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
Perform standard: USP 38
Description: Pregabalin powder cas 148553-50-8 also named, 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 (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: 3-(Aminomethyl)-5-methyl-hexanoic acid, (S)-(+)-Pregabalin-d4, Maxgalin 75, Pregabalin
Certificate of analysia
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Tests
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SPECIFICATIONS
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RESULTS
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Appearance
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Off-white to white powder
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White powder
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Identification
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The infrared absorption spectrum of the sample should concordant with that of the spectrum of working standard of product
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Conforms
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Solubility
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Sparingly soluble in water
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Conforms
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Specific Optical
Rotation (On anhydrous basis)（°）
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+10.0° ~ +12.0°
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+10.0°
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Loss on drying( w/w)
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≤0.5%
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0.32%
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Sulphate ash
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≤0.1%
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0.05%
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Heavy Metals(%)
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≤20ppm
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Conforms
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Enantiomeric purity
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The area of peak due to R-Pregabalin is not more than 0.5 % the area of the S-Pregabalin.
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Conforms
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Purity by HPLC
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Lactam impurities ≤0.5%
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Not detected
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Individual impurities ≤0.5%
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0.437%
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Total impurities ≤1.0%
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0.4%
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Purity≥99%
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99.6%
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Assay(%)
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98%~102.0%
It content not less than 98.0% and not more than 102.0% on dried basis.
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99.95%
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