Midazolam - Names and Identifiers
Name | Midazolam
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Synonyms | Midazolam MidazolamBaseE.P MIDAZOLAM-D4 MALEATE 4H-Imidazo1,5-a1,4benzodiazepine, 8-chloro-6-(2-fluorophenyl)-1-methyl- 5-a)(1,4)benzodiazepine,8-chloro-6-(2-fluorophenyl)-1-methyl-4h-imidazo( 8-Chlor-6-(2-fluorphenyl)-1-methyl-4H-imidazo(1,5-a)(1,4)benzodiazepin 8-Chloro-6-(2-fluorophenyl)-1-methyl-4H-imidazo[1,5-a][1,4]benzodiazepine 8-Chloro-6-(2-fluorophenyl)-1-methyl-4H-imidazo[1,5-α][1,4]benzodiazepine 4H-Imidazo(1,5-a)(1,4)benzodiazepine, 8-chloro-6-(2-fluorophenyl)-1-methyl- 8-Chloro-3A, 4-Dihydro-6-(2-Fluorophenyl)-1-Methyl-3H-Imidazo [1,5A][1,4]Benzodiazepine 8-chloro-6-(2-fluorophenyl)-1-methyl-4H-imidazo[1,5-a][1,4]benzodiazepine (2Z)-but-2-enedioate
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CAS | 59467-70-8
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EINECS | 261-774-5 |
InChI | InChI=1/C18H13ClFN3.C4H4O4/c1-11-21-9-13-10-22-18(14-4-2-3-5-16(14)20)15-8-12(19)6-7-17(15)23(11)13;5-3(6)1-2-4(7)8/h2-9H,10H2,1H3;1-2H,(H,5,6)(H,7,8)/b;2-1- |
Midazolam - Physico-chemical Properties
Molecular Formula | C18H13ClFN3
|
Molar Mass | 325.77 |
Density | 1.3136 (estimate) |
Melting Point | 161-164°C |
Boling Point | 496.9±55.0 °C(Predicted) |
Flash Point | 9 °C |
Water Solubility | 54mg/L(24 ºC) |
Solubility | Practically insoluble in water, freely soluble in acetone and in ethanol (96 per cent), soluble in methanol. |
Vapor Presure | 5.21E-10mmHg at 25°C |
Appearance | Solid:crystalline |
pKa | pKa 1.7±0.1;6.15± 0.1 (Uncertain) |
Storage Condition | Controlled Substance, -20°C Freezer |
Use | For sleep, can also be used to treat Anxiety, restlessness, muscle relaxation and anticonvulsants |
Midazolam - Risk and Safety
Risk Codes | R11 - Highly Flammable
R23/24/25 - Toxic by inhalation, in contact with skin and if swallowed.
R39/23/24/25 -
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Safety Description | S7 - Keep container tightly closed.
S16 - Keep away from sources of ignition.
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.)
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UN IDs | 3249 |
WGK Germany | 2 |
HS Code | 2933910000 |
Hazard Class | 6.1(b) |
Packing Group | III |
Midazolam - Standard
Authoritative Data Verified Data
This product is 1-methyl-8-chloro-6-(2-fluorophenyl)-4h-imidazo [l,5-a][l,4] Benzodiazepine cover. Based on the dry product, the content of C18H13ClFN3 should be 98.5% ~ 101.5%.
Last Update:2024-01-02 23:10:35
Midazolam - Trait
Authoritative Data Verified Data
- This product is white to yellowish crystal or crystalline powder; Odorless; Light gradient yellow.
- This product is soluble in glacial acetic acid or ethanol, soluble in methanol, almost insoluble in water.
melting point
The melting point of this product (General rule 0612 first method) is 160~164°C.
Last Update:2022-01-01 13:40:17
Midazolam - Differential diagnosis
Authoritative Data Verified Data
- take the product and the midazolam reference, add methanol to dissolve and dilute to prepare a solution containing about 10ug per 1 ml as the test solution and the reference solution, 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 according to the chromatographic condition test under the item of related substances.
- The infrared absorption spectrum of this product should be consistent with that of the control (Spectrum set 1084).
- This product shows the identification reaction of organic fluoride (General rule 0301).
- 2ml of the absorption solution prepared under identification (3) was taken to show the reaction of chloride identification (2) (General 0301).
Last Update:2022-01-01 13:40:18
Midazolam - Exam
Authoritative Data Verified Data
clarity and color of acidic solution
take 0.10g of this product, add 0.lmol/L hydrochloric acid solution 10ml after dissolution, the solution should be clear and colorless; If the color, with yellow or yellow-green No. 1 Standard Colorimetric liquid (General Principles 0901 The first method) comparison, not deeper.
