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Anhydrous Citric Acid BP EP USP Pharma Grade: A Closer Look

Historical Development

People discovered citric acid in lemon juice all the way back in 1784, thanks to a Swedish chemist named Carl Wilhelm Scheele. Through the years, researchers figured out new ways to make it so the world didn’t have to rely only on citrus fruits. A big shift arrived in the early twentieth century with the introduction of microbial fermentation, which gave the industry a cleaner, much more efficient process using the fungus Aspergillus niger. By the mid-1900s, anhydrous citric acid started showing up in medicine, food processing, and laboratory research. The BP, EP, and USP standards grew out of the need for tightly controlled quality, and these standards—British Pharmacopoeia, European Pharmacopoeia, United States Pharmacopeia—mean that chemists and manufacturers can communicate and trust what’s in the bag, no matter where the product comes from.

Product Overview

Citric acid stands out as a colorless, odorless substance, with a sharp, tangy flavor that crops up in everyday foods and beverages. The “anhydrous” part simply means no water molecules hitching a ride, as compared to the monohydrate form. The BP, EP, and USP grades mean it passes the strictest tests; every kilogram has the right purity and very low limits on heavy metals, citraconic acid, and other unwanted stuff. Anyone in pharmaceuticals or biotech counts on that purity. Handling anhydrous citric acid feels like dealing with a fine, crystalline powder—smooth to the touch, dissolves quickly in water, and stores well thanks to its dry, stable character.

Physical & Chemical Properties

Anhydrous citric acid forms colorless, white crystals or granular powder. It melts at around 153-154°C if kept dry enough. When it hits water, it dissolves completely, creating an acidic solution that works well for different applications where pH needs adjusting. Its molecular formula is C6H8O7, meaning it piles up three carboxylic acid groups and one hydroxyl group in a six-carbon ring structure. This allows it to bind with metals and minerals, forming complexes or chelates. The pH of a 1% solution sits around 2.2, useful in countless laboratory and pharmaceutical formulas to buffer and stabilize other ingredients.

Technical Specifications & Labeling

Strict legal and pharmaceutical requirements govern every detail, from the size of the crystals to the smallest impurities allowed. Citric acid BP EP USP pharma grade can only contain trace amounts of moisture—at most, 0.5% water. It meets or exceeds 99.5% minimum assay for C6H8O7. All heavy metals, lead, arsenic, and oxalic acid measures must fall below specified levels, often down to one part per million or less. Product labeling goes beyond a generic name; bulk containers and retail bottles display batch numbers, manufacturer and country of origin, expiry dates, and reference to the pharmacopoeia standards. Each label tells a story about quality, traceability, and responsibility, since pharma grade means no corners cut from factory to finished drug.

Preparation Method

Modern production lines rely on fermentation tanks packed with the fungal strain Aspergillus niger. Tanks fill with molasses or another sugar-rich medium, and the fungi do the work, pumping out citric acid as they digest the sugar. A chemical precipitation step, often using lime, separates out the raw acid, and a careful process of crystallization and drying finishes the job. Removing every bit of water without breaking or degrading the product demands precisely controlled temperatures and pure, filtered air. After collecting the anhydrous crystals, workers crush, sieve, and pack the powder under sanitary, controlled conditions to guarantee pharmacopeial quality.

Chemical Reactions & Modifications

Citric acid offers up a platform for reactions, not just a single-use ingredient. It acts as a chelating agent, binding tightly to metals like calcium, magnesium, or iron in solution. In the lab, it can react with calcium chloride to make calcium citrate, a dietary supplement. Under heat or strong acid, it can lose water and turn into aconitic acid, playing a key role as an intermediate in the Krebs cycle—a central process of biology. Chemists sometimes modify it into esters, like triethyl citrate, for use as plasticizers or additives in coatings, driven by that triple acidity and the ready hydroxyl group.

Synonyms & Product Names

People in the business use words like “Citric acid anhydrous,” “2-hydroxy-1,2,3-propanetricarboxylic acid,” or the shorter “C6H8O7,” depending on the context. Old manuals and trade documents occasionally mention “lemon salt,” but today’s importers and suppliers follow more formal naming conventions, often adding the grade and pharmacopoeial standard directly to the product name on documentation and safety datasheets.

