Lorazepam
Lorazepam
CAS: 846-49-1
Molecular Formula: C15H10Cl2N2O2
Lorazepam - Names and Identifiers
| Name | Lorazepam |
| Synonyms | 8133 CB Lorazepam LorazepaM (CIV), USP Lorazepam CIV (200 mg) (±)-Lorazepam solution (+-)-lorazepam methanol solution (+-)-lorazepam--dea schedule iv item 7-chloro-5-(2-chlorophenyl)-3-hydroxy-1,3-dihydro-1,4-benzodiazepin-2-one 7-Chloro-5-(2-chlorophenyl)-1,3-dihydro-3-hydroxy-2H-1,4-benzodiazepine-2-one |
| CAS | 846-49-1 |
| EINECS | 212-687-6 |
| InChI | InChI=1/C15H10Cl2N2O2/c16-8-5-6-12-10(7-8)13(19-15(21)14(20)18-12)9-3-1-2-4-11(9)17/h1-7,15,21H,(H,18,20) |
Lorazepam - Physico-chemical Properties
| Molecular Formula | C15H10Cl2N2O2 |
| Molar Mass | 321.16 |
| Density | 1.4835 (rough estimate) |
| Melting Point | 166-168°C |
| Boling Point | 533.8±50.0 °C(Predicted) |
| Flash Point | 11°C |
| Water Solubility | 54mg/L(temperature not stated) |
| Solubility | Practically insoluble in water, sparingly soluble in ethanol (96 per cent), sparingly soluble or slightly soluble in methylene chloride. |
| pKa | pK1 1.3; pK2 11.5(at 25℃) |
| Storage Condition | −20°C |
| Stability | hygroscopic |
| Refractive Index | 1.6070 (estimate) |
| Physical and Chemical Properties | Crystallization. Melting point 166-168 °c. Solubility (mg/ml): Water 0.08, chloroform 3, ethanol 14, ethyl acetate 30. |
| Use | Antipsychotics with sedative, muscle relaxant and anticonvulsant effects |
Lorazepam - Risk and Safety
| Risk Codes | R63 - Possible risk of harm to the unborn child R39/23/24/25 - R23/24/25 - Toxic by inhalation, in contact with skin and if swallowed. R11 - Highly Flammable R36 - Irritating to the eyes R20/21/22 - Harmful by inhalation, in contact with skin and if swallowed. |
| Safety Description | 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.) S16 - Keep away from sources of ignition. |
| UN IDs | UN 1230 3/PG 2 |
| WGK Germany | 3 |
| RTECS | DF0350000 |
| HS Code | 2933910000 |
| Toxicity | LD50 in mice, rats (mg/kg): 3178, >5000 orally (Owen) |
Lorazepam - Standard
Authoritative Data Verified Data
This product is 7-chloro-5-(2-chlorophenyl)-1, 3-dihydro-3-kino-2h-1, 4-benzodiazepine 2-one. The content of C15H10C12N202 shall be 98.5% ~ 102.0% calculated as dry product.
Last Update：2024-01-02 23:10:35
Lorazepam - Trait
Authoritative Data Verified Data
- This product is white or white crystalline powder; Odorless.
- This product is slightly soluble in ethanol and almost insoluble in water.
absorption coefficient
take an appropriate amount of this product, accurately weigh, add ethanol to dissolve and quantitatively dilute to make a solution containing about 5ug per lml, and measure by UV-visible spectrophotometry (General rule 0401), the absorbance was measured at a wavelength of 230nm, and the absorption coefficient should be 1070 to 1170.
Last Update：2022-01-01 11:56:07
Lorazepam - Differential diagnosis
Authoritative Data Verified Data
- take about 10 mg of this product, add 15ml of dilute hydrochloric acid, water bath heating for 15 minutes, let cool, filter, filtrate aromatic first amine identification reaction (General 0301).
- 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 control (Spectrum set 1144).
Last Update：2022-01-01 11:56:08
Lorazepam - Exam
Authoritative Data Verified Data
clarity and color of ethanol solution
take this product 0.lg, add anhydrous ethanol 50ml, shake to dissolve, the solution should be clear and colorless, such as color, and Yellow No. 2 Standard Colorimetric solution (General Principles 0901 The first method), not deeper.
Related substances
take this product, precision weighing, add acetonitrile to dissolve and quantitatively dilute the solution containing lmg per lml, as a test solution; in addition, an appropriate amount of reference substance of 2-amino -2 ', 5-dichlorobenzophenone (impurity I) was accurately weighed, and acetonitrile was added to dissolve and quantitatively dilute to prepare a solution containing 10ug per 1 ml as a reference solution; precisely, 1 ml of each of the test solution and the control solution was placed in the same 100ml measuring flask, diluted to the scale with acetonitrile, and shaken to obtain a control solution. According to the chromatographic condition test under the content determination item, 20ul of each of the test solution and the control solution is accurately measured and injected into the liquid chromatograph respectively, and the chromatogram is recorded to 3 times of the retention time of the main component peak. If there is a chromatographic peak in the chromatogram of the test solution that is consistent with the retention time of impurity I in the control solution, the peak area shall be calculated according to the external standard method, and shall not exceed 0.01%, if there are chromatographic peaks consistent with the retention time of 6-chloro-4-(2-chlorophenyl) quinazoline-2-carbaldehyde (impurity II), the peak area shall not be greater than 0.5 times (0.5%) of the peak area of laulazepam in the control solution, and the peak area of other individual impurities shall not be greater than 0.5 times (0.5%) of the peak area of laulazepam in the control solution, the sum of the peak areas of each impurity shall not be greater than the peak area of laulazepam in the control solution (1.0%).
