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Polyvinylpyrrolidone K17 BP EP USP Pharma Grade — An In-Depth Commentary

Historical Development

Back in the mid-20th century, a need for synthetic polymers that blend well with medicines and personal care products set off a search among scientists. Polyvinylpyrrolidone, often recognized as PVP or povidone, caught attention because of its unique water solubility and non-reactivity. The K17 grade marks a sweet spot of molecular weight, often chosen for its balance between viscosity and solubility. Early pharmaceutical innovators saw real value here, especially once PVP gained acceptance in British Pharmacopoeia (BP), European Pharmacopoeia (EP), and the US Pharmacopoeia (USP). The K17 specification has kept its relevance because many product formulations rely on polymers that both dissolve rapidly and offer consistent performance under tough manufacturing settings.

Product Overview

Polyvinylpyrrolidone K17 offers a moderate molecular weight with an average K value of around 13–18. It dissolves quickly in water and some organic solvents, making it popular in tablet binding, suspension stabilization, and enhancement of solubility for active pharmaceutical ingredients. K17 comes as a white to off-white, odorless powder or flakes. Drug manufacturers often reach for this grade because it blends easily and rarely triggers allergic reactions.

Physical & Chemical Properties

PVP K17 presents itself as a hygroscopic, amorphous solid. The polymer holds up well across a range of pH values, doesn’t break down under normal light exposure, and maintains stability in high-speed production lines. Its intrinsic viscosity sits between 0.055–0.065 dl/g in water, with a typical average molecular weight hovering at 7,900–10,800 Da. Hydrogen bonding bolsters its water solubility, while chains of vinylpyrrolidone units help it to form transparent solutions that don’t cloud up over time.

Technical Specifications & Labeling

Labels must match regulatory demands with exacting details—the product name, grade (K17), specifications in line with BP, EP, and USP standards, batch numbers, shelf life, and storage instructions. PVP K17 powder typically holds less than 5% moisture. Peroxide and heavy metal content remain tightly controlled, with impurities like hydrazine kept to trace levels as outlined by pharmacopoeial monographs. Handlers should always check certificate of analysis, and lot-to-lot consistency forms a key part of vendor qualification.

Preparation Method

Manufacturers polymerize N-vinylpyrrolidone monomers in the presence of initiators under strict temperature control. Purification steps strip away unreacted monomers, catalysts, and other impurities. Final product gets dried, milled, and sieved for tight particle size distribution. At this point, PVP K17 passes through quality checks to confirm compliance with pharma-grade standards—including microbial testing and residual solvent analysis, as any slip here can pose a risk to patients.

Chemical Reactions & Modifications

PVP K17 rarely gets involved in adverse reactions with active pharmaceutical ingredients or other excipients. But the pendant lactam group in the polymer’s backbone opens the door for cross-linking reactions (think crospovidone) or forming complexes with iodine (birth of povidone-iodine). Some research focuses on modifying PVP with hydrophobic groups to alter solubility and swelling behavior, expanding its use in controlled-release drugs or specialty gels.

Synonyms & Product Names

Industry shorthand refers to polyvinylpyrrolidone as PVP, povidone, or polyvidone. The K17 designation helps distinguish it by molecular weight—“K” coming from Fikentscher’s viscosity number. Trade names crowd the market: Kollidon 17, Plasdone K17, among others. USP and EP references keep naming standardized so that buyers and regulators don’t get tripped up by regional trademarks or branding.

Safety & Operational Standards

Workers should store K17 in tightly sealed containers, away from damp air—its hygroscopic nature draws moisture right out of the room. Inhalation rarely brings major risk, but dust can irritate sensitive airways, so masks and dust controls matter in large-scale handling. Quality systems require written SOPs for weighing, transferring, and blending the powder. Regulatory agencies cap residual peroxides, hydrazine, and other process-related impurities to defend against both acute and long-term toxicity. GMP inspections check every part of the sourcing and handling pipeline.

