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Piracetam

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Piracetam pharmaceutical raw material
Quick Facts
CAS Number7491-74-9
Molecular FormulaC6H10N2O2
Molecular Weight142.158
PharmacopoeiaEP/BP
Packaging25 KG/DRUM
GMP Certified EP/BP Standard

Product Overview

Piracetam was synthesized in 1964 by the Romanian-born neuroscientist Corneliu E. Giurgea at UCB Pharma in Belgium, marking the birth of an entirely new class of drugs: the nootropics. Giurgea himself coined the term "nootropic" from the Greek words nous (mind) and trepein (to bend) and defined five criteria a compound must meet: enhance learning and memory, facilitate interhemispheric information transfer, protect the brain against physical or chemical injury, increase cortical/subcortical control and lack sedation or stimulation. Piracetam was the first compound to meet all five and the racetam family that followed — aniracetam, oxiracetam, pramiracetam and levetiracetam — all trace their pharmacophore lineage to this original molecule.

Structurally, piracetam is a cyclic derivative of GABA (gamma-aminobutyric acid) — specifically, it is 2-oxo-1-pyrrolidine acetamide. Despite this structural relationship, piracetam does not act at GABA receptors. Its primary mechanism involves positive allosteric modulation of AMPA-type glutamate receptors, which enhances excitatory neurotransmission in the hippocampus and cortex — regions critical for memory formation and learning. Additionally, piracetam improves membrane fluidity in aging neurons, increases cerebral blood flow and oxygen consumption and enhances cholinergic neurotransmission possibly through modulation of high-affinity choline uptake. This multi-target pharmacology distinguishes piracetam from single-receptor-targeted cognitive drugs.

Clinically, piracetam's strongest evidence base is in cortical myoclonus, where it is recommended as a first-line treatment by the International Parkinson and Movement Disorder Society, with doses of 7.2-24 g daily. For cognitive indications (age-related cognitive decline, post-stroke cognitive impairment, dementia), meta-analyses show modest but statistically significant benefits at doses of 2.4-4.8 g daily. In pediatric neurology, piracetam is used as an adjunct in dyslexia and for breath-holding spells. The combination of piracetam with cinnarizine (marketed as a fixed-dose combination in many countries) is widely prescribed for vertigo of peripheral and central origin.

As of mid-2026, piracetam's global market reflects a unique regulatory paradox: it is available as a prescription drug in most of Europe, Asia and Latin America, but classified as a dietary supplement in the United States where the FDA has not approved it as a drug. This creates a complex global supply chain where API destined for regulated pharmaceutical markets must meet EP/BP monograph standards with full GMP documentation, while supplement-grade material follows a different regulatory path. China and India dominate global piracetam API production and the product remains one of the highest-volume nootropic APIs traded internationally. KingWish supplies pharmaceutical-grade piracetam meeting EP/BP specifications under ICH Q7 GMP conditions.

Quality Specifications

Purity (Titration)≥ 98.0% (dried basis), per EP/BP monograph
Related SubstancesIndividual impurity ≤ 0.1%, total impurities ≤ 0.3% (EP/BP)
2-Pyrrolidone≤ 0.1% (key process impurity, EP test)
Residual SolventsCompliant with ICH Q3C
Heavy Metals≤ 10 ppm
GMP StatusManufactured under ICH Q7 GMP conditions

Clinical Applications

Oral Tablets & Capsules

400 mg, 800 mg and 1200 mg tablets/capsules. Maintenance dose: 2.4-4.8 g daily in divided doses for cognitive disorders. High-dose: 7.2-24 g daily for cortical myoclonus.

Injectable & Oral Solution

1 g/5 mL and 3 g/15 mL injectable solutions for acute stroke and parenteral administration. 20% oral solution for pediatric use and patients with swallowing difficulties.

Therapeutic Areas

  • Cortical myoclonus: First-line treatment per MDS guidelines. High-dose 7.2-24g daily. Improves myoclonus rating scores and functional disability.
  • Cognitive impairment: Age-related cognitive decline, vascular dementia, post-stroke cognitive rehabilitation. Dose: 2.4-4.8g daily.
  • Vertigo: Often combined with cinnarizine or betahistine for peripheral and central vestibular disorders.
  • Pediatric indications: Adjunctive therapy in dyslexia, breath-holding spells and sickle cell disease-related cognitive effects.

