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PREGABALIN API POWDER

Price 2800 INR/ Kilograms

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MOQ : 25 Kilograms

PREGABALIN API POWDER Specification

Structural Formula
C8H17NO2 (Refer to chemical structure diagrams for details)

Taste
Characteristic

Molecular Formula
C8H17NO2

HS Code
29420090

Poisonous
Non-poisonous at pharmaceutical doses

Particle Size
Typically 10-50 micron

Solubility
Freely soluble in water, sparingly soluble in methanol, practically insoluble in diethyl ether

Color
White

Heavy Metal (%)
NMT 0.001%

Melting Point
194-196°C

Shelf Life
3 years

Loss on Drying
NMT 0.5%

Molecular Weight
159.23 g/mol

Ph Level
5.5 - 7.0 (1% aqueous solution)

Smell
Odorless

Boiling point
Not applicable (decomposes)

Storage
Store in tightly closed containers, protected from light and moisture at room temperature (<25°C)

Medicine Name
Pregabalin API Powder

Chemical Name
(S)-3-(aminomethyl)-5-methylhexanoic acid

CAS No
148553-50-8

Type
Active Pharmaceutical Ingredient (API)

Grade
Pharmaceutical Grade

Usage
Used in treatment of neuropathic pain, epilepsy, and generalized anxiety disorder

Purity(%)
>99%

Appearance
White to off-white crystalline powder

Physical Form
Powder

Related Substances
Total impurities NMT 0.5%

Certificate of Analysis
Provided with batch supply

Microbial Limit
Total bacterial count NMT 1000 cfu/g, Yeast & Molds NMT 100 cfu/g, Pathogenic bacteria Absent

Specific Optical Rotation
+2.0° to +3.0° (in water)

Residual Solvents
Within ICH limits

Packaging Type
HDPE bags, double polyethylene liners

Bulk Density
0.28 - 0.38 g/ml

Assay
98.5% - 101.0% (on dried basis)

Identification
By IR and HPLC meets reference standard

Water Content
NMT 0.5% (by KF)

Pharmacopoeial References
USP, EP, BP

USP/EP Compliance
Complies with USP/EP standards

PREGABALIN API POWDER Trade Information

Minimum Order Quantity
25 Kilograms

FOB Port
NHAVA SHEVA

Payment Terms
Cash Advance (CA), Cash in Advance (CID)

Supply Ability
100000 Kilograms Per Month

Delivery Time
4 Days

Sample Policy
If order is confirmed we will reimburse the sample cost

Packaging Details
DRUM

Main Export Market(s)
Asia, Australia, Central America, North America, South America, Eastern Europe, Western Europe, Middle East, Africa

Main Domestic Market
All India

Certifications
ALL

About PREGABALIN API POWDER

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

Strict Quality Standards

Each batch of Pregabalin API Powder undergoes rigorous quality control, including verification by IR and HPLC, testing for related substances, and compliance with USP, EP, and BP pharmacopoeias. Residual solvents are within ICH limits and microbial levels are tightly controlled to guarantee patient safety and product efficacy.

Optimal Packaging and Shelf Life

Pregabalin API Powder is packaged in high-density polyethylene (HDPE) bags with double polyethylene liners, minimizing exposure to moisture and light. When stored properly in tightly closed containers at room temperature below 25C, the product maintains a stable shelf life of up to three years.

Pharmaceutical Applications and Safety

This API is widely used in the manufacture of medications that manage neuropathic pain, epilepsy, and anxiety disorders. It is non-poisonous at standard therapeutic doses and features a high purity profile, making it suitable for diverse pharmaceutical formulations. A comprehensive Certificate of Analysis is provided with each supply for full transparency.

FAQ's of PREGABALIN API POWDER:

Q: How is Pregabalin API Powder identified and tested for quality?

A: Pregabalin API Powder is identified using Infrared Spectroscopy (IR) and High-Performance Liquid Chromatography (HPLC) to ensure conformity with reference standards. Each batch is extensively tested for purity, related substances, microbial limits, and residual solvents to meet strict pharmacopoeial requirements.

Q: What are the recommended storage conditions and shelf life for Pregabalin API Powder?

A: It is best stored in tightly closed containers, away from light and moisture, at temperatures below 25C. When stored correctly, the shelf life of Pregabalin API Powder is up to three years, ensuring long-term stability and effectiveness.

Q: Where is Pregabalin API Powder manufactured and how is it packaged?

A: Manufactured in India, Pregabalin API Powder is available through distributors, exporters, importers, manufacturers, and suppliers. The product is securely packed in HDPE bags with double polyethylene liners to protect against environmental contaminants and maintain product quality during transit and storage.

Q: What are the main pharmaceutical uses of Pregabalin API Powder?

A: This API is utilized in the preparation of medications for neuropathic pain, epilepsy, and generalized anxiety disorder. Its high purity and compliance with USP/EP/BP standards make it a preferred ingredient for pharmaceutical formulations targeting these conditions.

Q: How does Pregabalin API Powder benefit pharmaceutical manufacturers?

A: Pregabalin API Powder offers manufacturers a high-purity, pharmaceutically compliant ingredient, supported by a detailed Certificate of Analysis for every batch. Its stability, safety, and full traceability help streamline product development and regulatory compliance.

Q: What is the typical particle size and physical appearance of Pregabalin API Powder?

A: The powder typically features a particle size ranging from 10 to 50 microns and presents as a white to off-white crystalline powder. It is odorless, has a characteristic taste, and dissolves readily in water, making it easy to formulate into various dosage forms.

Q: Is Pregabalin API Powder safe and non-poisonous?

A: At pharmaceutical dosages, Pregabalin API Powder is considered non-poisonous. It undergoes thorough testing for heavy metals, microbial content, and related impurities to ensure pharmaceutical safety standards are met.

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