About Silde-nafil Citra-te API, Grade : IP / BP / USP
| CAS Numbe |
171599-83-0
|
| Molar Mass |
474.6 g/mol
|
| Chemical Formula |
C22H30N6O4S
|
| Density |
1.447g/cm3
|
| Country of Origin |
Made in India
|
| Usage |
Pharma Industry
|
| Minimum Order Quantity |
25 Kg
|
Product Specification
| Form |
Powder |
| Country of Origin |
Made in India |
| Packaging Type |
Drum |
| Usage |
Pharma Industry |
| Flash Point |
360.5 Degree Celsius |
| Density |
1.447g/cm3 |
| CAS Number |
171599-83-0 |
| Melting Point |
189 deg C |
| Boiling Point |
672.4 Degree Celsius at 760 mmHg |
| Molar Mass |
474.6 g/mol |
| Chemical Formula |
C22H30N6O4S |
| Manufacturer |
INDIA |
Product Description
Sildenafil Citrate API,isold under the brand name Viagra among others, is a medication used to treat erectile dysfunction and pulmonary arterial hypertension. It is unclear if it is effective for treating sexual dysfunction in women. It is taken by mouth or injection into a vein.
Exceptional Quality and ComplianceComplying with international pharmacopeial standards (IP, BP, USP), our Sildenafil Citrate API undergoes stringent identification and purity verification by IR, HPLC, and UV. Each batch is tested for related substances, microbial limits, residual solvents, and heavy metals, guaranteeing pharma-grade safety and effectiveness.
Versatile Pharmaceutical UsesAs a core ingredient in erectile dysfunction medications, Sildenafil Citrate is formulated for reliable performance. Its high purity, robust assay range (98.0%-102.0%), and controlled polymorphic form (Form I) ensure consistency in therapeutic outcomes across pharmaceutical applications.
Secure Packaging and Long Shelf LifeWith packaging options of 1 kg, 5 kg, and 10 kg in double polyethylene bags within HDPE drums, the product is shielded from light and contaminants. Storage at room temperature (15-30C) maintains quality and extends the shelf life to 36 months-ideal for exporters, importers, manufacturers, and suppliers.
FAQ's of Silde-nafil Citra-te API, Grade : IP / BP / USP:
Q: How is the identity of Sildenafil Citrate API confirmed?
A: The identity of Sildenafil Citrate API is confirmed using Infrared Spectroscopy (IR), High-Performance Liquid Chromatography (HPLC), and Ultraviolet Spectroscopy (UV), ensuring compliance with IP, BP, and USP pharmacopeial standards.
Q: What are the recommended storage conditions for this API?
A: Sildenafil Citrate API should be stored in tightly sealed containers, protected from light, at room temperature between 15C and 30C to maintain its stability and extend its shelf life.
Q: When is this API typically used in pharmaceutical manufacturing?
A: This API is primarily used during the formulation stage of pharmaceutical manufacturing, especially for medicines targeting erectile dysfunction. Its quality and purity ensure effective integration into end products.
Q: Where does the packaging and quality control take place?
A: Packaging and quality control are rigorously conducted in certified facilities in India, with the product packed in double polyethylene bags and HDPE drums to ensure safety during transit and storage.
Q: What is the process for verifying related substances and impurities?
A: Related substances and impurities are monitored through validated chromatographic methods. The API must contain not more than 0.2% of related substances, and residual solvents are maintained within ICH limits as per regulatory requirements.
Q: How does Sildenafil Citrate API benefit pharmaceutical manufacturers?
A: Manufacturers benefit from its high purity ( 99%), consistent polymorphic form, strict quality controls, and broad compliance with IP/BP/USP grades, ensuring reliable and safe pharmaceutical production.