Pregabalin API

CAS No: 148553-50-8
Appearance: White or almost white crystalline powder
Standard: in-house
Application:Anti epileptic Supply Ability: 1000kg per month
Shelf Life: Two years
Payment: T/T, LC or DA
Delivery Time: Ready Stock
Origin: China
Shipping: DHL, FedEx, TNT, EMS, By Sea, By Air
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Product Introduction

We supply Pregabalin API

We offer the loftiest quality Pregabalin API available on the request. Our product is strictly manufactured to insure chastity and energy, making it ideal for use in medicinal and medical applications. It has been proven effective in treating a variety of conditions, including neuropathic pain, anxiety diseases, and epilepsy. Trust our dependable and effective force chain to give you with the necessary raw accoutrements to develop your own high- quality phrasings. communicate us moment to learn further about our Pregabalin and how we can help meet your business requirements.

 

What's Pregabalin

Pregabalin powder, chemical name( S)-3-aminomethyl-5-methylhexanoic acid, molecular formula C8H17NO2, is an antiepileptic medicine substantially used in clinical treatment of postherpetic neuralgia.

it belongs to the order of non gamma aminobutyric acid( GABA) receptor agonists or antagonists, and is a new calcium channel controller that can block voltage dependent calcium channels and reduce neurotransmitter release. It's substantially used clinically for neuralgia related to diabetes supplemental neuropathy, post herpetic neuralgia and supplementary treatment of adult partial epilepsy, generalized anxiety complaint, central neuralgia( including neuralgia associated with spinal cord injury, stroke and multiple sclerosis) and fibromyalgia.

it is an analogue of the neurotransmitter gamma aminobutyric acid( GABA), retailed as Lyrica. In December 2004, FDA approved it as a medicine to treat diabetes neuralgia and herpes zoster neuralgia. it is the first medicine honored in the United States and Europe to be used contemporaneously to treat both types of pain. In June 2005, it was approved as an adjuvant remedy for adult original seizure epilepsy. In March 2006, the European Union approved it for the treatment of generalized anxiety complaint( GAD) and social anxiety complaint( SAD).

 

Basic Information

Product Name: Pregabalin

CAS:148553-50-8

MF:C8H17NO2

MW:159.23

EINECS:604-639-1

MDL No.:MFCD00917044

Structural formula:

product-1-1

Purity: 99%+

Application:Anti epileptic

Origin: China

Delivery Time: stock

 

Technical Specification:

Item

Standard

Result

Appearance

White or almost white crystalline powder

White crystalline powder

Specific rotation

+9.0~ +11.5°

+10.79°

PH

6.0~8.0

6.77

Loss on drying

≤0.5%

0.02%

Residue on ignition

≤0. 1%

0.04%

Heavy metals

≤0.002%

<0.002%

Assay (on dried basis)

≥98.5%

100.8%

R-pregabalin(HPLC)

≤0.5%

0.33%

 

Related substances

S-(+)-mandel ≤0. 1%

0.3%

Unspecific individual impurity≤0.4%

0.08%

Total impurities≤1.0%

0. 10%

Residual solvents

Isopropylketone ≤3000ppm tetrahydrofuran ≤720ppm

585.0ppm ND

Conclusion

Comply with the enterprise standard

Package: 1kg; 25kg or according to your demands

Storage conditions: keep tightly closed, store in a cool dry place.

 

Application

Pregabalin API, as an active pharmaceutical component( API), is primarily used for its remedial parcels in the treatment of colorful medical conditions. Then are some of its main applications:

Neuropathic Pain: it is extensively specified for the application of neuropathic pain, which includes pain caused by whim-whams damage due to conditions similar as diabetes, shingles(post-herpetic neuralgia), or injuries to the spinal cord.

Epilepsy:  It's also used as an spare remedy in the treatment of partial seizures in grown-ups with epilepsy. it helps in reducing the frequence of seizures when used in combination with other antiepileptic specifics.

Generalized Anxiety complaint( GAD): it is approved for the treatment of generalized anxiety complaint in several countries. It helps in reducing anxiety symptoms and perfecting overall quality of life in individualities with GAD.

Fibromyalgia: it is indicated for the application of fibromyalgia, a habitual condition characterized by wide musculoskeletal pain and tenderheartedness, frequently accompanied by fatigue, sleep disturbances, and cognitive difficulties.

