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Pregabalin API

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Pregabalin API Specification

Molecular Formula
C8H17NO2

Poisonous
Non-poisonous at therapeutic doses

Loss on Drying
<0.5%

EINECS No
Not Listed

Taste
Bitter

Melting Point
194-196C

Smell
Odorless

Boiling point
Not applicable (decomposes)

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

Shelf Life
2 Years

Color
White

Particle Size
D90 < 250 micron

Molecular Weight
159.23 g/mol

Solubility
Freely soluble in water

HS Code
29420090

Structural Formula
C8H17NO2

Ph Level
5.0-7.0 (in water)

Heavy Metal (%)
<0.001%

Medicine Name
Pregabalin API

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

CAS No
148553-50-8

Type
Active Pharmaceutical Ingredient

Grade
Pharmaceutical Grade

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

Purity(%)
99% min

Appearance
White to off-white crystalline powder

Physical Form
Solid

Identification
By IR, HPLC, and TLC

Stability
Stable under recommended storage conditions

Assay (by HPLC)
>99%

Residual Solvents
Meets ICH limits

Microbial Limit Test
Meets pharmacopeial specifications

Optical Rotation
+0.29° to +0.35° (c=1, H2O)

Packaging Type
HDPE drums or double polyethylene bags

Storage Temperature
15°C to 30°C

Related Substances
Total impurities < 0.5%

Pregabalin API Trade Information

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

About Pregabalin API

Get the latest in pharmaceutical excellence with our Pregabalin API, a world-class active ingredient used in the treatment of neuropathic pain, epilepsy, and generalized anxiety disorder. Decorated with invincible purity (>99% by HPLC) and minimal total impurities (<0.5%), this pharmaceutical-grade compound ensures reliability in every batch. Identified by rigorous IR, HPLC, and TLC methods, and meeting all ICH and pharmacopeial specifications, our Pregabalin API is supplied in secure HDPE drums or double polyethylene bags. Order today from India's trusted exporter, manufacturer, and supplier for assured global standards.

Comprehensive Medical Applications of Pregabalin API

Pregabalin API is extensively used by healthcare professionals across neurology and psychiatry for its efficacy in treating neuropathic pain, epilepsy, and generalized anxiety disorder. Its main site of application is pharmaceutical formulations manufactured by leading global companies. This API finds application in hospitals, clinics, and research institutions, ensuring patients receive reliable, high-quality medication. Recognized for its therapeutic value, Pregabalin API continues to support world-class treatment protocols worldwide.

Pregabalin API Packaging, Sampling, and Transport Details

Pregabalin API is meticulously packed in HDPE drums or double polyethylene bags to maintain integrity during transit. We offer sample availability for quality assurance, following a transparent policy-samples can be requested along with your purchase order or quotation. Our efficient transport services ensure prompt and safe delivery, preserving the API's quality from manufacturer to end user. Contact us directly for detailed shipping arrangements, sample requests, or specific packaging needs tailored to your operations.

FAQ's of Pregabalin API:

Q: How should Pregabalin API be stored to maintain its stability?

A: Pregabalin API should be stored in a cool, dry place, protected from light at a temperature between 15C and 30C to ensure its stability and potency throughout its 2-year shelf life.

Q: What identification methods are used for Pregabalin API?

A: The identification of Pregabalin API is conducted through advanced techniques such as Infrared Spectroscopy (IR), High Performance Liquid Chromatography (HPLC), and Thin Layer Chromatography (TLC), ensuring authenticity and quality.

Q: Where can Pregabalin API be applied?

A: Pregabalin API is used in the pharmaceutical industry for the production of medications aimed at treating neuropathic pain, epilepsy, and generalized anxiety disorder. It is primarily applied in licensed manufacturing plants, hospitals, and clinical environments.

Q: What are the packaging options for Pregabalin API?

A: Pregabalin API is offered in HDPE drums or double polyethylene bags, designed to protect the product during storage and international transport, meeting regulatory safety and hygiene requirements.

Q: What is the usual process for ordering Pregabalin API samples?

A: To request a sample of Pregabalin API, submit a purchase order or quotation request. Samples are provided according to our sample policy, ensuring you can verify quality before bulk procurement.

Q: What is the benefit of using Pregabalin API from your company?

A: Choosing our Pregabalin API guarantees pharmaceutical grade consistency-purity over 99%, compliance with ICH and pharmacopoeial guidelines, and packaging that preserves product integrity, all backed by reliable exporter and manufacturer credentials in India.

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