Application Area

Pharmaceutical companies lean heavily on PVP K17 as a binder for wet and dry granulation in oral tablets and capsules. Its water solubility gets exploited in solutions and oral syrups, while some topical gels depend on it for film formation and viscosity adjustment. Beyond drug applications, it sneaks into eye drops and contact lens cleaning solutions, stabilizing them for long-term use. PVP’s legacy as a plasma expander in mid-century medicine speaks to its biocompatibility—even if safer alternatives have since pushed it aside for blood volume replacement.

Research & Development

Scientists keep a close watch for ways PVP K17 enhances drug solubility and bioavailability—two big hurdles in modern pharma. Combination products that mix poorly-soluble actives with K17 have triggered a wave of studies on amorphous solid dispersions, new co-formers, and nanoparticle carriers. Research efforts dig into blending PVP K17 with polymers that improve targeted delivery or offer mucoadhesive effects. Universities work with industry labs to validate analytical methods that catch even subtle degradations or changes in PVP’s properties over storage.

Toxicity Research

Animal studies and human exposure assessments show a wide margin of safety for PVP K17 given orally or through skin contact. Most of it gets excreted unchanged from the body, and allergic reactions remain uncommon. Toxicity shows up mainly after repeated high-dose intravenous exposure, never in standard oral doses seen in medicines. Regulators insist on routine mutagenicity testing and long-term follow-up on chronic exposures, guided by evidence-based limits in pharmacopoeias and food safety guidelines.

Future Prospects

Demand for pharma-grade PVP K17 grows with the expansion of high-potency active ingredients and specialty dosage forms. More companies push digital tablet manufacturing and continuous processing lines, which not only stress material quality but call for polymers with tighter spec sheets and transparency in sourcing. The rise of personalized medicine and nanotechnology triggers new evaluations of PVP’s interactions at the cellular and sub-cellular level. Researchers expect improvements in analysis—faster methods for checking purity, even trace contaminants, and better prediction of stability across tough storage conditions. The next wave may include green chemistry initiatives, swapping out harsh solvents and exploring bio-based starting materials, keeping PVP K17 in step with future regulatory and consumer demands.




What are the main applications of Polyvinylpyrrolidone K17 BP EP USP Pharma Grade?

Why Polyvinylpyrrolidone K17 Stands Out

Polyvinylpyrrolidone K17, sometimes just called PVP K17, pops up in many spots across the pharmaceutical world. With a low-to-medium molecular weight, it brings a unique mix of stickiness and solubility that ends up shaping its greatest role in medicine. In my years writing about drug formulation, the constant comeback to PVP K17 always relates to how it handles itself as a binder, a stabilizer, and even a carrier, especially when other options fall short.

Tablets That Don’t Fall Apart on the Shelf

Anyone who’s wrestled with tablet production knows the headache that comes from pills crumbling or refusing to hold shape. PVP K17’s biggest fans are found in tablet manufacturing rooms. It acts as a dry binder, locking powders together when water causes nothing but sludge and clumps. You get tougher, smoother tablets that won’t give up their structure at the first spot of moisture but still break apart quickly enough for the body to absorb the medicine. No wonder generics and big brands both keep K17 in their formula lists.

Quick-Dissolve Medicines for Fast Relief

Not every patient can swallow pills, and that’s where instant-release tablets and oral dispersible films matter. PVP K17 keeps these medicines from sticking to everything but themselves and lets them dissolve evenly in the mouth. It doesn’t leave behind a bitter aftertaste or get in the way of flavorings, so pediatric and geriatric medicines depend on it. There’s something about seeing a child not panic over medicine that sticks with you.

Keeping Suspensions Stable on the Shelf

Anyone who has shaken a liquid medicine only to find stubborn lumps at the bottom knows the struggle. Syrups and suspensions benefit from K17’s knack for keeping fine drug particles floating evenly. Rather than sinking, the medicine stays mixed, ready for dosing. It steps up especially where temperature swings and long shelf times would separate weaker suspending agents.