Other Off- marker Uses: In addition to its approved suggestions, it is occasionally specified off- marker for conditions similar as restless leg pattern( RLS), wakefulness, and habitual pain runs.

Pregabalin works by binding to calcium channels in the central nervous system, which modulates the release of neurotransmitters involved in pain signaling and anxiety. It's generally well- permitted, however like all specifics, it can beget side goods similar as dizziness, doziness, weight gain, and supplemental edema.

 

Pharmacological action

Pregabalin powder has a good remedial effect on epilepsy. Studies on colorful beast seizure models have shown that it can significantly help seizures, and its cure of active action is 3- 10 times lower than gabapentin. The study set up that it can reduce the sensitive and motor spinal cord kickback convinced by toe pinching stimulation in rats, reduce the affiliated actions of pain models of diabetes, supplemental whim-whams injury or chemical treatment of neurogenic creatures, and inhibit or reduce the pain related actions caused by the stimulation given to the chine. Beast trials have set up that it may have advantages when used in combination with opioid medicines. it provides a new option for clinical treatment of neuropathic pain.

 

Mechanism of action

Pregabalin may reduce the calcium dependent release of some neurotransmitters by regulating calcium channel function. Although it is a structural outgrowth of the inhibitory neurotransmitter gamma aminobutyric acid( GABA), it doesn't directly bind to GABAA, GABAB, or benzodiazepine receptors, doesn't increase the GABAA response of dressed neurons in vitro, doesn't alter the attention of GABA in the rat brain, and has no acute effect on GABA uptake or declination. still, exploration has set up that long- term exposure of neurons dressed in vitro to it increases the viscosity of GABA transporters and the rate of functional GABA transport. it doesn't block sodium channels, has no exertion against opioid receptors, doesn't alter cyclooxygenase exertion, has no exertion against dopamine and serotonin receptors, and doesn't inhibit the reuptake of dopamine, serotonin, or norepinephrine.

 

Pharmacokinetics

Absorption: it is taken on an empty stomach and absorbed fleetly, reaching the peak tube attention within 1 hour after single or multiple boluses. It's estimated that the oral bioavailability of pregabalin is ≥ 90% and is cure independent. Stable state can be achieved within 24 to 48 hours after multi cure administration. When taken with food, the immersion rate of pregabalin diminishments, Cmax decreases by 25- 30%, and tmax is delayed to about2.5 hours. still, co administration of pregabalin with food doesn't have clinically significant goods on the immersion position of pregabalin.

Distribution: Preclinical studies have shown that it can pass through the blood- brain hedge in mice, rats, and monkeys. it can pass through the placenta of rats and can appear in the milk of lactating rats. In the mortal body, the apparent distribution volume of pregabalin after oral administration is roughly0.56 L/ kg. it doesn't bind to tube proteins.

Metabolism: Its metabolism in the mortal body can be negligible. After administering radiolabeled pregabalin, roughly 98% of pregabalin was recovered in urine in prototype form. The main metabolite of pregabalin, N- methylated derivations, was also set up in urine, counting for0.9% of the administered cure. In preclinical studies, no racemic effect of pregabalin on the transition from S- enantiomer to R- enantiomer was set up.

Excretion: it is substantially cleared from the systemic rotation and excreted through the feathers in the form of a prototype medicine. The average concurrence half- life of pregabalin is 6.3 hours. The tube concurrence rate and renal concurrence rate of pregabalin are directly commensurable to the creatinine concurrence rate. For cases with renal dysfunction or witnessing hemodialysis treatment, it's necessary to acclimate the lozenge.

 

Packing & Shipping

Packing: 1kg/foil bag;5kg/carton;25kg/fiber drum;or packing as your request.

Customization:Customized logo;Customized packaging;Graphic customization

Shipping:

Item

Quantity

ETA time

Shipping Method

By Courier

≤50kg

7-15days

Fedex, DHL,UPS,TNT,EMS ect.

Fast and convenient

By Air

50kg~200kg

3-5days

Fast and cheap

By Sea

Large quantity

20-35days

Cheapest way

Payment Term

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In summary, as a professional Pregabalin API manufacturer, we have advanced technology, scale advantage, the best quality, rich production experience, and excellent services. These advantages will make it stand out in the market competition and win more customer trust and support. if you need it, pls feel free to contact us any time. we will reply you asap.

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E-mail: sales@yihuipharm.com

Tel: 0086-29-89695240
WeChat or WhatsApp: 0086-17792415937

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