Safety & Operational Standards

Though widely used, anhydrous citric acid commands respect in handling. It can cause irritation if it comes in contact with skin or eyes, and breathing in the dust can trigger mild respiratory discomfort. Industry standards call for gloves, goggles, and workplace ventilation during weighing, mixing, or packaging. Spillage cleanup uses damp methods to keep the particulate count down, avoiding dust clouds. GMP (Good Manufacturing Practice) and ISO-certified systems govern every step from raw materials to finished, packaged product, with regular audits and traceability. Storage in sealed, moisture-proof packaging keeps the product good for up to three years in a cool, dry facility.

Application Area

Anhydrous citric acid turns up in tablet manufacturing, injectable solutions, and powder blends, checking the pH and keeping the final product steady and shelf-stable. I’ve seen it work as an excipient in both antibiotics and vitamin C products, making the difference between a gritty tablet and a formulation that stores well and tastes pleasant. Outside the pharmacy, food technologists use it to deliver a tart bite in soft drinks, jams, and confectionery, but only pharma grade guarantees freedom from latent toxins, pesticides, or microbiological contamination. It’s in cleaners, too, dissolving mineral scale and balancing acidity in detergents. Water treatment facilities reach for it to chelate metals and keep their systems running clean.

Research & Development

Researchers turn to anhydrous citric acid for new pharmaceutical delivery forms and for studies into kidney stones, calcium chelation, and metabolic pathways. Because it’s non-toxic at prescribed levels and offers reliable pH control, scientists in my circles use this compound for buffer systems in enzyme assays and vaccine formulation trials. Sophisticated particle-sizing and crystallinity controls attract interest from biotech startups, aiming to lower dust generation or improve speed of dissolution. Every year, studies roll in showing new uses as a base for biodegradable plastics and as a safer alternative to harsh acids in green chemistry.

Toxicity Research

Studies dating back decades support the safety of pharmaceutical-grade citric acid, with oral LD50 values for rats well above 3,000 mg/kg—compared to much more toxic substances used in processing. Beyond rare cases of hypersensitivity or GI upset at very high doses, the global consensus points to low risk, recognized by organizations like the FDA and EFSA. Still, regulatory agencies check every batch for heavy metals, pesticide residues, and microbial counts because even a trace of contamination harms medical patients. Hospital dietetics teams use this data to calculate safe intake for people with kidney disease or metabolic disorders—showing that rigorous scientific evidence steers every product lot from the lab to the pharmacy shelf.

Future Prospects

Looking down the road, pharma companies and researchers look for ways to make citric acid greener and more sustainable. New fermentation techniques promise higher yields from less energy and lower agricultural waste, and some projects explore converting agricultural byproducts directly into citric acid. Synthetic biology may soon engineer microorganisms to run continuous production at industrial scale, cutting costs and environmental impact. In medical research, advanced delivery forms and engineered crystal particles may improve bioavailability and offer safer, more efficient therapies. The broad utility of pharmaceutical-grade citric acid guarantees a steady push for safer, cleaner, and more adaptable methods, aligning with the future of medical science and sustainable technology.




What is Anhydrous Citric Acid BP EP USP Pharma Grade used for?

The Foundation in Pharmaceuticals

Citric acid isn’t only for food and household cleaners. In its purest, anhydrous form — and under strict pharmaceutical standards like BP, EP, and USP — citric acid becomes a key player in tablets, syrups, and even injectable medicines. The anhydrous variety contains no water, so it keeps medicines stable. A few years ago, I worked in a pharmacy and often checked ingredient labels. Citric acid’s name appeared again and again, helping turn bitter flavors into something bearable in oral solutions and chewable pills, especially for children’s medicines.

Pharmaceutical guidelines—marked by BP (British Pharmacopoeia), EP (European Pharmacopoeia), and USP (United States Pharmacopeia)—hold ingredients to strict standards. Manufacturers source citric acid that meets these requirements to ensure purity, safety, and traceability. This grade often goes through extra purification steps, which reduces the risks of impurities sneaking into the final drug product.

Blood and Chemistry

Citric acid’s value doesn’t stop with taste. Hospitals and blood banks use it as an anticoagulant in blood collection bags. Blood must remain fluid during transport and storage, otherwise it clots. Citrate ions bind to calcium — the mineral that helps blood clot. By locking up calcium, citric acid keeps blood ready for transfusions. This process directly impacts patient safety and treatment options during surgery or trauma care.

Manufacturing Consistency

In any lab setting, reliability matters as much as innovation. Pharmaceutical-grade citric acid brings tested batch-to-batch consistency, which helps researchers create predictable reactions. During quality control in my previous job, even slight differences could trigger months of investigation. When one batch of ingredient performed differently from another, we had to pause production, check equipment, and run more analysis. Pharma-grade citric acid reduces these production headaches, saving time and money while avoiding medicine shortages.

