Terbinafine Hydrochloride ( China GMP,EDMF Available)
terbinafine hydrochloride
CAS: 78628-80-5
Molecular Formula: C21H26ClN
Terbinafine Hydrochloride ( China GMP,EDMF Available) - Names and Identifiers
Terbinafine Hydrochloride ( China GMP,EDMF Available) - Physico-chemical Properties
| Molecular Formula | C21H26ClN |
| Molar Mass | 327.89 |
| Density | 1.007g/cm3 |
| Melting Point | 204-208°C |
| Boling Point | 417.9°C at 760 mmHg |
| Flash Point | 183.7°C |
| Solubility | DMSO 66 mg/mL Water <1 mg/mL Ethanol 66 mg/mL |
| Vapor Presure | 3.42E-07mmHg at 25°C |
| Appearance | powder |
| Color | white |
| Merck | 14,9156 |
| Storage Condition | 15-25°C |
| Refractive Index | 1.586 |
| MDL | MFCD00145430 |
| Physical and Chemical Properties | White to off-white crystalline powder. Melting Point 204-208 °c. |
Terbinafine Hydrochloride ( China GMP,EDMF Available) - Risk and Safety
| Risk Codes | R36/37/38 - Irritating to eyes, respiratory system and skin. R50/53 - Very toxic to aquatic organisms, may cause long-term adverse effects in the aquatic environment. |
| Safety Description | S26 - In case of contact with eyes, rinse immediately with plenty of water and seek medical advice. S36/37/39 - Wear suitable protective clothing, gloves and eye/face protection. S61 - Avoid release to the environment. Refer to special instructions / safety data sheets. S60 - This material and its container must be disposed of as hazardous waste. |
| UN IDs | UN 3077 9/PG 3 |
| WGK Germany | 3 |
| RTECS | QJ8600100 |
| HS Code | 29214990 |
| Toxicity | LD50 in mice, rats (mg/kg): 4000, 4000 orally; 393, 213 i.v. (Ganzinger) |
Terbinafine Hydrochloride ( China GMP,EDMF Available) - Standard
Authoritative Data Verified Data
This product is (E)-N-(6, 6-dimethyl-2-hepten-4-alkynyl)-n-methyl-1-naphthylamine hydrochloride. The content of C21H25N • HCl shall be 98.0% to 102.0% calculated on the dried product.
Last Update：2024-01-02 23:10:35
Terbinafine Hydrochloride ( China GMP,EDMF Available) - Trait
Authoritative Data Verified Data
- This product is white or off-white crystalline powder; Slightly odorless.
- This product is soluble in methanol or ethanol, slightly soluble or very slightly soluble in water, almost insoluble in ether.
Last Update：2022-01-01 15:33:20
Terbinafine Hydrochloride ( China GMP,EDMF Available) - Differential diagnosis
Authoritative Data Verified Data
- 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 840).
- the aqueous solution of this product was chloride identification (1) of the reaction (General 0301).
Last Update：2022-01-01 15:33:20
Terbinafine Hydrochloride ( China GMP,EDMF Available) - Exam
Authoritative Data Verified Data
hydrochloride
take this product about 0.26g, precision weighing, add methanol 25ml and nitric acid 0.5ml dissolved, then add water 25ml, according to the potential titration method (General rule 0701), using composite silver electrode, with silver nitrate titration solution (0.lmol/L) titration. Each 1 ml of silver nitrate titration solution (0.1 mol/L) corresponds to 3.646mg of hc1. Calculated as the dry product, containing hydrochloric acid (HCl), should be 10.90% ~ 11.35%. Appropriate amount of related substances, add acetonitrile-water (1:1) to dissolve and dilute to make a solution containing about 0.5mg per 1 ml, as a test solution; Precise amount to take appropriate amount, quantitative dilution with acetonitrile-water (1:1) to prepare a solution containing about 0.5ug per 1 ml, as a control solution; Take the appropriate amount of control solution, with acetonitrile-water (1:1) A solution containing about 0.05ug per 1 ml was prepared by dilution as a sensitivity solution. According to the chromatographic conditions under the content determination item, the sensitivity solution 20u1 is injected into the liquid chromatograph, and the signal to noise ratio of the main component peak should be greater than 5; then 20 u1 of the test solution and the control solution are accurately measured, and the human liquid chromatograph is injected respectively, and the chromatogram is recorded. If there are impurity peaks in the chromatogram of the test solution, the area of a single impurity peak shall not be greater than the area of the main peak of the control solution (0.1% ) , and the sum of each impurity peak area shall not be greater than 5 times the area of the main peak of the control solution (0.5%). The peaks in the chromatogram of the test solution which are smaller than the main peak area of the sensitivity solution are ignored.
