Troxerutin is a bioflavonoid derivative that is commonly used in pharmaceuticals and nutraceuticals due to its potential health benefits, particularly in managing venous disorders. It's typically available in different forms, including powders, tablets, capsules, or creams. As of my last update in January 2022, Troxerutin in powder form is used as an active pharmaceutical ingredient (API) for various medicinal products, especially those targeting circulatory system-related conditions.
Here is a general product description for Troxerutin powder as an API:
Product Name: Troxerutin Powder Chemical Formula: C33H42O19 Molecular Weight: Approximately 742.68 g/mol Category: Flavonoid derivative, often classified as a bioflavonoid Source: Troxerutin is a naturally occurring flavonoid found in certain plants, including the Japanese pagoda tree (Sophora japonica).
Mechanism of Action: Troxerutin is known for its venotonic and vasoprotective properties. It strengthens blood vessels, reduces capillary permeability, and exhibits antioxidant effects. Troxerutin primarily acts by improving blood flow, reducing inflammation, and protecting blood vessels, which can be beneficial in conditions like chronic venous insufficiency, hemorrhoids, and other venous disorders.
Indications: Troxerutin is often used in the formulation of medications or supplements targeting venous disorders, such as chronic venous insufficiency, varicose veins, venous ulcers, and hemorrhoids.
Dosage Form: Troxerutin powder is an active ingredient used in the manufacturing of various pharmaceutical dosage forms, including tablets, capsules, topical creams, and gels.
Usage: The dosage and administration of Troxerutin depend on the specific formulation and the patient's condition. Dosages may vary according to the severity of the condition and the product's specific instructions provided by healthcare professionals.
Side Effects: Troxerutin is generally considered safe when used as directed. However, some individuals may experience mild side effects such as gastrointestinal disturbances or allergic reactions. It's essential to consult a healthcare professional for guidance before using products containing Troxerutin, especially if you have any underlying health conditions or are taking other medications.
Availability: Troxerutin powder as an API is primarily available to pharmaceutical manufacturers and compounding pharmacies for the production of medications and supplements targeting venous disorders.
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Inspection Item
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standard
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Inspection consequence
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conclusion
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Characteristics
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yellowsh-green crystalline powder hygroscopic.
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Yellowsh crystalline powder,
hygroscopic.
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Conforms to regulation
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Identification
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A Infrared absorption CRS
BResults the principal peak in the
chromatogram obtained with the test
solution is similar in position and size to
the principal peak in the chromatogram
obtained with the reference
solution(a)
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B Results the principal peak in the
chromatogram obtained with the test
solution is similar in position and size
to the principal peak in the
chromatogram obtained with the
reference solution(a)
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Conforms to regulation
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TE
ST
S
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composition
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Principal peak:minimum 80 per cent ；
Except for I peak:which can be
maximum 10 per cent ;Any other
peak:for each peak, maximum 5 per
cent
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Principal peak:87per cent；Except for
I peak:which can be 7 per cent ；Any
other peak:for each peak, 3per cent
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Conforms to regulation
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Ethylene oxide
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maximums 1ppm
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Conforms /to regulation
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Conforms to regulation
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Loss on drying
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maximums 5 per cent
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1.5%
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Conforms to regulation
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Sulphated ash
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maximums 0.4 per cent
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0.15%
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Conforms to regulation
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Heavy metals
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maximums 20ppm
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Conforms to regulation
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Conforms to regulation
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Cadmium
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maximums 1 PPM
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Conforms to regulation
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Conforms to regulation
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Lead
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maximums 3 PPM
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Conforms to regulation
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Conforms to regulation
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Mer.cur.y
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maximums 0. 1 PPM
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Conforms to regulation
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Conforms to regulation
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Arsenic
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maximums 1 PPM
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Conforms to regulation
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Conforms to regulation
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|
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Total plate count
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Less than 1000CFU/G
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Less than 1000cfu/g
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Conforms to regulation
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Yeast&Mould
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Less than 100CFU/G
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Less than 100cfu/g
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Conforms to regulation
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E.coli
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Absent
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Absent
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Conforms to regulation
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P.aeruginosa
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Absent
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Absent
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Conforms to regulation
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Methanol
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maximums 0.3 per cent
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0.015%
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Conforms to regulation
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assay(dried substance)
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95.0%～105.0% 95.0 percent to105.0 percent
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98.5%
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Conforms to regulation
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conclusion
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based on EP Inspection ，Conforms to regulation
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