NATURAL YELLOW 18
Berberine hydrochloride
CAS: 633-65-8
Molecular Formula: C20H18ClNO4
NATURAL YELLOW 18 - Names and Identifiers
| Name | Berberine hydrochloride |
| Synonyms | ine HCl UMBELLATINE BERBERIN HCL Berberine hcl BERBERINE HCL NATURAL YELLOW 18 Berberine chloride TIMTEC-BB SBB006488 Berberine hydrochloride BERBERINE HYDROCHLORIDE NATURAL YELLOW 18 CHLORIDE BERBERINE HYDROCHLORIDE N-HYDRATE Berberberberine hydrochloride n-hydrate |
| CAS | 633-65-8 |
| EINECS | 211-195-9 |
| InChI | InChI=1/C20H18NO4.ClH/c1-22-17-4-3-12-7-16-14-9-19-18(24-11-25-19)8-13(14)5-6-21(16)10-15(12)20(17)23-2;/h3-4,7-10H,5-6,11H2,1-2H3;1H/q+1 |
| InChIKey | VKJGBAJNNALVAV-UHFFFAOYSA-M |
NATURAL YELLOW 18 - Physico-chemical Properties
| Molecular Formula | C20H18ClNO4 |
| Molar Mass | 371.81 |
| Melting Point | 204-206°C (dec.) |
| Water Solubility | SOLUBLE IN COLD WATER |
| Solubility | Insoluble in ethanol, chloroform and ether. |
| Appearance | Yellow small needle crystal |
| Color | Yellow powder |
| BRN | 3836585 |
| Storage Condition | Inert atmosphere,2-8°C |
| Sensitive | Easily absorbing moisture |
| MDL | MFCD00011939 |
| Physical and Chemical Properties | Melting point 200°C Water solubility SOLUBLE IN COLD WATER |
NATURAL YELLOW 18 - Risk and Safety
| Hazard Symbols | Xn - Harmful |
| Risk Codes | R20/21/22 - Harmful by inhalation, in contact with skin and if swallowed. R36/37/38 - Irritating to eyes, respiratory system and skin. |
| Safety Description | S24/25 - Avoid contact with skin and eyes. S36 - Wear suitable protective clothing. S26 - In case of contact with eyes, rinse immediately with plenty of water and seek medical advice. |
| UN IDs | 1544 |
| WGK Germany | 2 |
| RTECS | DR9866400 |
| FLUKA BRAND F CODES | 3-10 |
| TSCA | Yes |
| HS Code | 29349990 |
| Hazard Class | 6.1(b) |
| Packing Group | III |
| Toxicity | LD50 orl-rat: >15 g/kg KSRNAM 8,654,74 |
NATURAL YELLOW 18 - Standard
Authoritative Data Verified Data
This product is 5, 6-dihydro-9, 10-dimethoxybenzo [g]-l, 3-benzodioxolane [5,6-a] quinazine hydrochloride dihydrate. Calculated as anhydrous, containing not less than 97.0% of the C20H18ClN04 extract, and not less than 98.0% of the combined product
.Last Update：2024-01-02 23:10:35
NATURAL YELLOW 18 - Trait
Authoritative Data Verified Data
- This product is yellow crystalline powder; Odorless.
- This product is dissolved in hot water, slightly soluble in water or ethanol, slightly soluble in chloroform, insoluble in ether.
Last Update：2022-01-01 14:20:27
NATURAL YELLOW 18 - Differential diagnosis
Authoritative Data Verified Data
- take about 0.1g of this product, add 10ml of water, slowly heat and dissolve, add 4 drops of sodium hydroxide test solution, cool (filter if necessary), add 8 drops of acetone, then turbidity will occur.
- take about 5mg of this product, add 2ml of dilute hydrochloric acid, stir, and add a small amount of bleaching powder, that is, the cherry red.
- The infrared absorption spectrum of this product should be consistent with that of the control (Spectrum set 320).
- take about 0.LG of this product, add water 20ml, slowly heat and dissolve, add nitric acid 0.5ml, cool, place for 10 minutes, filter, filtrate chloride identification (1) reaction (General rule 0301).
Last Update：2022-01-01 14:20:27
NATURAL YELLOW 18 - Exam
Authoritative Data Verified Data
Related substances
take the appropriate amount of this product, precision weighing, and mobile phase dissolution and quantitative dilution of the solution containing lmg per lml, as a test solution; in addition, an appropriate amount of jatrorrhizine hydrochloride reference substance and palmatine hydrochloride reference substance was accurately weighed, dissolved and quantitatively diluted with mobile phase to make 0 in each lml. lmg solution, respectively, as the control solution (1) and (2); Precision take the sample solution 2ml and the control solution (1) and (2) 10ml, in a 100ml measuring flask, dilute to the scale with mobile phase, shake well and use as a control solution; Take 1 ml of the reference solution (2), dilute to 10ml with the test solution and shake well, as a system suitability solution. According to the high performance liquid chromatography (General 0512) test, using eighteen alkyl silane bonded silica gel as filler; The mobile phase was O · Olmol/L ammonium dihydrogen phosphate solution (adjusted to pH 2.8 with phosphoric acid)-acetonitrile (75:25); The detection wavelength was 345nm. Take the applicable solution 10 u1 of the system and inject it into the liquid chromatograph. The resolution between the peak of palmatine and the peak of berberine shall meet the requirements, human liquid chromatograph was injected respectively, and the chromatogram was recorded to 2 times of the retention time of the main component chromatographic peak. In the chromatogram of the test solution, if there are chromatographic peaks consistent with the retention time of jatrorrhizine peak and palmatine peak, the peak area shall be calculated according to the external standard method, and shall not exceed 1.0%; the sum of the peak areas of other impurities should not be greater than the peak area of the berberine peak in the control solution (2.0%).
