Ferulic Acid99%(Synthetic)

Short Description:

Enhance human bodys motility.,Inhibite platelet aggregation, increase 3H-5HT releasing from platelet;. Antioxidate, clear free radical, protective cell, accommodate body immune function; Anti-bacteria, anti-inflammatory, anti-tumor, anti- mutation, anti-ultraviolet radiation; Inhibit thrombosis.


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Coa

Product Name:  Ferulic acid

Latin name: Ferulic acid

Quality standard: National Standard

Specification: ≥98%

Test method:HPLC

CAS NO: 537-98-4

Appearance:  off-white fine powder

Storage method: Store in cool and dry place. Keep away from strong light and heat.

Shelf life: 24 month

Source of extraction: Synthetic

Package specification: 1kg / aluminum foil bag, 25kg/Drum or as required by customers

Product introduction: ferulic acid  is slightly soluble in water, fat soluble, alcohol soluble


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  • FERULIC ACID Quality standard,

    Document code: TS-QC-011-00

    1.Technical Standard

    Item

    Standard

     Factory control standard

    Appearance

    white to Pale yellow crystalline powder

    white to Pale yellow crystalline powder

    Content

    98.0 ~ 102.0%

    99.0 ~ 101.0%

    Melting point

    172.0 ~ 175.0 °C

    172.5 ~ 174.5 °C

    Identification

    the maximum absorption at the wavelength of 232 nm at 320 nm

    the maximum absorption at the wavelength of 232 nm at 320 nm

     Loss on drying

    ≤0.5%

    ≤0.4%

    Burning residue

    ≤0.1%

    ≤0.08%

    Heavy metal

    ≤10 PPM

    ≤10 PPM

    RELATED SUBSTANCES

    1.The area of each impurity peak shall not be larger than the main peak area of the control solution (0.1%)

    2. The area of each impurity peak and should not be larger than the microbial limit of the main peak area (0.5%) of the control solution.

    1.The area of each impurity peak shall not be larger than the main peak area of the control solution (0.08%)

    2. The area of each impurity peak and should not be larger than the microbial limit of the main peak area (0.4%) of the control solution.

    Limit of bacteria

    The number of bacteria should not exceed 1000 CFU PER 1G.

    Mold and Yeast Count: no more than 100 CFU per 1G.

    E. Coli: not detectable per 1G

    The number of bacteria should not exceed 500 CFU PER 1G.

    Mold and Yeast Count: no more than 50 CFU per 1G.

    E. Coli: not detectable per 1G

    Objective: to establish the quality standard of ferulic acid, to reflect the inherent quality of the product, and to ensure the stability, safety and effectiveness of the product.

    2. Scope of application

    2.1 for the determination of ferulic acid.

    3. The scope of responsibility, the technical quality department is responsible for the implementation of this standard.

    4. Structural formula and name Molecular Formula C10H10O4 molecular weight: 194.18 Chinese name: Ferulic acid chemical formula: FERULIC ACID 5. CONTENT: this product is 4-hydroxy-3-methoxy cinnamic acid, according to the dry product calculation, containing C10H10O4 should be 98.0 ~ 102.0% .

     5.1 properties, this product is white to light yellow crystalline powder; odorless, tasteless; this product can dissolve in ethanol, hot water and Ethyl Acetate, slightly soluble in ether, insoluble in benzene and petroleum ether. The melting point of this product is determined from 172.0 °C to 175.0 °C according to the operating rules of the melting point Determination method.

    5.2 identification

    5.2.1 the product was dissolved in anhydrous ethanol and diluted to a solution containing about 4 g ferulic acid per 1 ml. The maximum absorption was at 232 ± 2 nm and 320 ± 2 nm, as determined by the Spectrophotometer.

    5.3 check 5.3.1 dry weight loss, take this product at 105 °C drying to constant weight, in accordance with the “dry weight loss method operating procedures” to determine the loss of weight shall not exceed 0.5% .

    5.3.2 red-hot residue, take 1.0 g of this product, according to the law inspection “red-hot residue inspection procedures” , residue shall not exceed 0.1% .

    5.3.3 heavy metals, take the residue left under the burning residue and check according to the second law of the operating rules of the heavy metal inspection method, containing heavy metals not more than 10 parts per million (10 PPM) .

    5.3.4 the related substances are determined in accordance with the High-performance liquid chromatography. The product is precisely weighed and dissolved in a mobile phase to form a solution containing 0.25 mg ferulic acid in 1 ml. The solution is filtered through a PTFE membrane and the filtrate is taken as the test solution. The sample solution containing 2.5 ug ferulic acid in 1ml was made from the sample solution plus mobile phase. The sample solution was filtered by PTFE membrane and the filtrate was taken as the sample solution. The peak height of the main component chromatogram peak is about 10 ~ 30% of the full range by adjusting the detection sensitivity by injecting 20 l control solution into the liquid chromatograph according to the chromatogram condition determined under the content determination, according to the High-performance liquid chromatography, then, 20 l of sample solution and 20 L of Control Solution were injected into liquid chromatograph, and the retention time of Chromatogram to principal component peak was 3 times. If there are impurity peaks in the Chromatogram of the sample solution, the area of the single impurity peak shall not be greater than 0.1 times (0.1%) of the main peak area of the control solution, and the area of each impurity peak shall not be greater than 0.5 times (0.5%) of the main peak area of the control solution. 5.4 The content was determined by HPLC with octadecyl Silane Bonded Silica Gel as filler, methanol-1% glacial acetic acid solution (17:3) as mobile phase, column temperature 30 °C, detection wavelength 320 nm, flow rate 0.5 ml/min, the theoretical plate number should not be less than 2500 according to the ferulic acid peak, and the separation degree of ferulic acid from its neighboring impurity peaks should meet the requirements. Precision weighing at 105 °C drying to constant weight of ferulic acid reference material, add mobile phase made of 1ml containing 60ug ferulic acid solution, shake well, filter as reference material solution. Precision weighing this product, add mobile phase made of 1ML containing ferulic acid 60ug solution, shake well, filter as a reference solution. Precise measurement of sample solution and control solution 20 l each, respectively injected into the liquid chromatograph, record chromatogram, according to the external standard method to calculate the peak area, that is. 5.5 Microbial Limit

    5.5.1 bacteria count: no more than 1000 CFU per 1G

    . 5.5.2 mold and yeast counts: no more than 100 CFU PER 1G.

    5.5.3 E. COLI: not detectable per 1G.

    5.5.4 live MITES: not detectable. PURPOSE: PHARMACEUTICAL INTERMEDIATES AND COSMETIC RAW materials.

    5.7 storage: Keep Out of light, store in a closed container.

    5.8 specifications: 25kg/barrel.

    5.9 packing: one aluminum foil bag inside and one polythene medical plastic bag outside.

     5.10 validity: 2 years.

     6. Relevant documents and records the Spectrophotometer, the High-performance liquid chromatography, the dry weight loss method, the hot residue test method, the heavy metal test method, the microbial limit test method.

     7. Change reason and record, effective date, drafter, version number, change reason, basis and content 2015.03 Liu Jing 00 new file system.

     8. BACKGROUND: Chinese PHARMACOPOEIA, 2010 edition, Part II.

    Training

    9.1 training responsibility: Quality Manager.

     9.2 Target Audience: Quality Department Staff.

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