Solubility and Stability

Anhydrous citric acid dissolves quickly and evenly in water. This trait makes it handy for effervescent tablets, like vitamin C or pain relievers you drop in a glass of water. Because there’s no water to start with, these formulas last longer on the shelf — a big deal in places without strict climate control. I’ve seen firsthand how medications lose effectiveness in hot or humid climates. Using stable ingredients like this keeps patients on their treatment course.

Safety and Transparency

Regulated production and clear documentation underpin trust in any medicine. Pharma-grade ingredients come with detailed certificates covering identity, purity, and any trace contaminants. Patients rely on manufacturers to provide safe products, many of whom never see the paperwork involved. Still, pharmacists and doctors can ask for these certificates, and manufacturers must provide them. This openness supports health system credibility and patient confidence.

Challenges and Outlook

Global demand for pharmaceutical ingredients grows every year, raising questions about sustainability and secure sourcing. Some concerns have surfaced over the environmental impact of large-scale citric acid fermentation. Looking ahead, advances in green chemistry and biotechnology could reduce waste and energy use, easing pressure on both natural resources and supply chains. Collaboration between chemists, engineers, and healthcare professionals can chart a course toward safer, greener pharmaceutical production—where quality and safety remain front and center.

What are the specifications of Anhydrous Citric Acid Pharma Grade?

Why Quality Matters in Pharma Ingredients

Anyone working in pharmaceuticals knows how tight quality controls get. Only the purest ingredients go into medicines meant for human health. Anhydrous citric acid, a substance found in countless drugs and supplements, stands out as a backbone of those standards. Without high-quality acid, the entire chain—from researchers in the lab to patients receiving treatment—runs the risk of contamination or inconsistency.

Pharma Grade Specifications: What Really Counts

Pharma grade anhydrous citric acid is a colorless, odorless, crystalline powder. Its chemical formula is C6H8O7. Purity ranks as the most crucial demand. Most pharmacopeias, like the USP and EP, require purity upwards of 99.5%. You’re not going to find fillers, heavy metals, or microbial contaminants sneaking past these rigorous standards.

Moisture content sits at a strict limit—less than 0.5%. Even a little water lingering in anhydrous material risks product stability. Acidity sits in a tight range, usually with a titratable acidity requirement that confirms the substance delivers the right reaction in solution. The pH of a 5% solution runs between 1.8 and 2.2, reflecting this sharp, reliable acidity.

Physical and Chemical Limits

Every batch goes through rigorous visual checks. No yellow tint belongs here; only a brilliant white crystalline powder passes inspection. Odor signals trouble, because any detectable scent means contamination. Particle size isn’t just about looks, though. Granule consistency ensures even mixing in solid-tablet formulations. Most sources use screens around 20-40 mesh to get the expected fine powder.

Heavy metal content faces deep scrutiny. Lead must stay below 0.5 ppm (parts per million). Arsenic gets its own limit—no more than 1 ppm. The test for sulfates stands at under 150 ppm, while oxalates are capped at 100 ppm. Each test targets a possible impurity that could threaten patient safety.

Microbiological purity matters just as much. Microbial limits for total aerobic bacteria count at under 100 CFU/g, yeast and molds below 10 CFU/g. The absence of pathogens such as Salmonella and E. coli is mandatory.

Packaging and Storage: Protecting Integrity

No matter how pure the starting product, exposure to moisture or contaminants can tip the scales quickly. Air-tight, food-grade packaging keeps product integrity intact from factory to pharmacy. Warehouses keep it cool and dry—most guidelines recommend temperatures below 25°C.

Labeling is not just bureaucratic. True pharma-grade product comes with batch numbers, expiration dates, and manufacturer traceability. In an industry facing recalls and ongoing audits, this accountability helps everyone sleep easier at night.

Building Trust in Healthcare

The pharmaceutical world thrives on trust. Doctors, patients, and regulators count on assurance that every ingredient, down to simple citric acid, meets rock-solid standards. Modern lab testing—think HPLC analysis for purity or ICP-MS for heavy metals—keeps these promises real, not just theoretical. Trust grows only when every link in the chain holds firm. That’s why the tight specifications for pharma-grade anhydrous citric acid aren’t just checklist items—they’re cornerstones of modern healthcare.

Is this product suitable for food or pharmaceutical applications?

