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Name of the ingredient
Cyclocarya paliurus leaf extract dry (Approved Herbal Substance Name).
Definition of the ingredient
Cyclocarya paliurus leaf extract dry is a brown colour fine powder obtained by aqueous (hot water) extraction of the dried leaves of Cyclocarya paliurus followed by freeze-drying of the obtained extract. The typical extraction ratio is 10:1 for the aqueous extraction.
Table 1. Ingredient specific requirements
Test | Method reference | Acceptance criteria |
|---|---|---|
Description | ||
Characteristics | ||
Identification | ||
Assay | ||
Appearance | Organoleptic | Fine powder |
Colour | Organoleptic | Brown colour |
Odour | Organoleptic | Characteristic |
Particle size | USP<786> | 90% through 80 mesh |
Total ash | Ph. Eur. 2.4.16 | Not more than 10% |
Loss on drying | Ph. Eur. 2.8.17 | Not more than 5% |
TLC | TLC[1] | The characteristic spot has an Rf value of 0.51, and the colour and position of the characteristic spot correspond to the authenticated reference material. |
HPLC (Quercetin) | As prescribed in the USP monograph for Quercetin[2] | The retention time of the major peak in the chromatogram corresponds to the retention time of the authenticated reference material ±2%. |
Chromatographic fingerprinting | HPLC[3] | Chromatographic profile uniquely identifies the presence of major characteristic peaks with retention times of 15.6, 20.5, 21.4, 38.8, 42.6, 46.0 minutes, with the principal peak (20.5 minutes) corresponds to chlorogenic acid reference material. |
Quercetin | HPLC[4] | 0.2–2% |
Total flavonoids | Spectrophotometry[5] | 10-22% |
Polysaccharides | Spectrophotometry[6] | 4.5-15% |
Total sugar | Spectrophotometry[6] | 15-25% |
Total polyphenols | Spectrophotometry[7] | 24-35% |
Table 2. Incidental constituents
Test | Method reference | Acceptance criteria |
|---|---|---|
Incidental metals and non-metals | ||
Pesticide residues and environmental contaminants: (including agricultural and veterinary substances) | ||
Other organic or inorganic impurities or toxins | ||
Microbiology | ||
Lead Arsenic Mercury Cadmium | Ph. Eur. 2.4.27 | Not more than 3 mg/Kg Not more than 2 mg/Kg Not more than 0.1 mg/Kg Not more than 0.5 mg/Kg |
Pesticide residues | Ph. Eur. 2.8.13 | Complies |
Aflatoxins B1 | Ph. Eur. 2.8.18 | Not more than 2 μg/Kg |
Aflatoxins B1, B2, G1 and G2 | Ph. Eur. 2.8.18 | Not more than 4 μg/Kg |
Ochratoxin A | Ph. Eur. 2.8.22 | Not more than 5 μg/Kg |
While substance manufacturers are encouraged to include limits for objectionable microorganisms, it is the product into which those substances are formulated that is subject to a legally binding set of criteria. The Therapeutic Goods Order No. 100 ‘Microbiological Standards for Medicines’ mandates that any finished product that contains the ingredient, alone or in combination with other ingredients, must comply with the microbial acceptance criteria set by Clause 11 of the Order. | ||
Footnotes
1. TLC: Chromatographic plate: silica gel G thin layer plate; Developing agent: toluene, ethyl acetate and formic acid (5:4:0.5); Colour developing agent: ethanol solution of aluminium trichloride; Colour rendering: spray aluminium trichloride ethanol solution. The test product chromatography should show the same yellow spots in the corresponding positions with the reference material. It should also show the same fluorescent spots under UV lamp (365 nm) in the corresponding positions with the reference material.
2. HPLC: Column: 4.6 mm × 25 cm, packing L1 (i.e. Octadecyl silane chemically bonded to porous or nonporous silica particles, superficially porous particles, or ceramic microparticles, 1.5–10 µm in diameter, or a monolithic silica rod); Mobile phase: methanol, water, and phosphoric acid (100:100:1); Wavelength: 370 nm; Flow rate: 1.0 mL/min; Injection volume: 20 µL.
3. HPLC: Column: Phenomenex Gemini C18, 250 mm × 4.6 mm, 5 µm; Mobile phase A: 0.1% formic acid aqueous solution (Gradient elution as per the table below); Mobile phase B: Acetonitrile; Wavelength: 245 nm; Column temperature: 35oC; Flow rate: 1.0 mL/min; Injection volume: 10 µL.
Time (min) | Mobile phase A (%) |
|---|---|
0 | 97 |
10 | 91 |
12 | 90 |
16 | 87 |
30 | 81 |
60 | 65 |
70 | 3 |
79 | 3 |
80 | 97 |
88 | 97 |
4. HPLC: Column: ACQUITY UPLC® CSH C18, 2.1 × 100 mm, 1.7 µm; Mobile Phase A: 0.3% phosphoric acid aqueous solution (Gradient elution as per the table below); Mobile Phase B: Acetonitrile; Wavelength: 360 nm; Column temperature: 30oC; Flow rate: 0.3 mL/min; Injection volume: 2 µL.
Time (min) | Mobile phase A (%) |
|---|---|
0 | 85 |
1.8 | 70 |
3 | 65 |
4.3 | 60 |
5.5 | 55 |
6.5 | 60 |
7 | 85 |
5. Spectrophotometry: Reference standard: Rutin; Wavelength: 510 nm.
6. Spectrophotometry: Reference standard: D-(+)-Glucose; Wavelength: 485 nm (for Polysaccharides) or 490 nm (for Total sugars).
7. Spectrophotometry: Reference standard: Gallic acid; Wavelength: 778 nm.
Key to abbreviations:
USP: United State Pharmacopoeia
Ph. Eur.: European Pharmacopoeia
Rf: Retention Factor
TLC: Thin Layer Chromatograph
HPLC: High Pressure Liquid Chromatography