Related substances
take this product, add methanol to dissolve and dilute the solution containing 1 mg per 1ml as the test solution; Take 1ml for precision measurement and put it in a 100ml measuring flask, as a control solution, it was diluted to the scale with methanol and shaken. According to the high performance liquid chromatography (General rule 0512) test, octyl silane bonded silica gel was used as filler; Acetic acid salt buffer solution (40% G of ammonium acetate and tetrabutylammonium hydroxide solution, water was added to dissolve and diluted to 5.3 ML, and the pH value was adjusted to with glacial acetic acid)-methanol (44:56) as mobile phase; The detection wavelength was 254nm. Take the appropriate amount of midazolam control and impurity I control, add methanol to dissolve and make a solution containing about 10ug per 1 ml, as the system applicable solution, take lol injection liquid chromatograph, record chromatogram, the resolution of midazolam peak and impurity I peak should be greater than 4.0; Take 10ul of control solution and sample solution respectively, and inject human liquid chromatograph respectively, the chromatogram was recorded to 2.5 times of the retention time of the main component peak. If there are impurity peaks in the chromatogram of the test solution, the area of a single impurity peak shall not be greater than 0.2 times (0.2%) of the area of the main peak of the control solution, the sum of each impurity peak area shall not be greater than 0.5 times (0.5%) of the main peak area of the control solution. The chromatogram of the test solution is 0.05 times smaller than the main peak area of the control solution.
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
take l.Og of this product and check it according to law (General rule 0841). The residue left shall not exceed 0.1%.
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 13:40:19
Midazolam - Content determination
Authoritative Data Verified Data
take this product about 0.12g, precision weighing, add glacial acetic acid 30ml dissolved, add acetic anhydride 20ml, according to the potentiometric titration method (General rule 0701), with perchloric acid titration solution (0.1 mol/L) titration, and the results of the titration were corrected with a blank test. Each 1 ml of perchloric acid titration solution (0.1 mol/L) corresponds to 16.29mg of Cl8H13CIFN3.
Last Update:2022-01-01 13:40:19
Midazolam - Category
Authoritative Data Verified Data
Last Update:2022-01-01 13:40:20
Midazolam - Storage
Authoritative Data Verified Data
light shielding, sealed storage.
Last Update:2022-01-01 13:40:20
Midazolam - Dormicum (Midazolam Maleate Tablets)
Authoritative Data Verified Data
This product contains midazolam maleate by midazolam (C18H13C1FN3) calculation, should be 90.0% ~ 110.0% of the label amount.
trait
This product is a film-coated tablet, after removing the coating, white or white.
identification
- in the chromatogram recorded under the content determination item, the retention time of the two main peaks of the test solution should be consistent with the retention time of the corresponding two main peaks of the control solution.
- take an appropriate amount of fine powder of this product and add 0.1 mol / L hydrochloric acid solution was dissolved and made into a solution containing about 15ug of midazolam per 1 ml, filtered, and the filtrate was taken and determined by UV-Vis spectrophotometry (General 0401), there is an absorption maximum at a wavelength of 258Nm.
examination
- Related substances appropriate amount of the fine powder of this product is taken, and the mobile phase is added for ultrasonic treatment to dissolve midazolam maleate and prepare a solution containing midazolam 0.5mg per 1ml as a test solution; take 1ml of precision, 100ml flask, diluted with mobile phase to scale, shake, as a control solution. According to the chromatographic conditions under the content determination item, the control solution and the test solution are respectively injected into the liquid chromatograph, and the chromatogram is recorded to 3 times of the retention time of the main component peak. If there are impurity peaks in the chromatogram of the test solution, except the maleic acid peak, the area of a single impurity peak shall not be more than 2 times (2.0%) the area of the main peak of the control solution, the sum of each impurity peak area shall not be greater than 3 times (3.0%) of the main peak area of the control solution. The chromatogram of the test solution is 0.05 times smaller than the main peak area of the control solution.
- Content uniformity 1 tablet of this product was placed in a mortar, ground finely, transferred to a 100ml measuring flask with mobile phase, dissolved midazolam maleate by ultrasound, and diluted to scale with mobile phase, shake well, filter, take appropriate amount of filtrate with precision, and quantitatively dilute with mobile phase to prepare a solution containing midazolam 7.5ug per 1 ml as a test solution; another midazolam maleate control sample was precision weighed, dissolved and quantitatively diluted with mobile phase to prepare a solution containing about 9ug per 1 ml as a control solution. Determine the content according to the method under the content determination item, multiply the result by 0.7373, that is, the content of C18H13C1FN3, should meet the requirements (General 0941).
- dissolution of this product, according to the dissolution and release determination method (General 0931 second method), with 0.lmol / L hydrochloric acid solution 500ml is the dissolution medium, the rotation speed is 50 rpm, the operation is carried out according to law, after 20 minutes, take 10ml of the solution, filter, take the continued filtrate as the test solution (specification 7.5mg) or take an appropriate amount of the continued filtrate in a precise amount, and quantitatively dilute it with the dissolution medium to make a solution containing 15ug of midazolam per 1 ml, as a test solution (specification 15mg); According to UV-visible spectrophotometry (General rule 0401), absorbance was measured at the wavelength of 258nm; Another midazolam maleate control, the solution containing about 18% per 1 ml was prepared by precise weighing, dissolving and quantitatively diluting with dissolution medium. The dissolution amount of each tablet was calculated by the same method, and the result was multiplied by 0.7373, which was the dissolution amount of C18H13C1FN3. The limit is 85% 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 with eighteen alkyl silane bonded silica gel as filling agent; Phosphate buffer (take the same volume of 0.1 mol / L phosphoric acid solution was mixed with 0.03mol / L triethylamine solution. 1 mol / L sodium hydroxide solution adjusted the pH of the mixture to 3.5)-methanol (35:65) as mobile phase; The detection wavelength was 220nm; The column temperature was 40°C. Take appropriate amounts of midazolam maleate control and impurity I control, add mobile phase to dissolve and dilute to prepare a solution containing 10ug of midazolam and impurity I per 1 ml, as a system applicable solution, take lOul, inject into liquid chromatograph, record chromatogram, midazolam peak and impurity I peak separation degree should be greater than 3.0.
