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Pregabalin / Lyrica Pharmaceutical Raw Materials , Active Pharmaceutical Ingredients

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Pregabalin / Lyrica Pharmaceutical Raw Materials , Active Pharmaceutical Ingredients

Pregabalin / Lyrica Pharmaceutical Raw Materials , Active Pharmaceutical Ingredients
Pregabalin / Lyrica Pharmaceutical Raw Materials , Active Pharmaceutical Ingredients

Large Image :  Pregabalin / Lyrica Pharmaceutical Raw Materials , Active Pharmaceutical Ingredients

Product Details:
Place of Origin: CHINA
Brand Name: TINGYI
Certification: GMP , ISO 9001:2008
Model Number: CAS: 148553-50-8
Payment & Shipping Terms:
Minimum Order Quantity: 10g
Price: Contact Us
Packaging Details: Stealth And Discreet Packaging
Delivery Time: Within 7 Working Days
Payment Terms: Bank Transfer - Bitcoin - Western Union - MoneyGram
Supply Ability: 2000 KG/Month
Detailed Product Description
Product Name: Pregabalin Synonyms: Lyrica
MF: C8H17NO2 MW: 159.23
EINECS: 200-659-6 Melting Point: 194-196°C
Appearance: Off-White Solid
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99.8% High Quality Pregabalin / Lyrica Powder With Safe Delivery & Favorable Price

 


Description:


Pregabalin is described chemically as (S)-3-(aminomethyl)-5-methylhexanoic acid. The

 

molecular formula is C8H17NO2 and the molecular weight is 159.23. Pregabalin is a white to off-

 

white, crystalline solid with a pKa1 of 4.2 and a pKa2 of 10.6. It is freely soluble in water and both

 

basic and acidic aqueous solutions. The log of the partition coefficient (n-octanol/0.05M

 

phosphate buffer) at pH 7.4 is 1.35.

 

LYRICA (pregabalin) Capsules are administered orally and are supplied as imprinted hard-shell

 

capsules containing 25, 50, 75, 100, 150, 200, 225, and 300 mg of pregabalin, along with

 

lactose monohydrate, cornstarch, and talc as inactive ingredients. The capsule shells contain

 

gelatin and titanium dioxide. In addition, the orange capsule shells contain red iron oxide and the

 

white capsule shells contain sodium lauryl sulfate and colloidal silicon dioxide. Colloidal silicon

 

dioxide is a manufacturing aid that may or may not be present in the capsule shells. The

 

imprinting ink contains shellac, black iron oxide, propylene glycol, and potassium hydroxide.
 


LYRICA (pregabalin) oral solution, 20 mg/mL, is administered orally and is supplied as a clear,

 

colorless solution contained in a 16 fluid ounce white HDPE bottle with a polyethylene-lined

 

closure. The oral solution contains 20 mg/mL of pregabalin, along with methylparaben,

 

propylparaben, monobasic sodium phosphate anhydrous, dibasic sodium phosphate anhydrous,

 

sucralose, artificial strawberry #11545 and purified water as inactive ingredients.

 


Application:

 

Pregabalin belongs to a group of medicines known as anti-epileptic medicines, although it is

 

prescribed for the treatment of several different conditions. You may have been prescribed it for

 

the treatment of partial seizures, which is a type of epilepsy. A seizure is a short episode of

 

symptoms which is caused by a burst of abnormal electrical activity in the brain. With a partial

 

seizure, the burst of electrical activity stays in one part of the brain. Therefore, you tend to have

 

localised or 'focal' symptoms. Pregabalin is also prescribed to treat certain types of long-lasting

 

pain caused by damage to nerves. This type of pain, called neuropathic pain, can be caused by a

 

number of different conditions, including diabetes (where it is called diabetic neuropathy) and

 

shingles(where it is called postherpetic neuralgia).

 

 

Medical uses:

 

1. Seizures
 

Pregabalin is useful when added to other treatments, when those other treatments are not

 

controlling partial epilepsy. Its use alone is less effective than some other seizure medications.

 

It is unclear how it compares to gabapentin for this use.

 

 

2. Neuropathic pain
 

The European Federation of Neurological Societies recommends pregabalin as a first line agent

 

for the treatment of pain associated with diabetic neuropathy, post-herpetic neuralgia, and central

 

neuropathic pain. A minority obtain substantial benefit, and a larger number obtain moderate

 

benefit. Other first line agents, including gabapentin and tricyclic antidepressants, are given equal

 

weight as first line agents, and unlike pregabalin, are available as less expensive generics.

 

 

Pregabalin is not recommended for certain other types of neuropathic pain such as pain that of

 

trigeminal neuralgia or HIV infection and its use in cancer-associated neuropathic pain is

 

controversial. There is no evidence for its use in the prevention of migraines and gabapentin has

 

been found not to be useful. It has been examined for the prevention of post-surgical chronic pain,

 

but its utility for this purpose is controversial.

 

 

3. Anxiety disorders

 

 

Lab Test Result:

 


Test Items

 

Specification

 

Results

 

Appearance

 

A white to off white powder

 

White powder

 

 

Identification

 

A. Meets the requirement

 

Complies

 

B. IR: similar to Reference Substance

 

Complies

 

Loss on drying

 

≤0.5%

 

0.21%

 

Specific Rotation

 

+10.0°~+13.0°

 

+10.8°

 

 

Related Substances

 

Any single impurity ≤0.1%
 

Total impurity ≤0.8%

 

0.05%
 

0.10%

 

Purity By HPLC R-isomer

 

≤0.15%

 

0.10

 

Residue on ignition

 

≤0.1%

 

0.05%

 

 

Residual solvents

 

Isopropyl alcohol ≤5000ppm
 

Ethyl Acetate ≤5000ppm

 

150ppm
 

250ppm

 

Heavy metals

 

≤10ppm

 

Complies

 

Chlorides

 

≤0.05%

 

Complies

 

Assay

 

98%~102.0%

 

99.8%

 

Conclusion

 

It conforms with EP standard

 

 

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