Kono Chemical Industry Co.

1. Introduction

Hydroxypropyl- -cyclodextrin is one of the most thoroughly studied and widely used cyclodextrin derivatives. The white powder, which has good solubility in water, can also be dissolved in 50- percent ethanol and methanol. It has a certain relative hygroscopicity. But the relative surface activity and hemolytic activity are relatively low. It does not irritate muscles and is an ideal solubilizer and filler for injections. Hydroxypropyl- -cyclodextrin or its derivatives with drugs to increase the solubility of drugs in water has been widely studied for many years. However, the low solubility of- -cyclodextrin limits its use, while hydroxypropyl-8. Cyclodextrin has good solubility in water, high thermal stability and low hemolysis, therefore it is a low-toxic, safe and effective drug solubilizer and is considered as a potential auxiliary material for injection.

 

2. Function

In medicine.

Hydroxypropyl- -cyclodextrin can solve the problem of water solubility of insoluble or insoluble drugs (including herbal extracts).

Through molecular entrapment, we can improve the biosolubility of drugs, control the release rate of drugs, improve the bioavailability of drugs, increase the stability of drugs, and reduce the side effects of drugs. Inclusion with cyclodextrin can increase the drug's stability to light, reduce volatility, prolong effectiveness and reduce contact toxicity to humans and animals, such as pyrethroid, DDVP, organophosphorus and other inclusion complexes have the above characteristics.

In the food industry.

It can improve the stability and long-term effect of food molecules, hide or correct the unpleasant odor and taste of food nutrient molecules, improve the production process and product quality, and increase the shelf life of products. The food industry uses cyclodextrin as a preservative for spices, pigments, preservatives, seasonings, emulsifying foaming agents, etc.

In cosmetics.

Used as a stabilizer, emulsifier and deodorant in cosmetic raw materials, it can reduce the stimulation of organic molecules to the skin and mucous membrane in cosmetics, improve the stability of effective components, prevent the volatilization and oxidation of nutrients, increase the water solubility of insoluble substances. flavors and spices, and maintain slow release and long-lasting aroma. Cyclodextrin can be used as a flavor preservative, tone modifier, external matrix and deodorant in everyday chemical applications.

 

3. Application

Hydroxypropyl- -cyclodextrin is mainly used in the food, medical and cosmetic industries.

 

4. Quality standard

Items	Standard	Results
Appearance	White or almost white amorphous or crystalline powder. Easily dissolves in water and propylene glycol	Compliant
Identification	IR: same absorption bands as Hydroxypropyl Betadex USP USP.	Compliant
	Solution purity: Positive	Compliant
Molar substitution	0.40~1.50	0.7
Betadex	Less than or equal to 1.5 percent	0.4 percent
Propylene glycol	Less than or equal to 2.5 percent	0.1 percent
Any other single impurity	Less than or equal to 0.25 percent	Not found
Total impurities excluding betadex and propylene glycol	Less than or equal to 1.0 percent	Not found
propylene oxide	Less than or equal to 1 ppm	0.01ppm
Clarity of solution	1.0g/2ml aqueous solution is clean and clear	Compliant
Damage due to drying out	Less than or equal to 10.0 percent	4.2 percent
conductivity	Less than or equal to 200Us/cm	77 Us/cm
Total number of combined molds and yeasts	Less than or equal to 100 CFU/g
Total number of combined molds and yeasts	Less than or equal to 1000 CFU/g

Total number of aerobic microbes

Less than or equal to 1000 CFU/g	10 CFU/g
Total number of molds and yeasts count	Less than or equal to 100 CFU/g	10 CFU/g
Conclusion: According to enterprise standard

 

5. Method of analysis

[identification] take {{0}}percentage aqueous solution 0.5 ml, place it in a 10 ml test tube, add 2 drops 10-percentage solution of ethanol - naphthol, shake well, slowly add 1 ml of sulfate along the wall test tubes test tube and show the purple ring at the interface between the two liquids.