Safety Drives Every Decision

Assessing a product for food or pharmaceutical use starts with ingredient safety. Health always comes first. Growing up in a household where family members routinely checked every food label and prescription, I saw how even small ingredients cause big problems if they’re not properly assessed. Regulatory agencies like the FDA and EFSA set tough rules, checking for toxins, allergens, impurities, and consistent quality. Looking at safety data sheets and toxicology reports gives confidence or sends up red flags. If a product doesn’t have full traceability and purity data, it belongs nowhere near dinner plates or pill bottles.

Documentation Opens Doors

Long before any batch reaches shelves, manufacturers tuck a thick file of paperwork into their operation. Materials need proper origin traceability, GMP certification, and rigorous third-party audits. My time consulting for an organic snack producer taught me that ingredient trust always dovetails with proof. Without verifiable documentation and audit trails, both food and pharmaceutical companies risk devastating recalls or even hurting someone. Customer trust dries up quickly when companies fumble something so basic.

Purity and Quality Testing Matter Every Time

We’ve all heard stories of recall disasters traced back to cross-contamination. At a bakery job, I once saw a shipment of oats quarantined because of a faint trace of peanut dust. That was critical since the oats formed part of a gluten-free bar for allergic kids. Whether an ingredient goes into pasta or a prescription tablet, constant purification and batch testing using methods like HPLC, microbiological assays, and heavy metal analysis shield the public from health hazards. Products for pharmaceutical use jump through higher hoops, since even trace levels of pathogens or solvents could turn lifesaving drugs into liabilities.

Functionality Feeds Performance

Sometimes choosing materials just comes down to what works best in real life. Over the years, I’ve watched techs hand-test ingredients for flow, mixing, and storage stability, sometimes going through frustrating cycles until something holds up. In a pharmaceutical setting, even tiny differences in particle size can affect medicine release and absorption, which impacts whether the drug does what the doctor promises. For food, taste, texture, and shelf life rule the day, so functional tests like moisture analysis or stability trials uncover hidden deal-breakers. Sometimes, products shine in the lab but fizzle out at production scale, so pilot runs catch those hiccups early.

Environmental and Social Factors Count

More companies now weigh sustainability and ethical sourcing before putting anything new into their supply chain. Friends working at major food brands told me how public pressure pushes for fair labor, reduced emissions, and transparency. Certifications such as Fairtrade, USDA Organic, and RSPO don’t fix everything, but they help shoppers trust what ends up on their plate or in their medicine cabinet.

Keeping Eyes on Both Science and Public Trust

Years spent in product development taught me that no shortcut exists for safe, high-quality ingredients. Whether food or medicine, the best products clear every regulatory hurdle, meet or exceed customer expectations, and never compromise on traceability or quality testing. Open communication about sourcing, purity, and allergen controls goes a long way in earning public and regulatory trust. If companies slip up on any of these steps, people talk—and they remember.

How should Anhydrous Citric Acid be stored?

Why Smart Storage Matters

Most people know citric acid as part of what makes citrus fruits taste sharp, but the powdery white version—anhydrous citric acid—plays a big role in food production, cleaning, and even skin care. One of the things I've seen, whether working in small kitchens or bigger labs, is that folks can get casual about storage. Yet, citric acid isn’t just another pantry item. Without proper handling, this powder ends up clumping, losing potency, or worse, becoming unsafe for use because of contamination.

Keep It Dry, Keep It Effective

Humidity spells trouble for citric acid. Damp air creeps in and causes the fine powder to harden or form lumps. That sticky mess won’t dissolve the same way and doesn’t measure properly. It only takes one rushed job—using it with damp hands or in a muggy environment—for the whole container to cake up. A sealed, airtight container makes a difference. Glass jars with sturdy lids or thick plastic tubs work best. I’ve watched people rely on bags with cheap twist ties, but over time, moisture sneaks through. Humidity packs, like the ones found with vitamins, offer extra protection in areas where the air feels thick.

While it sounds simple, keeping citric acid off the kitchen counter cuts down the risk. Busy kitchens get steamy, especially near stoves or kettles. A cool, dry cupboard away from water sources keeps the powder ready for action. Basements and laundry rooms tend to feel damp, so steer clear of those storage spots.

Protect Against Contamination

Scooping with wet spoons or not sealing the container between uses opens the door for impurities. Suppose you ever dump a spoon back into the container after stirring something else—you risk introducing bits of residue. Food safety takes a hit fast. Clean, dry utensils are a must. I’ve found that storing a scoop in the container keeps things easy and safer, but only if the scoop stays bone dry. Once contamination sets in, mold can start and spoil an otherwise long shelf life.

