uridinal
PHENAZOPYRIDINE HYDROCHLORIDE
CAS: 136-40-3
Molecular Formula: C11H12ClN5
uridinal - Names and Identifiers
| Name | PHENAZOPYRIDINE HYDROCHLORIDE |
| Synonyms |
sedural urazium uriplex pyrizin uridinal PYRIDACIL BISTERIL MALLOPHENE urobiotic-250 PHENAZODINE thiosulfil-aforte PHENAZOPYRIDINE HCL PHENAZOPYRIDINE HYDROCHLORIDE PHENYLAZODIAMINOPYRIDINE HYDROCHLORIDE 3-[(E)-phenyldiazenyl]pyridine-2,6-diamine 3-phenylazopyridine-2,6-diamine hydrochloride 3-PHENYLAZO-2,6-DIAMINOPYRIDINE HYDROCHLORIDE 2,6-DIAMINO-3-[PHENYLAZO]PYRIDINE HYDROCHLORIDE 2,6-diamino-3-(phenylazo)-pyridinmonohydrochloride 3-PHENYLAZO-2,6-DIAMINOPYRIDINE MONOHYDROCHLORIDE 3-BENZENEAZO-2,6-DIAMINOPYRIDINE MONOHYDROCHLORIDE 2,6-DIAMINO-3-(PHENYLAZO)PYRIDINE MONOHYDROCHLORIDE 3-(PHENYLAZO)-2,6-PYRIDINEDIAMINE, MONOHYDROCHLORIDE |
| CAS | 136-40-3 |
| EINECS | 205-243-8 |
| InChI | InChI=1/C11H11N5.ClH/c12-10-7-6-9(11(13)14-10)16-15-8-4-2-1-3-5-8;/h1-7H,(H4,12,13,14);1H |
| InChIKey | QQBPIHBUCMDKFG-GEEYTBSJSA-N |
uridinal - Physico-chemical Properties
| Molecular Formula | C11H12ClN5 |
| Molar Mass | 249.7 |
| Density | 1.2645 (rough estimate) |
| Melting Point | 139°C |
| Boling Point | 394.6°C (rough estimate) |
| Flash Point | 233.8°C |
| Water Solubility | 0.01-0.1 g/100 mL at 20 ºC |
| Solubility | Soluble in Methanol and Slightly Soluble in Cold Water |
| Vapor Presure | 5.66E-09mmHg at 25°C |
| Appearance | Powder |
| Color | Clear to hazy colorless to yellow |
| Merck | 14,7210 |
| Storage Condition | Sealed in dry,2-8°C |
| Refractive Index | 1.6110 (estimate) |
| MDL | MFCD00035347 |
| Physical and Chemical Properties | Light red to dark purple crystalline powder. |
| Use | For the relief of cystitis, prostatitis, urethritis, gonorrheal urethritis and endoscopy, urethral intubation caused by the urethra and bladder pain, burning sensation and frequent urination, urgency and other discomfort |
| In vitro study | Phenazopyridine:(I) enhances neural cell differentiation, (ii) increases cell survival, (iii) reduces the number of non-neuronal and undifferentiated cells and (iv) synchronizes the state of cell differentiation. |
| In vivo study | Phenazopyridine can directly inhibit the mechanically sensitive A δ-fibers of normal rat bladder. |
uridinal - Risk and Safety
| Risk Codes | R22 - Harmful if swallowed R36/37/38 - Irritating to eyes, respiratory system and skin. R40 - Limited evidence of a carcinogenic effect R34 - Causes burns R42/43 - May cause sensitization by inhalation and skin contact. |
| Safety Description | S26 - In case of contact with eyes, rinse immediately with plenty of water and seek medical advice. S36/37 - Wear suitable protective clothing and gloves. S45 - In case of accident or if you feel unwell, seek medical advice immediately (show the label whenever possible.) S36/37/39 - Wear suitable protective clothing, gloves and eye/face protection. S27 - Take off immediately all contaminated clothing. S22 - Do not breathe dust. |
| UN IDs | 2811 |
| WGK Germany | 3 |
| RTECS | US7875000 |
| HS Code | 29333990 |
| Toxicity | LD50 orally in rats: 403 mg/kg (Becker, Swift) |
uridinal - Standard
Authoritative Data Verified Data
This product is 2, 6-diamino-3-(phenylazo) pyridine hydrochloride. The content of C11H11N5.HC1 shall be between 98.0% and 102.0% based on the dry product.
Last Update：2024-01-02 23:10:35
uridinal - Trait
Authoritative Data Verified Data
- This product is light red or dark red to dark purple crystal or crystalline powder; Odorless.
- This product is slightly soluble in water, fermentation or ethanol, and almost insoluble in three gas methane.
