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Gentisic acid came into the spotlight not overnight, but after years of poking around in nature and the laboratory. Chemists stumbled upon it in plant sources like gentian roots and certain kinds of berries back in the 19th century. It didn’t become a pharmaceutical staple right away. Researchers spent years mapping its structure; the breakthrough really picked up as analytical chemistry advanced, which allowed producers to refine extraction and synthesis methods. Its inclusion in reference pharmacopeias—BP, EP, USP—wasn’t just about putting another chemical in the books. Gentisic acid’s antioxidant potential, paired with its stable, crystalline nature, made it valuable both in formulation and stability studies. My own experience in pharmaceutical sciences highlights its undervalued importance: not just another chemical, but a marker for purity and reliability in research-grade products.
Pharma grade gentisic acid isn’t just about a white powder in a vial. Production houses treat it like any critical input for human health, running everything through strict process controls and regular audits. Sourcing matters. Manufacturers keep a relentless focus on batch consistency, as even a small slip in purity or contaminant profile can trigger cascade failures in sensitive drug formulations. GMP and ICH guidelines don’t get taken lightly here. Material coming from BP, EP, or USP compliant facilities reflects a commitment not just to rules, but to long-term patient safety and scientific progress. I’ve seen facilities in action: paperwork stretches as long as the process piping, but every document means another layer of traceability and accountability.
Gentisic acid shows up as a white to slightly beige crystalline powder, without any real odor, and a taste only a brave chemist would forget. It melts at around 203°C, dissolving much better in hot water than cold, and reacts warmly to ethanol. Its molecular formula, C7H6O4, keeps the structure simple but effective: two hydroxyl groups set on a benzoic acid skeleton. Its chemical stability under typical storage conditions reduces headaches in warehouses and pharmacies, where light, air, and moisture can sabotage less robust compounds. Every kilogram gets analyzed for pH, moisture, and specific absorbance before release. Slight impurities stick out like a sore thumb in chromatographic assays, driving home just how narrow the margin for error runs in this business.
Labels on gentisic acid pharma grade containers don’t leave much to the imagination. The substance must not only match pharmacopeia monographs for content and contaminants, but also detail batch number, production date, and retest times. Regulations require tamper-evident seals and secondary containment. Lab staff verify not just the substance, but its label before use, echoing my own audits where deviations—even in English spelling—would halt production. These aren’t red tape exercises. With gentisic acid often acting as preservatives or analytical standards, someone’s daily medication might depend on a single bottle’s reliability. Each container carries a promise, written in dense technical jargon, but trusted by pharmacists and clinicians alike.
Production starts with aromatic ring oxidation, usually using salicylic acid as feedstock. Careful control of temperature, pressure, and oxidant choice—often potassium permanganate—makes or breaks batch quality. The whole process runs on scalability: lab glassware up to reactor vessels, filtration, washing, and drying cycles. The yield, if handled right, can nudge towards industrial viability, but even minor blips in solvent quality or reaction timing can tank a whole batch. Much depends on water purity and the absence of metal impurities, which tend to sneak in from older reaction vessels.
Gentisic acid’s structure gives it eager reactivity in esterification, amidation, and substitution reactions. The para-dihydroxybenzoic structure plays well with further functionalization, which opens up options for prodrug synthesis and conjugate development. Academic teams push boundaries with side-chain extensions and salt formation—not just for patent novelty, but for real-world improvements in bioavailability and solubility. I remember one particularly tough project, tracking down the source of troublesome side-products during a condensation step. Details matter: gentle heating averts unwanted decarboxylation; controlled pH maintains the base skeleton for downstream chemistry.
In the literature and the market, gentisic acid wears many hats: 2,5-dihydroxybenzoic acid; Gentisic acidum; and even archaic names from early botanic exploration. Catalogs list it under CAS number 490-79-9, simplifying cross-border trade and regulatory submission. Pharma distributors might brand it with their specific serials, but seasoned chemists always squint at the monograph to confirm identity. Confusion between close analogs like salicylic acid and gallic acid is not just a beginner’s mistake; it’s a potential risk that accurate nomenclature shields against.
