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Sodium Thiosulfate BP EP USP Pharma Grade: Insight Beyond the Label

Historical Development

Sodium thiosulfate, often recognized as hypo in darkrooms, steps back into history as a solution for silver recovery in photographic processes. In the 19th century, Humphry Davy and other early chemists marked its growing relevance by experimenting with its dechlorination properties. As chemistry made strides, scientists mapped out clearer industrial processes that shaped its role far beyond fixer trays, landing it in medicine, water treatment, and gold mining by the start of the 20th century. Pharmacopeial standards arrived over decades, after physicians and chemists demanded greater control in purity for injectable and oral formulas. Today, BP, EP, and USP standards anchor confidence for pharmacists and clinicians who use the substance in hospitals and labs around the world.

Product Overview

Ask any lab technician to pick a straightforward, functional compound and sodium thiosulfate always belongs on that list. The salt usually appears as colorless crystals or as a fine white powder that dissolves well in water. Modern pharmaceutical batches strictly follow BP, EP, and USP monographs—a careful routine from raw procurement to packaging. Sourcing from trusted producers matters for keeping out sulfurous or metallic contaminants since poor-quality thiosulfate can derail therapy or lab results. It never plays solo, but helps neutralize chlorine, assists with cyanide poisoning cases, and rounds out a chemist’s toolkit for analytical titrations.

Physical & Chemical Properties

Sodium thiosulfate’s formula, Na2S2O3·5H2O, spells out its pentahydrate form with five water molecules clinging to each unit. Its molecular weight lands at 248.18 g/mol. Most batches showcase strong water solubility, a transparent crystalline appearance, and a faintly salty taste. The substance melts around 48°C, though it starts losing its water of crystallization at temperatures above room level. Chemists know its reducing power, which helps neutralize halogens, bleach, and many oxidizers in a flash. That same reduction knack fuels the antidote effect against cyanide, joining up with cyanide ions to form harmless thiocyanate.

Technical Specifications & Labeling

Pharmaceutical labeling never skips the basics—assay value, water content, heavy metal limits, clarity of solution, and pH range—owing to BP, EP, and USP checklists. Most medical-grade materials fall within 99.0% to 101.0% Na2S2O3·5H2O by dry weight. Labels highlight any stabilizers, residual sulfites, or secondary ingredients, especially for injectable grades. Proper labeling reduces risk of dosage mistakes and guides clinicians, whether treating calciphylaxis or prepping an antichlor solution in dialysis units. Packaging, with tamper-proof seals and clear batch numbers, nails the traceability crucial for recalls or adverse reaction tracking.

Preparation Method

Walk into an industrial plant and you’ll find sodium thiosulfate made by bubbling sulfur dioxide through a chilled sodium sulfite solution. The chemical marriage forms thiosulfate, which then crystalizes upon concentration and gentle cooling. Stringent GMP controls set water quality, vessel materials, and filtration to weed out heavy metals or unreacted sulfur byproducts. For pharmacopoeia-grade batches, repeated recrystallization and purity checks stay routine. Waste-handling addresses even the small, non-hazardous sushi of sulfate byproducts, keeping environmental inspectors off the company’s back and maintaining trust in pharma supply chains.

Chemical Reactions & Modifications

Ask a chemist and he’ll rattle off reactions in seconds. Sodium thiosulfate reacts briskly with iodine—turning brown solutions clear, which helps clean up excess halogen in food testing or swimming pools. It neutralizes chlorine in a snap too, a favorite in tap water treatments before samples head to cell culture. Modified forms rarely see action in mainstream pharma, but researchers search for new coordination complexes and derivatives, aiming for longer shelf-lives or improved stability. Access to both bulk and small-batch modifications lets scientists adjust sodium thiosulfate for oncology infusions or rare metabolic disorder treatments.

Synonyms & Product Names

In English, French, German, or Japanese, sodium thiosulfate’s identity changes just a bit. Some call it thiosulfuric acid, disodium salt, pentahydrate, hypo, or sodium hyposulfite. Pharmacies might see it listed under Na2S2O3·5H2O in raw material lists, while analytical labs stick to IUPAC or EINECS nomenclature for regulatory compliance. Such diversity in language sometimes brings headaches for inventory managers, who juggle between synonyms while meeting auditor demands for clear and complete documentation. Suppliers don’t get far skipping the synonyms table on procurement paperwork, especially during cross-border medical audits.