Formulas That Play Nice With Other Ingredients

Different drugs, even in the same pill, sometimes hate sharing space. In those cases, K17 works as a solubilizing agent, hiding drugs inside tiny molecular cages and making sure they dissolve easily once swallowed. It brings out the best in compounds that otherwise resist water, rescuing ideas that might never reach patients’ hands. This is one of the secret weapons behind making poorly soluble drugs actually useful in the clinic.

Supporting Clean Delivery With Safety in Mind

It’s tough to overstate the value of safety in excipients. Decades of clinical research back PVP K17’s safety, which means regulatory agencies around the world—including the US and those working under the BP and EP standards—trust it for use in everything from eye drops to injectables. Having passed purity and toxicology hurdles, manufacturers and doctors can count on consistent results, free from contaminants. Patients with allergies and sensitivities feel safer, and doctors sleep easier.

Paving the Way for Innovation in Drug Delivery

Every year brings new types of medicines, demanding smart solutions for delivery. I’ve watched pharmaceutical teams use K17 to tweak drug release rates, adapting older therapies for new uses. In the world of next-gen medicine, such as controlled drug-release microspheres, K17 builds the structure and keeps active ingredients protected until the body needs them most. If you want real progress, using established tools like K17 shows that experience and innovation often go hand in hand.

Is Polyvinylpyrrolidone K17 suitable for use in pharmaceutical formulations?

What Matters Most in Pharma Ingredients

In the world of medicine production, every ingredient lands under a microscope. People rely on medication for their well-being, so trust hinges on the safety and reliability of every tablet, capsule, or syrup. Polyvinylpyrrolidone K17, or PVP K17, pops up on ingredient lists for several reasons. I’ve seen it mentioned in technical documents and talked about in industry meetings. But its advantages reach beyond just technical jargon.

PVP K17: A Little Polymer with a Big Role

PVP K17 is a synthetic polymer. It’s recognized for its water solubility, reasonable molecular weight, and its capacity to bond other substances together. Tablet makers turn to it when they want to make sure powders stick together and form a solid shape without crumbling. Its lower molecular weight compared to other grades means that it dissolves readily—this comes in handy, as fast breakdown in the stomach lets active drugs do their jobs smoothly.

The U.S. Food and Drug Administration (FDA) tags PVP as “Generally Recognized as Safe.” That kind of rubber stamp doesn’t come easy. PVP K17 has been used since the 1940s. Makers of everything from antipyretics to antihistamines have chosen it to aid in dissolving medicines, thickening solutions, or stabilizing drug suspensions.

What Makes Safety and Performance Non-Negotiable

Nobody wants unpleasant surprises from their medicine. Thankfully, batches of PVP K17 go through serious tests for purity and quality—monitoring for impurities and residual chemicals. Manufacturers must meet strict pharmacopeia standards. Even with the green light, it’s smart to pay attention to allergic reactions or unexpected interactions, especially in people with sensitive systems.

PVP K17’s predictability in how it behaves with other ingredients gives formulators room to combine it with a range of actives. Historically, it hasn’t caused big problems in terms of toxicity, and it doesn’t stick around in the body. I’ve noticed that in research, very high doses could cause gastrointestinal issues, but these levels are way above what anyone would find in regular tablets.

Challenges and Finding the Right Fit

No single ingredient checks every box. A formulator has to weigh how a polymer like PVP K17 interacts with other substances. Moisture can make it swell or break tablets if humidity isn’t controlled. On the flip side, PVP K17 can speed up disintegration, a positive trait when rapid onset is needed.

Cost is another key consideration. K17 isn’t as expensive as some specialty excipients, but it does create its own handling challenges—clumping, picking up moisture, sometimes needing drying agents in storage. These real-world headaches demand attention, especially as regulations tighten and product recalls sting companies both financially and in reputation.

Moving Toward Better Practices

Industry standards evolve constantly. I’ve seen more focus on transparent sourcing and traceability, especially for products ending up in injections, eye drops, or other sensitive routes. Engineers advise regular review of suppliers and fresh batch testing, even in long-standing supply chains. Careful documentation and compliance reviews avoid pitfalls before they become headline news.

