130-40-5
Riboflavin sodium phosphate
CAS: 130-40-5
Molecular Formula: C17H20N4NaO9P
130-40-5 - Names and Identifiers
130-40-5 - Physico-chemical Properties
| Molecular Formula | C17H20N4NaO9P |
| Molar Mass | 478.33 |
| Melting Point | >300°C |
| Specific Rotation(α) | [α]D20 +38～+43° (c=1.5, dil. HCl) (Calculated on dehydrous basis) |
| Water Solubility | almost transparency |
| Solubility | H2O: soluble50mg/mL, clear, orange |
| Appearance | Yellow powder or crystal |
| Color | Yellow to Dark Orange |
| Merck | 14,8201 |
| BRN | 4106529 |
| Storage Condition | 2-8°C |
| Stability | Stable. Incompatible with strong oxidizing agents, reducing agents, bases, calcium, metallic salts. Protect from light, air and moisture. |
| Refractive Index | 41 ° (C=1.5, 5mol/L |
| MDL | MFCD00065362 |
| Use | Vitamin drugs for the treatment of a variety of VB2 deficiency, but also can be used in a large number of food additives |
130-40-5 - Risk and Safety
| Hazard Symbols | Xi - Irritant |
| Risk Codes | 36/38 - Irritating to eyes and skin. |
| Safety Description | S22 - Do not breathe dust. S24/25 - Avoid contact with skin and eyes. S37/39 - Wear suitable gloves and eye/face protection S26 - In case of contact with eyes, rinse immediately with plenty of water and seek medical advice. |
| WGK Germany | 3 |
| FLUKA BRAND F CODES | 3-8-10 |
| HS Code | 29362300 |
130-40-5 - Standard
Authoritative Data Verified Data
This product is riboflavin 5 '-(dihydrogen phosphate) monosodium salt dihydrate. The riboflavin content (C17H20N406) should be between 74.0% and 79.0% based on the dry product.
Last Update：2024-01-02 23:10:35
130-40-5 - Trait
Authoritative Data Verified Data
- This product is orange-yellow crystalline powder; Almost odorless; With hygroscopicity.
- This product is dissolved in water, almost insoluble in ethanol, chloroform or ether.
specific rotation
operation in the dark. Take this product, precision weighing, and hydrochloric acid solution (45-100) dissolved and quantitatively diluted into solution containing about 15mg per lml, determined according to law (General 0621 ), the specific rotation was 38.0 ° to 42.0 °.
Last Update：2022-01-01 15:36:23
130-40-5 - Differential diagnosis
Authoritative Data Verified Data
- take about 1 mg of this product and add 100ml of water to dissolve it. The solution shows light yellow and strong yellow-green fluorescence under transmitted light. Add inorganic acid or alkali solution, and the fluorescence will disappear.
- take this product, add phosphate buffer (pH 7.0) to dissolve and dilute to make a solution containing 10ug per lml, and measure it by UV-Vis spectrophotometry (General 0401), there is maximum absorption at wavelengths of 267nm, 372nm and 444nm, and minimum absorption at a wavelength of 240nm.
- The infrared absorption spectrum of this product should be consistent with that of the control (Spectrum set 628).
- take 0.5g of this product, Add 10ml of nitric acid, evaporate on a water bath, Flash, add 5ml of water to dissolve the residue, if necessary, filter, filtrate sodium salt identification reaction (General rule 0301).
Last Update：2022-01-01 15:36:24
130-40-5 - Exam
Authoritative Data Verified Data
acidity
take 0.40g of this product, add 20ml of water to dissolve, and then measure it according to law (General rule 0631). The pH value should be 4.0~6.5.
clarity of the solution
take 0.20g of this product and add 10ml of water to dissolve. The solution should be clarified.
sensate
take 35mg of this product, add 10ml of alcohol-free chloroform, shake for 5 minutes, filter, filtrate UV-visible spectrophotometry (General rule 0401), at the wavelength of 440nm, the absorbance should not exceed 0.025.
