Pregabaline API

Pregabaline API Specification

HS Code
29224990

Structural Formula
C8H17NO2

Melting Point
186C to 188C

Storage
Store in a well-closed container at room temperature, away from moisture and light

Molecular Formula
C8H17NO2

Solubility
Freely soluble in water and alcohol

Shelf Life
5 Years

Molecular Weight
159.23 g/mol

Smell
Odorless

Poisonous
Non-poisonous under prescribed usage

Color
White to Off-White

Loss on Drying
Not more than 0.5%

Heavy Metal (%)
Not more than 0.001%

Medicine Name
Pregabaline

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

CAS No
148553-50-8

Type
API (Active Pharmaceutical Ingredient)

Grade
Pharmaceutical Grade

Usage
For Neuropathic Pain, Epilepsy, Fibromyalgia, Generalized Anxiety Disorder

Purity(%)
99.0% Min

Appearance
White to Off-White Crystalline Powder

Physical Form
Solid

Optical Rotation
+0.5 to +1.5 (c=1 in water)

Shelf Life Condition
Unopened, at recommended storage

Assay
99.0% to 101.0% (on dried basis)

Residual Solvents
Complies with ICH guidelines

Packaging
HDPE drum with double polyethylene bags

Related Substances
Total impurities: NMT 0.2%

Identification
HPLC/IR confirmation

Pregabaline API Trade Information

Minimum Order Quantity
50 Kilograms

Payment Terms
Cash in Advance (CID)

Supply Ability
5000 Kilograms Per Month

Delivery Time
2-5 Days

Main Domestic Market
All India

Minimum Order Quantity
50 Kilograms

Supply Ability
5000 Kilograms Per Month

Delivery Time
2-5 Days

Main Domestic Market
All India

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