Polyvinylpyrrolidone K17 BP EP USP Pharma Grade: Properties, Structure, and Material Insight

What is Polyvinylpyrrolidone K17?

Polyvinylpyrrolidone K17, sometimes referred to by the shorthand PVP K17, serves as a pharmaceutical excipient known for its solubility and functional versatility. This polymer shows up as a raw material in solid, powder, or sometimes flake form, each batch offering a white to off-white color that signals purity and direct usability. The HS Code assigned for customs and trade typically lands under 39059990, similar to other synthetic resins and plastics. PVP K17 offers a molecular formula of (C₆H₉NO)_n, making it a synthetic cyclic amide conforming to international pharmacopoeial standards such as BP, EP, and USP.

Chemical Structure and Molecular Properties

Structurally, Polyvinylpyrrolidone K17 takes the form of linear soluble polymer chains, each built from repeating N-vinylpyrrolidone units. The value K17 refers to a K-value tied directly to average molecular weight, which for K17 falls around 7,900 to 10,800 g/mol. On a molecular level, these chains bring in high polarity, which allows PVP K17 to dissolve in water and many organic solvents, carrying remarkable dispersant properties. The characteristic density sits around 1.18 g/cm³ in the solid state, while solutions can vary by mixing rate. Its melting point often goes undetected due to decomposition well before reaching a melting phase, reinforcing this material’s role as a stable and robust excipient under ordinary processing conditions.

Physical Forms: Flakes, Solid, Powder, Pearls, and Solutions

In pharma manufacturing and lab handling, PVP K17 most often appears as a fine powder or free-flowing flakes, minimizing dust formation when transferred or weighed in batch reactors. This powder feels slightly tacky under humid conditions, showing its strong affinity for water. Some suppliers also offer PVP K17 as small pearls, each irregular in size yet highly manageable for volumetric and gravimetric mixing. Crystal forms remain rare, as this polymer prefers to retain an amorphous structure. Liquid concentrates, typically a 10% solution in purified water or ethanol, provide fast solubilization and reduce operator burden in blending. One liter of a 10% PVP K17 solution delivers both traceability and measured viscosity, aligning closely with regulatory expectations.

Key Specifications and Safety Profile

Regulatory specifications require K-value determinations, moisture content below 5%, pH between 3.0 and 7.0 at 5% aqueous solution, and minimal trace impurity levels, such as peroxide and aldehyde, to reduce cross-linking and chromophore development. An average particle size between 100 and 300 microns avoids excessive dusting and streamlines downstream blending. Even small fluctuations in density or particle distribution can complicate scale-up and process validation, so reliable suppliers run comprehensive lot testing. Extensive toxicology reviews show PVP K17 to be chemically stable, non-hazardous, and well-tolerated when used as an excipient, according to ICH and REACH guidelines. This safety margin supports its widespread adoption in tableting, granulation, topical gels, and parenteral solution stabilization.

Safe Use and Handling: Harmful or Hazardous Status

Exposure data confirms that PVP K17 introduces little risk under common manufacturing protocols. Inhalation of dust should always be avoided through localized ventilation and use of dust masks during scaling or transfer. Eye and skin irritation probability remains low when following basic industrial hygiene practices. No evidence suggests the material, either as a raw bulk powder or in end-product doses, generates acute or chronic harmful effects unless gross over-exposure takes place. Though officially listed as non-hazardous, abiding by Safety Data Sheet (SDS) recommendations keeps line workers protected and ensures all containment protocols meet global GMP standards.

Raw Material Significance in Pharmaceutical Manufacturing

Raw Polyvinylpyrrolidone K17 defines broad scope across drug formulation technologies, acting as a binder, film-former, solubilizer, and suspending agent. Building a drug product from well-documented materials like PVP K17 offers traceability and compliance for multinational launches. The demand for precisely controlled viscosity, molecular uniformity, and purity makes PVP K17 a permanent fixture in raw material inventory for oral, dermal, and injectable pharmaceutical applications. It enhances the fluidity of tablet blends, boosts powder compressibility, and locks in active ingredients, ensuring product performance batch-to-batch. By supplying robust technical data and validated manufacturing origin, this grade supports quality objectives and meets constantly evolving regulatory expectations.