Operators in the supply chain follow exhaustive protocols for handling gentisic acid. That means gloves, masks, dust control, and monitored storage temperatures. The chemical, though considered safe at low exposures, gets dust-checked in the air, given its respiratory irritation potential. MSDS sheets—required on every material transfer—outline not just first aid measures but firefighting tactics and environmental controls. Emergency drills around chemical spills, though rare, make sure no shock follows in the event of an incident. Experience teaches that cutting corners in PPE or secondary containment is a gamble not worth taking, especially with regulatory inspections hovering around the corner.
Gentisic acid turns up in a surprising number of applications. Its antioxidant behavior stabilizes formulations from simple syrups to advanced injectables. Pharmaceutical analysis uses it as an internal standard for assay calibration. Topical creams draw on its gentle anti-inflammatory effect, piggybacking on its family resemblance to salicylic acid. Research labs rely on it in enzyme assays and as a reference compound in metabolic profiling. Even food chemistry gives it a nod for trace-level fingerprinting. My own time in process development saw gentisic acid crop up in unlikely places: not just directly in finished products, but as a crucial stopgap in process troubleshooting and analytical validation.
Application-driven teams keep looking for new ways gentisic acid can support therapeutic and diagnostic needs. Modified forms pop up in principle manuscripts, including metal complexes for imaging or bioactive esters aimed at controlled drug delivery. Collaborations between academic chemists and pharmaceutical firms often start with gentle tweaks to gentisic acid’s backbone, targeting better solubility or expanded metabolic profiles. Investment in this area outstrips its headline appeal because the payoffs—stabilized drugs, improved shelf lives, or better biocompatibility—translate directly into patient benefits and reduced manufacturing losses. Those moments in the lab when a new analog clears toxicity screens bring a sense of genuine progress.
Toxicologists and clinicians monitor gentisic acid’s behavior closely. Acute toxicity remains low in mammalian systems, but chronic or high-dose exposures deserve attention. Metabolism studies chart its breakup into benign fragments, though at high quantities, its role as a phenolic acid triggers oxidative stress in cell cultures. Regulatory dossiers collect data on immune responses, hepatic clearance, and neurotoxicity markers. Animal model research feeds into periodic safety data updates mandated by pharmacopoeia committees. From a healthcare worker’s perspective, it’s the rare incidents—accidental spills, airborne dust, skin contact—that drive home the point: familiarity with chemical doesn’t erase responsibility for safety or record-keeping.
Market chatter on gentisic acid rarely hits front pages, but signs point to steady growth. Clean label trends and pressure for “safer” excipients put a premium on time-tested stabilizers, and gentisic acid checks that box. Continuous flow synthesis stands out as a way to boost purity while slashing waste. Green chemistry pushes for water-based reactions and biosynthetic routes, cutting down both environmental impact and input costs. Researchers look to attach this molecule to peptides or polymers for use in slow-release injectables or advanced diagnostics. As the pharmaceutical sector faces tougher scrutiny on both safety and environmental impact, the demand for trusted, well-characterized chemicals like gentisic acid won’t slacken. Upgrading quality controls, exploring novel modifications, and investing in robust supply chains remain key steps for anyone aiming to keep this “old” molecule relevant in an evolving field.
Gentisic acid gets a lot of attention in pharmaceutical settings, but its importance stretches beyond the lab bench. This compound, with qualities rooted in its antioxidant nature, shapes the formulation of many medicines people use every day—especially those focused on pain relief and inflammation. For pharmacists, scientists, and patients, it’s more than a chemical name; it touches real therapies for common and chronic conditions.
Gentisic acid features in the manufacturing of certain non-steroidal anti-inflammatory drugs. It helps build medicines that target aches, fevers, and swelling. Its structural similarity to salicylic acid links it directly to aspirin production. Drug makers count on gentisic acid to help keep processes both standardized and reliable. If you’ve ever reached for something in the aspirin family, gentisic acid had a role in making the tablets safe and effective.
Compounds with antioxidant properties help shield the body from damage caused by free radicals—those molecules tied to aging and disease progression. Gentisic acid belongs to this antioxidant group. Studies back up its role in dealing with oxidative stress, and researchers often select it to test how compounds can protect cells in human bodies. Researchers rely on trusted reference samples while evaluating the potential of new drugs, making pharma-grade gentisic acid essential for laboratory accuracy.