residual solvent
take about 0.lg of this product, precision weighing, in the top empty bottle, precision plus human internal standard solution (take an appropriate amount of N-propanol, diluted with dimethyl sulfoxide to make a solution containing about 200ug per 1 ml) 1.0, shake, seal, as a test solution; Accurately weigh the appropriate amount of methanol, ethanol, dichloromethane, ethyl acetate and toluene respectively, and dilute with internal standard solution to make methanol 300ug per 1 ml, A mixed solution of 500ug of ethanol, 60ug of dichloromethane, 500ug of ethyl acetate and 89ug of toluene was accurately weighed and 1.0ml was placed in the headspace bottle, sealed and used as a reference solution. Determined according to the residual solvent assay (General 0861 second method). The capillary column with 6% cyanopropylphenyl-94% dimethylpolysiloxane (or similar polar) as stationary liquid is used as the chromatographic column; The starting temperature is 45°C, and it is maintained for 7 minutes, and the rate of 55°C per minute is increased to 200°C, it was maintained for 2 minutes; The inlet temperature was 200°C, the detector temperature was 250°C, the headspace bottle equilibrium temperature was 85°C, and the equilibrium time was 30 minutes. The reference solution was injected in Headspace, and the chromatogram was recorded. The peak sequence was methanol, ethanol, dichloromethane, n-propanol (internal standard), ethyl acetate, toluene, the degree of separation between adjacent chromatographic peaks shall meet the requirements. Then the sample solution and the reference solution were injected with headspace, and the chromatogram was recorded. According to the internal standard method to calculate the peak area, methanol, ethanol, dichloromethane, ethyl acetate and toluene residues should be in accordance with the provisions.
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 1.0g of this product and check it according to law (General rule 0841). The remaining residue shall not exceed 0.1%.
Heavy metals
The residue left under the item of burning and residual flooding shall be taken and inspected according to law (General rule 0821 second law), and the content of heavy metal shall not exceed 10 parts per million.
Last Update：2022-01-01 15:33:21
Terbinafine Hydrochloride ( China GMP,EDMF Available) - 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 (3.0mm X 0.2%, 5um or equivalent column); Triethylamine buffer (7.5 triethylamine solution, pH adjusted to with glacial acetic acid)-Methanol-acetonitrile (30:42:28) as mobile phase A, with triethylamine buffer-methanol-acetonitrile (5:57:38) as mobile Phase B, the following table for linear gradient elution; the flow rate was 0.8 per minute; The detection wavelength was 280nm. Take an appropriate amount of terbinafine hydrochloride, add acetonitrile-water (1:1) to dissolve and dilute to prepare a solution containing about 1 mg per 1 ml, and put the UV lamp at 254nm for 1 hour, take 20u1 injection human liquid chromatograph and record the chromatogram. The retention time of terbinafine peak is about 16 minutes, and there should be three major impurity peaks between the relative retention time of 0.8 and 1.2, the relative retention times were about 0.87,0.95 and 1.1, respectively. Terbinafine peak and relative retention time of about 0.95,1.1 impurity peak separation degree should be greater than 2.0.
assay
take about 20mg of this product, weigh it accurately, put it in a 100ml measuring flask, add acetonitrile-water (1:1) to dissolve and dilute to the scale, shake it well, as a test solution, a 20u1 injection liquid chromatograph was used for precision measurement, and the chromatogram was recorded. An appropriate amount of terbinafine hydrochloride reference was taken, and acetonitrile-water (1:1) was added. Dissolve and dilute to make a solution containing about 0.2 mg per 1 ml, the same method. According to the external standard method to calculate the peak area, that is.
Last Update：2022-01-01 15:33:22
Terbinafine Hydrochloride ( China GMP,EDMF Available) - Category
Authoritative Data Verified Data
antifungal drugs.
Last Update：2022-01-01 15:33:22
Terbinafine Hydrochloride ( China GMP,EDMF Available) - Storage
Authoritative Data Verified Data
light shielding, sealed storage.
Last Update：2022-01-01 15:33:22
Terbinafine Hydrochloride ( China GMP,EDMF Available) - Terbinafine hydrochloride tablets
Authoritative Data Verified Data
This product contains terbinafine hydrochloride by terbinafine (C21H25N) calculation, should be 90.0% ~ 110.0% of the label amount.
trait
This product is white or off-white.