Newer polymers and natural binders get a lot of attention, but PVP K17 holds its ground due to decades of reliable use. Companies still find it valuable in solid dose and liquid preparations, especially when balancing cost, accessibility, and patient needs. With careful handling, rigorous testing, and a willingness to adapt, manufacturers can keep using PVP K17 responsibly in modern formulations.

What are the specification parameters of Polyvinylpyrrolidone K17 BP EP USP Pharma Grade?

Quality In, Quality Out

Pharmaceutical production always demands a level of trust in materials that few other fields can claim. Polyvinylpyrrolidone K17, or PVP K17, steps into this world as a binding agent, stabilizer, and sometimes as a carrier in drugs. Day in, day out, companies look at its purity, its consistency, and its ability to meet strict international standards, including BP, EP, and USP.

Specification Parameters: What Are We Really Looking At?

Discussing technical specs might sound dry, but a closer look reveals the real-world impact of each parameter. Take appearance. PVP K17 should come as a white or nearly white, hygroscopic powder. This means the absence of strange colors or clumping, which often signals something went wrong—a telltale sign to anyone who has worked in a lab. Small details have big consequences: a contaminated excipient can mess up a whole batch.

Next, its molecular weight. For PVP K17, the average sits between 7,900 and 10,800 Daltons. This isn’t just a number for a data sheet; this range governs solubility and how the polymer behaves in solution. Step out of line, and formulations won’t perform predictably.

Water content stays under 5% by weight (sometimes 3% per certain monographs), which matters because excessive moisture can lead to microbial growth or degrade both PVP and active ingredients. In hot, humid environments, powders that soak up too much water clump or start to break down.

Purity Isn’t Just a Buzzword

During batch testing, ash content comes under the spotlight. K17 keeps this below 0.04%. High ash means uninvited inorganics—maybe process residues or dust. Not what you want inside a tablet or capsule. Alcohol-soluble substances, measured at less than 0.2%, reveal anything from process leftovers to additives that snuck in. This standard doesn’t just keep numbers pretty on a report—it keeps drugs safe and predictable for people who depend on them.

We also check for heavy metals (below 10 ppm), chloride (under 0.07%), and nitrogen content (11.5–12.8%). Every number here reflects a hard lesson learned somewhere along the line about what actually matters during production.

The Role of Microbes and Residual Peroxides

Microbial limits play an important part in any excipient. Microbial counts for aerobic bacteria should remain under 1000 CFU/g, fungi under 100 CFU/g, and the absence of pathogens like E. coli gets confirmed in every batch. Certain labs push hard on this, swabbing, checking, and rechecking, because failures here tarnish reputations and risk recalls.

Residual peroxides offer another warning sign. K17 usually maintains them below 400 ppm. High peroxides could hint at poor storage or issues during production, which doctors and patients cannot afford in their supply chains.

Pharma Grade Really Means Accountability

Working through specifications for PVP K17 makes it obvious these standards came from real practice—not just bureaucracy. Each requirement speaks to stamina under pressure, purity, and safety. Problems start small—a percent here, a ppm there—but multiply when out in the world, inside someone's medicine cabinet. Responsible sourcing, batch testing, and open reporting prevent headaches before they start.

Demand for transparency has never been higher. Manufacturers supply batch certifications, show independent laboratory data, and talk openly about their processes. PVP K17's specification sheet isn't just paperwork; it’s a signal of keeping promises to doctors, pharmacists, and most of all, patients.

How should Polyvinylpyrrolidone K17 be stored to maintain stability?

The Real World of PVP K17

Polyvinylpyrrolidone K17, known as PVP K17, shows up in labs, factories, and even in some household items you’d never expect. Its short polymer chain offers big advantages in solubility and film formation, whether you’re working in pharmaceuticals, cosmetics, or adhesives. The catch? Like a lot of useful chemicals, it isn’t invincible. Humidity, heat, sunlight—these can all ruin a stash of PVP K17 before you ever get around to using it for your project.

