About Guaifenesin API
| Grade Standard |
IP
|
| Form |
Powder
|
| Grade |
Pharma Grade
|
| CAS Number |
93 14 1
|
| Purity |
99%
|
| Usage/Application |
Pharmaceutical
|
| Molecular Weight |
198.22 g/mol
|
| Chemical Formula |
C10H14O4
|
| Products Packaging Type |
Loose
|
| Minimum Order Quantity |
25 Kg
|
- CAS No: 93-14-1
- Guaifenesin is used to help clear mucus or phlegm (pronounced flem) from the chest when you have congestion from a cold or flu.
- Indigenous manufacturingi
Precise Identification MethodsGuaifenesin API is rigorously verified using identification techniques such as Infrared Spectroscopy (IR), High-Performance Liquid Chromatography (HPLC), and chemical tests outlined in pharmacopeias. These processes guarantee the authenticity, purity, and compliance of the compound for pharmaceutical applications, providing reliable results for quality assurance.
Superior Quality AssuranceEach batch of Guaifenesin undergoes comprehensive testing including assay by HPLC (99.0%), residue on ignition (0.1%), and related substances checks according to pharmacopeia specifications. Microbial limits are strictly controlled, with total bacterial count not exceeding 1000 CFU/g and yeast & mold capped at 100 CFU/g.
Safe and Compliant PackagingGuaifenesin is packed securely in double polyethylene bags placed in fiber drums, with each drum holding 25kg net. This packaging method safeguards the purity and stability of the API during transportation and storage, ensuring compliance with pharmaceutical standards and maintaining product integrity.
FAQ's of Guaifenesin API:
Q: How is the identity and purity of Guaifenesin confirmed?
A: The identity of Guaifenesin API is established using procedures such as Infrared Spectroscopy (IR), High-Performance Liquid Chromatography (HPLC), and chemical tests as specified by relevant pharmacopeias. Its purity is verified by HPLC assay, with results consistently meeting or exceeding 99%.
Q: What is the recommended process for storing Guaifenesin API?
A: It should be stored in a cool, dry, well-ventilated area, away from direct sunlight. Proper storage ensures its stability and effectiveness throughout its five-year shelf life.
Q: Where does the manufacturing and supply of Guaifenesin occur?
A: Guaifenesin API is manufactured, supplied, exported, and imported by certified companies in India. The API is distributed globally and adheres to international quality and regulatory standards.
Q: When is it beneficial to use Guaifenesin in pharmaceutical formulations?
A: Guaifenesin is beneficial when formulating medications for respiratory conditions, particularly those aimed at relieving chest congestion. Its expectorant properties aid in loosening mucus in the airways, making coughing more productive.
Q: What are the safety and regulatory compliances of Guaifenesin API?
A: Guaifenesin complies with ICH guidelines and international pharmacopeia standards (USP/NF, BP/EP upon request). It is non-poisonous, has strict control over heavy metals and microbial limits, and meets all requirements for pharmaceutical-grade APIs.
Q: How is Guaifenesin packaged for export and long-term storage?
A: To prevent contamination and moisture ingress, Guaifenesin is packaged in double polyethylene bags, which are then sealed within a fiber drum. This method upholds the product's quality throughout shipping and storage.
Q: What is the benefit of using Guaifenesin sourced from this supplier?
A: Sourcing Guaifenesin from a reputable supplier in India guarantees pharmaceutical-grade quality, verified purity, regulatory compliance, and reliable packaging-ensuring the product's performance in final dosage forms.