Safety & Operational Standards

Hospitals never receive sodium thiosulfate without a safety data sheet stapled to its case. At most facilities, PPE—goggles, gloves, and lab coats—remain mandatory, since dust can irritate skin or eyes and spillage creates slick, accident-prone floors. In medical treatments, risks stay low at recommended intravenous doses, but rapid boluses sometimes trigger nausea or mild hypotension, so clinicians monitor patients closely. Within the plant, operators lean on local exhausts and dust suppression to keep airways and hands safe from repeat exposures. The chemical itself is not highly toxic, but mishandling big shipments leads to unnecessary workplace incidents.

Application Area

Sodium thiosulfate lives a double life. On one side, doctors use it in emergencies—neutralizing cyanide after smoke inhalation or nitroprusside overdose, and reversing some toxic effects in calciphylaxis for kidney failure patients. On the other, techs in municipal labs rely on it for water dechlorination, fixing silver-based photographs, and treating wastewater. Dentists sometimes use it to soothe oral ulcerations. Each field applies different regulatory pressure. Medical applications require residue testing and sterility, which can triple cost compared to technical grade. Despite this, hospitals keep bulk inventory on hand for its life-saving role.

Research & Development

Universities and health agencies fund studies on sodium thiosulfate every year. Recent trials examine its effect on chronic kidney disease and vascular calcification, which disables many patients who spend years on dialysis. Researchers dig deeper into dosing regimens to minimize side effects and search for oral formulas that sidestep IV drips. Analytical chemists expand its scope with new complexes, creating diagnostic agents or imaging enhancers. Innovations move slowly from pilot scale to approved therapy, given the stringency of FDA and EMA requirements, but strong teamwork from academic and pharma circles keeps the momentum going.

Toxicity Research

Judging from published studies, sodium thiosulfate rarely triggers severe toxicity in humans when properly dosed. Animal studies show wide safety margins, but reckless administration—overdose or rapid IV push—can present headaches, vomiting, hypotension, or even severe calcium depletion. Children and those with renal impairment bear a higher risk, pressing the need for strict infusion guidelines and complete clinical monitoring. Toxicologists test metabolites in blood, urine, and tissues to understand elimination kinetics. The relative safety doesn’t mean ignoring detailed training for new clinicians or skimping on product purity, so batch testing persists in every hospital pharmacy.

Future Prospects

Looking ahead, sodium thiosulfate draws growing attention from nephrologists and emergency physicians as new research highlights its benefits in soft tissue calcification, hearing loss prevention during chemotherapy, and potential roles in rare mitochondrial disorders. Formulators hunt for more stable injectable formats, freeze-dried powders, and easy-to-administer tablets. Raw material shortages and global supply chain hiccups nudge manufacturers to scout for new suppliers and rethink regional sourcing models. Advances in cytokine research may unlock additional therapeutic angles, driving up demand as new protocols earn regulatory nods. Investment in cleaner, greener synthesis and packaging could also shrink pharma’s environmental footprint while keeping pace with the world’s need for reliable, effective sodium thiosulfate.




What is Sodium Thiosulfate BP EP USP Pharma Grade used for?

The Heart of the Matter: Medical Uses of Sodium Thiosulfate

Few chemicals carry the medical importance of sodium thiosulfate, especially the pharmaceutical grade versions that meet BP, EP, and USP standards. In hospitals, nurses reach for sodium thiosulfate to counteract cyanide poisoning. It’s a real lifesaver in emergencies, acting as an antidote that helps the body neutralize cyanide, converting it into a less toxic substance that the body can flush out through urine.

Doctors also use it in the treatment of calciphylaxis, a painful and often deadly condition seen in patients with late-stage kidney disease. Sodium thiosulfate makes a difference for these people by helping dissolve calcium deposits in blood vessels and soft tissue, offering relief where few options exist. Without access to the pharma grade quality, these vital applications wouldn’t be possible because lower purities or contamination can cause complications for already vulnerable patients.

