Piracetam is a synthetic pharmaceutical active pharmaceutical ingredient (API) belonging to the racetam class of compounds. Chemically, it is known as 2-(2-oxopyrrolidin-1-yl)acetamide and is structurally related to 2-pyrrolidone compounds. Piracetam has been used in pharmaceutical preparations for neurological applications and is classified pharmacologically as a nootropic agent.
Piracetam has the molecular formula C₆H₁₀N₂O₂, molecular weight 142.16 g/mol, and CAS Number 7491-74-9. PubChem identifies 2-(2-oxopyrrolidin-1-yl)acetamide as its IUPAC name and confirms the molecular identity.
Piracetam is described in pharmacopoeial references as a white or almost white powder. It is freely soluble in water and soluble in ethanol (96%). The substance exhibits polymorphism, which is recognized in the European Pharmacopoeia monograph.
The Ph. Eur./BP monograph specifies Piracetam with a content of 98.0% to 102.0%, calculated on the dried substance. Identification is performed using infrared absorption spectrophotometry with Piracetam CRS.
Pharmacopoeial quality control for Piracetam includes identification, appearance of solution, pH, related substances, loss on drying and sulfated ash. The Ph. Eur. specification gives a pH range of 10.5–12.0 for the specified solution.
The related-substances test identifies specified impurities A, B, C and D. The pharmacopoeial limits include NMT 0.1% for each specified impurity, NMT 0.1% for each unspecified impurity, and NMT 0.3% total impurities, with a 0.05% disregard limit. Loss on drying is NMT 1.0%, while sulfated ash is NMT 0.1%.
Heavy metals are specified at NMT 10 ppm in the referenced BP monograph.
Piracetam is used as an API in pharmaceutical formulations associated with neurological and cognitive applications. Historical pharmacopoeial references describe its therapeutic category as nootropic, with use associated with conditions including cortical myoclonus.
The API can be used for pharmaceutical development and manufacturing where controlled identity, assay, related substances, moisture, inorganic residue and other applicable quality parameters are required.
Piracetam API manufactured for pharmaceutical applications should be controlled according to the applicable pharmacopoeial standard and approved product specification. Quality evaluation can include IR identification, assay, related substances, pH, loss on drying, sulfated ash and elemental impurity testing, as applicable.
For commercial requirements, customers can request the applicable Certificate of Analysis (CoA), product specification, technical documentation and quality/regulatory documentation for Piracetam API.
| Parameter | Specification |
|---|---|
| Appearance | white to off-white crystalline powder |
| Loss on Drying | NMT 1.0% |
| Heavy Metals | NMT 10 ppm |
| pH (1% Solution) | 10.5 – 12.0 |
| Individual Impurity | NMT 0.1% |
| Total Impurities | NMT 0.3% |
| Water Content | NMT 0.5% |