Capsicum Oleoresin
(kap' si kum oh'' lee oh rez' in).
DEFINITION
Capsicum Oleoresin is an alcoholic extract of the dried ripe fruits of Capsicum annum var. minimum and small fruited varieties of C. frutescens (Fam. Solanaceae). It contains NLT 8.0% of total capsaicins [capsaicin (C18H27NO3), dihydrocapsaicin (C18H29NO3), and nordihydrocapsaicin (C17H27NO3)].
[Caution—Capsicum Oleoresin is a powerful irritant, and even in minute quantities produces an intense burning sensation when it comes in contact with the eyes and tender parts of the skin. Care should be taken to protect the eyes and to prevent contact of the skin with Capsicum Oleoresin. ]
IDENTIFICATION
•  A.
Sample:  0.5 g of Capsicum Oleoresin
Analysis:  To the Sample, add 5 mL of water and 10 mL of a mixture of water, 0.2 M potassium chloride, and 0.2 N hydrochloric acid (135:50:13). Mix. Add 5.0 mL of 0.5 M sodium nitrite and 5.0 mL of 0.02 M sodium tungstate, and mix. Heat the Sample at 55–60 for 15 min, allow to cool, and filter. To the filtrate add 10 mL of 1 N sodium hydroxide.
Acceptance criteria:  A bright yellow color is produced (presence of capsaicin).
ASSAY
•  Procedure
Mobile phase:  Methanol and 2% acetic acid (56:44). Pass through a filter of 0.5-µm or finer pore size.
Standard solution:  0.5 mg/mL of USP Capsaicin RS in methanol. Pass a portion of this solution through a filter of 0.2-µm pore size, and use the filtrate as the Standard solution.
Sample solution:  10 mg/mL of Capsicum Oleoresin in methanol. Pass a portion of this solution through a filter of 0.2-µm pore size, and use the filtrate as the Sample solution.
Chromatographic system 
Mode:  LC
Detector:  UV 280 nm
Column:  3.9-mm × 30-cm; packing L1
Flow rate:  2 mL/min
Injection size:  10 µL
System suitability 
Samples:  Standard solution and Sample solution
[Note—The relative retention times for nordihydrocapsaicin, capsaicin, and dihydrocapsaicin are about 0.9, 1.0, and 1.6, respectively. ]
Suitability requirements 
Resolution:  NLT 1.2 between nordihydrocapsaicin and capsaicin, Sample solution
Tailing factor:  NMT 2.0, Standard solution
Relative standard deviation:  NMT 2.0% in repeated injections, Standard solution
Analysis 
Samples:  Standard solution and Sample solution
Calculate the percentage of total capsaicins in the portion of Capsicum Oleoresin taken:
Result = (rU/rS) × (CS/CU) × 100
rU== sum of the peak areas for nordihydrocapsaicin, capsaicin, and dihydrocapsaicin from the Sample solution
rS== peak area from the Standard solution
CS== concentration of USP Capsaicin RS in the Standard solution (mg/mL)
CU== concentration of Capsicum Oleoresin in the Sample solution (mg/mL)
Acceptance criteria:  NLT 8.0%
ADDITIONAL REQUIREMENTS
•  Packaging and Storage: Preserve in tight containers.
•  Labeling: Label it to indicate that if separation occurs, it should be warmed and mixed before use.
•  USP Reference Standards 11
USP Capsaicin RS Click to View Structure
Auxiliary Information— Please check for your question in the FAQs before contacting USP.
Topic/Question Contact Expert Committee
Monograph Maged H. Sharaf, Ph.D.
Principal Scientific Liaison
1-301-816-8318
(DS2010) Monographs - Dietary Supplements
Reference Standards RS Technical Services
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USP35–NF30 Page 2476