Keywords

• terbinafine hydrochloride
• 78628-80-5
• terbinafine

Quick Details

• ProName: Factory high quality terbinafine hydro...
• CasNo: 78628-80-5
• Molecular Formula: C21H26ClN
• Appearance: white powder
• Application: Dietary supplements;Food;Additives;Pha...
• DeliveryTime: 7
• PackAge: 1kg/bag,5kg/bag,25kg/drum
• Port: any port in china
• ProductionCapacity: 1 Metric Ton/Day
• Purity: purity 98%-101%
• Storage: 20°
• Transportation: 20
• LimitNum: 1 Gram
• Related Substances: 1
• Residue on Ignition: 1
• Heavy Metal: 1
• Valid Period: 1

Superiority

78628-80-5 - Physico-chemical Properties

78628-80-5 - Risk and Safety

78628-80-5 - 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

78628-80-5 - 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

78628-80-5 - Differential diagnosis

Authoritative Data Verified Data

1. 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.
2. The infrared absorption spectrum of this product should be consistent with that of the control (Spectrum set 840).
3. the aqueous solution of this product was chloride identification (1) of the reaction (General 0301).

Last Update：2022-01-01 15:33:20

78628-80-5 - 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.

Details

Terbinafine Hydrochloride

CAS:

78628-80-5

MF:

C21H26ClN

MW:

327.89

EINECS:

616-640-4

MDL No.:

MFCD00145430

Properties

Melting point:

204-208°C

storage temp. 

15-25°C

solubility 

methanol: soluble50mg/mL

form 

powder

color 

white

Merck 

14,9156

BCS Class

1

InChI

InChI=1S/C21H25N.ClH/c1-21(2,3)15-8-5-9-16-22(4)17-19-13-10-12-18-11-6-7-14-20(18)19;/h5-7,9-14H,16-17H2,1-4H3;1H/b9-5+;

InChIKey

BWMISRWJRUSYEX-SZKNIZGXSA-N

SMILES

C12C=CC=CC1=CC=CC=2CN(C)C/C=C/C#CC(C)(C)C.Cl

Xi'an Eastling biotech Co., Ltd. is dedicated to the research and development, production, and sales of natural plant extracts; With nearly 15 years of experience in identifying, researching, developing, and producing active ingredients for medicinal plants, we focus on providing innovative products and services to customers in industries such as pharmaceuticals, health food, and cosmetics.

Eastling Biotechnology has established a global direct harvesting system for plant raw materials, ensuring the high quality and authenticity of raw materials, while also protecting the continuity and diversity of plants; Having strong research and development capabilities, we can develop more effective and specialized plant active ingredients for the pharmaceutical, health food, and cosmetics industries; We have established an advanced quality control system, and the quality control of our products depends on advanced testing instruments and high-level technical experts. The effective combination of the two forms Eastling's ability to quickly and rigorously control product quality.

We have a production system that complies with Chinese GMP and American cGMP certifications, as well as advanced and optimized large-scale industrial production technology. In addition to producing specific products for Eastling Biotechnology, we also provide customized services to meet the characteristics and needs of different customers to produce customized products.

We believe that natural active ingredients are the foundation of our service to customers. Scientific and effective production technology is the foundation for us to provide customers with specialized products. We have the ability to serve customers in the pharmaceutical, health food, and cosmetics industries, provide new product solutions, and add new value to their products.