4O3 in the portion of Oral Solution taken:
Result = (rU/rS) × (CS/CU) × 100
| rU | = | = peak response of the Sample solution |
| rS | = | = peak response of the Standard solution |
| CS | = | = concentration of USP Didanosine RS in the Standard solution (mg/mL) |
| CU | = | = nominal concentration of didanosine in the Sample solution (mg/mL) |
Acceptance criteria:
90.0%–110.0%
PERFORMANCE TESTS
• Deliverable Volume 
698
:
Meets the requirements
698:
Meets the requirements
IMPURITIES
Organic Impurities
• Procedure
Solution A, Mobile phase, Sample solution, Chromatographic system, and System suitability:
Proceed as directed in the Assay.
Standard solution:
5 µg/mL of USP Didanosine Related Compound A RS in water
[Note—Use this solution within 48 h of preparation. ]
Analysis
Samples:
Standard solution and Sample solution
Calculate the percentage of didanosine related compound A in the portion of Oral Solution taken:
Result = (rU/rS) × (CS/CU) × 100
| rU | = | = peak response of didanosine related compound A from the Sample solution |
| rS | = | = peak response of didanosine related compound A from the Standard solution |
| CS | = | = concentration of USP Didanosine Related Compound A RS in the Standard solution (mg/mL) |
| CU | = | = nominal concentration of didanosine in the Sample solution (mg/mL) |
Acceptance criteria:
NMT 1%
SPECIFIC TESTS
• Water Determination, Method Ia 921:
NMT 3%
921:
NMT 3%
ADDITIONAL REQUIREMENTS
• Packaging and Storage:
Preserve in tight containers, and store between 15
and 30.
and 30.
• Labeling:
The label contains directions for constitution of the powder and states the equivalent amount of C10H12N4O3 in a given volume of Oral Solution obtained after constitution.
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Auxiliary Information—
Please check for your question in the FAQs before contacting USP.
| Topic/Question | Contact | Expert Committee |
|---|---|---|
| Monograph | Behnam Davani, Ph.D., M.B.A.
Senior Scientific Liaison 1-301-816-8394 |
(SM12010) Monographs - Small Molecules 1 |
| Reference Standards | RS Technical Services 1-301-816-8129 rstech@usp.org |
USP35–NF30 Page 2889
Pharmacopeial Forum: Volume No. 34(6) Page 1443