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Silodosin Api Powder

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Silodosin Api Powder Specification

HS Code
29420090

Molecular Formula
C25H32FN3O4

Smell
Odorless

Solubility
Soluble in methanol, sparingly soluble in water

Color
White to off-white

Shelf Life
2 years from date of manufacture

Molecular Weight
453.54 g/mol

Particle Size
D90 < 10 microns

Loss on Drying
Not more than 0.5%

Structural Formula
(See image reference for structure)

Storage
Store in a cool, dry place, protected from light

Melting Point
105-107C

Heavy Metal (%)
Not more than 0.001%

Poisonous
Non-poisonous as per standard handling

Medicine Name
Silodosin API Powder

Chemical Name
Silodosin

CAS No
160970-54-7

Type
API (Active Pharmaceutical Ingredient)

Grade
Pharmaceutical Grade

Usage
Used in the formulation of medications for the treatment of benign prostatic hyperplasia (BPH)

Purity(%)
>=99%

Appearance
White to off-white crystalline powder

Physical Form
Powder

Microbial Limit
Total aerobic microbial count < 100 CFU/g; total yeast & mold < 10 CFU/g; E. coli: absent

Identification
Complies by IR and HPLC

Assay (by HPLC)
>=99.0%

Specific Optical Rotation
+24.0° to +28.0° (c=1, Methanol)

Stability
Stable under recommended storage conditions

Residual Solvents
Within ICH limits

Related Substances
Total impurities < 1.0%

Packing
Packed in HDPE containers or as per customer requirement

Silodosin Api Powder Trade Information

Supply Ability
100 Per Day

Delivery Time
7 Days

Sample Available
No

Sample Policy
Contact us for information regarding our sample policy

About Silodosin Api Powder

Physical State	Powder
Purity	99%
Prescription/Non prescription	Non prescription
Grade	API
Form	Powder
Packaging Details	25 KG
Minimum Order Quantity	1000 Kg

Silodosin Api Powder, 1 kg 300/iGramGet Latest Price

Packaging Size	1 kgi
Treatment	to treat signs and symptoms of an enlarged prostate gland
Prescription/Non prescription	Prescription
Type of API	Anti Infective API
Shelf life	3-5 years

Premium-Grade API for Advanced BPH Treatments

Silodosin API Powder is engineered to meet rigorous international pharmaceutical standards, with purity levels of 99% or higher. Its consistent quality and safety profiles make it an essential ingredient for the reliable production of effective BPH medications. The product's strict control of impurities, microbial content, and heavy metals ensures safety and efficacy in every batch.

Strict Quality Assurance for Safety and Performance

Manufactured in state-of-the-art facilities in India, this API undergoes comprehensive identification (IR and HPLC), purity analysis, and impurity profiling. The final powder is subjected to stringent microbial and heavy metal testing, ensuring all parameters fall within ICH and pharmacopoeia standards. Silodosin API Powder retains its stability and potency under appropriate storage and shelf life conditions.

FAQ's of Silodosin Api Powder:

Q: How is the quality and purity of Silodosin API Powder assured?

A: The quality and purity of Silodosin API Powder are verified through identification by IR and HPLC, with assay results of 99.0% by HPLC. Impurity levels are kept below 1.0%, while heavy metals and residual solvents adhere to strict ICH guidelines. These comprehensive tests ensure the product meets pharmaceutical-grade standards for safety and effectiveness.

Q: What is the primary use of Silodosin API Powder in the pharmaceutical industry?

A: Silodosin API Powder is primarily used in the formulation of medications for treating benign prostatic hyperplasia (BPH), helping improve urinary flow and reduce symptoms associated with this condition in men.

Q: Where should Silodosin API Powder be stored to maintain its efficacy?

A: For optimal stability and shelf life, Silodosin API Powder should be stored in a cool, dry place, protected from light. Proper storage ensures a shelf life of two years from the date of manufacture.

Q: What are the recommended packing options for Silodosin API Powder?

A: The powder is typically packed in high-quality HDPE containers, but packing options can be customized to meet specific customer requirements, ensuring safe transport and storage.

Q: How does Silodosin API Powder benefit pharmaceutical manufacturers?

A: Pharmaceutical manufacturers benefit from Silodosin API Powder's high purity, well-defined particle size, and consistent quality, which translate to effective and stable BPH medications. Its compliance with international standards simplifies regulatory processes and enhances end-product reliability.

Q: What safety and handling precautions should be observed with Silodosin API Powder?

A: Although non-poisonous under standard handling, users should follow good manufacturing practices (GMP), use personal protective equipment, and avoid inhalation or direct contact to ensure safety during processing.

Q: When does Silodosin API Powder expire?

A: Silodosin API Powder maintains its original quality and performance for two years from the date of manufacture when kept under recommended storage conditions.

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