cyanide
take this product 0.50g, inspection according to law (General Principles 0806 The first law), should comply with the provisions (combined products).
organic nitrile
take the refined product about 0.25g, weigh it accurately, put it in a 25ml plug Erlenmeyer flask, add 5ml of anhydrous ether, shake it for 5 minutes, and filter it through a vertical melting funnel (G5), wash with anhydrous diethyl ether for 3-4 times (2ml each time), combine the filtrate and the washing solution, concentrate to about 0.5, as the test solution; Take an appropriate amount of pepper acetonitrile reference substance, weigh precisely, chloroform is added to dissolve and dilute to make about 0.1 mg solution, as a control solution. According to the thin layer chromatography (General 0502) test, draw 10m of the reference solution and the total amount of the test solution, respectively, on the same silica gel G (thickness 0.5) thin layer plate, with benzene-glacial acetic acid (25:0.1) as the developing solvent, expand, dry, spray with 5% ammonium molybdate sulfuric acid solution, heated at 105°C for 10~20 minutes, the test solution shall not show impurity spots (combined product) at the corresponding positions of the main spots displayed by the control solution.
moisture
take this product, according to the moisture determination method (General 0832 first method 1), the water content shall not exceed 12.0%.
ignition residue
take l.Og of this product and check it according to law (General rule 0841). The remaining residue shall not exceed 0.2% (extract) or 0.1% (combined product).
Heavy metals
The residue left under the ignition residue item shall not contain more than 20 parts per million of heavy metals (combined product) after inspection by law (General rule 0821, Law II).
Last Update：2022-01-01 14:20:28
NATURAL YELLOW 18 - Content determination
Authoritative Data Verified Data
take about 0.3g of this product, weigh it accurately, put it in a beaker, add 150ml boiling water to dissolve, let it cool, and move it into a 250ml measuring flask, precision Add 50ml of potassium dichromate titration solution (0.01667mol/L), dilute to the scale with water, shake for 5 minutes, filter with dry filter paper, take 100ml of continued filtrate, put it in 250ml plug Erlenmeyer flask, add 2g of potassium iodide, shake to dissolve, Add 10ml of hydrochloric acid solution (1-2), Pack, shake well, place in the dark for 10 minutes, use sodium thiosulfate titration solution (0.1 mol/L) titration, when the end point is near, add 2ml of starch indicator solution, continue titration until the blue disappears, the solution is bright green, and the titration result is corrected by blank test. Each l of potassium dichromate titrant (0.016 mol/L) corresponds to 12.39mg of C20H18C1NO4.
Last Update：2022-01-01 14:20:29
NATURAL YELLOW 18 - Category
Authoritative Data Verified Data
antibacterial drugs.
Last Update：2022-01-01 14:20:29
NATURAL YELLOW 18 - Storage
Authoritative Data Verified Data
sealed storage.
Last Update：2022-01-01 14:20:29
NATURAL YELLOW 18 - Berberine hydrochloride tablets
Authoritative Data Verified Data
This product contains berberine hydrochloride (C20H18CIN04 • 2H20) should be 93.0% ~ 107.0% of the label amount.
trait
This product is yellow, sugar-coated or film-coated tablets, yellow after removing the coating.
identification
take an appropriate amount of fine powder of this product (about 0.lg of berberine hydrochloride), add 10ml of water, slowly heat to dissolve berberine hydrochloride, filter, and take the filtrate, the same reaction was shown according to the tests of identification (1), (2) and (4) under the item of berberine hydrochloride.
examination
- the dissolution of this product, according to the dissolution and release determination method (General rule 0931 method), with water 1000ml as the dissolution medium, the speed is 120 rpm, according to the law, after 45 minutes, take the solution and filter, take the appropriate amount of the filtrate, dilute with water to make a solution containing about 5ug of berberine hydrochloride per 1 ml, shake, the absorbance was measured at a wavelength of 0401 NM according to ultraviolet-visible spectrophotometry (General rule 724), and the elution amount of each tablet was calculated as the absorption coefficient of C20H18C1N04 · 2H20 was. The limit is 70% of the labeled amount and shall be in accordance with the provisions.
- others shall be in accordance with the relevant provisions under the item of tablets (General rule 0101).
Content determination
- measured by high performance liquid chromatography (General 0512).