Why Good Storage Beats Clean-Up

A well-sealed drum of PVP K17 can keep its qualities for years, but just one slip with moisture control and you get a sticky mess. Water loves to sneak in because PVP K17 actually pulls in moisture from the air. Eventually, it clumps or forms a crust, which no one wants in their blend. Keeping it dry seems obvious, but I’ve seen plenty of half-used bags sitting open on shelves in more than one lab. Tossing away product due to lazy storage racks up costs on top of supply headaches.

Climate and Packaging Matter More Than Labels

You can read storage instructions on a label all day, but it won’t matter if stuff gets shoved into a drafty warehouse. Temperature swings can wreck PVP K17. Heat sends chemical reactions into overdrive, which changes viscosity and color. The result: unusable powder or chunks that don’t dissolve like they should. I’ve seen bags stored near boiler rooms turn yellowish, which says degradation is already happening. Blame oxygen and UV light in some of those cases, too.

Using airtight packaging solves half the battle. Foil-lined bags or well-sealed drums keep out excess moisture and block light. Silica gel packets tossed into a drum can make a world of difference. Every time the drum opens, the product faces a fresh hit of humidity, so factories that have automated, closed systems tend to lose much less product compared to labs with hand-scooped samples.

Learning from the Field

It’s one thing to quote a storage temperature of 15–25°C, but lots of facilities don’t have strict climate control. I’ve visited places running PVP K17 handling in unconditioned warehouses—one hot summer and the whole shipment starts to degrade. Those sticky clumps lead to downtime while workers struggle to break up the product or clean out machinery. Tracking air moisture with cheap humidity meters can catch a problem early before a whole shipment goes bad.

What Actually Helps

Clear storage routines work better than detailed memos. I’ve seen positive results from teams that never leave bags open, always label open dates, and cycle inventory so older batches don’t sit forgotten. Training workers to spot the first signs of product change—stickiness, color shifts, odors—lets them pull questionable batches before bigger trouble starts.

From my experience, setting up a simple system with clear feed-through hatches, designated cool and dry zones in storage, and reliable recordkeeping keeps waste low. Investing in modest environmental controls often pays back fast in product quality and less headache for everyone on the production line. PVP K17 isn’t especially demanding, but ignoring its quirks costs real money in lost batches and wasted time.

Is Polyvinylpyrrolidone K17 BP EP USP safe and compliant with pharmaceutical regulations?

Sitting at my kitchen table, I remember when I first came across the term “Polyvinylpyrrolidone K17.” Most people call it PVP K17 for short—it doesn’t sound fancy, but this stuff is everywhere in drug manufacturing. Whether someone is dealing with tablets, capsules, or topical gels, PVP acts as a binder, stabilizer, and even a film-forming agent. It's not as flashy as an active ingredient, though it pulls serious weight behind the scenes.

Regulatory Standards in the Spotlight

Handling any pharmaceutical ingredient means following some of the strictest rules out there. The notations BP, EP, and USP? Those stand for the British Pharmacopoeia, European Pharmacopoeia, and United States Pharmacopeia. All three lay down specific purity, solubility, and quality guidelines. If PVP K17 meets these marks, it's cleared for use in medicines across Europe and the US.

Quality control isn’t just a regulatory box to check. It’s personal. I saw a neighbor’s father suffer after a medication recall a few years back. Turns out, contaminated inactive ingredients had slipped through. Stories like his remind me, safety in pharmaceutical manufacturing is not negotiable. PVP K17 batches go through serious testing for substances like peroxides, residual solvents, and heavy metals. For medical use, the standard asks for low impurity levels—measured in tiny fractions of a percent.

Patient Impact and Trust

No drug company wants to end up on the evening news because of an ingredient failure. Patients and doctors trust regulators to keep dangerous stuff out of medicine. PVP K17 with BP, EP, and USP stamps gives that reassurance. The risk of toxic byproducts and allergens drops when the ingredient lines up with these standards.

Checking the paperwork helps, but nobody lives in a world where mistakes never happen. The reality: regulatory bodies run inspections, labs audit supplies, and companies constantly re-test batches. When PVP K17 scores BP, EP, and USP compliance, it’s not just a rubber stamp—it's a process that keeps repeating.