Impact on Cancer Care and Chemotherapy

Oncology teams see another important side of this salt’s story. After some chemotherapy drugs, hearing loss in children keeps parents up at night, even if the cancer battle gets won. Sodium thiosulfate, given after specific chemotherapy treatments like cisplatin, lowers the risk of permanent hearing loss. Clinical trials keep confirming its value. A 2018 NEJM study showed a significant drop in hearing damage when sodium thiosulfate was added to the protocol for pediatric cancer patients. This sort of evidence brings direct hope to families and patients—proof that research delivers benefits that reach hospital rooms in real life.

Role in Medical Laboratories and Research

Walk into a clinical lab and you’ll notice sodium thiosulfate on the shelves. Lab techs use it to neutralize chlorine in water samples for microbiological testing. This kind of detail only works when the chemical arrives in pharma grade. Anything less, and test results could get skewed, possibly leading to a misdiagnosis or wasted resources. I saw this firsthand volunteering at a clinic, where tight control over chemical purity made all the difference on a quality assurance audit.

What Makes Pharma Grade Different?

It’s not enough to grab any version of this compound off the supply room rack. Pharma grade sodium thiosulfate means the manufacturer followed strict guidelines set by big regulatory bodies like the British Pharmacopoeia, European Pharmacopoeia, and United States Pharmacopeia. These standards protect patients, ensuring that every dose meets precise requirements for purity, stability, and safety. I’ve spoken to pharmacists who double-check certificates of analysis because they know patients depend on these standards being met, every single time.

Safeguarding Quality and Trust in Healthcare

Without proper oversight, even a time-tested antidote like sodium thiosulfate can become risky. Regulatory agencies require pharmaceutical suppliers to submit to regular inspections, audits, and paperwork, all to protect the final user. Those processes help prevent tragedies like contamination scandals seen in some parts of the world. Doctors and nurses can do their jobs because they trust what’s in the IV bag matches the highest quality standards.

Facing Challenges Ahead

There’s a call for better global access, especially in low-resource settings where both quality and supply can fall short. Public and private sector investment in strong regulatory systems, better training, and transparent supply chains matters for keeping patients safe. It’s easy to forget the humble chemicals behind daily care—until one patient’s life depends on it.

Sodium thiosulfate BP EP USP pharma grade proves that every ingredient counts in healthcare, and any shortcut puts patients at risk. Focusing on accuracy, vigilance, and high-quality sourcing isn’t optional—it’s essential for medicine that works and restores hope.

What are the specifications and purity levels of this product?

Beyond the Label: The Real Weight of Product Specifications

Any time a new product arrives on the market, especially in chemicals or supplements, people want straight answers about exactly what’s inside. What shows up on the specification sheet isn’t just for show—it’s the backbone for trust, safety, and purpose. Whether it’s a fine powder for research or a food-grade compound for daily use, specs answer a couple of critical questions: what are you putting in your process, and will it really do what you expect?

From the factory floor to the pharmacy, purity levels play a starring role. Impurities—trace metals, residual solvents, environmental contaminants—can drift in even during the best manufacturing processes. No system is immune to the tiny quirks of chemistry and supply chains. Getting clear numbers on things like assay (how much of the main ingredient you’re actually getting), water content, and byproduct concentrations goes a long way for people who need to vouch for product performance and avoid nasty surprises down the line.

Why Purity Numbers Mean So Much on the Ground

Pure doesn’t always mean perfect, but it means predictable. Over the years, I’ve seen what happens when mislabeled or low-grade material sneaks into labs or production lines—reactions stall, colors shift, and, suddenly, you’re tossing out batches and eating the costs. High-spec materials, up in the upper nineties percentile, let engineers and scientists sleep a little easier. Food and pharmaceutical grade standards go the extra mile, demanding even tighter controls. For example, pharmaceutical active ingredients often push past the 99% mark, not just to do what they’re meant to, but to dodge hidden risks from unknown or unregulated contaminants.

Outside strict science, those numbers still tell their own story. In nutritional supplements, high purity can cut out allergens, heavy metals, or banned substances. In manufacturing, pure ingredients mean fewer hiccups and greater consistency in end goods. Without clear, detailed specifications, everyone down the line—from the worker at the mixing station to the consumer—takes a gamble.

The Shortfalls and Scrutiny in Spec Sheets

It’s tempting to scan a spec sheet and take everything at face value. Trust, but verify—lab audits, third-party certificates of analysis (CoAs), and batch tracking matter more than ever. Economic pressures sometimes push companies to trim corners. Dilution, substitution, or lazy sampling sneak up slowly when unchecked. Stories from the field show it: one missed contaminant spirals into recalls or regulatory headaches.

