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Items | Test Items | Standard Specifications | Results |
【Characters】 | Appearance | This product is a colorless and clear viscous liquid | Colorless and clear viscous liquid |
Relative density | 1.035-1.037 | 1.035 | |
【Identification】 | Identification(A) | The infrared absorption spectrum of this product should be consistent with that of the control | Conform |
Identification(B) | Diethylene glycol shall not exceed 0.10% | Undetected | |
Identification(C) | The retention time of the propylene glycol peak of the test solution should be consistent with that of the reference solution in the chromatogram recorded by the identification test item B. | Conform | |
【Tests】 | Acidity | ≤0.20ml | 0.02ml |
Chloride | ≤0.007% | <0.007% | |
Sulfate | ≤0.006% | <0.006% | |
Water | ≤0.2% | 0.04% | |
Residue on ignition | The residue weighs not more than 3.5 mg | 1.1mg | |
【Content】 | Content | ≥99.5% | 99.60% |
Items | Test Items | Standard Specifications | Results |
【Characters】 | Appearance | A viscous clear color less hygroscopic liquid | Conform |
Solubility | miscible with water and with ethanol(96 percent) | Conform | |
【Identification】 | A: Relative density | 1.035-1.040 | 1.036 |
B: Refractive index | 1.431-1.433 | 1.433 | |
C: Boiling point | 184℃-189℃ | 185-187℃ | |
D: Melting point | Melt at 121C to128°C | 123-126℃ | |
【Tests】 | Acidity | ≤0.05ml | 0.01ml |
Oxidizing substances | ≤0.2ml | 0.1ml | |
Reducing substances | The solution does not change its appearance | Conform | |
Water | ≤0.2% | 0.10% | |
Sulfated ash | The residue weighs not more than 5 mg | 1.8mg | |
Heavy metals | ≤5ppm | Conform | |
Appearance of solution | It is clear and colorless | Conform |
Propylene Glycol(1,2-propanediol) is a colorless, clarified viscous liquid obtained by hydrolysis and purification of propylene oxide.
In order to further ensure the safety of the medication, Gedian Renfu Pharmaceutical has introduced propylene glycol (for injection) products on the basis of pharmaceutical-grade propylene glycol and has completed the filing with the State Food and Drug Administration.
Our propylene glycol products are widely used as a solvent for pharmaceutical preparations for injection and non-injection, a better solvent than glycerin, and have antibacterial and antiseptic effects similar to glycerin.
Propylene glycol has good solubility, and less toxicity and irritation. It is widely used as solvent, extraction solvent and preservative for injection (such as intramuscular injection, intravenous injection) and non-injection drug preparations (such as oral liquid, eye preparation, ear preparation, dental preparation, rectovaginal preparation, transdermal preparation, etc.), and is better than glycerol, It can dissolve many substances, such as corticosteroids (sex hormones), chloramphenicol, sulfonamides, barbiturates, reserpine, quinidine, dehydrocortisone acetate, tetrahydropalmatine sulfate, nitrogen mustard hydrochloride, vitamin A, vitamin D, many volatile oils, most alkaloids and many local anesthetics.
However, propylene glycol chemicals can be used in many fields.
1. A certain proportion of the mixture of propylene glycol and water can delay the hydrolysis of some drugs and increase their stability.
2. When its concentration is appropriate, Propylene glycol can be used as the solvent of injection, which has a quick or delayed effect.
3. A certain concentration of propylene glycol can also be used as a penetration enhancer for drug absorption through skin or mucosa.
4. Propylene glycol is an important raw material for unsaturated polyester, epoxy resin and polyurethane resin. Its consumption accounts for about 45% of the total consumption of propylene glycol. This kind of unsaturated polyester is widely used in surface coatings and reinforced plastics.
5. Propylene glycol has good viscosity, hygroscopicity and nontoxicity, so propylene glycol is widely used as a hygroscopic agent, antifreeze agent, lubricant and solvent in the food, medicine and cosmetics industry.
6. Propylene glycol reacts with fatty acids to form propylene glycol fatty acid esters, which are mainly used as food emulsifiers.
7. Propylene glycol is an excellent solvent for condiments and pigments. Propylene glycol is commonly used in the pharmaceutical industry as a solvent, softener and excipient for manufacturing various ointments and ointments. Due to its good mutual solubility with various spices, propylene glycol is also used as a solvent and softener for cosmetics.
8. Propylene glycol is also used as a humidifier for tobacco, an anti-mildew agent, a lubricant for food processing equipment and a solvent for food marking inks.
9. The aqueous solution of propylene glycol is an effective antifreeze.
Higher safety: sterility, control of bacterial endotoxin, meeting the requirements of injection, ophthalmology, inhalation preparations
Better appearance: Nearly colorless appearance for better quality
Better stability: The filling process adopts nitrogen-filling protection measures to ensure consistent quality during product storage.
Lower impurity residue: strict control of ethylene glycol, diethylene glycol, propylene oxide impurity residues
Under the standard conditions for injection, a variety of packaging specifications meet the needs of different customers.
GMP-compliant production line to avoid cross-contamination.
Precautions
Propylene glycol is easily opened when it is opened at high temperatures.
It is strictly forbidden to be compatible with oxides.
Hubei Gedian Renfu Pharmaceutical Excipients Co., Ltd. is a professional company of R&D, production and sales of listed company Renfu Pharmaceutical Group Co., Ltd. (leading pharmaceutical company in Hubei Province, top 30 in China's pharmaceutical industry) and a pharmaceutical excipient supplier.
We are committed to the research and development of high-end pharmaceutical excipients, and we have a research and development team of more than 30 people led by doctors. At present, the company has more than 20 products under research, and the main development direction of research and development is injection-grade pharmaceutical excipients with independent intellectual property rights and high-end solid preparation accessories.
◆ We are a leading pharmaceutical company in Hubei Province, top 30 in China's pharmaceutical industry.
◆ We have the independent technology research and development center and the most advanced small and medium-scale testing equipment and functional evaluation equipment for pharmaceutical excipients.
◆ The company has obtained approvals for producing 69 pharmaceutical excipients, declared 15 patents, and assumed several national and provincial projects.
We are a manufacturer, and we own a factory located in Ezhou City, Hubei Province, China, with a history of 10 years. And it covers an area of about 100 mu.
TT, LC, OA, and DA, all the payments are optional, with the support of Chemball.
We understand most customers prefer stock, so we will try to keep stock for most products. However, there is no stock available for some of them, and it needs some time to synthesize.
Prices can be negotiated under different conditions and different quantities have different discounts. We guarantee that you will get the most competitive price.
Contact us by Chemball page, email, mobile phone, any way you like! We will try our best to respond ASAP!
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