Lingering Doubts: What Else Can Be Done?

Even with strict rules, errors creep in. I’ve seen news stories about counterfeit and subpar additives showing up in developing countries. That’s scary. So, what should companies do? Sourcing directly from audited suppliers makes a difference. Third-party certification, not just internal claims, closes gaps. Companies with real skin in the game audit their own suppliers and keep clear records.

Digital tools are changing the landscape. Blockchain can track a batch of PVP K17 from the factory all the way into a finished tablet. This cuts the risk of switching or tampering. Some manufacturers have laid out plans to use tamper-evident seals and routine spot-checks. These steps might not make headlines, but they save lives.

Hard Facts Matter

Hundreds of studies back up the safety of pharmaceutical-grade PVP. The FDA and EMA both list it as “generally recognized as safe” under the right conditions. Toxicology reports show low absorption by the body, making it unlikely to cause harm at approved doses. Ten years ago, the story might have been different, but ongoing research and batch inspections keep risks minimal.

For me, trust builds every time a medicine works as expected. Behind that pill or cream is a chain of decisions built on strict science and lived experience—adding up to safety that patients can count on.

Polyvinylpyrrolidone K17 BP EP USP Pharma Grade
Names
Preferred IUPAC name 1-ethenylpyrrolidin-2-one polymer
Other names Povidone
PVP K17
Polyvidone
1-Vinyl-2-pyrrolidone polymer
Povidonum
Kollidon 17
Plasdone K17
Polyvinylpyrrolidone K17
Pronunciation /ˌpɒliˌvɪnɪlˌpɪˈrɒlɪˌdoʊn keɪ sɛvənˈbiːpiː iːˈpiː juːˈɛsˈpiː ˈfɑːrmə ɡreɪd/
Identifiers
CAS Number 9003-39-8
Beilstein Reference 25340
ChEBI CHEBI:53248
ChEMBL CHEMBL1201473
ChemSpider 2021652
DrugBank DB09338
ECHA InfoCard 03b2c7af-6beb-41ef-bae8-775402d7c9c5
EC Number 9003-39-8
Gmelin Reference 16304
KEGG C00556
MeSH D25.502.984.600.650
PubChem CID 24818045
RTECS number SG4525000
UNII 6YKS8NFU3M
UN number Not classified
CompTox Dashboard (EPA) CompTox Dashboard (EPA) identifier for 'Polyvinylpyrrolidone K17 BP EP USP Pharma Grade' is "DTXSID2058140
Properties
Chemical formula (C6H9NO)n
Molar mass 40000 g/mol
Appearance White to yellowish powder
Odor Odorless
Density 0.29–0.39 g/cm³
Solubility in water Freely soluble in water
log P -2.0
Vapor pressure < 0.01 hPa (20°C)
Basicity (pKb) pKb: 9.68
Refractive index (nD) 1.46
Viscosity 2.5 to 3.5 mPa·s (10% solution in water)
Dipole moment 7.21 D
Thermochemistry
Std molar entropy (S⦵298) 144 J·mol⁻¹·K⁻¹
Pharmacology
ATC code V06DA
Hazards
Main hazards May cause respiratory irritation. May cause eye irritation. May cause skin irritation.
GHS labelling GHS07
Pictograms GHS07
Hazard statements No hazard statements.
Precautionary statements Precautionary Statements: P261, P305+P351+P338, P304+P340, P312
NFPA 704 (fire diamond) 1-1-0
Autoignition temperature AUTOIGNITION TEMPERATURE: > 500 °C
Lethal dose or concentration LD50 (oral, rat) > 100,000 mg/kg
LD50 (median dose) > 100 g/kg (rat, oral)
NIOSH Not Listed
PEL (Permissible) Not established
REL (Recommended) 0.5 – 10%
IDLH (Immediate danger) Not established
Related compounds
Related compounds Polyvinylpyrrolidone K30
Polyvinylpyrrolidone K90
Crospovidone
Copovidone
Polyvinyl alcohol
Polyethylene glycol