About Simethicone 100% (Ip/Bp/ Usp)
| Packaging Type |
Bottle
|
| Composition |
SIMETHICONE 100 %
|
| Brand Name |
DRP
|
| Manufacturer |
DRP
|
| Shelf Life |
36 Months
|
| Prescription/Non-Prescription |
Non-Prescription
|
| Also Gives |
PCD Pharma Franchise, Third Party Manufacturing
|
| Minimum Order Quantity |
100 Litre
|
Product Specification
| Brand |
DRP |
| Viscosity |
2000 CST |
| Defoaming Performance |
15 Seconds maximum at 50 R.P.M. |
| Compound |
Activated Dimethyl Polysioxane |
| Color |
Translucent |
| Stability |
Maximum 5% separation after 15 minutes at 1600 R.P.M |
| Active |
100% |
| Consistency |
Syrupy |
| Sp. Gravity |
0.975 to 0.010 @ 25 Deg C |
| Refractive Index |
1.402 to 1.406 @ 25 Deg C |
| Free Acid |
0.025 to 0.04 |
| Moisture |
< 0.5% |
| Suitable Diluent |
Aliphatic, Aromatic and Chlorinated Solvents |
Product Description
It is widely used as a versatile Defoamer, in both general industrial applications. In medical and pharmaceutical applications, the requirements for this chemically inert silicone defoamer is unique and exacting.
Wide-Ranging Pharmaceutical ApplicationsSimethicone 100% meets stringent IP/BP/USP specifications and is widely used as an effective antifoaming agent in the pharmaceutical industry. Its primary function is to alleviate symptoms like bloating and abdominal discomfort caused by excessive gas. This versatile compound is also used in various formulations where efficient gas dispersion is needed and has a high safety profile, making it ideal for digestive products.
Outstanding Physical and Chemical AttributesWith a silica content of approximately 3.0% to 7.0%, Simethicone 100% is characterized by its white, viscous liquid form. It has a viscosity of 2000~3500 cSt, density close to 0.97 g/cm, and is insoluble in water but disperses easily with surfactants. Renowned for its non-toxic, tasteless, and odorless properties, this compound stays stable in storage, provided it is kept in tightly sealed containers in a cool, dry area.
Secure Packaging and Reliable StorageDelivered in robust HDPE drums or carboys, Simethicone 100% ensures product integrity during transportation and storage. It requires secure storage in a cool, dry place, away from contaminants. The products high stability allows for a shelf life of up to 36 months, provided optimal storage conditions are maintained. Its ease of handling and packaging suits both large-scale manufacturing and pharmaceutical distribution.
FAQs of Simethicone 100% (Ip/Bp/ Usp):
Q: How is Simethicone 100% with silica content used in pharmaceuticals?
A: Simethicone 100% functions as an antifoaming agent in pharmaceutical preparations. It is primarily used to treat flatulence, bloating, and related digestive discomfort by reducing surface tension and collapsing gas bubbles in the gastrointestinal tract. It can be formulated into tablets, capsules, or suspensions, often in combination with surfactants for better dispersibility.
Q: What are the main benefits of using Simethicone 100% as a digestive aid?
A: The primary benefits of Simethicone 100% include rapid relief from gas-related symptoms such as bloating, abdominal pain, and discomfort. It acts locally in the stomach and intestines, is non-poisonous, tasteless, and is compatible with most pharmaceuticals, ensuring patient safety and efficacy.
Q: Where should Simethicone 100% be stored to maintain its effectiveness?
A: Simethicone 100% should be stored in tightly closed containers, preferably HDPE drums or carboys, in a cool, dry place. Avoid exposure to moisture and extreme temperatures to preserve its physical and chemical stability throughout its 36-month shelf life.
Q: When is it appropriate to use Simethicone 100% in formulations?
A: Simethicone 100% is suitable for use during the development of pharmaceutical products designed to alleviate symptoms of gas accumulation, flatulence, and bloating. It is often added during the blending stage of manufacturing, especially in liquid or semi-solid preparations where antifoaming properties are required.
Q: What is the process for dispersing Simethicone 100% in water-based applications?
A: Simethicone 100% is insoluble in water; however, it can be easily dispersed in aqueous solutions by incorporating suitable surfactants. This process is common in pharmaceutical manufacturing for producing uniform suspensions or emulsions required for effective delivery in oral or topical dosage forms.
Q: Is Simethicone 100% safe and non-toxic for human consumption?
A: Yes, Simethicone 100% is classified as non-poisonous and is widely recognized as safe for pharmaceutical use. It is tasteless, odorless, and free of heavy metals above safety thresholds, making it suitable for regular and therapeutic use under recommended guidelines.