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 the solution under the item of dissolution, according to UV-visible spectrophotometry (General 0401), there is a maximum absorption at the wavelength of 283nm, there is minimal absorption at a wavelength of 258Nm.
examination
- Related Substances: take an appropriate amount of the fine powder of this product, add acetonitrile-water (1:1) to dissolve and dilute to prepare a solution containing about 0.5mg of terbinafine per 1 ml, shake well, filter, the continuous filtrate was taken as the test solution, and an appropriate amount was quantitatively diluted with acetonitrile-water (1:1) to prepare a solution containing about 0.5ug of terbinafine per 1 ml as a control solution; an appropriate amount of the control solution was taken and diluted with acetonitrile-water (1:1) to prepare a solution containing about 0.05ug of terbinafine per 1 ml as a sensitivity solution. If there are impurity peaks in the chromatogram of the test solution, the area of a single impurity peak shall not be greater than the area of the main peak of the control solution (0.1% ) , the sum of each impurity peak area shall not be greater than 5 times (0.5%) of the main peak area of the control solution. The peaks in the chromatogram of the test solution which are smaller than the main peak area of the sensitivity solution are ignored.
- dissolution of this product, according to the dissolution and release determination method (General 0931 second method), with pH 3.0 citrate buffer (citric acid 21.0G, add 200ml of 1 mol/L sodium hydroxide solution to dissolve, dilute to 1000ml with water, take 403ML, use 0. Dilute 1 mol/L hydrochloric acid solution to 1000ml, shake well, then get) 500ml as dissolution medium, rotation speed is 50 rpm, operate according to law, after 30 minutes, take 10ml solution, filter, the appropriate amount of the continued filtrate was taken and quantitatively diluted with the dissolution medium to prepare a solution containing about 25ug terbinafine per 1 ml, and the absorbance was measured at the wavelength of 0401 NM according to ultraviolet-visible spectrophotometry (general rule); in addition, an appropriate amount of terbinafine hydrochloride reference substance was taken, dissolved and quantitatively diluted with dissolution medium to prepare a solution containing about 25ug of terbinafine per 1 ml, and the dissolution amount of each tablet was calculated by the same method. 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 with eighteen alkyl silane bonded silica gel as filler (3.0mm X 150 mm,5um or performance equivalent column); With triethylamine buffer solution (take 0.2% triethylamine solution, using glacial acetic acid to adjust the pH value to 7.5)-methanol-acetonitrile (30:42:28) as mobile phase A, triethylamine buffer-methanol-acetonitrile (5:57:38) as mobile Phase B, the linear gradient elution was carried out as follows; The flow rate was 0.8 per minute; The detection wavelength was 280nm. Take an appropriate amount of terbinafine hydrochloride, add acetonitrile-water (1:1) to dissolve and dilute to make a solution containing about 1 mg per 1 ml, put the UV lamp (254nm) under irradiation for 1 hour, take 20u1 injection human liquid chromatograph and record the chromatogram. The retention time of terbinafine peak is about 16 minutes, and there should be three major impurity peaks between the relative retention time of 0.8 and 1.2, the relative retention times were about 0.87,0.95 and 1.1, respectively. Terbinafine peak and relative retention time is about 0.95,1.1 impurity peak separation degree should be greater than 2.0
- determination of 20 tablets of this product, ground fine, precision weighing fine powder appropriate amount, plus acetonitrile-water (1:1) dissolved and quantitatively diluted to prepare a solution containing terbinafine 0.2 mg per 1 ml, shake well, filter, take the filtrate as the test solution, take 20u1 injection of human liquid chromatography with precision, record chromatogram; Take appropriate amount of terbinafine hydrochloride reference, add acetonitrile-water (1:1) dissolve and quantitatively dilute to prepare a solution containing about 0.2 mg of terbinafine per 1 ml, which is determined by the same method. According to the external standard method to calculate the peak area, that is.
category
with terbinafine hydrochloride.
specification
by C21H25N (1)0.125g (2)0.25g
storage
light shielding, sealed storage.
Last Update：2022-01-01 15:33:23
Terbinafine Hydrochloride ( China GMP,EDMF Available) - Terbinafine Hydrochlorido Cream
Authoritative Data Verified Data
This product contains terbinafine hydrochloride (C21H25N • HCl) should be 90.0% ~ 110.0% of the label amount.
trait
This product is white or white-like milk tone.
