Metoclopramide
metoclopramide
CAS: 364-62-5
Molecular Formula: C14H22ClN3O2
Metoclopramide - Names and Identifiers
| Name | metoclopramide |
| Synonyms | Metoclopramide metoclopramide Methoxychlorprocainamide Metoclopramide anhydrous Methoxychloroprocainamide 4-Amino-5-chloro-N-(2-diethylamino) ethyl-o-anisamide 4-amino-5-chloro-n-(2-(diethylamino)ethyl)-n-anisamid 4-amino-5-chloro-N-(2-diethylaminoethyl)-2-methoxybenzamide 4-Amino-5-chloro-N-(2-(diethylamino)ethyl)-2-methoxybenzamide Benzamide, 4-amino-5-chloro-N-2-(diethylamino)ethyl-2-methoxy- |
| CAS | 364-62-5 |
| EINECS | 206-662-9 |
| InChI | InChI=1/C14H22ClN3O2/c1-4-18(5-2)7-6-17-14(19)10-8-11(15)12(16)9-13(10)20-3/h8-9H,4-7,16H2,1-3H3,(H,17,19) |
Metoclopramide - Physico-chemical Properties
| Molecular Formula | C14H22ClN3O2 |
| Molar Mass | 299.8 |
| Density | 1.2432 (rough estimate) |
| Melting Point | 146-148°C |
| Boling Point | 418.7±45.0 °C(Predicted) |
| Flash Point | 207°C |
| Solubility | Practically insoluble in water, sparingly soluble or slightly soluble in ethanol (96 per cent), slightly soluble in methylene chloride |
| Vapor Presure | 3.22E-07mmHg at 25°C |
| Appearance | neat |
| Color | White to Off-White |
| BRN | 1884366 |
| pKa | pKa 0.42± 0.03;9.71± 0.02(H2O)(Approximate) |
| Storage Condition | 2-8°C |
| Refractive Index | 1.5200 (estimate) |
| MDL | MFCD00211338 |
| Physical and Chemical Properties | The product two hydrochloride monohydrate ([7232-21-5]) melting point 145 ℃ (decomposition), soluble in water, methanol, slightly less soluble in ethanol. Stable in acidic solution. The product a hydrochloride monohydrate ([54143-57-6]) is a white crystalline powder, melting point of 182.5-184 ℃. |
| Use | Used as an antiemetic |
Metoclopramide - Risk and Safety
| Hazard Symbols | Xn - Harmful |
| Risk Codes | R22 - Harmful if swallowed R64 - May cause harm to breast-fed babies |
| Safety Description | 36/37 - Wear suitable protective clothing and gloves. |
| WGK Germany | 3 |
Metoclopramide - Reference
| Reference Show more | 1. Jin Weihua, Yu Botao, Zhang Ming, Pu Zhiqiang, Li Xue. Preparation and determination of metoclopramide hydrochloride mucilage for rectal administration [J]. Pharmaceutical Care and Research, 2020,20(05):389-391. |
Metoclopramide - Standard
Authoritative Data Verified Data
This product is N-[(2-diethoxy) ethyl]-4-chloro-2-methoxy-5-chloro-benzamide. Calculated as dried product, including C14H22C1N302 shall not be less than 99.0%.
Last Update：2024-01-02 23:10:35
Metoclopramide - Trait
Authoritative Data Verified Data
- This product is white crystalline powder; Odorless.
- This product is dissolved in chloroform, slightly soluble in ethanol or acetone, very slightly soluble in ether, almost insoluble in water; Dissolved in acidic solution.
melting point
The melting point of this product (General rule 0612 first method) is 147~151°C.
Last Update：2022-01-01 11:38:03
Metoclopramide - Differential diagnosis
Authoritative Data Verified Data
- take about 5mg of this product, put it in a test tube, add 1ml sulfuric acid, heat it with small fire until the solution is purplish black, take out several drops of 5ml water, shake well, then show green fluorescence; the fluorescence disappeared after alkalization.
- Take 15mg of this product, add 0.1 mol / L hydrochloric acid solution dissolved and diluted to 50ml, shake, take 2ml, with 0.lmol / L hydrochloric acid solution diluted to 50ml, shake, according to UV-visible spectrophotometry (General 0401), there is maximum absorption at the wavelength of 308nm, there is minimal absorption at a wavelength of 290 nm.
