Keywords

• Bpc157
• 98319-26-7
• high quality Bpc157

Quick Details

• ProName: Factory high quality Finasteride
• CasNo: 98319-26-7
• Molecular Formula: C23H36N2O2
• 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

98319-26-7 - Physico-chemical Properties

examination

• Related substances take an appropriate amount of the contents of this product (about 25mg equivalent to finasteride), put it in a 25ml measuring flask, add an appropriate amount of mobile phase, shake to dissolve finasteride and dilute it to the scale, shake and filter, the continuous filtrate was taken as the test solution; 1ml of the test solution was accurately measured, placed in a 200ml measuring flask, diluted to the scale with the mobile phase, and shaken to serve as a control solution. According to the chromatographic conditions under the content determination item, 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 to 2 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 the area of the main peak of the control solution (0.5%), the sum of each impurity peak area shall not be greater than 2 times (1.0%) of the main peak area of the control solution. The peaks in the chromatogram of the test solution which were 0.1 times smaller than the main peak area of the control solution were ignored.
• Content uniformity: Take 1 capsule of this product, pour the content into a 50ml measuring flask, wash the capsule shell with mobile phase, incorporate the washing solution into the measuring flask, and add an appropriate amount of mobile phase, shake to dissolve finasteride and dilute to the scale, shake well, filter, take 20 u1 of continued filtrate with precision, measure according to the method under the content determination item, calculate the content of each particle, the provisions shall be met (General rule 0941).
• the dissolution of this product, according to the dissolution and release determination method (General rule 0931 second method), with water 1000ml as the dissolution medium, the speed is 50 rpm, according to the law, after 45 minutes, take 10ml of the solution, filter, and take the filtrate as the test solution; Take about 12.5mg of finasteride reference substance, weigh it accurately and put it into a 50ml measuring flask, add a small amount of methanol to dissolve, dilute to scale with water, shake well, take 2ml of precision, put in lOOml measuring flask, dilute to scale with water, shake well, as a reference solution. According to the chromatographic conditions under the content determination item, 50 u1 of each of the test solution and the reference solution are accurately measured and injected into the liquid chromatograph respectively to record the chromatogram, according to the external standard method, the dissolution amount of each particle was calculated by the peak area. The limit is 75% of the labeled amount and shall be in accordance with the provisions.
• others should comply with the relevant provisions under the capsule (General 0103).

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, acetonitrile-water (50:50) as mobile phase, the detection wavelength was 210nm, the column temperature was 30°C. Take the appropriate amount of finasteride and impurity I, add the appropriate amount of mobile phase to dissolve and dilute to make finasteride in 1 ml. lmg with impurities 10.Olmg solution, as the system applicable solution, take 20u1 injection of human liquid chromatography, record chromatogram. The number of theoretical plates shall not be less than 3000 calculated by finasteride peak, and the separation degree between finasteride peak and impurity I peak shall meet the requirements ^
• The determination method is to take 20 capsules of this product, accurately weigh and calculate the average loading. Take the content, mix and grind it finely, weigh an appropriate amount of fine powder (about 25mg of finasteride), put it in a 50ml measuring flask, add an appropriate amount of mobile phase, shake to dissolve finasteride and dilute it to the scale, shake well, filter, take 10ml filtrate accurately, put it in 50ml measuring flask, dilute it with mobile phase to scale, shake well, use it as test solution, take human liquid chromatograph accurately, the chromatogram was recorded, and finasteride reference substance was measured by the same method, about 25mg. According to the external standard method to calculate the peak area, that is.

Details

Finasteride

CAS:

98319-26-7

MF:

C23H36N2O2

MW:

372.54

EINECS:

620-534-3

MDL No.:

MFCD00869737

Properties

Melting point:

253 °C

alpha 

405 -59° (c = 1 in methanol)

Boiling point:

576.6±50.0 °C(Predicted)

Density 

1.065±0.06 g/cm3(Predicted)

storage temp. 

room temp

solubility 

DMSO: 32 mg/mL, soluble

pka

14.17±0.70(Predicted)

form 

solid

color 

white to beige

Water Solubility 

insoluble

Merck 

14,4082

BCS Class

1

InChIKey

DBEPLOCGEIEOCV-WSBQPABSSA-N

LogP

3.030

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.