- chromatographic conditions and system suitability test using eighteen alkyl silane bonded silica gel as filler; Phosphate buffer [0.05mol/L potassium dihydrogen phosphate solution and 0.05mol/L sodium heptane sulfonate solution (1:1 ), the mobile phase contained 0.2% triethylamine and adjusted pH to 3.0]-acetonitrile (60:40) with phosphoric acid; The detection wavelength was 263nm. The number of theoretical plates shall not be less than 3000 calculated by berberine peak, and the separation degree between berberine peak and adjacent impurity peaks shall meet the requirements.
- determination of 20 tablets of this product, such as sugar-coated tablets, remove the sugar coating, precision weighing, fine grinding, precision weighing fine powder appropriate amount (about 40mg equivalent to berberine hydrochloride), 100ml measuring flask, add an appropriate amount of boiling water to dissolve berberine hydrochloride, let it cool, dilute to the scale with water, shake well, filter, discard about 8ml of the initial filtrate, take 5ml of the additional filtrate and put it in a 50ml measuring flask, dilute to scale with water, shake well, as a test solution, take 20 u1 with precision, inject human liquid chromatograph, record chromatogram; Take appropriate amount of berberine hydrochloride reference, weigh precisely, the solution was dissolved in boiling water, allowed to cool, and quantitatively diluted with water to prepare a solution containing about 40ug per 1 ml, which was determined by the same method. According to the external standard method to calculate the peak area, that is.
category
with berberine hydrochloride.
specification
(1)0.025g (2)0.05g (3)0.lg (4)0.15g
storage
light shielding, sealed storage.
Last Update：2022-01-01 14:20:30
NATURAL YELLOW 18 - Berberine hydrochloride capsules
Authoritative Data Verified Data
This product contains berberine hydrochloride (C20H18C1N04 • 2H20) should be 93.0% ~ 107.0% of the label amount.
trait
The content of this product is yellow powder or granules.
identification
- take an appropriate amount of the content of this product (about 0.1g of berberine hydrochloride), add 10ml of water, slowly heat to dissolve berberine hydrochloride, filter, and test according to the following method.
- 5ml of filtrate was taken, 2 drops of sodium hydroxide solution were added, which was orange-red in color. After cooling, 4 drops of acetone were added, resulting in turbidity, add 1 drop of acetone, If turbidity still occurs, add appropriate amount of acetone to make the precipitate complete, filter, and the filtrate shows chloride to identify the reaction of (1) (General rule 0301).
- 0.5ml of the filtrate was taken, and 2ml of dilute hydrochloric acid was added.
- in the chromatogram recorded under the content determination item, the retention time of the main peak of the test solution should be consistent with the retention time of the main peak of the reference solution.
examination
- water content of this product, mixed evenly, according to the moisture determination method (General rule 0832 first method 1> determination, moisture content shall not exceed 12.0%.
- the dissolution of this product, according to the dissolution and release determination method (General rule 0931 method), with water 1000ml as the dissolution medium, the speed is 120 rpm, according to the law, after 45 minutes, take 5ml of the solution, filter, take 2ml of the filtrate, put it in a 25ml measuring flask, dilute it to the scale with water, shake it well, and measure it by UV-Vis spectrophotometry (General rule 0401), the absorbance was measured at a wavelength of 263nm, and the amount of dissolution per particle was calculated as the absorption coefficient of c20h18c1n04-2h20 was 724. The limit is 70% of the labeled amount and shall be in accordance with the provisions.
- others should comply with the relevant provisions under the capsule (General 0103).
Content determination
- measured by high performance liquid chromatography (General 0512).
- chromatographic conditions and system suitability test using eighteen alkyl silane bonded silica gel as filler; Phosphate buffer [0.05mol/L potassium dihydrogen phosphate solution and 0.05mol/L sodium heptane sulfonate solution (1:1 ) , the mobile phase contained 0.2% triethylamine and adjusted pH to 3.0]-acetonitrile (60:40) with phosphoric acid; The detection wavelength was 263nm. The number of theoretical plates shall not be less than 3000 calculated by berberine peak, and the separation degree between berberine peak and adjacent impurity peaks shall meet the requirements.
- determine the contents under the item of loading difference, mix evenly, weigh an appropriate amount (about 40mg equivalent to berberine hydrochloride) accurately, put it in a 100ml measuring flask, and add an appropriate amount of boiling water, dissolve berberine hydrochloride, let it cool, dilute to the scale with water, shake well, filter, discard about 8ml of the initial filtrate, take 2ml of the continued filtrate and put it in a 25ml measuring flask, dilute to scale with water, shake well, as a test solution, take 20ul of precision volume, inject human liquid chromatograph, record chromatogram; Take appropriate amount of berberine hydrochloride reference, precision weigh, the solution was dissolved in boiling water, allowed to cool, and quantitatively diluted with water to prepare a solution containing about 32ug per 1 ml, which was determined by the same method. According to the external standard method to calculate the peak area, that is.
category
with berberine hydrochloride.
specification
O.lg
storage
shading, sealed storage.
Last Update：2022-01-01 14:20:31
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