ALPRAZOLAM USP C IV
Alprazolam
CAS: 28981-97-7
Molecular Formula: C17H13ClN4
ALPRAZOLAM USP C IV - Names and Identifiers
| Name | Alprazolam |
| Synonyms | Esparon alprazolam ALPRAZOLAM,USP ALPRAZOLAM USP C IV alprazolam-dea schedule iv item alprazolam--dea schedule iv item ALPRAZOLAM BENZODIAZEPINE ANXIOL ALPRAZOLAM CONTROLLED SUBSTANCE EPA(CRM STANDARD) 8-chloro-1-methyl-6-phenyl-4H-[1,2,4]triazolo[4,3-a][1,4]benzodiazepine |
| CAS | 28981-97-7 |
| EINECS | 249-349-2 |
| InChI | InChI=1/C17H13ClN4/c1-11-20-21-16-10-19-17(12-5-3-2-4-6-12)14-9-13(18)7-8-15(14)22(11)16/h2-9H,10H2,1H3 |
ALPRAZOLAM USP C IV - Physico-chemical Properties
| Molecular Formula | C17H13ClN4 |
| Molar Mass | 308.76 |
| Density | 1.2000 (rough estimate) |
| Melting Point | 228-228.50C |
| Boling Point | 463.51°C (rough estimate) |
| Flash Point | 11°C |
| Water Solubility | 70mg/L(ambient temperature) |
| Solubility | H2O: insoluble |
| Vapor Presure | 1.77E-10mmHg at 25°C |
| pKa | 2.37±0.40(Predicted) |
| Storage Condition | 2-8°C |
| Refractive Index | 1.6110 (estimate) |
| Physical and Chemical Properties | Yellow-brown crystal. Melting Point: 228-228.5 ℃ |
| Use | Used as a sedative |
ALPRAZOLAM USP C IV - Risk and Safety
| Risk Codes | R22 - Harmful if swallowed R39/23/24/25 - R23/24/25 - Toxic by inhalation, in contact with skin and if swallowed. R11 - Highly Flammable |
| Safety Description | S36 - Wear suitable protective clothing. S45 - In case of accident or if you feel unwell, seek medical advice immediately (show the label whenever possible.) S36/37 - Wear suitable protective clothing and gloves. S16 - Keep away from sources of ignition. S7 - Keep container tightly closed. |
| UN IDs | 3249 |
| WGK Germany | 3 |
| RTECS | XZ5473000 |
| HS Code | 2933910000 |
| Hazard Class | 6.1(b) |
| Packing Group | III |
| Toxicity | LD50 in mice, rats (mg/kg): 1020, >2000 orally; 540, 610 i.p. (Nakajima) |
ALPRAZOLAM USP C IV - Standard
Authoritative Data Verified Data
This product is 1-methyl-6-phenyl-8-chloro-4h-(1,2, 4-triazole) o [4,3-a][l,4]-benzodiazepine. Calculated as dried product, the content of C17H13C1N4 shall not be less than 98.5%.
Last Update：2024-01-02 23:10:35
ALPRAZOLAM USP C IV - Trait
Authoritative Data Verified Data
- This product is white or off-white crystalline powder.
- This product is soluble in chloroform, slightly soluble in ethanol or acetone, and almost insoluble in water or ether.
Last Update：2022-01-01 13:31:55
ALPRAZOLAM USP C IV - Differential diagnosis
Authoritative Data Verified Data
- take about 5mg of this product, add 2ml of hydrochloric acid solution (9-1000) and dissolve it in two parts: one part adds 1 drop of silicotungstic acid test solution to generate white precipitate; in the other portion, 1 drop of bismuth potassium iodide solution was added, and orange-red precipitate was generated.
- The infrared absorption spectrum of this product should be consistent with that of the control (Spectrum set 1271).
Last Update：2022-01-01 13:31:56
ALPRAZOLAM USP C IV - Exam
Authoritative Data Verified Data
chloride
take 0.50g of this product, add 50ml of water, shake for 10 minutes, filter, take 25ml of filtrate, check according to law (General rule 0801), and standard sodium chloride solution 5.0ml of the control solution should not be more concentrated (0.02%).
Related substances
take this product, add N, N-dimethylformamide to dissolve and quantitatively dilute to prepare a solution containing about 10 mg per lml as a test solution; Take an appropriate amount of precision and use N, N-dimethylformamide was quantitatively diluted to prepare a solution containing 25ug per 1 ml as a control solution. According to the high performance liquid chromatography (General rule 0512) test, with phenyl silane bonded silica gel as filler; Ammonium acetate buffer (pH4.2)(take ammonium acetate 7.7g, add water shaking to dissolve, adjust pH to 4.2 with glacial acetic acid)-methanol (44:56) as mobile phase A, ammonium acetate buffer (pH 4.2)-methanol (5:95) as mobile phase B; the detection wavelength was 254nm. Take the appropriate amount of alprazolam reference and triazolam reference, add N,N-dimethylformamide to dissolve and dilute to make a mixed solution containing about 20ug per 1 ml, as the system applicable solution, 10u1 was injected into the liquid chromatograph, and the chromatogram was recorded, so that the retention time of the alprazolam peak was 10-11 minutes, and the separation degree between the triazolam peak and the alprazolam peak should meet the requirements. l0ul of the control solution and the test solution were respectively injected into the human liquid chromatograph, and the chromatograms were recorded. If there are impurity peaks in the chromatogram of the test solution, the sum of each impurity peak area shall not be greater than 4 times (1.0%) of the main peak area of the control solution. The chromatogram of the test solution is 0.2 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
not more than 0.3% (General rule 0841).