- The infrared absorption spectrum of this product should be consistent with the spectrum of the control (Spectrum set 107).
Last Update：2022-01-01 11:38:04
Metoclopramide - Exam
Authoritative Data Verified Data
clarity of acidic solution
take this product 0.20g, add hydrochloric acid solution (9 a 100) ml to dissolve, add water to 20ml, the solution should be clear.
Related substances
take 25mg of this product, put it in a 100ml measuring flask, add 0.1 mol/L salt solution (2ml) was dissolved, diluted to scale with mobile phase, and then shaken. 1ml was accurately weighed as test solution I, and placed in a 200ml measuring flask, dilute to the scale with the mobile phase, shake, and serve as a control solution. According to high performance liquid chromatography (General 0512) determination. Silica gel was bonded with eighteen alkyl silane as filler; 0.02mol/L phosphoric acid solution (adjusted to pH 4.0 with triethylamine)-acetonitrile (81:19) as mobile phase; The detection wavelength was 275nm. The number of theoretical plates is not less than 4000 calculated from the metoclopramide peak. 20 u1 of each of the control solution and the test solution were accurately measured and injected into the human liquid chromatograph respectively, and the chromatogram was recorded to 4 times of the retention time of the main component chromatographic peak. If there are impurity peaks in the chromatogram of the test solution, the sum of each impurity peak area shall not be greater than the main peak area of the control solution (0.5%).
loss on drying
take this product, dry to constant weight at 105°C, weight loss shall not exceed 0.5% (General rule 0831).
ignition residue
not more than 0.1% (General rule 0841).
Last Update：2022-01-01 11:38:04
Metoclopramide - Content determination
Authoritative Data Verified Data
take this product about 0.25g, precision weighing, according to the permanent stop titration method (General 0701), with sodium nitrite titration solution (0.05mol/L) titration. Each 1 ml of sodium nitrite titration solution (0.05mol/L) corresponds to 14.99mg of C14H22C1N302.
Last Update：2022-01-01 11:38:05
Metoclopramide - Category
Authoritative Data Verified Data
antiemetics.
Last Update：2022-01-01 11:38:06
Metoclopramide - Storage
Authoritative Data Verified Data
sealed storage.
Last Update：2022-01-01 11:38:06
Metoclopramide - Metoclopramide tablets
Authoritative Data Verified Data
This product contains metoclopramide (C14H22ClN302 should be 90.0% to 110.0% of the label.
trait
This product is white tablet.
identification
- take an appropriate amount of fine powder of this product (equivalent to 15mg of metoclopramide), add 5ml of chloroform to extract, filter, and evaporate the filtrate to dryness, and test the residue according to item (1) of metoclopramide identification, the same reaction was shown.
- 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 (equivalent to 15mg of metoclopramide), put it in a 50ml measuring flask, add 0.1 mol/L hydrochloric acid solution appropriate amount of metoclopramide dissolved and diluted to the scale, shake, filtered, take the filtrate 2ml, to 50ml flask, with 0.lmol/L hydrochloric acid solution diluted to the scale, shake, according to UV-visible spectrophotometry (General 0401), there is maximum absorption at the wavelength of 308nm, there is minimal absorption at a wavelength of 290nm.
examination
- Content uniformity take 1 tablet of this product, put it in a 25ml measuring flask, add 0.5ml of 1 mol/L hydrochloric acid solution, fully shake to dissolve metoclopramide, dilute to the scale with mobile phase, shake well, filter, take 3ml of continuous filtrate accurately, put it in 10ml measuring flask, dilute to scale with mobile phase, shake well, and determine the content according to the method under the content determination item, which shall comply with the regulations (General rule 0941).
- dissolution of this product, according to the dissolution and release determination method (General rule 0931 The first method), with hydrochloric acid solution (9-1000)500ml(5mg specification) or 900ml(10mg specification) dissolution medium, speed of 100 rpm, according to the law, after 30 minutes, take the solution filtration, continued filtrate UV-visible spectrophotometry (General 0401), the absorbance was measured at the wavelength of 308mn; The appropriate amount of the reference substance of methoxyprotamine was accurately weighed, dissolved with dissolution medium and quantitatively diluted to prepare a solution containing about 10ug per lml, which was determined by the same method, the dissolution amount of each tablet was calculated. The limit is 80% 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; 0.02mol/L phosphoric acid solution (adjusted to pH 4.0 with triethylamine)-acetonitrile (81:19) the detection wavelength was 275nm. The number of theoretical plates is not less than 4000 calculated from the metoclopramide peak.
