GABAPENTIN

Gabapentin is a gamma-aminobutyric acid (GABA) analogue used as an anticonvulsant and neuropathic pain management drug. It is primarily indicated for the treatment of epilepsy, postherpetic neuralgia, diabetic neuropathy, and restless legs syndrome (RLS).

At Bluepill Express, we manufacture and export pharma-grade Gabapentin API compliant with IP, BP, USP, and EP pharmacopeial specifications. Our product is synthesized under WHO-GMP and ISO-certified facilities, ensuring high purity, low impurity profile, and superior stability. Gabapentin produced by Bluepill Express offers excellent solubility, consistent particle size, and optimal flow characteristics, making it ideal for tablets, capsules, and oral suspension formulations.

We ensure complete regulatory support with COA, MSDS, TDS, and stability data, suitable for both regulated and semi-regulated markets worldwide.

Pharmacological Information:

• Therapeutic Class: Anticonvulsant / Antineuralgic
• Pharmacological Category: GABA Analog
• CAS Number: 60142-96-3
• Molecular Formula: C9H17NO2
• Molecular Weight: 171.24 g/mol
• Appearance: White to off-white crystalline powder
• Solubility: Freely soluble in water and ethanol
• Melting Point: 162°C – 166°C
• Storage: Store in a cool, dry place below 25°C, away from light and moisture

Mode of Action:

Gabapentin acts by binding to the α2δ subunit of voltage-gated calcium channels in the central nervous system. This action reduces calcium influx at nerve terminals, thereby decreasing the release of excitatory neurotransmitters. As a result, Gabapentin stabilizes neural activity, reducing seizure frequency and alleviating neuropathic pain sensations.

Applications and Uses:

• Epilepsy: Adjunctive therapy in partial seizures with or without secondary generalization
• Neuropathic Pain: Effective in diabetic neuropathy, postherpetic neuralgia, and nerve injury pain
• Restless Legs Syndrome (RLS): Reduces symptoms and improves sleep quality
• Anxiety Disorders (off-label): Used in generalized anxiety and panic disorder management

Technical Specifications:

• Assay (Purity): ≥ 99.5%
• Identification: IR spectrum complies with reference
• Loss on Drying: ≤ 0.5%
• Residue on Ignition: ≤ 0.1%
• Specific Optical Rotation: +20° to +25°
• Related Substances: ≤ 0.1% (individual impurity)
• Heavy Metals: ≤ 10 ppm
• Microbial Limit: Complies with pharmacopeial standards

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Manufacturing & Quality Assurance – Bluepill Express:

• Manufactured under WHO-GMP, ISO 9001:2015, and cGMP standards
• Micronized and free-flowing powder form for easy processing
• COA, MSDS, and TDS provided with every export batch
• Pharmacopeial grades: IP / BP / USP / EP
• Analytical testing using HPLC and IR spectroscopy
• Custom packaging and labeling as per buyer’s specifications

Packaging & Export Details:

• Available Packs: 1 kg, 5 kg, 10 kg, 25 kg HDPE drums with inner liner
• Shelf Life: 36 months from manufacturing date
• Labeling: As per pharmacopeial and export standards
• Export Markets: Asia, Africa, Europe, Latin America, Middle East
• Documentation Provided:
  • Certificate of Analysis (COA)
  • Material Safety Data Sheet (MSDS)
  • Technical Data Sheet (TDS)
  • Stability Data (on request)
  • Non-GMO and Allergen Declaration