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 control solution.
examination
- appropriate amount of related substances shall be taken, dissolved and diluted with isopropyl alcohol to prepare a solution containing 0.5mg of terbinafine hydrochloride per 1 ml, filtered, and the continued filtrate shall be taken as the test solution; precise amount of appropriate amount, quantitative dilution with isopropanol to prepare a solution containing terbinafine hydrochloride 2.5ug per 1 ml, as a control solution, A solution containing about 0.25ug of terbinafine hydrochloride per 1 ml was prepared as a sensitivity solution by dilution with isopropanol. If there are impurity peaks in the chromatogram of the test solution, except the peak of the auxiliary material (the chromatographic peak before 2 minutes), the single impurity peak area shall not be greater than the main peak area of the control solution (0.5% ) , and the sum of each impurity peak area shall not be greater than 4 times (2.0%) of the main peak area of the control solution. The peaks in the chromatogram of the test solution which are smaller than the main peak area of the sensitivity solution are ignored.
- microbial limit take this product as non-sterile product microbial limit test: microbial count method (General 1105) and control bacteria test method (General 1106) and non sterile drugs microbial limit standard (General 1107) inspection, should meet the requirements.
- others should be in accordance with the relevant provisions under the term milk origin (General rule 0109).
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 (3.0mm X 150 mm,5um or performance equivalent column); With triethylamine buffer solution (take 0.2% triethylamine solution, using glacial acetic acid to adjust the pH value to 7.5)-methanol-acetonitrile (30:42:28) as mobile phase A, triethylamine buffer-methanol-acetonitrile (5:57:38) as mobile Phase B, the linear gradient elution was carried out as follows; The flow rate was 0.8 per minute; The detection wavelength was 280nm. Take an appropriate amount of terbinafine hydrochloride, add acetonitrile-water (1:1) to dissolve and dilute to make a solution containing about 1 mg per 1 ml, put the UV lamp (254nm) under irradiation for 1 hour, take 20u1 injection human liquid chromatograph and record the chromatogram. The retention time of terbinafine peak is about 16 minutes, and there should be three major impurity peaks between the relative retention time of 0.8 and 1.2, the relative retention times were about 0.87, 0.95 and 1.1, respectively. The degree of separation between the terbinafine peak and the impurity peaks at relative retention times of about 0.95 and 1.1 should be greater than 2.0.
- determination method: take an appropriate amount of this product, weigh it accurately, add isopropyl alcohol to dissolve and quantitatively dilute to prepare a solution containing about 0.2mg terbinafine hydrochloride per 1 ml, shake and filter, the continued filtrate was taken as the test solution, and 20u1 was accurately measured and injected into the human Liquid Chromatograph. The chromatogram was recorded, isopropyl alcohol was added to dissolve and quantitatively diluted to prepare a solution containing about 0.2mg per 1 ml, which was determined by the same method. According to the external standard method to calculate the peak area, that is.
category
with terbinafine hydrochloride.
specification
1 %
storage
light shielding, closed storage.
Last Update：2022-01-01 15:33:24
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Product Name: terbinafine hydrochloride Request for quotation
CAS: 78628-80-5
Tel: 0086-551-65418684
Email: sales@tnjchem.com
info@tnjchem.com
Mobile: 0086 189 4982 3763
QQ: 2881500840
Wechat: 0086 189 4982 3763
WhatsApp: 0086 189 4982 3763
Product List: View Catalog
CAS: 78628-80-5
Tel: 0086-551-65418684
Email: sales@tnjchem.com
info@tnjchem.com
Mobile: 0086 189 4982 3763
QQ: 2881500840
Wechat: 0086 189 4982 3763
WhatsApp: 0086 189 4982 3763
Product List: View Catalog
Multiple SpecificationsSpot supply
Product Name: Terbinafine Hydrochloride Visit Supplier Webpage Request for quotationCAS: 78628-80-5
Tel: 18301782025
Email: 3008007409@qq.com
Mobile: 18021002903
QQ: 3008007409
Wechat: 18301782025
Product Name: Terbinafine Hy Request for quotation
CAS: 78628-80-5
Tel: 02787887055
Email: 307906085@qq.com
Mobile: 18971192287
QQ: 307906085Send QQ message
CAS: 78628-80-5
Tel: 02787887055
Email: 307906085@qq.com
Mobile: 18971192287
QQ: 307906085
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