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Silde-nafil Citra-te API, Grade : IP / BP / USP
Silde-nafil Citra-te API, Grade : IP / BP / USP

Silde-nafil Citra-te API, Grade : IP / BP / USP

Price 1700.0 INR/ Piece

MOQ : 30 Pieces

Silde-nafil Citra-te API, Grade : IP / BP / USP Specification

  • Ph Level
  • 5.0 - 6.0 (solution)
  • Color
  • White to off-white
  • Molecular Weight
  • 666.7 g/mol
  • Loss on Drying
  • Not more than 1.0%
  • Structural Formula
  • As per IUPAC structure
  • Particle Size
  • 90% < 100 microns
  • Smell
  • Odorless
  • Heavy Metal (%)
  • 0.001%
  • Solubility
  • Freely soluble in water and methanol
  • Taste
  • Bitter
  • Poisonous
  • NO
  • Storage
  • Store in tightly sealed containers, protected from light, at room temperature (15-30C)
  • HS Code
  • 29335990
  • Melting Point
  • 187-189C
  • Molecular Formula
  • C22H30N6O4S C6H8O7
  • Boiling point
  • Not applicable (decomposes)
  • Shelf Life
  • 36 months
  • Medicine Name
  • Silden*afil Citrate
  • Chemical Name
  • 1-[[3-(6,7-dihydro-1-methyl-7-oxo-3-propyl-1H-pyrazolo[4,3-d]pyrimidin-5-yl)-4-ethoxyphenyl]sulfonyl]-4-methylpiperazine citrate
  • CAS No
  • 171599-83-0
  • Type
  • Active Pharmaceutical Ingredient (API)
  • Grade
  • IP / BP / USP
  • Usage
  • Pharmaceutical formulations, mainly in erectile dysfunction medications
  • Purity(%)
  • 99%
  • Appearance
  • White or almost white crystalline powder
  • Physical Form
  • Solid
  • Identification
  • Complies with standard tests (IR, HPLC, UV) as per IP/BP/USP
  • Microbial Limits
  • Total aerobic microbial count NMT 100 cfu/g; total yeast & molds NMT 10 cfu/g
  • Packing
  • 1 kg / 5 kg / 10 kg double polyethylene bags in HDPE drum
  • Residual Solvents
  • Within ICH limits
  • Related Substances
  • Not more than 0.2%
  • Assay (on dried basis)
  • 98.0% - 102.0%
  • Polymorphic Form
  • Form I (Standard)
 

Silde-nafil Citra-te API, Grade : IP / BP / USP Trade Information

  • Minimum Order Quantity
  • 30 Pieces
  • Supply Ability
  • 10000 Pieces Per Day
  • Delivery Time
  • 7 Days
  • Sample Available
  • No
  • Sample Policy
  • Contact us for information regarding our sample policy
 

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 DescriptionSildenafil 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 Compliance

Complying 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 Uses

As 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 Life

With 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.

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