Last Update：2022-01-01 13:31:56
ALPRAZOLAM USP C IV - Content determination
Authoritative Data Verified Data
take this product about 0.12g, precision weighing, add acetic anhydride 10ml, shake dissolved, add crystal violet indicator solution 1 drop, with high gas acid titration solution (O. 1 mol/L) titration to the solution yellow green, and the results of the titration with blank test correction. Each 1 ml perchloric acid titration solution (0.1 mol/L) corresponds to 15.44mg of C17H13C1N4.
Last Update：2022-01-01 13:31:57
ALPRAZOLAM USP C IV - Category
Authoritative Data Verified Data
hypnotics.
Last Update：2022-01-01 13:31:57
ALPRAZOLAM USP C IV - Storage
Authoritative Data Verified Data
light shielding, sealed storage.
Last Update：2022-01-01 13:31:57
ALPRAZOLAM USP C IV - Alprazolam tablets
Authoritative Data Verified Data
This product contains alprazolam (C17H13C1N4) should be 90.0% ~ 110.0% of the label amount.
trait
This product is white or off-white.
identification
- take an appropriate amount of fine powder of this product (equivalent to about 2mg of alprazolam), add 3ml of hydrochloric acid solution (9-1000), shake to dissolve alprazolam, filter, the filtrate showed the same reaction according to the Identification Test (1) under the item of alprazolam.
- 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
- Content uniformity take 1 tablet of this product, put it in a 20ml measuring flask, add 2ml of water, ultrasonic to disintegrate, add appropriate amount of acetonitrile, ultrasonic to dissolve alprazolam, cool, dilute with acetonitrile to the scale, shake, filter, take and continue the filtrate to determine the content according to the method under the content determination item, should comply with the provisions (General 0941).
- dissolution: according to the determination method of dissolution and release (General rule 0931, Method 1), dissolve the product in phosphate buffer solution (16g of potassium dihydrogen phosphate and 4g of Dipotassium hydrogen phosphate), add water to dissolve and dilute, adjust the pH value to 6.0±0.1 with phosphoric acid or 1 mol/L sodium hydroxide solution) 500ml as the dissolution medium, the rotation speed is 100 rpm, operate according to law, after 30 minutes, take the appropriate amount of solution, filter, the continued filtrate was taken as the test solution; An appropriate amount of alprazolam reference substance was added for precision weighing, methanol was added for dissolution and dilution to prepare 16ug solution per lml, and 5ml was taken for precision measurement, set in a 100ml measuring flask, dilute to the scale with dissolution medium, and shake to serve as a reference solution. Take the above two kinds of solution, according to the chromatographic conditions under the content determination item, the injection volume is lool, and the same method is used to calculate the dissolution amount of each tablet. 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; Phosphate buffer (pH 6.0) (under the same dissolution)-acetonitrile-tetrahydrofuran (78:19:3) as mobile phase; The detection wavelength was 254nm. Take the appropriate amount of alprazolam reference and triazolam reference, add acetonitrile-water (9:1) to dissolve and quantitatively dilute to make a mixed solution containing about 20ug per 1 ml, respectively, as a system applicable solution, 20 u1 shall be accurately measured, and human liquid chromatograph shall be injected to record the chromatogram. The number of theoretical plates shall not be less than 2000 based on alprazolam peak. The separation degree between alprazolam peak and triazolam peak shall meet the requirements.
- determination Method: Take 20 tablets of this product, precise weighing, fine grinding, precise weighing appropriate amount (about equivalent to alprazolam lmg ), put it in a 50ml measuring flask, add 5ml of water, ultrasound to disperse the powder evenly, add appropriate amount of acetonitrile, sonicate alprazolam to dissolve, let it cool, dilute with acetonitrile to scale, shake, filter, and take the continued filtrate as the test solution, accurately measure 20u1 and inject human liquid chromatograph, record chromatogram; Accurately weigh appropriate amount of alprazolam reference substance, add acetonitrile-water (9:1) dissolved and diluted to prepare a solution containing about 20ug per lml, determined by the same method, calculated by peak area according to external standard method.
category
Same as alprazolam.
specification
0.4mg
storage
light shielding, sealed storage.
Last Update：2022-01-01 13:31:58
