Cranberry Liquid Preparation
This article is exempt from the requirements of the General Notices with respect to the pregnancy and lactation statement (section 10.40.50, Labeling Botanical-Containing Products).USP35
DEFINITION
Cranberry Liquid Preparation is a bright red juice derived from the fruits of Vaccinium macrocarpon Ait. or Vaccinium oxycoccos L. (Fam. Ericaceae). It contains no added substances.
IDENTIFICATION
• A. HPLC
The retention times of the quinic acid, malic acid, and citric acid peaks of the Sample solution correspond to those of the Standard solution, as obtained in the test for Content of Organic Acids.
• B. Absence of Adulterants
Standard solution:
1.0 mg/mL of tartaric acid and 0.1 mg/mL of fumaric acid
Sample solution:
Use the Liquid Preparation.
Mobile phase and Chromatographic system:
Proceed as directed in the test for Content of Organic Acids.
Analysis
Samples:
Standard solution and Sample solution
Injection size:
20 µL
Acceptance criteria:
The retention times of the tartaric acid and fumaric acid peaks of the Standard solution do not correspond to any of the retention times for peaks observed from the Sample solution.
COMPOSITION
• Content of Dextrose and Fructose
Mobile phase:
Water
Standard solution:
6.0 mg/mL of USP Dextrose RS and 2.0 mg/mL of USP Fructose RS in water
Sample solution:
Transfer 1.0 g of sodium carboxylate cation-exchange resin to a 50-mL beaker, add 5 mL of water to make a slurry, and transfer the slurry to a polypropylene automatic pipet fitted with a small plug of silanized glass wool. Quantitatively transfer the slurry to a small chromatographic tube, rinsing the beaker with water and packing the column evenly. Keep the column wet until ready for use. Using a volumetric pipet, transfer 1.0 mL of Liquid Preparation to the column, collect the eluate, and discard it. Pipet 4.0 mL of water onto the top of the column, collect the eluate in a clean vial, and filter if necessary.
Chromatographic system
Mode:
LC
Detector:
Refractive index
Columns
Guard:
Packing L19
Analytical:
7.8-mm × 30-cm; packing L19
Column temperature:
85
Flow rate:
0.6 mL/min
Injection size:
20 µL
System suitability
Sample:
Standard solution
[Note—The approximate relative retention times for dextrose and fructose are about 0.8 and 1.0, respectively. ]
Suitability requirements
Resolution:
NLT 1.8 between the dextrose and fructose peaks
Relative standard deviation:
NMT 2.0%
Analysis
Samples:
Standard solution and Sample solution
Calculate the percentages of dextrose and fructose in the volume of Liquid Preparation taken:
Result = (rU/rS) × (CS/V) × 0.5
| rU | = | = peak response of each appropriate analyte from the Sample solution |
| rS | = | = peak response of each appropriate analyte from the Standard solution |
| CS | = | = concentration of the appropriate USP Reference Standard in the Standard solution (mg/mL) |
| V | = | = volume of Liquid Preparation taken for the Sample solution (mL) |
Acceptance criteria:
NLT 2.4% dextrose and NLT 0.7% fructose
• Content of Organic Acids
Mobile phase:
Transfer 27.2 g of monobasic potassium phosphate to a 1000-mL volumetric flask, and dissolve in 950 mL of water. Adjust with phosphoric acid to a pH of 2.4, and dilute with water to volume.
Standard solution:
1.0 mg/mL each of USP Citric Acid RS, USP Malic Acid RS, and USP Quinic Acid RS
Sample solution:
Use the filtered Liquid Preparation.
Chromatographic system
Mode:
LC
Detector:
UV 214 nm
Columns
Guard:
5-µm; packing L1
[Note—Before use, condition the column with methanol, then with water, and finally with Mobile phase. ]
Analytical:
4.6-mm × 25-cm analytical; packing L1
Flow rate:
0.6 mL/min
Injection size:
20 µL
System suitability
Sample:
Standard solution
[Note—The approximate relative retention times for quinic acid, malic acid, and citric acid are 0.4, 0.5, and 1.0, respectively. ]
Suitability requirements
Resolution:
NLT 2.5 between quinic acid and malic acid
Relative standard deviation:
NMT 2.0%
Analysis
Samples:
Standard solution and Sample solution
Measure the peak areas. Calculate the percentages of quinic acid, malic acid, and citric acid in the volume of Liquid Preparation taken:
Result = (rU/rS) × CS × 0.1
| rU | = | = peak area of each appropriate analyte from the Sample solution |
| rS | = | = peak area of each appropriate analyte from the Standard solution |
| CS | = | = concentration of the appropriate USP Reference Standard in the Standard solution (mg/mL) |
Acceptance criteria:
NLT 0.9% each of quinic acid and citric acid; NLT 0.7% of malic acid. The ratio of quinic acid to malic acid is NLT 1.0.
ADULTERANTS
• Limit of Sorbitol and Sucrose
Mobile phase and Sample solution:
Prepare as directed in the test for Content of Dextrose and Fructose.
Standard solution:
0.5 mg/mL each of USP Sorbitol RS and USP Sucrose RS
Chromatographic system:
Proceed as directed in the test for Content of Dextrose and Fructose.
System suitability
Sample:
Standard solution
[Note—The relative retention times for sucrose and sorbitol are about 0.4 and 1.0, respectively. ]
Suitability requirements
Resolution:
NLT 1.8 between the sucrose and sorbitol peaks
Relative standard deviation:
NMT 2.0%
Analysis
Samples:
Standard solution and Sample solution
Injection size:
20 µL
Calculate the percentages of sucrose and sorbitol in the volume of Liquid Preparation taken:
Result = (rU/rS) × (CS/V) × 0.5
| rU | = | = peak response of each appropriate analyte from the Sample solution |
| rS | = | = peak response of each appropriate analyte from the Standard solution |
| CS | = | = concentration of the appropriate USP Reference Standard in the Standard solution (mg/mL) |
| V | = | = volume of Liquid Preparation taken for the Sample solution (mL) |
Acceptance criteria:
NMT 0.05% each of sorbitol and sucrose
SPECIFIC TESTS
• Refractive Index 
831
:
1.3435–1.3445
831:
1.3435–1.3445
• pH 791:
2.5 ± 0.1
791:
2.5 ± 0.1
ADDITIONAL REQUIREMENTS
• Packaging and Storage:
Preserve in well-closed containers, and store in a refrigerator.
Change to read:
• Labeling:
The label states the Latin binomial name and, following the official name, the parts of the plant source from which the article was derived. The label also states that it is for manufacturing purposes only. This article is exempt from the requirements of the General Notices with respect to the pregnancy and lactation statement (section 10.40.50, Labeling Botanical-Containing Products).USP35
• USP Reference Standards 11
11
USP Citric Acid RS 
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USP Dextrose RS
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USP Fructose RS
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USP Malic Acid RS
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USP Quinic Acid RS
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USP Sorbitol RS
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USP Sucrose RS
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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 1-301-816-8129 rstech@usp.org |
USP35–NF30 Page 1254
Pharmacopeial Forum: Volume No. 36(6) Page 1586