free phosphoric acid precision scale
take 0.20g of this product (calculated according to the dry product), put it in a 100ml measuring flask, add 30ml of water, shake to dissolve, and use it as a test solution; in addition, take phosphate control solution (105g of potassium dihydrogen phosphate dried at 0.42°C for 2 hours), put it in a 1000ml measuring flask, add 10ml of sulfuric acid solution (3-10) and an appropriate amount of water to dissolve, dilute to scale with water, shake well, and dilute 5 times more if necessary] 20ml, place in another 100ml measuring flask, Add 10ml of water, and shake well, as a control solution. Add 2.5ml of ammonium molybdate sulfuric acid test solution and 1-amino -2-naphthol -4-sulfonic acid solution (take 5g of anhydrous sodium sulfite, 0.7g of sodium bisulfite and 1.5g of 1-amino-2-naphthol -4-sulfonic acid were mixed thoroughly, g of the mixture was added with 10ml of water to dissolve, filtered if necessary), shake well, dilute with water to scale, shake well, place at 20°C for 30 minutes, measure absorbance at 740nm by UV-visible spectrophotometry (General rule 0401 ), the absorbance of the test solution shall not be greater than that of the control solution.
Related substances
operation in the dark. Take the test solution under the content measurement item as the test solution; Take 2ml with precision, put it in a 50ml measuring flask, dilute to the scale with the mobile phase, shake well, and use as the control solution. 1 ml of the riboflavin control solution under the content determination item was accurately measured, placed in a 10ml measuring flask, diluted to the scale with the mobile phase, and shaken to be used as the riboflavin control solution. According to the chromatographic conditions under the content determination item, the sample solution, the control solution and the riboflavin reference solution are respectively injected into the liquid chromatograph, the chromatogram was recorded to 2.5 times of the retention time of the main component peak. If there are impurity peaks corresponding to those in the chromatogram of the solution applicable to the system, the peak area shall be calculated according to the external standard method. According to the dry product, riboflavin diphosphate (according to riboflavin) content shall not exceed 6.0%, free riboflavin content shall not exceed 6.0%. In addition to the main component peak, free riboflavin peak and riboflavin diphosphate peak in the chromatogram of the test solution, if there are other impurity peaks, the single impurity shall not be greater than 0.25 times (1.0%) of the area of the main peak of the control solution, the sum of the peak areas of other impurities shall not be greater than the main peak area of the control solution (4.0%).
loss on drying
take about 0.3g of this product, dry to constant weight at 130°C, and lose no more than 10.0% of weight (General rule 0831).
Last Update：2022-01-01 15:36:25
130-40-5 - Content determination
Authoritative Data Verified Data
measured by high performance liquid chromatography (General 0512).
chromatographic conditions and system suitability test
silica gel bonded with eighteen alkyl silane was used as the filler; Methanol -0.054mol /L potassium dihydrogen phosphate solution (15:85) was used as the mobile phase; The detection wavelength was 267nm. Take 10mg of riboflavin sodium phosphate mixed reference, put it in a 50ml measuring flask, add the mobile phase to dissolve and dilute to the scale, shake well, and use it as a system applicable solution. 20ml was injected into the liquid chromatograph, and the flow rate was adjusted so that the retention time of the riboflavin sodium phosphate peak was about 40 minutes, and the chromatogram was recorded to be 2.5 times of the retention time of the main component peak. The peak sequence of each chromatographic peak is shown in the table below. The resolution of riboflavin sodium phosphate peak and V-riboflavin sodium phosphate peak should be greater than 2.0.
assay
operation in the dark. Take lOmg of this product, weigh it accurately, put it in 50ml measuring flask, add appropriate amount of mobile phase, shake to dissolve it, dilute it to scale with mobile phase, shake it well, and use it as test solution; in addition, 10mg of the riboflavin control was accurately weighed, placed in a 50ml measuring flask, dissolved by adding 1 ml of hydrochloric acid, diluted to the scale with the mobile phase, and shaken well to serve as the control solution. 20ul of the test solution and the reference solution were respectively injected into the liquid chromatograph, and the chromatograms were recorded. According to the external standard method to calculate the peak area, that is.
Last Update：2022-01-01 15:36:26
130-40-5 - Category
Authoritative Data Verified Data
vitamins.
Last Update：2022-01-01 15:36:26
130-40-5 - Storage
Authoritative Data Verified Data
light shielding, sealed storage.
