Bulk Pregabalin Powder

Bulk Pregabalin Powder is a white to off-white crystalline chemical raw material. Its molecular formula is C8H17NO2 with a molecular weight of 159.23. It is commonly supplied in the form of Bulk Pregabalin Powder for handling and formulation.

Product Name: Pregabalin
Appearance: White to off-white crystalline powder
Assay/Purity: ≥99% (HPLC)
CAS No.: 148553-50-8
Molecular Formula: C8H17NO2
Molecular Weight: 159.23
Quality System/Compliance: ISO / GMP / USP / EP
Manufacturing Capability: 1 factory, 3 production lines; GMP workshop; 2 independent laboratories
Packaging: 1 kg aluminum foil bag / 25 kg drum
Storage: Store in a cool, dry place, tightly sealed
MOQ: 1 kg

分类:

Genbay Biotechnology Co., Ltd. provides high-grade Bulk Pregabalin Powder as a pharmaceutical-grade raw material for global supply, used for the treatment of neuropathic pain, epilepsy, and generalized anxiety disorder (GAD). As a potent gabapentinoid and a structural analog of gamma-aminobutyric acid (GABA), this compound is highly valued for its ability to modulate calcium channels in the central nervous system. Bulk Pregabalin Powder works by binding to the $\alpha_2\delta$ subunit of voltage-gated calcium channels, reducing the release of several neurotransmitters including glutamate, norepinephrine, and substance P. Our manufacturing process ensures a high-purity crystalline form with exceptional stability, making it an ideal active pharmaceutical ingredient (API) for the production of hard capsules, oral solutions, and extended-release tablets.

Specification

The following data represents the typical profile for our Bulk Pregabalin Powder.

  • Assay: ≥99.0% (HPLC)
  • Loss on Drying: ≤0.5%
  • Residue on Ignition: ≤0.1%
  • Heavy Metals: ≤10 ppm
  • Specific Rotation: +10° to +13°
Uses
  • Neuropathic Pain Management: The primary direct use of Bulk Pregabalin Powder is as the active ingredient in medications for diabetic peripheral neuropathy and postherpetic neuralgia.
  • Anticonvulsant Applications: Used in formulations as adjunctive therapy for adult patients with partial onset seizures.
  • Anxiety Disorder Treatment: Utilized in clinical medicine to manage symptoms of generalized anxiety disorder (GAD) due to its calming effect on the nervous system.
  • Fibromyalgia Relief: Acts as a critical component in treatments designed to reduce widespread musculoskeletal pain and improve sleep quality in affected patients.
  • Neurological Research: Used in laboratory settings to study calcium channel modulation and the pathophysiology of excitatory neurotransmission.
Quality Assurance & Certifications

Genbay produces Bulk Pregabalin Powder in specialized facilities that strictly adhere to international GMP and safety protocols.

  • Testing Protocol: Every batch is subjected to rigorous analytical procedures, including HPLC for purity, NMR for structural identity, and full microbial screening.
  • Certifications: Our production infrastructure is ISO and GMP certified, ensuring a reliable and consistent supply chain for pharmaceutical manufacturers worldwide.
  • Documentation: We provide a comprehensive Certificate of Analysis (COA) and Material Safety Data Sheet (MSDS) with every shipment to ensure professional transparency.
Packaging & Shipping
  • Packaging: 1 kg aluminum foil bags with vacuum sealing for moisture protection or 25 kg industrial-grade fiber drums for large-scale production requirements.
  • Shipping: We offer secure and discreet international shipping through specialized couriers to ensure the material arrives safely at its destination.
  • Storage: Bulk Pregabalin Powder should be stored in a cool, dry place, protected from direct sunlight and moisture to maintain its chemical integrity.
Frequently Asked Questions(FAQ)
Q1: What is the mechanism of action for this powder?
A1: Bulk Pregabalin Powder binds to calcium channels in the CNS to dampen overactive neurons, effectively reducing pain signals and seizure activity.
Q2: Is the powder soluble in water?
A2: It is freely soluble in water and in both basic and acidic aqueous solutions, which facilitates its formulation into oral liquids.
Q3: What is the shelf life of the material?
A3: When stored in a cool, dry environment and kept tightly sealed, the shelf life is typically 36 months from the date of manufacture.
Q4: Do you provide batch-specific purity certificates?
A4: Yes, a detailed COA is issued for every batch of Bulk Pregabalin Powder to confirm its exact purity level and safety parameters.
Q5: What is the typical lead time for an international order?
A5: Standard orders are processed and dispatched within 3 to 5 business days, followed by worldwide tracked delivery.

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Email: info@genbaybio.com

WhatsApp/Telegram: +852 94249370

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