I still think about a case early in my career where a supplier delivered an ingredient with just a couple decimals below the spec—but that tiny slip scrambled an entire line of experiments. Chasing answers wasted weeks. Ever since, I push for regular third-party sampling and transparent sharing of the whole analytic profile—not just the highlights.

Solutions for Honest Specifications

Trust grows with transparency. Full-panel testing gives buyers a full spectrum look at what comes in the container. Sharing batch numbers and tracking each lot means that if a problem pops up—or if regulators call—there’s a paper trail. Every supplier worth their salt should willingly hand over up-to-date CoAs and offer clarification about oddities on the readout.

When specs and purity overlap with health, safety, and quality, shortcuts just don’t pay. Industry groups that set gold-standard testing protocols lift the tide for everyone. Smart regulation, routine audits, and honest communication between suppliers and customers build a system where specs aren’t just fine print, but the foundation for real confidence at every step—on paper and in practice.

Is this grade suitable for pharmaceutical and medical applications?

Trust and Safety in Every Batch

Growing up, medicine always felt reliable. You go to the pharmacy, expect the products to work, and trust that they do no harm. That confidence has a foundation—manufacturing standards. In pharmaceuticals, the grade of every ingredient tells a story about safety and trust. It’s not about sweeping labels or marketing gloss; it’s about real standards, tested integrity, and patient health.

Quality Standards and What They Really Mean

Imagine a drug, as simple as a tablet for a headache. The active ingredient grabs the spotlight, but every inactive additive—the fillers, binders, and coatings—matters for safety just as much. Pharmaceutical-grade means strict controls on purity and contaminants. Ingredients live up to a pharmacopeial standard, such as USP, EP, or JP, which means rigorous testing for everything from heavy metals to microbial contamination.

Consumers benefit from these strict limits. Take, for example, talc. Cosmetic-grade talc might look just as white and powdery as the pharmaceutical-grade variety. But only the latter endures batch testing to verify the absence of asbestos, and only the latter meets the documentation needed for full traceability. The standard is clear: every lot must pass these safety checks—no exceptions, no shortcuts.

Consequences of the Wrong Grade

During my years working with pharmacists, I saw firsthand what happens when suppliers cut corners. Even trace elements of impurities in a non-pharmaceutical grade can spell disaster—unwanted side effects, toxic interactions, recalls, or lawsuits brought by injured patients. The news cycles occasionally catch stories about contaminated raw materials slipping into circulation. Those cases do not just damage reputations; they harm real people who may already be vulnerable.

Consistency is a core principle. If a tablet or injectable isn’t consistent from batch to batch, the efficacy of treatment and the safety profile are both at risk. The U.S. FDA, EMA, and other regulators carry out inspections not only at the finished product stage but throughout the entire supply chain. Audits require documentation that shows every ingredient meets published standards. Even now, recalls often start when a supplier tries to offer an “industrial” or “food-grade” variant for a pharmaceutical use. Risks then grow quietly in every bottle.

Continuous Vigilance and Room for Improvement

It’s tempting to trust a label or a supplier without checks. But regulations exist for a reason. Open dialogue between manufacturers, suppliers, and clinicians must keep the focus on robust quality controls. Regular third-party audits and clear, detailed Certificates of Analysis support transparency. Digital batch tracking can also detect deviations before they reach patients, giving health professionals and consumers greater security.

Change doesn’t happen in isolation. Feedback from clinicians and pharmacists on incidents or near-misses informs new rules. Greater collaboration with regulators and standards organizations helps refine what “pharmaceutical grade” really requires, especially as novel therapies and manufacturing technologies evolve. The path forward asks everyone in the system to stay curious, to question the source and suitability of every ingredient. Only then does that simple pill or vial on the shelf retain the trust families like mine count on.

How should Sodium Thiosulfate BP EP USP Pharma Grade be stored and handled?

Why Storage Conditions Shape Quality

Sodium thiosulfate shows up across the pharma world, especially in the lab and in manufacturing. The science behind its stability isn’t mysterious, but ignoring good storage often leads to spoiled batches and headaches for staff. It comes as a white, crystalline powder or sometimes flakes, looking innocuous enough. Little details catch up fast: it absorbs water from air and breaks down under harsh conditions. I’ve seen storerooms turn valuable chemicals into cake-like lumps that no one trusts anymore—all because the air was just a bit too humid.

