Clindamycin Palmitate Hydrochloride
C34H63ClN2O6S·HCl 699.85
l-threo-
-d-galacto-Octopyranoside, methyl 7-chloro-6,7,8-trideoxy-6-[[(1-methyl-4-propyl-2-pyrrolidinyl)carbonyl]amino]-1-thio-2-hexadecanoate, monohydrochloride, (2S-trans)-;
Methyl 7-chloro-6,7,8-trideoxy-6-(1-methyl-trans-4-propyl-l-2-pyrrolidinecarboxamido)-1-thio-l-threo--d-galacto-octopyranoside 2-palmitate monohydrochloride
[25507-04-4].
(klin'' da mye' sin pal' mi tate hye'' droe klor' ide).
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C34H63ClN2O6S·HCl 699.85
l-threo-
-d-galacto-Octopyranoside, methyl 7-chloro-6,7,8-trideoxy-6-[[(1-methyl-4-propyl-2-pyrrolidinyl)carbonyl]amino]-1-thio-2-hexadecanoate, monohydrochloride, (2S-trans)-;
Methyl 7-chloro-6,7,8-trideoxy-6-(1-methyl-trans-4-propyl-l-2-pyrrolidinecarboxamido)-1-thio-l-threo-
-d-galacto-octopyranoside 2-palmitate monohydrochloride
[25507-04-4].DEFINITION
Clindamycin Palmitate Hydrochloride has a potency equivalent to NLT 540 µg of clindamycin (C18H33ClN2O5S)/mg.
IDENTIFICATION
ASSAY
• Procedure
Mobile phase:
Dissolve 2 g of docusate sodium and 1.54 g of ammonium acetate in a mixture of 2 mL of glacial acetic acid and 75 mL of water. Dilute with methanol to 1 L. Pass through a suitable filter, and degas.
Standard solution:
14 mg/mL of USP Clindamycin Palmitate Hydrochloride RS in Mobile phase
Sample solution:
14 mg/mL of Clindamycin Palmitate Hydrochloride in Mobile phase
Chromatographic system
Mode:
LC
Detector:
Refractive index
Column:
3.9-mm × 30-cm; 10-µm packing L1
Flow rate:
1.2 mL/min
Injection size:
20 µL
System suitability
Sample:
Standard solution
Suitability requirements
Relative standard deviation:
NMT 2.0%
Analysis
Samples:
Standard solution and Sample solution
Calculate the potency in µg/mg of C18H33ClN2O5S in the portion of Clindamycin Palmitate Hydrochloride taken:
Result = (rU/rS) × (CS/CU) × P
| rU | = | = peak response of clindamycin palmitate from the Sample solution |
| rS | = | = peak response of clindamycin palmitate 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:
NLT 540 µg
IMPURITIES
Inorganic Impurities
• Residue on Ignition 
281
:
NMT 0.5%
281:
NMT 0.5%
SPECIFIC TESTS
• pH 791:
2.8–3.8, in a 10 mg/mL solution
791:
2.8–3.8, in a 10 mg/mL solution
• 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 2704
Pharmacopeial Forum: Volume No. 34(6) Page 1442