Pregabalin Powder CAS 148553-50-8

Pregabalin powder cas 148553-50-8 also named lyrica, is an alternative adjuvant analgesic for refractory neuropathic pain. Pregabalin is superior in efficacy to placebo and appears to be non-inferior in efficacy and safety to amitriptyline and gabapentin (from indirect comparisons).

Description

Pregabalin powder cas 148553-50-8

Product introduction

CAS: 148553-50-8

MF: C8H17NO2

Purity: ≥99%
Stock: ≥700kg

Storage: Room temperature

Appearance: White crystalline powder

Other name: Lyrica

Perform standard: USP 38

Description: Pregabalin powder cas 148553-50-8 also named lyrica, is an alternative adjuvant analgesic for refractory neuropathic pain. Pregabalin is superior in efficacy to placebo and appears to be non-inferior in efficacy and safety to amitriptyline and gabapentin (from indirect comparisons).

Pregabalin powder cas 148553-50-8 works in the central nervous system (CNS) to control seizures and pain. It is an anticonvulsant and neuropathic pain agent.

Application: Pregabalin powder cas 148553-50-8 is used with other medicines to help control partial-onset seizures (convulsions) in the treatment of epilepsy in patients 1 month of age and older. This medicine will not cure epilepsy and will only work to control seizures for as long as you continue to take it.

Pregabalin is also used for postherpetic neuralgia (pain that occurs after shingles) and pain caused by nerve damage from diabetes or a spinal cord injury.

Other chemical names: Lyrica, 3-(Aminomethyl)-5-methyl-hexanoic acid, (S)-(+)-Pregabalin-d4, Maxgalin 75, Pregabalin/Lyrica powder


Certificate of analysia

Tests

SPECIFICATIONS

RESULTS

Appearance

Off-white to white powder

White powder

Identification

The infrared absorption spectrum of the sample should concordant with that of the spectrum of working standard of product

Conforms

Solubility

Sparingly soluble in water

Conforms

Specific Optical

Rotation (On anhydrous basis)(°)

+10.0° ~ +12.0°

+10.0°

Loss on drying( w/w)

≤0.5%

0.32%

Sulphate ash

≤0.1%

0.05%

Heavy Metals(%)

≤20ppm

Conforms

Enantiomeric purity

The area of peak due to R-Pregabalin is not more than 0.5 % the area of the S-Pregabalin.

Conforms

Purity by HPLC

Lactam impurities ≤0.5%

Not detected

Individual impurities ≤0.5%

0.437%

Total impurities ≤1.0%

0.4%

Purity≥99%

99.6%

Assay(%)

98%~102.0%

It content not less than 98.0% and not more than 102.0% on dried basis.

99.95%


Company Information

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