Last Update：2022-01-01 15:06:05
uridinal - Differential diagnosis
Authoritative Data Verified Data
- take about 10mg of this product, add 1 ml of formaldehyde test solution-sulfuric acid (1:9), and the solution will appear purple-black.
- 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.
- The infrared absorption spectrum of this product should be consistent with that of the reference product (General rule 0402).
- the aqueous solution of this product can identify the reaction of (1) (General rule 0301).
Last Update：2022-01-01 15:06:05
uridinal - Exam
Authoritative Data Verified Data
Related substances
take this product, precision weighing, adding mobile phase to dissolve and quantitatively dilute to make a solution containing about 0.5mg per lml as a test solution; Take 1ml for precision measurement, in a 100ml measuring flask, dilute to the scale with mobile phase, shake well, and use as a control solution; Take the appropriate amount of 2, 6-diaminopyridine reference product and aniline reference product respectively, and weigh them precisely, the mobile phase was added to dissolve and quantitatively dilute to prepare a mixed solution each containing about 1 UG and 0.5ug per 1ml as a control solution. According to the chromatographic conditions under the content determination item, the sample solution, the control solution and the reference solution were accurately measured, and the human liquid chromatograph was injected respectively, the chromatogram was recorded to 3 times of the retention time of the main component peak. If there are chromatographic peaks consistent with the retention time of 2, 6-diaminopyridine and aniline in the chromatogram of the test solution, the peak area shall be calculated according to the external standard method, 6-diaminopyridine shall not exceed 0.2%, aniline shall not exceed 0.1%; Other individual impurities shall not exceed 0.5 times (0.5%) of the main peak area 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 (1.0%).
loss on drying
take this product, dry to constant weight at 105°C, weight loss shall not exceed 1.0% (General rule 0831).
insoluble in water
take 2.0g of this product, accurately weigh it, put it in a plug Erlenmeyer flask, add 200ml of water, heat it to boiling to dissolve it, and heat it on a water bath for 1 hour, while hot, filter through a No. 4 vertical melting crucible with constant weight at 105°C, fully wash with hot water, and dry at 105°C to constant weight. Residual flooding shall not exceed 0.1%.
ignition residue
take l.Og of this product and check it according to law (General rule 0841). The residue left shall not exceed 0.2%.
Heavy metals
The residue left under the item of taking the ignition residue shall not contain more than 20 parts per million of heavy metal when examined by law (General rule 0821, Law II).
Last Update：2022-01-01 15:06:06
uridinal - Content determination
Authoritative Data Verified Data
measured by high performance liquid chromatography (General 0512).
chromatographic conditions and system suitability test
with eighteen alkyl silane bonded silica gel as filler; Phosphate buffer solution (take diammonium hydrogen phosphate 2.64g, add water 900ml to dissolve, adjust the pH value with phosphoric acid to 3.0, add water to make 1000ml)-Fermentation broth (50:50) as mobile phase with detection wavelength at 240nm. Take appropriate amount of Phenazopyridine hydrochloride, 2, 6-diaminopyridine and aniline, add mobile phase to dissolve and dilute to make mixed solution containing about 0.5mg, lug and 0.5ug in each lml, 20ul was injected into the liquid chromatograph and the chromatogram was recorded. The number of theoretical plates was not less than 2000 ,2, 6-diaminopyridine peak based on Phenazopyridine peak, the degree of separation between the aniline peak and the Phenazopyridine peak should meet the requirements.
assay
take the right amount of this product, precision weighing, plus mobile phase dissolution and quantitative dilution made in each lml containing about 0.1 mg solution, as the test solution, the precision amount of 20u1 injection of human liquid chromatography, record the chromatogram; Another hydrochloric acid Phenazopyridine reference substance, the same method for determination. According to the external standard method to calculate the peak area, that is.
Last Update：2022-01-01 15:06:07
uridinal - Category
Authoritative Data Verified Data
pain medication for the urinary tract.
Last Update：2022-01-01 15:06:07
uridinal - Storage
Authoritative Data Verified Data
light-shielded, sealed, and stored in a dry place.
Last Update：2022-01-01 15:06:07
uridinal - Phenazopyridine hydrochloride tablets
Authoritative Data Verified Data
This product contains Phenazopyridine hydrochloride (C11H11N5 • HCI) should be labeled for the amount of 90.0% to 110.0%.
trait
This product is sugar-coated tablet or film-coated tablet, after removing the coating appear brown red to dark red.
identification
- 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.