Sourcing Piracetam API: Key Checks

Documentation

Request CoA with titration assay and HPLC impurity data (including 2-pyrrolidone content), residual solvent statement (ICH Q3C), heavy metals report and GMP certificate. For EU markets, EP compliance is essential; verify that the supplier's CoA explicitly references the current EP monograph.

Red Flags

Elevated 2-pyrrolidone above 0.1% (process impurity), missing EP-specific impurity tests (some suppliers only test to USP, which may lack piracetam-specific impurity controls) and prices significantly below market range may indicate non-pharmaceutical grade material.

Packaging & Logistics

Standard: 25 KG/DRUM with PE liner. Store at room temperature (15-30 deg C), protect from moisture. Piracetam is hygroscopic — ensure packaging integrity for sea freight shipments to humid destinations. Standard lead time 4-6 weeks.

Market Context

Piracetam is one of the highest-volume nootropic APIs traded globally. Regulatory status varies dramatically: prescription drug in EU/Asia/Latin America, dietary supplement in the US. This regulatory split creates distinct quality tiers. Pharmaceutical manufacturers must verify GMP compliance and EP/BP specification conformance regardless of destination market.

Frequently Asked Questions

Piracetam is the original nootropic agent, first synthesized in 1964 by Dr. Corneliu Giurgea at UCB Pharma in Belgium — the scientist who coined the term "nootropic." Structurally, it is a cyclic derivative of GABA (2-oxo-1-pyrrolidine acetamide), but it does not act on GABA receptors. Its mechanism includes positive allosteric modulation of AMPA-sensitive glutamate receptors, enhancement of cholinergic neurotransmission, improvement of neuronal membrane fluidity (especially in aging) and increased cerebral blood flow and oxygen utilization. It meets all five of Giurgea's original nootropic criteria: enhances learning and memory, facilitates information transfer between brain hemispheres, protects against brain injury, increases cortical control and lacks sedation or stimulation.
Piracetam has three well-established clinical indications: (1) Cortical myoclonus — it is a first-line treatment recommended by the International Parkinson and Movement Disorder Society, with doses of 7.2-24 g daily; (2) Cognitive disorders — including age-related cognitive decline, dementia (vascular and Alzheimer's), post-stroke cognitive rehabilitation and dyslexia as adjunctive therapy in children, with doses of 2.4-4.8 g daily in divided doses; (3) Vertigo — particularly when combined with cinnarizine or betahistine for peripheral and central vertigo. Its safety profile is excellent, with agitation and insomnia being the most common dose-dependent side effects.
Piracetam is monographed in the EP and BP. Key specifications: assay by non-aqueous titration of 98.0-101.0% on the dried basis; related substances by HPLC with individual impurities at or below 0.1% and total impurities at or below 0.3% (with specific identification and limits for 2-pyrrolidone, a key process impurity); loss on drying of 0.5% maximum (piracetam is slightly hygroscopic); residue on ignition of 0.1% maximum; and heavy metals at 10 ppm or below. The EP monograph is more comprehensive than the USP for piracetam and is the preferred standard for international trade.
Yes, piracetam's regulatory status varies dramatically by country. It is approved as a prescription drug for cognitive disorders and/or cortical myoclonus in most European countries China, India, Brazil and many other Asian and Latin American markets. In the United States, the FDA has not approved piracetam as a drug and it is primarily marketed as a dietary supplement — this means supplement-grade and pharmaceutical-grade supply chains coexist. In Australia and the UK, it is a prescription-only medicine. This regulatory diversity creates distinct quality requirements for API buyers: always specify which market you are targeting and whether EP/BP pharmaceutical-grade documentation is required.
Standards: EP/BP  |  CAS: 7491-74-9  |  Quality data verified against pharmacopoeia monograph COA and MSDS available  |  DrugBank  |  July 2026

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