Description of Pregabalin from Wuhan Fortuna Chemical Co.,Ltd
Basic Information of Pregabalin |
Product Name | Pregabalin |
CAS NO. | 148553-50-8 |
Apperance | White or almost white powder |
Assay | 100.1% |
Pacakge | 1kg/Foil Bag, 25kg/ Box/carton |
MOQ | 1kg |
Storage | Cool and dry place |
Shelf Life | 2 Years |
Brand | Fortunachem |
Specifications(COA) of Pregabalin CAS 148553-50-8
Items | Specifications | Results |
Appearance | White or almost white powder | Almost white powder |
Solubility | Sparingly soluble in water,very slightly soluble in methanol,practically insoluble in heptane. | Conforms |
Identification | IR spectrum should be corresponded to that of reference standard. | Conforms |
The retention time of the major peak of the test solution corresponds to that of the system suitability solution, as obtained in the Enantiomeric purity. | Conforms |
Water | ≤0.5% | 0.06% |
Sulfated ash | ≤0.1% | 0.02% |
Related substances Method A | Single impurity≤0.1% | 0.02% |
Related substances Method B | Impurity A≤0.15% | 0.001% |
Other single impurity≤0.1% | 0.01% |
Total impurities | ≤0.5% | 0.05% |
Enantiomer(lmpurity B) | ≤0.15% | 0.01% |
Residual solvents | Methanol≤3000ppm | 1.6ppm |
Ethanol≤5000ppm | ND |
lsopropanol≤5000ppm | 17.7ppm |
N-hexane≤290ppm | ND |
Benzene≤2ppm | ND |
Toluene≤890ppm | ND |
Acetic acid | ≤5000ppm | ND |
Assay(HPLC) | 98.0 %~102.0 % as anhydrous substance | 100.1% |
Conclusion | All the results conform to the requirement of EP11 and In-house. |
Introduction of Pregabalin is a prescription medication classified as a gabapentinoid, used to treat neuropathic pain (e.g., diabetic neuropathy, postherpetic neuralgia), fibromyalgia, and partial-onset seizures. It also treats generalized anxiety disorder (GAD) in some countries. By binding to calcium channels in the nervous system, it reduces neurotransmitter release, calming nerve hyperactivity. Common side effects include dizziness, drowsiness, weight gain, and dry mouth. Serious risks include angioedema, suicidal thoughts (black box warning), and dependence. It’s a controlled substance (Schedule V in the US) due to abuse potential. Dosing requires adjustment for kidney impairment. Avoid abrupt discontinuation to prevent withdrawal symptoms like insomnia or anxiety.
Application of Pregabalin is a medication primarily used to treat neuropathic pain, epilepsy, and generalized anxiety disorder. Below is a structured overview:
Classification
Class: Gabapentinoid (analog of gabapentin), anticonvulsant, and analgesic.
Mechanism of Action:
Binds to the α2-δ subunit of voltage-gated calcium channels in the central nervous system (CNS).
Reduces calcium influx, decreasing the release of excitatory neurotransmitters (e.g., glutamate, substance P).
Modulates hyperexcitability in damaged nerves and suppresses seizure activity.
Indications
1. Neuropathic Pain:
Diabetic peripheral neuropathy.
Postherpetic neuralgia (shingles pain).
Spinal cord injury-related pain.
2. Fibromyalgia: Approved for chronic widespread pain.
3. Epilepsy: Adjunctive therapy for partial-onset seizures.
4. Generalized Anxiety Disorder (GAD): Approved in some countries (e.g., EU, not in the US).
5. Off-Label Uses: Chronic pain syndromes, restless legs syndrome, social anxiety.
Pharmacokinetics
Administration: Oral (capsules, oral solution).
Absorption: Rapid and linear; bioavailability ≥90%.
Half-life: ~6 hours (dosed 2–3 times daily).
Metabolism: Minimal hepatic metabolism; excreted unchanged (95% renal).
Dosing Adjustment: Required for renal impairment (creatinine clearance <60 mL/min).
Dosage
Neuropathic Pain/Fibromyalgia: Start at 75 mg twice daily; max 300–450 mg/day.
Epilepsy: Start at 75 mg twice daily; max 600 mg/day.
GAD: 150–600 mg/day (region-dependent).
Take: With or without food.
Side Effects
Common: Dizziness, somnolence (drowsiness), dry mouth, peripheral edema, weight gain, blurred vision.
Serious:
Angioedema (rare but life-threatening).
