PREGABELIN

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Product Details:

Molecular Weight 159.23 g/mol
Molecular Formula C8H17NO2
Storage Store below 25C, protect from moisture
EINECS No None assigned
Color White to off-white
Shelf Life 36 months
Ph Level 6.0-7.5 (in 1% solution)
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PREGABELIN Product Specifications

Smell Odorless
Usage Used in the treatment of neuropathic pain, epilepsy, fibromyalgia, and generalized anxiety disorder
Heavy Metal (%) 0.001%
Chemical Name (S)-3-(aminomethyl)-5-methylhexanoic acid
Taste Slightly bitter
Boiling point Not available (decomposes)
HS Code 29224990
Structural Formula C8H17NO2
Melting Point 194-196C
Loss on Drying 0.5%
Physical Form Solid
Purity(%) 98% minimum
Poisonous No (when used as directed)
CAS No 148553-50-8
Particle Size 90% passes through 60 mesh
Solubility Freely soluble in water, sparingly soluble in ethanol
Medicine Name Pregabalin
Storage Store below 25C, protect from moisture
Type Pharmaceutical Raw Material
Molecular Weight 159.23 g/mol
Appearance White to off-white crystalline powder
Molecular Formula C8H17NO2
Shelf Life 36 months
Ph Level 6.0-7.5 (in 1% solution)
Grade Pharma Grade
EINECS No None assigned
Color White to off-white

PREGABELIN Trade Information

Payment Terms Telegraphic Transfer (T/T)
Sample Available Yes
Main Export Market(s) Western Europe, Australia, South America, Eastern Europe, Middle East, Asia, Africa
Main Domestic Market All India

Product Description

Pregabalin is used to treat epilepsy and anxiety. It is also taken to treat nerve pain. Nerve pain can be caused by different illnesses including diabetes and shingles, or an injury.

Pharmaceutical Excellence Guaranteed

Pregabalin is manufactured and tested according to stringent USP/EP standards, ensuring high purity (98.0102.0%), minimal impurity levels, and robust quality control. Its appearance as a white to off-white crystalline powder and strict assay specifications make it a reliable ingredient for pharmaceutical formulations.

Wide Range of Therapeutic Uses

As an active pharmaceutical ingredient, pregabalin is employed in the management of various medical conditions, including neuropathic pain, epilepsy, fibromyalgia, and generalized anxiety disorder. Its efficacy and safety have made it a preferred choice for healthcare professionals across different treatment protocols.

Optimal Packaging and Storage Conditions

To maintain its chemical integrity, pregabalin is packed in tightly closed containers and stored at temperatures below 25C, away from moisture. This ensures sustainability of quality throughout its 36-month shelf life, making it a dependable option for manufacturers and healthcare providers.

FAQs of PREGABELIN:

Q: How should pregabalin be stored to ensure maximum stability?

A: Pregabalin should be stored below 25C, in tightly closed containers, and protected from moisture. These conditions help maintain its stability and potency throughout its 36-month shelf life.

Q: What are the primary uses and benefits of pregabalin?

A: Pregabalin is primarily used for the treatment of neuropathic pain, epilepsy, fibromyalgia, and generalized anxiety disorder. Its benefit lies in its efficacy at reducing nerve pain and improving quality of life for patients with these conditions.

Q: How is pregabalin identified and tested for quality assurance?

A: Pregabalin is subjected to rigorous identification using IR (infrared) spectroscopy and must meet specific criteria for assay, purity, and impurities as outlined by the USP/EP pharmacopoeial standards, including microbial limits and heavy metals testing.

Q: When should pregabalin be used as a raw material in pharmaceutical production?

A: Pregabalin should be incorporated into finished pharmaceutical products by manufacturers who require high-purity, pharma-grade raw materials for approved treatments in accordance with regulatory guidelines and validated production processes.

Q: Where does the manufacturing and distribution of pregabalin occur?

A: Pregabalin is manufactured, distributed, and supplied by qualified pharmaceutical companies in India, adhering to regulatory quality standards and safety guidelines for global export.

Q: What is the recommended method for handling pregabalin during processing?

A: Pregabalin should be handled in controlled environments using proper personal protective equipment to prevent contamination and maintain product integrity. Process areas should be clean, dry, and meet the required pharmaceutical manufacturing standards.

Q: What factors contribute to the high purity and quality of pregabalin?

A: Strict manufacturing protocols, comprehensive quality checks for assay, impurities, and microbial limits, as well as adherence to USP/EP standards, all contribute to the high purity (minimum 98%) and consistent quality of pregabalin provided to the pharmaceutical industry.

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