- determination of 20 tablets of this product, precision weighing, fine grinding, precision weighing an appropriate amount (about 15mg equivalent to metoclopramide), put it in a 50ml measuring flask, add 0.5ml of 1 mol/L hydrochloric acid solution, fully shake to dissolve metoclopramide, dilute to scale with mobile phase, shake well, filter, Take 5ml of continuous filtrate accurately, put it in 25ml measuring flask, dilute to the scale with mobile phase, shake well, as a test solution, take 20u1 injection of human liquid chromatography with precise volume, record the chromatogram; Take about 15mg of methoxyprotamine reference substance, precision weigh, in a 50ml measuring flask, add 0.1 mol/L hydrochloric acid solution (5ml) was dissolved by shaking, diluted to scale with mobile phase, shaken well, 5ml was accurately weighed, and placed in a 25ml children's bottle, diluted to scale with mobile phase, and shaken well, same method determination. According to the external standard method to calculate the peak area, that is.
category
with metoclopramide.
specification
(l)5mg (2)10mg
storage
sealed storage.
Last Update：2022-01-01 11:38:07
Metoclopramide - Metoclopramide Dihydrochloride Injection
Authoritative Data Verified Data
This product is a sterilized aqueous solution prepared by adding appropriate amount of metoclopramide and hydrochloric acid. Containing metoclopramide hydrochloride (C14H22C1N302 • 2HC1 • H20) shall be between 90.0% and 110.0% of label load.
trait
This product is a clear colorless liquid.
identification
- 1ml of this product was taken and evaporated to dryness, and the residue showed the same reaction according to the Identification Test (1) under the item of metoclopramide.
- 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 this product and use 0.lmol/ L hydrochloric acid solution is diluted to prepare a solution containing about 10ug per lml, which is determined by ultraviolet-visible spectrophotometry (General rule 0401) and has a maximum absorption at a wavelength of 309nm, there is minimal absorption at a wavelength of 290nm.
examination
- the pH value should be 2.5 to 4.5 (General 0631).
- relevant substances: take 3ml of the product and put it in a 100ml measuring flask, dilute it to the scale with mobile phase, shake it well, and use it as a sample solution, set in a 100ml measuring flask, dilute to the scale with the mobile phase, and shake to serve as a control solution. The determination was carried out according to the method for related substances of metoclopramide. If there are impurity peaks in the chromatogram of the test solution, the sum of each impurity peak area shall not be greater than the main peak area of the control solution (1.0%).
- bacterial endotoxin take this product, according to the law inspection (General 1143), each 1 mg metoclopramide containing endotoxin amount should be less than 10EU.
- sterile take this product, by membrane filtration method, with Staphylococcus aureus as positive control bacteria, according to law inspection (General Principles 1101), should comply with the provisions.
- others should comply with the relevant provisions under injection (General 0102).
Content determination
- measured by high performance liquid chromatography (General 0512).
- chromatographic conditions and system suitability test using eighteen alkyl silane bonded silica as filler; 0.O2mol/L phosphoric acid solution (adjusted to pH 4.0 with triethylamine)-acetonitrile (81:19) as mobile phase; The detection wavelength was 275nm. The number of theoretical plates is not less than 4000 calculated from the metoclopramide peak.
- determination precision measure 2ml of the product, put it in a 50ml measuring flask, dilute it to scale with mobile phase, shake it well, take 5ml of precision measurement, put it in a 25ml measuring flask, dilute it to scale with mobile phase, shake well, as a test solution, take 20u1 injection liquid chromatograph with precision, record the chromatogram; Take 15mg precision weighing of metoclopramide control, put it in 50ml measuring flask, add O. 1 mol/L hydrochloric acid solution (5ml) was dissolved by shaking, diluted to scale with mobile phase, and shaken well. 5ml was accurately weighed into a 25ml measuring flask, diluted to scale with mobile phase, and shaken well, same method determination. According to the external standard method to calculate the peak area, the result is multiplied by 1.303.
category
with metoclopramide.
specification
(l ) lml:10mg (2)2ml:10mg
storage
sealed storage.
Last Update：2022-01-01 11:38:08
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