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Pregabalin API

Price 8000.0 INR/ Kilograms

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MOQ : 100 Kilograms

Pregabalin API Specification

Loss on Drying
0.5%

Poisonous
Non-poisonous under prescribed dosage

Melting Point
194-196C

Boiling point
Not available (decomposes)

Color
White or almost white

HS Code
29224990

Shelf Life
36 months (3 years)

Ph Level
4.0 - 7.0 (1% solution)

Heavy Metal (%)
0.001%

Storage
Store in a tightly closed container at 2-8C, protected from light and moisture

Molecular Formula
C8H17NO2

Particle Size
90% < 10 microns

Structural Formula
(See image or as per IUPAC naming)

Taste
Bitter

Solubility
Freely soluble in water, sparingly soluble in methanol, practically insoluble in acetone

Molecular Weight
159.23 g/mol

Smell
Odorless

Medicine Name
Pregabalin API

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
Solid

Water Content (by KF)
0.5%

Residual Solvents
Complies with ICH Guidelines

Packing
HDPE drums with double polyethylene bags, 1 kg, 5 kg, 10 kg, 25 kg

Specific Optical Rotation
+10.5 to +12.0 (in water)

Related Substances (Individual)
0.2%

Microbial Limit
Meets pharmacopeial standards

Assay (by HPLC)
99.0% - 101.0%

Total Impurities
0.5%

Identification
Complies with IR spectrum of standard

Pregabalin API Trade Information

Minimum Order Quantity
100 Kilograms

Supply Ability
100 Kilograms Per Day

Delivery Time
7 Days

Sample Available
No

Sample Policy
Contact us for information regarding our sample policy

About Pregabalin API

Product Specification

Packaging Size	25 kg
Brand	compny
Prescription/Non prescription	Non prescription
Shelf life	2 year
Country of Origin	Made in India
Minimum Order Quantity	25 Kg

Product Description

Purity	99.99%
Prescription/Non prescription	Prescription
CAS Number	148553-50-8
Form	Powder
Capacity	5 MT
Moisture	0.15%
Usage/Application	Pharmaceutical Medicine
Molar Mass	159.23 g/mol
Molecular Formula	C8H17NO2
Grade Standard	Medicine Grade
Regulatory Status	Yes
Therapeutic Category	Anticonvulsants
Country of Origin	Made in India
Minimum Order Quantity	5 Kg

Additional Information

Delivery Time	week
Production Capacity	12000
Packaging Details	25 kg

High Purity & Quality Assurance

Our Pregabalin API meets stringent pharmaceutical standards, maintaining an assay range of 99.0% to 101.0% (by HPLC) and a total impurity content of less than 0.5%. Each batch undergoes comprehensive analysis to ensure compliance with pharmacopeial microbial limits, residual solvents in line with ICH guidelines, and traces of heavy metals below 0.001%. The result is a reliable and safe ingredient for pharmaceutical applications.

Flexible Packing & Storage Solutions

Pregabalin API is available in HDPE drums with double polyethylene inner bags, ensuring maximum safety during transit and storage. Choose from quantities of 1 kg, 5 kg, 10 kg, or 25 kg to suit your requirements. To maintain optimal efficacy, store the API at 2-8C in tightly closed containers, protected from light and moisture.

Versatility & Therapeutic Benefits

This API is widely used in the treatment of neuropathic pain, epilepsy, and generalized anxiety disorder. With a stable crystalline form and high solubility in water, Pregabalin is easily formulated into a variety of dosage forms. Its proven efficacy and safety profile make it a preferred choice for global pharmaceutical manufacturers.

FAQ's of Pregabalin API:

Q: How should Pregabalin API be stored to maintain its quality and efficacy?

A: Pregabalin API should be stored in a tightly closed container at a temperature between 2-8C, protected from light and moisture. Following these storage guidelines helps preserve its purity and extend its 36-month shelf life.

Q: What is the recommended usage of Pregabalin API in pharmaceutical manufacturing?

A: Pregabalin API is used in the formulation of medicines for neuropathic pain, epilepsy, and generalized anxiety disorder. It is intended for pharmaceutical manufacturing and must be used as per prescribed guidelines and dosage regulations.

Q: What quality control measures are in place for Pregabalin API?

A: Each batch of Pregabalin API is tested for assay (by HPLC), related substances, specific optical rotation, water content (by KF), and heavy metals. It also complies with ICH guidelines for residual solvents and meets pharmacopeial microbial limits, ensuring safety and quality.

Q: Where is Pregabalin API manufactured and in what packaging is it supplied?

A: Pregabalin API is manufactured in India and is supplied in HDPE drums lined with double polyethylene bags to protect from contamination and moisture. Packaging sizes include 1 kg, 5 kg, 10 kg, and 25 kg to meet varying customer needs.

Q: What are the solubility and physical characteristics of Pregabalin API?

A: Pregabalin API appears as a white to off-white crystalline powder. It is freely soluble in water, sparingly soluble in methanol, and practically insoluble in acetone, making it suitable for various pharmaceutical formulations.

Q: How does Pregabalin API benefit pharmaceutical manufacturers?

A: Pregabalin API offers high purity, controlled impurity profiles, stability, and compliance with international quality standards. This ensures consistent performance and safety in finished pharmaceutical products, providing a competitive advantage for manufacturers.

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