Some active ingredients need support to stay potent through the life of a medicine. Gentisic acid plays a protective role, helping stabilize vitamins and drugs that lose strength over time. This stabilizing effect also supports consistent dosing—essential for both doctors and patients. With the stakes high in regulated medicine, producers rely on established quality standards such as BP, EP, and USP to guarantee performance in their finished products.
Drug makers must show that every tablet or capsule matches health authority expectations. Gentisic acid, recognized by the main pharmacopoeias, gives labs a tested standard for measuring content and purity. Labs use it to check if batches hit their target strength, and health agencies in the US, Europe, and elsewhere recognize its value as a control sample. This role helps prevent unsafe products from reaching pharmacy shelves, building trust in the system for everyone.
Researchers tap gentisic acid for more than its therapeutic profile. Because it reacts in predictable ways, it finds use as a marker in laboratory studies, helping track how drugs break down or get absorbed. This clear tracking makes studies more trustworthy, offering doctors and regulators fresh insight into how products work in real life.
The grade matters. Meeting BP, EP, and USP benchmarks separates gentisic acid suitable for industry or medicine from less pure alternatives. Patients trust their medicine to do its job, so shortcuts just aren’t an option. Manufacturing plants invest in the technology and know-how to keep every shipment at top quality—protecting both their patients and their hard-won reputation.
With research digging deeper into the causes of inflammation and oxidative stress, compounds like gentisic acid will keep their spot in scientists’ toolkits. Drug development moves quickly, but building medicines on a foundation of trusted, well-characterized ingredients remains key. Without mainstays like gentisic acid produced to accepted standards, progress slows down for everyone—researchers, companies, and patients alike.
Gentisic acid quietly powers a slice of the pharmaceutical world as an antioxidant and intermediate. This compound, also known as 2,5-dihydroxybenzoic acid, shows up across chemical labs and pharma lines. High-purity gentisic acid isn’t a side detail; it forms the backbone of trust and performance in medicines and research.
The British Pharmacopoeia (BP), European Pharmacopoeia (EP), and United States Pharmacopeia (USP) set out a series of purity tests for gentisic acid. Each pharmacopoeia prints detailed monographs with clear chemical benchmarks.
To meet BP standards, gentisic acid needs to take the form of a fine, white to pale yellow powder. Labs quickly spot trouble if the compound takes on a shade or odor outside the norm. BP calls for a minimum assay—usually no less than 99% on the dried basis. That figure isn’t just a number; it marks a line that separates lab-grade from pharmaceutical-grade, giving the finished product reliability you can hold in your hand.
EP shares a similar approach: the identification tests scrutinize spectral signatures, reflectance, and melting points. purity doesn’t exist in isolation, so they check for related compounds, organic impurities, and residual solvents. EP standards lay down specifics such as chloride less than 0.02%, sulfate capped at 0.02%, and heavy metals under 10 ppm. Water sits near 1% or lower, judged by methods like Karl Fischer titration, giving a snapshot of how moisture can nudge purity downward and trigger degradation.
The USP rounds out this trio with its own angle. USP specifications often align with BP and EP, especially around assay, identification, and contaminants. You’ll find assay requirements that hover around that same 99%, with strict identification by infrared absorption. Heavy metals, again, stay under 10 ppm. Related substances get measured with TLC or HPLC, showing that even minor errors in synthesis can carry over unless checked. USP spells out loss on drying, generally less than 1%, covering both quality and shelf-stability.
From my time in labs and in quality control, slipping on purity pushes everything off balance. Impurities may seem harmless at first, yet they can change how gentisic acid interacts in a reaction or in a drug’s formula. Stories of batches recalled for impurities reinforce the lesson: one weak link can sour a drug launch and shake public trust. My colleagues who keep an eye on water content, heavy metals, and residual solvents know a single bad metric signals risk for users down the line.
Tough requirements take teamwork. Analysts, production managers, and R&D all carry responsibility. Automated HPLC systems catch what the naked eye can’t. Tight storage and transport protocols keep the product dry and away from contaminants. In my work, regular staff training made the difference. Understanding not only “how” but “why” the checks are run changes the motivation behind each batch record and sample.