Determination of 20 tablets of this product, precision weighing, fine grinding, precision weighing appropriate amount (about 10mg equivalent to midazolam), 100ml flask, plus mobile phase ultrasound to dissolve midazolam maleate, dilute to scale with mobile phase, shake, filter, take filtrate as test solution, take sample solution 10 u1 accurately, inject into liquid chromatograph, record chromatogram; another precision weighing midazolam maleate reference, precision weighing, plus mobile phase dissolution and quantitative dilution into 0.12mg per 1 mL solution, the same method for determination. The midazolam peak area was calculated according to the external standard method, and the result was multiplied by 0.7373 to obtain the content of C18H13C1FN3.
category
with midazolam.
specification
calculated as C18H13C1FN3 (1)7.5mg (2)15Mg
storage
light shielding, sealed storage.
Last Update:2022-01-01 11:31:47
Midazolam - Midazolam injection
Authoritative Data Verified Data
This product is a sterilized aqueous solution prepared by adding appropriate amount of hydrochloric acid and sodium chloride to midazolam. Containing midazolam (C18H13C1FN3) shall be 95.0% to 105.0% of the labeled amount.
trait
This product is colorless to yellowish or yellowish green clear liquid.
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.
- This product shows the reaction of sodium salt and chloride identification (1) (General rule 0301).
examination
- the pH value should be 2.9 to 3.7 (General 0631).
- color take this product, according to the law inspection (General Principles 0901 The first law), and yellow or yellow green No. 2 standard color liquid comparison, shall not be deeper.
- relevant substances take an appropriate amount of this product (about 5mg of midazolam), put it in a 10ml measuring flask, add 1 ml of 0.01mol/L sodium hydroxide solution, and place it in the dark for 1 hour, dilute with mobile phase to the scale, shake, as a test solution; Precision take 1 ml, 100ml flask, diluted with mobile phase to the scale, shake, as a control solution. According to the chromatographic conditions under the content determination item, take the test solution and the control solution and place them in the dark for 3 hours, and take the control solution and the test solution in a precise amount of 10 u1 respectively, human liquid chromatograph was injected respectively, and the chromatogram was recorded to 3 times of the retention time of the main component peak. If there are impurity peaks in the chromatogram of the test solution, the area of a single impurity peak shall not be greater than 0.5 times (0.5%) of the area of the main peak of the control solution, not greater than the main peak area of the control solution (1.0%). The chromatogram of the test solution is 0.05 times smaller than the main peak area of the control solution.
- the bacterial endotoxin content of this product should be less than 8.3EU per 1 mg of midazolam for inspection according to law (General rule 1143).
- sterile take this product, with membrane filtration method, with Staphylococcus aureus as positive control bacteria, according to the law (General Principles 1101), should comply with the provisions.
- others should comply with the relevant provisions under injection (General rule 0102).
Content determination
- 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 (take the same volume of 0.1 mol/L phosphoric acid solution was mixed with 0.03mol/L triethylamine solution. 1 mol/L sodium hydroxide solution adjusted the pH of the mixture to 3.5)-methanol (35:65) as mobile phase; The detection wavelength was 220nm; The column temperature was 40°C. Take the appropriate amount of midazolam control and impurity I control, add mobile phase to dissolve and dilute to prepare about 10% solution per 1 ml, and place in the dark for 3 hours as the system applicable solution, lOul was injected into the liquid chromatograph, and the chromatogram was recorded. The resolution of midazolam peak and impurity I peak should be greater than 3.0.
- determination method: take an appropriate amount of this product (about 10mg of midazolam), put it in a 100ml measuring flask, dilute it to the scale with mobile phase, shake it well, and place it in the dark for not less than 2 hours, as a sample solution, take 10ul injection liquid chromatograph accurately, record the chromatogram; Take about 10mg midazolam reference, weigh it accurately, put it in 100ml measuring flask, add the mobile phase to dissolve and dilute to the scale, shake, place in the dark for not less than 2 hours, the same method for determination. According to the external standard method to calculate the peak area, that is.
category
with midazolam.
specification
(l)2ml:2mg (2) 5ml:5mg (3) lml:5mg⑷ 2ml:lOmg
storage
light shielding, closed storage.
Last Update:2022-01-01 13:40:21