Last Update：2022-01-01 15:36:26
130-40-5 - Riboflavin sodium phosphate injection
Authoritative Data Verified Data
This product is a sterile aqueous solution of riboflavin sodium phosphate. Riboflavin-containing sodium phosphate shall be calculated as riboflavin (C17H20N406) and shall be 90.0% to 115.0% of the labeled amount.
trait
This product is yellow to orange yellow clear liquid; Light deterioration.
identification
- take an appropriate amount of this product (about 1 mg equivalent to riboflavin), add water to 100ml, the solution shows light yellow and strong yellow-green fluorescence under transmitted light; Add hydrochloric acid or sodium hydroxide solution, the fluorescence disappeared.
- 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 riboflavin sodium phosphate in the solution applicable to the system.
- take an appropriate amount of this product (about 0.lg of riboflavin sodium phosphate), steam dry on a water bath, add 10ml of nitric acid, steam dry on the water bath, Flash, add 5ml of water to dissolve the residue, if necessary, filter, filtrate sodium salt and phosphate identification reaction (General 0301).
examination
- the pH value should be 5.6 to 6.5 (General 0631).
- the related substances were protected from light. Take the test solution under the content measurement item as the test solution; Take 2ml with precision, put it in a 50ml measuring flask, dilute to the scale with the mobile phase, shake well, and use as the control solution. 1 ml of the riboflavin control solution under the content determination item was accurately measured, placed in a 10ml measuring flask, diluted to the scale with the mobile phase, and shaken to be used as the riboflavin control solution. The determination was carried out according to the test method for related substances of riboflavin sodium phosphate. Riboflavin diphosphate (based on riboflavin) content shall not exceed 6.0% of the labeled amount and free riboflavin content shall not exceed 10.0% of the labeled amount. In addition to the main component peak, free riboflavin peak and riboflavin diphosphate peak in the chromatogram of the test solution, if there are other impurity peaks, the single impurity shall not be greater than 0.5 times (2.0%) of the area of the main peak of the control solution, the sum of the peak areas of other impurities shall not be greater than 1.5 times (6.0%) of the main peak area of the control solution.
- bacterial endotoxin take this product, according to the law inspection (General 1143), each 1 mg of riboflavin containing endotoxin amount should be less than 2.5EU.
- others should comply with the relevant provisions under injection (General 0102).
Content determination
operation in the dark. Precision take the appropriate amount of this product, quantitative dilution with the mobile phase made of each 1 ml containing about 0.2mg (C17H20N406) of the solution, as a test solution. According to the method under the item of determination of riboflavin sodium phosphate content, obtained.
category
with riboflavin sodium phosphate.
specification
Based on riboflavin (l)2ml:5mg (2)2ml:lO mg
storage
light shielding, closed storage.
Last Update：2022-01-01 15:36:27
130-40-5 - Reference Information
| FEMA | 2976 | QUININE HYDROCHLORIDE |
| EPA chemical information | Information provided by: ofmpub.epa.gov (external link) |
| introduction | riboflavin sodium phosphate is a precursor of flavin mononucleotide (FMN) and flavin adenine dinucleotide (FAD), Chinese aliases vitamin B2 sodium phosphate, flavin mononucleotide sodium, riboflavin -5 '-(dihydrophosphate) monosodium salt, FMN and FAD are important cofactors of flavin family. Flavinase catalyzes many biochemical reactions, the most typical of which are oxidation and other reactions, which are key factors of cell respiration. |
| physiological functions and effects | riboflavin sodium phosphate is a vitamin drug. Riboflavin (vitamin B2) is an important nutrient in the human body and plays a key role in energy metabolism. This drug is a precursor of flavin mononucleotide (FMN) and flavin adenine dinucleotide (FAD), and FMN and FAD are important cofactors of flavin family. Flavinase catalyzes many biochemical reactions, most typically redox reactions, which are key factors in cell respiration. FAD and FMN pass hydrogen in the mitochondrial transport chain, producing cellular energy in the process. |
| deficiency | riboflavin sodium phosphate deficiency can affect the body's biological oxidation and cause metabolic disorders. its lesions are mostly manifested as inflammation of mouth, eyes and external genitalia. |