Sourcing matters. Laboratories picking up gentisic acid from reputable suppliers decrease the odds of costly surprises. Audits and quality certifications, like GMP, build another safety net under supply chains.
Stronger digital tracking makes life easier, too. Batch-to-batch tracking with clear data helps catch deviations early. What used to take hours on paper now happens with a click, keeping teams ahead of problems.
As science keeps pushing expectations higher, these standards will evolve. Gentisic acid’s specs explain in plain numbers what safe, reliable, and effective really look like in the pharma world. Folks who chase these values day to day know the smallest impurity rarely stays small for long.
Gentisic acid, known in the chemical world as 2,5-dihydroxybenzoic acid, pops up in a variety of pharmaceutical contexts. It acts as an antioxidant and sometimes as a stabilizer in drug blends. Anyone working with actives sensitive to oxidation often looks for additives that help medicines last longer on the shelf and stay effective by the time they reach the patient.
Pharma grade really means something here. In manufacturing, small impurities might not seem like a big deal at low doses, yet they can trigger reactions or cause medicines to work differently. With gentisic acid, pharma grade goes through tough checks — purity usually lands at or above 99%, and labs test for heavy metals, microbial contamination, and related substances. This level of scrutiny isn’t just about ticking boxes; it matters every time someone swallows a pill or injections reach a vein.
Quality takes center stage because patients with weakened immune systems, such as the elderly or young children, rely on predictability and safety in their treatments. Chemicals that go into formulations, even “inactive” ingredients, must carry medical-grade certifications. Medicinal chemistry has shown over decades how bad batches or unnoticed contaminants lead to product recalls and, in rare cases, harm.
I’ve watched pharmacists and industrial chemists work closely with suppliers to pick the right grade of every ingredient. Gentisic acid, in pharmaceutical form, gets chosen specifically because it keeps breaking down unwelcome oxygen radicals in drugs prone to spoilage. Especially with injectable, ophthalmic, or oral liquid medicines, small changes in formulation matter. Most regulatory bodies, like the FDA or EMA, draw a clear line: if it’s not pharma grade, it stays out of anything heading toward a prescription.
Stability studies show gentisic acid helps formulations like parenteral solutions hold up in higher heat or light. In paracetamol products, it helps keep breakdown byproducts in check. The science behind all this isn’t just lab trivia; it shows itself in how long products stay within their shelf life, even after stressful shipping or storage.
Pharmacopoeias like the USP and EP lay out exact specs for what passes as pharma grade. You can find gentisic acid listed and described in these references, which not only cover purity but highlight the need for rigorous batch-to-batch consistency. Papers in “Journal of Pharmaceutical Sciences” and similar peer-reviewed sources highlight gentisic acid’s function as an antioxidant in practical drug production.
Every drug manufacturer signs off that their raw materials come with a full trail — certificates of analysis, stability data, origin tracking, and evidence they follow GMP rules. This traceability, backed by decades of published research, puts pharma grade gentisic acid on solid ground whenever it’s built into a formulation.
Not every supplier meets global standards. In my experience, companies that cut corners with lower-purity grades run into trouble during audits or clinical studies. Labs must check each new batch, sometimes with independent testing, to keep trust high. Open communication between ingredient suppliers, pharmaceuticals, and regulators cuts down on surprises and keeps the focus on patient wellbeing.
Improving transparency—such as third-party verification and making analytical data available to buyers—has helped the industry weed out questionable batches. In the end, gentisic acid pharma grade earns its place in pharmacy only when it meets the demanding needs of real-world drug safety and performance, supported by clear evidence and expertise every step of the way.
Every warehouse manager I’ve worked with knows that keeping active compounds stable is not just about following a datasheet. It’s personal, because a lax moment with climate or labeling can drag down the reliability of the whole production chain. Gentisic acid—popular in pharma labs and research supply rooms—demands a thoughtful approach, as its potency and purity ride on those everyday decisions.
