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

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

Price 1700.0 INR/ Piece

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MOQ : 30 Pieces

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

Storage
Store in tightly sealed containers, protected from light, at room temperature (15-30C)

Heavy Metal (%)
0.001%

Melting Point
187-189C

HS Code
29335990

Shelf Life
36 months

Color
White to off-white

Molecular Weight
666.7 g/mol

Ph Level
5.0 - 6.0 (solution)

Loss on Drying
Not more than 1.0%

Smell
Odorless

Molecular Formula
C22H30N6O4S C6H8O7

Boiling point
Not applicable (decomposes)

Solubility
Freely soluble in water and methanol

Taste
Bitter

Structural Formula
As per IUPAC structure

Poisonous
NO

Particle Size
90% < 100 microns

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

Related Substances
Not more than 0.2%

Assay (on dried basis)
98.0% - 102.0%

Residual Solvents
Within ICH limits

Polymorphic Form
Form I (Standard)

Packing
1 kg / 5 kg / 10 kg double polyethylene bags in HDPE drum

Microbial Limits
Total aerobic microbial count NMT 100 cfu/g; total yeast & molds NMT 10 cfu/g

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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