Clindamycin Palmitate Hydrochloride
(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].
Clindamycin Palmitate Hydrochloride has a potency equivalent to NLT 540 µg of clindamycin (C18H33ClN2O5S)/mg.
•  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%
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
Inorganic Impurities 
•  Residue on Ignition 281: NMT 0.5%
•  pH 791: 2.8–3.8, in a 10 mg/mL solution
•  Packaging and Storage: Preserve in tight containers.
•  USP Reference Standards 11
USP Clindamycin Palmitate Hydrochloride RS Click to View Structure
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
(SM12010) Monographs - Small Molecules 1
Reference Standards RS Technical Services
USP35–NF30 Page 2704
Pharmacopeial Forum: Volume No. 34(6) Page 1442