From experience, most chemical ingredients lose their edge fast if temperatures swing around. Gentisic acid, with its sensitivity to heat, calls for cool and steady storage. Scientists recommend keeping it below 25°C—room temperature at the high end, but never on a sunny shelf or near heat vents. A climate-controlled room, ideally around 15–20°C, does the trick for most warehouses. Let a storeroom creep up to regular summer highs, and degradation picks up fast, which can foul up batch results and waste money.
I’ve toured facilities where staff keep all the finest compounds in clear jars, thinking it’s no big deal. Light—especially harsh lab fluorescents or sunlight—pushes unwanted reactions, even in stable-looking powders. Gentisic acid thrives in darkness, best kept in amber glass or opaque containers. Oxygen exposure is another foe to watch. Reseal packaging tightly, always. A careless lid can mean oxidation starts to mess with the compound, and by the time someone notices, it’s already degraded from its labeled potency.
If the storeroom air feels muggy, expect trouble. Gentisic acid attracts moisture, so humidity levels over 60% threaten to clump it up or seed microbial growth. Dehumidifiers do more than a daily sweep; they stave off those gradual losses that calculators and spreadsheets never show. A dry room with a reliable humidity monitor gives peace of mind, and for smaller stocks, desiccant packs in the container make a simple insurance policy.
Industry documents put gentisic acid’s shelf life at two to three years from the production date if storage instructions aren’t ignored. I’ve seen some labs stretch supplies a little longer, but every inspection turns up the same lesson: batches beyond three years often disappoint, showing subtle drops in assay values. Regular audits—dating batches, rotating inventory, and discarding the oldest—keep product consistency and help avoid the headache of failed quality checks.
The highest quality assurance isn’t just a paper process. Training staff to treat each container as if contamination lurks everywhere is pivotal. Manufacturers should always supply certificates with batch details and recommended expiration dates. If a delivery arrives with signs of heat stress or compromised seals, return it. If documentation goes missing, set aside the batch for extra testing before committing it to production.
Labs that have earned a track record for reliability always take those small daily steps—monitoring, labeling with open dates, and logging storage data. That’s where confidence starts, and it's exactly how trust grows in the pharma supply chain.
Anyone in the pharmaceutical industry will tell you paperwork is never just about bureaucracy. Each document tells a story about safety, consistency, and responsibility. Certificates of Analysis (COAs) might seem like just another form, but missing or incomplete documentation creates real doubt. Speaking from experience in pharmaceutical quality assurance, nothing rattles confidence more than vague sourcing. Gentisic Acid, a compound widely used for its antioxidant and anti-inflammatory properties, falls squarely into this category. Reliable documentation separates a trustworthy product from one shrouded in uncertainty.
Without a proper COA, no responsible manufacturer or distributor expects a buyer to take them at their word. COAs provide batch-specific proof on purity, potency, heavy metals, residual solvents, and microbial limits—key for Gentisic Acid when sourced for pharmaceutical use. In my work, collaborating with suppliers across Europe and Asia, delays almost always result from mismatched or missing documentation, not the logistics of chemicals themselves.
This isn’t just about regulatory box-ticking. Take the United States Pharmacopeia (USP), British Pharmacopoeia (BP), and European Pharmacopoeia (EP) standards. A batch of Gentisic Acid might meet one set of requirements and fall short elsewhere. Only a comprehensive COA lets you verify compliance each step of the way. It also matters for internal audits, as most companies have their own quality dashboards tracking each batch from arrival to release. Clients want to see numbers and signatures, not marketing copy.
COAs aren’t all equal. The bare minimum includes details like the batch number, manufacturing date, expiration date, identification, content or assay, melting point, and microbiological tests. Important for Gentisic Acid—especially since this acid sometimes carries impurity risks—chromatography results should state what, exactly, matches the reference standard. No shortcuts. Sometimes, I’ve seen COAs without residue on ignition, chloride, sulfate, or heavy metal results. That won’t satisfy any seasoned purchasing or regulatory team. Skimpy documentation signals a supplier might be hiding shortcuts in their process.
Regulators don’t accept excuses. Regulatory inspectors routinely ask to match physical stock of raw materials with documentation, and some of the stingiest penalties handed out in GMP audits link back to incomplete paperwork, not failed chemical tests. Major pharma clients might run their own verification checks or even request raw chromatograms. They look for transparency and traceability. The answer to “Do you provide COAs?” influences more outcomes than many realize—from which suppliers get on the approved list to whether a consignment sits unopened at a dock.