- take an appropriate amount of fine powder of this product, add sulfuric acid fermentation solution (1-360) to dissolve and dilute to prepare a solution containing 5ug of Phenazopyridine hydrochloride per 1 ml, shake and filter, take the filtrate, according to UV-visible spectrophotometry (General 0401), there is a maximum absorption at the wavelength of 239nm and 392nm.
examination
- Related substances take an appropriate amount of fine powder of this product (about 25mg equivalent to Phenazopyridine hydrochloride), weigh it accurately, put it in a 50ml measuring flask, dissolve it with mobile phase, dilute it to the scale, and shake it well, filter, take the filtrate as a test solution; Take 1 ml of precision, put in a 100ml measuring flask, dilute with mobile phase to the scale, shake, as a control solution; Take another 2, the appropriate amount of 6-diaminopyridine reference substance and aniline reference substance was precisely weighed, dissolved and quantitatively diluted with mobile phase to prepare a mixed solution containing about 1UG and 0.5ug for each 1 ml, which was used as the reference solution. Determination of the related substances of Phenazopyridine hydrochloride according to the method. If there are chromatographic peaks consistent with the retention time of 2, 6-diaminopyridine and aniline in the chromatogram of the test solution, the peak area shall be calculated according to the external standard method, 6-diaminopyridine shall not exceed 0.2% of the nominal amount of Phenazopyridine hydrochloride and aniline shall not exceed 0.1% of the nominal amount of Phenazopyridine hydrochloride; other single impurity peak area shall not be greater than 0.5 times (0.5%) of the main peak area of the control solution, and the sum of other impurity peak areas shall not be greater than the main peak area of the control solution (1.0%).
- the dissolution of this product is determined by the dissolution and release determination method (General rule 0931 second method), using water as the dissolution medium, the speed is 50 rpm, and the operation is carried out according to law, after 45 minutes, take the appropriate amount of the solution, filter, take 3ml of the filtrate accurately, put it in a 50ml measuring flask, dilute it with water to the scale, shake it well, the absorbance was measured at a wavelength of 0401 NM according to UV-Vis spectrophotometry (general rule). In addition, the reference substance of Phenazopyridine hydrochloride was accurately weighed, dissolved with water and quantitatively diluted to prepare a solution containing about 6.7ug per 1 ml, which was determined by the same method to calculate the dissolution amount of each tablet. The limit is 75% 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 solution (take diammonium hydrogen phosphate 2.64g, add water 900ml to dissolve, adjust the pH value to 3.0 with phosphoric acid, water was added to form 5050 ml)-methanol () as the mobile phase; The detection wavelength was 240nm. Take appropriate amounts of Phenazopyridine hydrochloride, 2, 6-diaminopyridine and aniline, add mobile phase to dissolve and dilute to make a mixed solution containing about 0.5mg,1ug and 0.5ug in each lml, take 20u1 injection human liquid chromatograph, record chromatogram, and the number of theoretical plates shall not be less than 2000 ,2, 6-diaminopyridine peak based on Phenazopyridine peak, the separation degree of aniline peak and Phenazopyridine peak shall meet the requirements.
- determination of 20 tablets of this product, precision weighing, fine, precision weighing an appropriate amount (equivalent to 25mg of Phenazopyridine hydrochloride), put it in a 50ml measuring flask, add an appropriate amount of mobile phase, shake to dissolve Phenazopyridine hydrochloride, dilute to scale with mobile phase, shake well, filter, Take 5ml of continued filtrate precisely, put it in 25ml measuring flask, dilute to scale with mobile phase, shake, as a test solution, take 20ul of precision, inject into the liquid chromatograph, record the chromatogram; Take the reference substance of Phenazopyridine hydrochloride, the mobile phase was added to dissolve and quantitatively dilute to make about O per 1 ml. lmg solution, the same method for determination. According to the external standard method to calculate the peak area, that is.
category
with Phenazopyridine hydrochloride.
specification
O.lg
storage
sealed and stored in a dry place.
Last Update：2022-01-01 15:06:08
uridinal - Reference Information
| (IARC) carcinogen classification | 2B (Vol. 24, Sup 7) 1987 |
| EPA chemical information | Information provided by: ofmpub.epa.gov (external link) |
| introduction | phenazide hydrochloride (Phenazopyridine) is an azide drug, which can relieve pain and discomfort to inflamed parts when excreted with urine after taking it. It has analgesic or local anesthetic effect on urinary tract mucosa. This product is excreted from the urine as a prototype after oral administration, and directly acts on the urinary tract mucosa to exert an analgesic effect. |
| biological activity | Phenazopyridine HCl is a topical analgesic that has been used to treat urinary system diseases. It is an inhibitor of sodium channel protein type 1 subunit alpha. |
| adverse reactions | gastrointestinal discomfort, headache and rash. Anemia, neutropenia, thrombocytopenia, kidney stones and nephrotoxic reactions have been reported. Occasionally abnormal liver function, hemolytic anemia, methemoglobinemia and acute renal failure have been reported. |
| use | used to relieve urethra and bladder pain, burning sensation, frequent urination, urgent urination and other discomfort caused by cystitis, prostatitis, urethritis, gonorrhea urethritis, endoscopy, urethral intubation, etc. dark red crystalline powder |
Last Update：2024-04-09 21:01:54
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