Clindamycin Palmitate Hydrochloride for Oral Solution
DEFINITION
Clindamycin Palmitate Hydrochloride for Oral Solution is a dry mixture of Clindamycin Palmitate Hydrochloride and one or more suitable buffers, colors, diluents, flavors, and preservatives. It contains the equivalent of NLT 90.0% and NMT 120.0% of the labeled amount of clindamycin (C18H33ClN2O5S), the labeled amount being 15 mg/mL when constituted as directed in the labeling.
ASSAY
• Procedure
Solution A:
300 mg/mL of sodium carbonate
Internal standard solution:
5 mg/mL of cholesteryl benzoate in chloroform
Standard solution:
Transfer 150 mg of USP Clindamycin Palmitate Hydrochloride RS to a glass-stoppered, 15-mL conical centrifuge tube. Add 5 mL of water, 5.0 mL of Internal standard solution, and 1 mL of Solution A. Insert the stopper, shake vigorously for NLT 10 min, and centrifuge. Remove the upper aqueous layer, and transfer 1.0 mL of the lower chloroform layer to a 15-mL centrifuge tube. Add 1.0 mL of pyridine and 1.0 mL of acetic anhydride. Agitate the tube to ensure complete mixing, cover the top of the centrifuge tube with a plastic cap through which a small hole has been punched, heat at 100
for 2.5 h, and allow to cool. Mix, and centrifuge if necessary. Use the clear solution.
for 2.5 h, and allow to cool. Mix, and centrifuge if necessary. Use the clear solution.
Sample solution:
Constitute the Clindamycin Palmitate Hydrochloride for Oral Solution as directed in the labeling, and transfer 5.0 mL of the constituted solution to a glass-stoppered, 15-mL conical centrifuge tube. Add 5.0 mL of Internal standard solution and 1 mL of Solution A. Insert the stopper, shake vigorously for NLT 10 min, and centrifuge. Remove the upper aqueous layer, and transfer 1.0 mL of the lower chloroform layer to a 15-mL centrifuge tube. Add 1.0 mL of pyridine and 1.0 mL of acetic anhydride. Agitate the tube to ensure complete mixing, cover the top of the centrifuge tube with a plastic cap through which a small hole has been punched, heat at 100 for 2.5 h, and allow to cool. Mix, and centrifuge if necessary. Use the clear solution.
for 2.5 h, and allow to cool. Mix, and centrifuge if necessary. Use the clear solution.
Chromatographic system
Mode:
GC
Detector:
Flame ionization
Column:
0.6-m × 3-mm glass; packing 1% phase G36 on support S1AB
Temperature
Column:
290
Detector:
320
Carrier gas:
Dry helium
Flow rate:
60 mL/min
Injection size:
1.0 µL
System suitability
Sample:
Standard solution
The elution order is: cholesteryl benzoate, clindamycin palmitate.
Suitability requirements:
In a suitable chromatogram, the peaks are completely resolved.
Analysis
Samples:
Standard solution and Sample solution
Calculate the percentage of the labeled amount of clindamycin (C18H33ClN2O5S) in each mL of the solution constituted from Clindamycin Palmitate Hydrochloride for Oral Solution taken:
Result = (RU/RS) × (CS/CU) × P × 100
| RU | = | = internal standard ratio (peak response of clindamycin palmitate/peak response of cholesteryl benzoate) from the Sample solution |
| RS | = | = internal standard ratio (peak response of clindamycin palmitate/peak response of cholesteryl benzoate) from the Standard solution |
| CS | = | = concentration of USP Clindamycin Palmitate Hydrochloride RS in the Standard solution (mg/mL) |
| CU | = | = nominal concentration of clindamycin palmitate hydrochloride in the Sample solution (mg/mL) |
| P | = | = potency of clindamycin in USP Clindamycin Palmitate Hydrochloride RS (µg/mg ) |
Acceptance criteria:
90.0%–120.0%
PERFORMANCE TESTS
• Uniformity of Dosage Units 
905
905
For solids packaged in single-unit containers:
Meets the requirements
• Deliverable Volume 698:
Meets the requirements
698:
Meets the requirements
SPECIFIC TESTS
• pH 791:
2.5–5.0, in the solution constituted as directed in the labeling
791:
2.5–5.0, in the solution constituted as directed in the labeling
• Water Determination, Method I 921:
NMT 3.0%
921:
NMT 3.0%
ADDITIONAL REQUIREMENTS
• Packaging and Storage:
Preserve in tight containers.
• USP Reference Standards 11
11
USP Clindamycin Palmitate Hydrochloride RS 
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Auxiliary Information—
Please check for your question in the FAQs before contacting USP.
| Topic/Question | Contact | Expert Committee |
|---|---|---|
| Monograph | Ahalya Wise, M.S.
Senior Scientific Liaison 1-301-816-8161 |
(SM12010) Monographs - Small Molecules 1 |
| Reference Standards | RS Technical Services 1-301-816-8129 rstech@usp.org |
USP35–NF30 Page 2705