Humidity and Temperature Call the Shots

Dry air remains the cardinal rule for housing sodium thiosulfate. If the storage area gets damp or the packages get left open, the contents clump and sometimes dissolve, spoiling both appearance and function. Temperature sets another baseline. At typical room temperature, sodium thiosulfate stays stable, but heat ramps up the risk. Put it next to a steam line or near direct sunlight and you’ll run into decomposition, giving off sulfur dioxide fumes that corrode both lungs and metal shelving. A cool, shaded, and dry environment keeps problems far away.

Packaging That Keeps Out Trouble

It doesn’t matter how tight your workflow gets if packaging lets in air or moisture. Sealed fiber drums or high-quality plastic pails, lined with moisture barriers, work best. I recall a project that lost two full drums to humidity before switching to proper lined containers with tight lids. Labels must stay clear, showing material grade and storage instructions. Every worker appreciates when the next batch comes with visible warnings about moisture and heat.

Handling Hazards: Eyes Wide Open

Direct contact with sodium thiosulfate rarely causes drama. On my roughest days, a little skin exposure meant little more than a quick wash. Eyes tell a different story. Powder can irritate if you rub your face or skip goggles. Simple gloves, dust masks, and eyewear mean fewer injuries and less paperwork. Spills attract more trouble if ignored—even a thin layer turns slippery, endangering people moving through the area. Scooping up material, then cleaning the floor with water, always proved smarter than hurrying to finish the job.

Cross-Contamination: One Bad Move Is Enough

In pharma production, cross-contamination can block an entire shipment from release. Sodium thiosulfate must stay away from acids and oxidizers. The stuff reacts in nasty ways, giving off sulfur dioxide or even sulfur. Once, a leaky drum stored too close to common acids set off alarms and called for emergency cleaning that stretched into a full day of lost work.

Training and Documentation Make a Real Difference

Nothing beats solid training and clear documentation. Workers who understand the risks, from humidity to mishandling, treat materials—and each other—better. I saw shops cut their spoilage in half just by going over handling steps every quarter. Records showing storage temperatures and humidity help catch problems early, saving both money and reputation.

Safe, careful storage and daily attention to how sodium thiosulfate gets handled save product and keep teams healthy. In pharma, everyday actions count more than fancy slogans. Reliable packaging, clean labeling, and keeping the work area organized make these chemicals work for us, not against us.

What packaging sizes are available for Sodium Thiosulfate BP EP USP Pharma Grade?

Looking at What’s Actually Available

Pharmaceutical-grade sodium thiosulfate lands in hospitals, compounding pharmacies, manufacturers, and labs in a surprisingly varied range of packaging sizes. Many folks picture industrial barrels or sacks when they hear “bulk chemicals,” but pharma standards require cleaner, more controlled packaging—think less dust, fewer contaminants, and a stamp of compliance with the British (BP), European (EP), and United States (USP) Pharmacopoeias.

Small Units: Steady Hands and Precise Measurements

Practitioners often see sodium thiosulfate in 100-gram, 250-gram, or 500-gram bottles. These small containers serve hospitals and pharmacies with modest compounding or antidote needs. Easily handled and resealed, they make sense for specialized labs or clinics mixing fresh solutions. Single-use vials or pre-packed ampoules can also pop up when sterility and accuracy carry extra weight. Packaging this way helps cut down on tampering and cross-contamination, which matters deeply in pharma environments.

Medium Packaging: Good Balance for Medium Operations

Pharmaceutical distributors and contract manufacturing organizations commonly work with 1-kilogram, 5-kilogram, or 10-kilogram tamper-evident HDPE drums or bags. In daily operations, this size bracket offers balance: not so small that refills or reorder requests slow down the lab, but not so big that you end up storing the chemical longer than safety procedures allow. These drums and bags usually come double-lined or with moisture barriers because sodium thiosulfate clumps up if it catches humidity.