There’s room for improvement. Suppliers can train staff to ensure COAs meet all international standards before shipments leave the factory. Digital inventory systems should link documentation directly to inventory. I’ve worked with teams where just scanning a QR code on a drum brings up its COA and all test results. This cuts down time and errors, and often speeds up in-house QA release. Open, accurate labeling and documentation aren’t mere formalities in this business—they’re the foundation of reputation and compliance. For buyers of Gentisic Acid, the right paperwork means less risk, fewer delays, and, ultimately, safer medicines.
| Names | |
| Preferred IUPAC name | 2-hydroxybenzoic acid |
| Other names |
2,5-Dihydroxybenzoic acid Gentisinic acid Acide gentisique Acido gentisico |
| Pronunciation | /ˈdʒɛn.tɪ.sɪk ˈæs.ɪd/ |
| Identifiers | |
| CAS Number | 99-96-7 |
| Beilstein Reference | 1720990 |
| ChEBI | CHEBI:30762 |
| ChEMBL | CHEMBL1419 |
| ChemSpider | 1727 |
| DrugBank | DB01604 |
| ECHA InfoCard | 03b9503e-437e-40d5-b1d3-cda23a3257e2 |
| EC Number | 3.1.1.58 |
| Gmelin Reference | 7547 |
| KEGG | C00631 |
| MeSH | D007090 |
| PubChem CID | 346 |
| RTECS number | MD1600000 |
| UNII | OE7C70K43D |
| UN number | UN3077 |
| CompTox Dashboard (EPA) | DTXSID6043074 |
| Properties | |
| Chemical formula | C7H6O4 |
| Molar mass | 154.12 g/mol |
| Appearance | White or almost white, crystalline powder |
| Odor | Odorless |
| Density | 1.68 g/cm³ |
| Solubility in water | Slightly soluble in water |
| log P | 1.76 |
| Vapor pressure | 0.0000125 mmHg (25°C) |
| Acidity (pKa) | 3.15 |
| Basicity (pKb) | 11.51 |
| Magnetic susceptibility (χ) | -85.0 × 10⁻⁶ |
| Refractive index (nD) | 1.554 |
| Dipole moment | 1.69 D |
| Thermochemistry | |
| Std molar entropy (S⦵298) | 170.0 J·mol⁻¹·K⁻¹ |
| Std enthalpy of formation (ΔfH⦵298) | -541.0 kJ/mol |
| Std enthalpy of combustion (ΔcH⦵298) | -2957 kJ/mol |
| Pharmacology | |
| ATC code | M01BA02 |
| Hazards | |
| Main hazards | Harmful if swallowed, causes skin and eye irritation, may cause allergic skin reaction. |
| GHS labelling | GHS labelling: Signal word: Warning. Hazard statements: H315 – Causes skin irritation, H319 – Causes serious eye irritation, H335 – May cause respiratory irritation. Precautionary statements: P261, P264, P271, P280, P302+P352, P305+P351+P338, P312. |
| Pictograms | GHS07,GHS09 |
| Signal word | Warning |
| Hazard statements | Not a hazardous substance or mixture according to the GHS (Globally Harmonized System). |
| Precautionary statements | Keep container tightly closed. Store in a cool, dry place. Avoid contact with skin, eyes, and clothing. Use personal protective equipment as required. Wash thoroughly after handling. Do not breathe dust or fumes. |
| Flash point | 210°C |
| Autoignition temperature | 440°C |
| Lethal dose or concentration | LD50 (oral, rat): 2,010 mg/kg |
| LD50 (median dose) | LD50 (median dose): 1240 mg/kg (oral, rat) |
| NIOSH | Not Listed |
| PEL (Permissible) | Not established |
| REL (Recommended) | 500 mg |
| IDLH (Immediate danger) | Not established |
| Related compounds | |
| Related compounds |
Salicylic acid Aspirin (Acetylsalicylic acid) 3,5-Dihydroxybenzoic acid Gallic acid p-Hydroxybenzoic acid Vanillic acid Protocatechuic acid |
Chengguan District, Lanzhou, Gansu, China