[check] the acidity and alkalinity of this product 1.0g. After dissolving 40 ml with water, determine according to the law (general rule 0631). The pH value should be 5.0-7.5.

The transparency and color of the solution is 2.5 g, add 25 ml of water to dissolve, check according to the law (general rule 0901 and general rule 0902), the solution must be transparent and colorless.

Take {{0}}.1 g of chloride and test it according to the law (General Rule 0801). Compared to the control solution prepared from a standard 5.0 ml sodium chloride solution, it should not be thicker (0.05%).

Beta-cyclodextrin about 1.0 g, accurately weighed, placed in a 10 ml volumetric flask, add water to dissolve and dilute to the desired size, shake well as a test solution; take the corresponding sample of beta-cyclodextrin about 50mg, weigh accurately, place a 100ml measuring bottle, add water to dissolve and dilute on the scale, shake well as a control solution. According to the definition of high-performance liquid chromatography (general rule 0512), amino-linked silica gel was used as a filler, acetonitrile-water (65:35) was used as a mobile phase, a differential refractive index detector and a column temperature of 35 degrees C were introduced into the liquid chromatograph, respectively. µl of control solution and 20 µl of test solution and recorded the chromatogram. If there is a chromatographic peak corresponding to the retention time of the beta-cyclodextrin peak in the chromatogram of the sample solution, the peak area should be calculated according to the external standard method and the beta-cyclodextrin content should not exceed 0.5 percent.

1Be 2-Propylene glycol about 1 g, weigh accurately, put into 10ml measuring bottle, add methanol to dissolve and dilute on balance, shake well like a test solution. Additionally, 1 50mg of 2-propanediol were accurately weighed, placed in a 100 mL volumetric flask, diluted with methanol to the desired size, shaken well, and used as a reference solution. It was determined using the residual solvent method (General Rule 0861). Using 100-percentage polydimethylsiloxane chemically cross-linked capillary column as the chromatography column, the initial temperature is 70 degrees, heating to 100 degrees at a rate of 10 degrees per minute, and then increasing to 220 degrees at a rate of 40 degrees per minute for 4 minutes . . Injection port temperature 250C; detector temperature 280C; the number of theoretical plates calculated based on the 1 m peak of 2-propylene glycol should be at least 3000. The reference solution and the test solution were taken, injected into the gas chromatograph, respectively, and the chromatogram was recorded. The content of 1 min 2-propanediol calculated from the peak area using the external standard method should not exceed 0.5 percent.

The moisture content of this product is determined in accordance with the moisture determination method (general principle 0832, method 1). Humidity should not exceed 6.0 percent.

The combustion residue is 1.0 g and is tested in accordance with the law (General Rule 0841). The residual balance should not exceed 0.2 percent.

Heavy metals are extracted from the combustion residue and tested in accordance with the law (general principle 0821, second method). The content of heavy metals should not exceed 10/1000000.

[determination of content] About 0.1 g of hydroxypropoxyl was obtained by accurately weighing and determining methoxy-, ethoxy-, and hydroxypropoxyl (general principle 0712).

 

6. HPLC

 

7. Stability and security

Stability:

Stable under proper conditions (room temperature). Stability data sheet available upon request.

Safety:

According to the study, it is safe for human consumption.

 

8. Block diagram

 

9. Customer comments

We have stores on Alibaba, Chemicalbook and LookChem and have received many positive reviews due to our high quality products and unconditional services.

 

10. Our certificate

Over the years, we have been optimizing product production and creating a quality system. We have created a quality management system and received a certificate for it.

 

11.Our clients

We have established business relationships with Abbott, Unilever, Shiseido, KANS and SIMM, etc.

 

12.Exhibitions

We often attend international exhibitions, including CPhI, FIC, API, Vitafoods, SupplesideWest.

http://www.konochems.com/