Bulk Supply for Manufacturing

On the manufacturing floor, scale goes even bigger. Drum sizes stretch from 25 kilograms to 50 kilograms. IBC (intermediate bulk container) totes or lined fiber drums become more common for facilities producing hundreds or thousands of units of injectable products, dialysate concentrates, or even photographic fixer. I can recall walking through a pharmaceutical warehouse, seeing rows of 25-kg drums because that’s the sweet spot for automated feeders—easy enough for a forklift, but large enough to supply a production run.

Pharma grade sodium thiosulfate demands tough packaging. Rigid HDPE drums, steel drums with interior liners, or fiber drums with polyethylene inners—these protect the chemical from light, moisture, and contamination. Product traceability and labeling must match strict batch documentation, which is no place for shortcuts.

Safety and Environmental Considerations

Safety, transport, and storage regulations shape how big you’ll see packages. Any material classified as hazardous (even slightly so) rides in packaging designed for the long haul: UN-rated barrels and drums withstand bumps in the supply chain. Smaller containers, sealed and tamper-evident, cut down on exposure during use. The pharmaceutical sector faces mounting pressure for eco-friendlier packaging, so more suppliers now offer drums made from recyclable, food-grade plastic or use liners that reduce waste volume after use.

What’s Best for Each User?

Every healthcare setting and manufacturer favors a different size. The solo compounding pharmacist finds more value in small HDPE bottles—less waste, more nimbleness. Manufacturing outfits reach for palletized drums. Even within a single company, the requested size depends on what’s being made that week. The drive for cGMP compliance and lean distribution makes packaging decisions more than a logistical issue; it directly shapes quality and cost.

Choices in packaging sizes for sodium thiosulfate BP EP USP aren’t just numbers—they influence workflow, efficiency, and safety. There’s no perfect container, only the best fit for the job and the standards that need meeting.

Sodium Thiosulfate BP EP USP Pharma Grade
Names
Preferred IUPAC name sodium thiosulfate
Other names Sodium Hyposulfite
Thiosulfuric Acid Disodium Salt
Disodium Thiosulfate
Pronunciation /ˌsəʊdiəm ˌθaɪ.əˈsʌl.feɪt/
Identifiers
CAS Number 7772-98-7
Beilstein Reference 3566510
ChEBI CHEBI:32119
ChEMBL CHEMBL1201159
ChemSpider 21510
DrugBank DB00764
ECHA InfoCard 03-2119445825-43-0000
EC Number 231-867-5
Gmelin Reference 8739
KEGG C01380
MeSH D013604
PubChem CID 24846
RTECS number WB4900000
UNII 6F5P9X387T
UN number UN3077
Properties
Chemical formula Na2S2O3
Molar mass 158.11 g/mol
Appearance White, crystalline powder
Odor Odorless
Density 1.667 g/cm³
Solubility in water Freely soluble in water
log P -4.45
Acidity (pKa) ~11.96
Basicity (pKb) 10.06
Magnetic susceptibility (χ) -8.9×10⁻⁶
Refractive index (nD) 1.448
Dipole moment 0 D
Thermochemistry
Std molar entropy (S⦵298) 165.0 J·mol⁻¹·K⁻¹
Std enthalpy of formation (ΔfH⦵298) -635.0 kJ/mol
Std enthalpy of combustion (ΔcH⦵298) -360.4 kJ/mol
Pharmacology
ATC code V03AB06
Hazards
Main hazards May cause irritation to eyes, skin, and respiratory system.
GHS labelling GHS07, GHS hazard pictogram: exclamation mark, Signal word: Warning
Pictograms GHS07,GHS09
Hazard statements Not a hazardous substance or mixture according to Regulation (EC) No. 1272/2008.
Precautionary statements Precautionary statements: P264, P270, P301+P312, P330
NFPA 704 (fire diamond) Health: 1, Flammability: 0, Reactivity: 0, Special: -
Lethal dose or concentration LD50 (oral, rat): >5000 mg/kg
LD50 (median dose) Oral rat LD50: > 5,000 mg/kg
NIOSH WN5070000
PEL (Permissible) Not Established
REL (Recommended) Recommended Exposure Limit (REL): 5 mg/m³ (as nuisance particulate)
IDLH (Immediate danger) Not established
Related compounds
Related compounds Sodium sulfate
Sodium sulfite
Sodium bisulfite
Sodium tetrathionate
Potassium thiosulfate
Calcium thiosulfate
Ammonium thiosulfate