Suicidal ideation (black box warning for anticonvulsants).
Myopathy/rhabdomyolysis (with prolonged use).
Dependence/Withdrawal: Taper gradually to avoid symptoms (insomnia, nausea, anxiety).
Drug Interactions
CNS Depressants: Enhanced sedation (e.g., opioids, benzodiazepines, alcohol).
Thiazolidinediones (e.g., pioglitazone): May increase fluid retention/edema.
ACE Inhibitors: Increased risk of angioedema.
Contraindications & Precautions
Hypersensitivity: To pregabalin or gabapentinoids.
Cautions:
Renal impairment: Dose adjustment required.
Heart failure: Risk of fluid retention.
Pregnancy: Category C (risk unknown; avoid unless benefits outweigh risks).
Lactation: Excreted in breast milk; not recommended.
History of substance abuse: Potential for misuse (pregabalin is a controlled substance in many countries).
Abuse Potential
Schedule V Controlled Substance (US): Due to reports of euphoria and dependence, especially at high doses.
Misuse Risk: Higher in patients with opioid/benzodiazepine addiction history.
Brand Names & Availability
Prescription: Lyrica®, Lyrica CR® (extended-release).
Generics: Widely available.
Cost: Higher than gabapentin but often covered by insurance.
Key Differentiators
Superior Bioavailability compared to gabapentin (no dose saturation).
Faster Onset: Effective within 1 week for neuropathic pain.
Versatility: Addresses both neurological and psychiatric conditions.
Safety Warnings
FDA Alert: Increased risk of respiratory depression when combined with CNS depressants (e.g., opioids).
Withdrawal Protocol: Taper over ≥1 week to avoid rebound symptoms.
Note: Monitor for mood changes, weight gain, and edema. Avoid abrupt discontinuation. Use the lowest effective dose for the shortest duration.
FAQ From Wuhan Fortuna Chemical Co.,Ltd |
Q | Can I get a sample for free ? |
A | For small QTY and low value product, we can provide sample for free exclude shipping cost. For high value sample, we will charge the basic sample cost, but we can refund all the cost if customers place order after sample test. |
|
|
Q | How to confirm the product quality before placing orders ? |
A | Most of our products confirm to international standards like USP/EP/BP/JP/CP. We will provide COA/TDS/MSDS for customers to confirm the specification before placing order. |
|
|
Q | What is the payment you accept? |
A | For small and low value order, we accept CreditCard, MaterCard,VISA,Western Union and T/T.For large order, we can do T/T and L/C. Any pay on delivery or pay-after are not available for us. |
|
|
Q | What is your shipment way ? |
A | For less than 100kg gross weight order will ship with courier like FedEx or UPS, we support customers to place courier orders remotely by their account, we will package the goods well and wait for pick up.For more than 100kg goods, we will transport by Air or Sea according to customers' requirement. |
|
|
Q | How long is your after-sales service? |
A | We accept customer’s quality complaint in three month after customer received the goods. We provide tech.support for all-life if customer place order from our company. |
|
|
Q | How do you treat quality complaint ? |
A | We support customer to provide our products to any rightful third party testing organization to test our products according to the COA specification, if the test result is confirm with COA, we will take all the loss for customers. |
Wuhan Fortuna Chemical Co.,Ltd established in 2006, is a big integrative chemical enterprise being engaged in Pharmaceutical and Intermediates, Food and Feed additives, Fine chemicals,Biochemical and Reagent, which is the members of Hubei E-commerce Chamber.
Our company has professional persons who major in chemical R&D and sicentific management, supply fine chemical products with high quality and close service, also supply custom-tailored products according to our clients' requirement.
We have a positive and self-motivated management work team with a common philosophy, caring and commitment through teamwork, our team strive to achieve success in delighting our clients and ourselves.
Since Wuhan Fortuna Chemical Co., Ltd founded, we continuously innovate our products and improve our service, sales network. Hence, we initiate the first sale mode on net in China, which is the retail trade of small package bring along wholesale of diversified management modes. Our products are exported widely to South Korea, Vietnam, Australia, Europe and South America, highly recommended by our clients.We insist on the management creed “Market is our compass, Quality is our life, Credit is our soul”. Clients’ trust is our forward power, their satisfaction is our struggling goal.
Wuhan Fortuna Chemical Co.,Ltd is a professional manufacturer which provide Pregabalin with good quality and best price, welcome to contact us to get COA/TDS/MSDS of Pregabalin.
China