residual solvent
take this product, precision weighing, plus N, N-dimethylformamide dissolved and diluted to make about 0.lg of the solution, as the test solution; Another precision weighing acetone, ethyl acetate and dichloromethane each appropriate amount, plus N, N-dimethylformamide quantitative dilution made containing acetone 0.5mg per 1 ml, A solution of ethyl acetate 0.5mg and dichloromethane 60 °c was used as a control solution. 2ml of each of the reference solution and the test solution were respectively placed in the headspace bottle and sealed. According to the determination method of residual solvent (General Principle 0861 second method), the capillary column with 6% cyanopropylphenyl-94% dimethyl polysiloxane (or similar polarity) as stationary liquid is used as the column; the inlet temperature is 200°C, the detector temperature is 250°C; The initial temperature is 100°C, the temperature is maintained for 5 minutes, and the temperature is raised to 200°C at a rate of 10°C per minute; the Headspace bottle equilibration temperature was 100°C and the equilibration time was 30 minutes. Take the reference solution into the headspace, and the separation degree between the peaks of each component shall meet the requirements. The sample solution and the reference solution were sampled by Headspace injection respectively, and the chromatogram was recorded. According to the external standard method, the residual amount of acetone, ethyl acetate and two gas methane is in accordance with the regulations.
loss on drying
take this product, at 105°C under reduced pressure drying to constant weight, weight loss should 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 10 parts per million of heavy metal when examined by law (General Principles 0821, Law II).
Last Update：2022-01-01 11:56:09
Lorazepam - Content determination
Authoritative Data Verified Data
measured by high performance liquid chromatography (General 0512).
chromatographic conditions and system suitability test
silica gel bonded with octylsilane as filler; 0.05mol/L ammonium dihydrogen phosphate solution (containing 0.5% triethylamine, adjusted to pH 2.5 with phosphoric acid)-methanol-acetonitrile (40:35:30) as mobile phase; The detection wavelength was 230mn. Take lorazepam reference material lOmg, put it in 50ml measuring flask, add 30ml mobile phase to dissolve, add 5 drops of phosphoric acid, heat it in 80°C water bath for 1 hour, let it cool, dilute it with mobile phase to scale, shake well, as the system applicable solution containing impurity II, take 20m1 injection liquid chromatograph, record the chromatogram, the separation degree of impurity II peak and lorazepam peak should be greater than 4.0.
assay
take this product, precision weighing, add 60% acetonitrile to dissolve and quantitatively dilute the solution containing 20ug per lml, shake, as a test solution, l0ul was injected into human liquid chromatograph accurately, and the chromatogram was recorded. According to the external standard method to calculate the peak area, that is.
Last Update：2022-01-01 11:56:09
Lorazepam - Category
Authoritative Data Verified Data
sedative hypnotic drugs.
Last Update：2022-01-01 11:56:10
Lorazepam - Storage
Authoritative Data Verified Data
light shielding, sealed storage.
Last Update：2022-01-01 11:56:10
Lorazepam - Lorazepam tablets
Authoritative Data Verified Data
This product should contain 90.0% ~ 110.0% of the label amount of lorazepam.
trait
This product is white or white-like tablets or film-coated tablets, White after removing the coating.
identification
- the sample solution under the dissolution test item was taken and measured by ultraviolet-visible spectrophotometry (General rule 0401), and the maximum absorption was found at a wavelength of 230mn.
- 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
- appropriate amount of the fine powder under the content determination item is taken, dissolved with acetonitrile and diluted to prepare a solution containing about 0.2mg of lorazepam per 1 ml, filtered, the filtrate was taken as a test solution; 1 ml was accurately measured, placed in a 50ml measuring flask, diluted to a scale with acetonitrile, and shaken to obtain a control solution. According to the chromatographic condition test under the content determination item, 20ul of the control solution and the test solution are injected into the liquid chromatograph respectively, and the chromatogram is recorded to 3 times of the retention time of the main component peak. If there are peaks in the chromatogram of the test solution that are consistent with the retention time of impurity II, the peak area shall not be greater than that of the control solution (2.0%), the sum of the peak areas of each impurity shall not be greater than 1.5 times (3.0%) The Peak area of laulazepam in the control solution.
- Content uniformity take 1 tablet of this product, put it in a measuring flask of 25ml(0.5mg specification) or 50ml( lmg specification), dissolve lorazepam with an appropriate amount of 60% acetonitrile and ultrasonically dissolve it, dilute with 60% acetonitrile to the scale, shake, filter, according to the method under the item of content determination, from the "precision amount of filtrate 10ul injection of human liquid chromatography", according to the law, the provisions shall be met (General rule 0941).
- the dissolution of this product, according to the dissolution and release determination method (General rule 0931 The first method), with water as the dissolution medium, the speed is 100 rpm, according to the law, after 30 minutes, 10ml of the solution was filtered, and the filtrate was taken as the test solution, A small amount of acetonitrile was added and dissolved, followed by quantitative dilution with water to prepare a solution containing lug(0.5mg specification) or 2UG (1 mg specification) per 1 ml as a control solution. Take 50 u1 of each of the reference solution and the test solution, and calculate the dissolution amount of each tablet according to the method under the content determination item. 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
Take 20 tablets of this product, precision weighing, fine, precision weighing to take appropriate amount, plus 60% acetonitrile ultrasonic dissolution and quantitative dilution to prepare 20% solution containing lorazepam per lml, filtered, as a test solution, according to the method under the item of lorazepam content determination, the same method determination, obtained.
category
Same as lorazepam.
specification
(1)0.5mg (2)lmg
storage
light shielding, sealed storage.
Last Update：2022-01-01 11:56:10
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CAS: 846-49-1
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