| pharmacological mechanism | according to literature, riboflavin is mainly absorbed in the proximal small intestine after oral administration. food can promote the absorption of the product and bile salt can accelerate the absorption of the product. In the dose range of 2~25mg, its bioavailability is 50 ~ 60%, the maximum absorption amount of a single oral administration is 27mg, and the excess part is excreted from feces. Flavin mononucleotide (FMN) and flavin adenine dinucleotide (FAD) were less absorbed. This medicine enters the liver through the portal vein and enters the blood circulation, and then reaches the tissue. Most of the serum riboflavin is transported by albumin or immunoglobulin and diffuses into cells through concentration gradient. In cells, riboflavin is converted to FMN by flavin kinase, and FMN is converted to FAD by FAD synthetase. FAD is the main form of riboflavin in tissues. Riboflavin exceeding the body's requirements is mainly excreted from the kidneys, and some metabolites are also excreted from the kidneys. The half-life of this drug is 66 to 84 minutes by oral or intramuscular injection. |
| uses | the main uses of riboflavin sodium phosphate are: 1. it can promote cell development and regeneration; 2. it can also promote the continued growth of hair, nails and skin; 3 can help prevent and eliminate inflammation in the oral cavity, tongue and lip, which is also called oral reproductive syndrome; 4 can also help reduce eye fatigue, enhance vision; 5 can affect the body's absorption of iron. Vitamin drugs are used to treat various VB2 deficiencies, and can also be used as food additives in large quantities |
| indications | riboflavin sodium phosphate can be used as riboflavin supplement, which can be used for the treatment of stomatitis, cheilitis, glossitis, conjunctivitis and scrotum caused by riboflavin deficiency. |
| Synthesis method | The current synthesis method is mainly to phosphorylate riboflavin and phosphorus oxychloride in a mixed solvent of pyridine and acetonitrile, Then hydrolyze the reaction mixture, and then neutralize with sodium hydroxide to obtain riboflavin sodium phosphate. There is also a synthetic method of using γ-butyrolactone instead of pyridine. The product produced by the above synthesis method has a low content of riboflavin sodium phosphate, which is difficult to meet the requirements of the Chinese Pharmacopoeia. The related substance riboflavin diphosphate has a higher content and a higher content of free phosphoric acid; more impurities, The quality is not high; the amount of contaminated waste liquid is large. The main factors affecting the quality of riboflavin sodium phosphate are related substances and free phosphoric acid content. The related substances are riboflavin diphosphate and free riboflavin, of which riboflavin diphosphate is 3 ', 4'-riboflavin diphosphate, 3 ', 5'-riboflavin diphosphate, 4 ', 5'-riboflavin diphosphate, the sum of 4 ', 5'-riboflavin diphosphate; the pharmacopoeia standard content control limit is 6%. |
| identification test | solubility dissolved in water. Insoluble in ethanol. Measured according to OT-42 method. The sample was vacuum dried on phosphorus pentoxide at 100 ℃ for 5 hours by specific rotation, and then 1.5%(W/V) sample solution was prepared with 20%(W/V) hydrochloric acid as solvent, and then determined by conventional method. Its [α]D20 should be 38 ° ~ 42 °. Sodium salt Determination of sodium in sulfate ash by IT-28 method. The maximum absorbance ratio of sample aqueous solution at 375nm and 267nm wavelengths is 0.30~0.34, and the ratio at 444nm and 26.7nm is 0.35~0.40. |
| content analysis | content analysis should be carried out under non-direct light. Take 100mg of sample and put it into a 500ml brown volumetric flask, add 100ml of water and 2.5ml of glacial acetic acid, and fix the volume with water. Take 20.0ml of the solution and transfer it into a 200ml brown volumetric flask, add 3.5ml of 1.4%(W/V) sodium acetate solution, and fix the volume with water. The maximum absorbance (A) of the solution at 444nm was determined. Total pigment quantity =(A × 5000/328 × W)× 1.367 formula W-sample quantity, g. |
| toxicity | ADI 0~0.5 mg/kg(FAO/WHO,2001). LD50510mg/kg (subcutaneous injection in mice). GRAS(FDA,§ 182.5697,2000). |
| use limit | GB 1-4880-94: same as "01022, riboflavin". 2.FAO/WHO(1988): The synthetic product is limited to pigment. FDA § 184.1697(2000):GMP is limited. |
Last Update：2024-04-09 20:45:29
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