Labeling: More Than a Good Habit

Any seasoned food handler knows how easy it is to grab the wrong powder. Citric acid looks a lot like baking powder, salt, or even laundry boosters. One mix-up with an unlabeled container leads to ruined recipes or cleaning mistakes. Clear labels, including date of purchase, help anyone spot old product or recall when the bag first opened. If you ever need to trace a batch because of a quality issue, a label saves time and confusion.

Safety Beyond the Basics

Citric acid brings a low risk compared to harsh chemicals but shouldn’t sit loose where kids or pets can reach it. Even natural acids can cause mild skin irritation if handled carelessly or if powder flies into the air. Store above eye level for kids and keep it in containers that won’t shatter if dropped. Common sense goes a long way—if storing it near other white powders, consider a dedicated bin to avoid mix-ups.

How Small Steps Prevent Big Problems

Experience shows that people treat proper storage as an afterthought—until problems hit. Solid containers, dry storage conditions, and labeling sound basic, but they save product and prevent headaches every time. Whether handling citric acid for cooking, cleaning, or crafts, these steps prove themselves over and over, not just in professional settings but at home too.

References:
  • Food and Drug Administration (FDA) guidance on food-grade acids
  • Centers for Disease Control and Prevention (CDC) advice on safe chemical storage
  • Personal experience in professional kitchens and home use

What is the shelf life of Anhydrous Citric Acid BP EP USP Pharma Grade?

Understanding the Basics

I’ve seen citric acid used for everything from food preservation to bath bombs in craft stores. At its core, anhydrous citric acid is a white, crystalline powder. Pharmaceutical grade—marked BP, EP, or USP—just means tighter purity specs. It’s found in everything from chewable vitamins to injectable medicines. People often ask about shelf life, and for good reason. Can it last for years without going bad, or does it quietly lose potency as months pass?

How Long Does Citric Acid Last?

As someone who has handled chemical ingredients in manufacturing and home labs, I’ve noticed citric acid holds its quality much longer than many think. Kept in a tightly closed container, away from moisture, it generally keeps for about three years. Big suppliers like Merck or Sigma-Aldrich print two to three years as standard, but that’s based on storage in cool, dry rooms. Open a package in a damp basement, and shelf life shortens. Pharmaceutical guidelines aren’t just picky—they’re rooted in science. Moisture is the enemy. Humidity causes clumping and can make even pure citric acid go from rock-solid to soggy mess, which triggers quicker decomposition or potential microbial growth.

Why Does Shelf Life Matter?

I worked with a compounding pharmacy where precision mattered. If you use expired citric acid to balance pH in an IV drip, you risk more than just a flavor change—patients could end up with unintended contaminants if breakdown goes undetected. Food and beverage makers pay attention for similar reasons; nobody wants a lemon-lime soda that tastes off because the acid component lost its edge. The tiny expiration date stamped on a pharma-grade drum ripples through entire production chains. Hospitals and supplement makers stake their business on this reliability.

How to Extend Shelf Life

Simple steps make a big difference. Factory-sealed containers protect best. Never scoop with a wet or soiled spoon. I’ve seen labs repack big bags into airtight plastic buckets with desiccant packs to suck out moisture. Glass jars with screw caps work at home. Temperature swings—like storing close to kitchen ovens—can cause condensation inside containers, so stable, cool environments win out. I always tell friends not to fridge citric acid since frequent door openings let humid air in.

Spotting Trouble Before It Starts

Discoloration, clumps, or a musty smell are all warning signs. In lines of work where ingredient purity feeds into patient safety, playing detective is built into the job. Test strips for pH might show drift if citric acid ages too long. Although FDA or European Pharmacopoeia tests outline exact purity checks, people working on a smaller scale can avoid trouble by simply not hanging onto old supplies “just in case.”

Room for Improvement

Industry leaders keep refining packaging and handling instructions. There’s room for better training, especially in small operations that re-pack bulk materials. Sharing simple guides with new staff—like always using dry scoops—helps prevent mistakes. Manufacturers might offer better storage solutions, including resealable packaging with indicator strips for humidity.

Final Thoughts

Citric acid looks simple but plays a crucial supporting role in so many products. Respecting its shelf life, storing it dry and sealed, and rotating stock keep everything running as it should. These small acts of care ripple outward, guarding quality and safety in medicine, food, and beyond.

Anhydrous Citric Acid BP EP USP Pharma Grade
Identifiers
DrugBank DB04272
Properties
Odor Odorless