Piperacillin is a semisynthetic, broad-spectrum β-lactam antibiotic belonging to the ureidopenicillin class. It is an ampicillin-derived penicillin with antibacterial activity against a broad range of Gram-positive and Gram-negative bacteria, including activity against Pseudomonas aeruginosa. Piperacillin exerts its antibacterial effect by binding to penicillin-binding proteins and interfering with bacterial cell-wall synthesis.
Piperacillin has the molecular formula C₂₃H₂₇N₅O₇S and molecular weight 517.55 g/mol. The free-acid CAS Number is 61477-96-1. PubChem identifies Piperacillin as the parent compound, while Piperacillin Sodium is a separate sodium salt with CAS 59703-84-3 and molecular weight 539.5 g/mol.
Piperacillin is a pharmaceutical active ingredient used primarily in parenteral antibacterial formulations. Because Piperacillin is susceptible to degradation and is commonly formulated as its sodium salt or hydrate, pharmaceutical specifications should clearly identify the API form being tested.
The Indian Pharmacopoeia includes a Piperacillin monograph, and IPC identifies Piperacillin among its pharmacopoeial monographs. IP is the official book of standards for drugs manufactured or marketed in India.
Piperacillin is used in the development and manufacture of pharmaceutical antibacterial products, particularly injectable formulations. It is commonly used in combination with tazobactam, a β-lactamase inhibitor, to extend antibacterial coverage against organisms producing susceptible β-lactamases.
Applications include:
Piperacillin and tazobactam are commonly formulated together for injection.
The Indian Pharmacopoeia contains a Piperacillin monograph. Available IP monograph material specifies water content of 2.0%–4.0% for Piperacillin and a pH of 4.8–6.8 for a 10.0% w/v solution. The monograph uses liquid chromatography for assay and related-substance testing.
The IP material also specifies an additional bacterial-endotoxin requirement for Piperacillin intended for manufacture of parenteral preparations without a subsequent endotoxin-removal procedure: NMT 0.07 Endotoxin Unit per mg of Piperacillin.
Japanese Pharmacopoeia independently recognizes Piperacillin Hydrate, with potency specified as 970–1020 µg/mg, calculated on the anhydrous basis. It identifies Piperacillin Hydrate as a white crystalline powder, freely soluble in methanol, soluble in ethanol and DMSO, and very slightly soluble in water.
Piperacillin API for pharmaceutical manufacturing requires controlled production, appropriate microbiological controls and validated analytical testing because it is a β-lactam antibiotic intended primarily for parenteral pharmaceutical applications.
Quality testing can include identity, potency/assay, water, pH where applicable, related substances, residual solvents, bacterial endotoxins and other applicable quality attributes.
For parenteral applications, bacterial-endotoxin control is particularly important. The IP requirement cited above establishes NMT 0.07 EU/mg for the specified Piperacillin material intended for parenteral manufacture without a subsequent endotoxin-removal procedure.
Piperacillin is an established broad-spectrum ureidopenicillin API used in parenteral antibacterial formulations. The free acid is identified by CAS 61477-96-1, molecular formula C₂₃H₂₇N₅O₇S, and molecular weight 517.55 g/mol. Piperacillin Hydrate and Piperacillin Sodium are distinct API forms and should not be treated as chemically interchangeable specifications.
| Parameter | Specification |
|---|---|
| Appearance | white to off-white crystalline powder |
| Identification | IR & HPLC compliant |
| Assay (HPLC) | 98.0% – 102.0% |
| Loss on Drying | NMT 0.5% |
| Residue on Ignition | NMT 0.1% |
| Heavy Metals | NMT 20 ppm |
| pH (1% Solution) | 4.8–6.8 |
| Water Content | 2.0%–4.0% |