Chengguan District, Lanzhou, Gansu, China sales01@liwei-chem.com 1557459043@qq.com
Follow us:



Cysteine Hydrochloride BP EP USP Pharma Grade: A Deep Dive

Historical Development

Cysteine hydrochloride carved out its spot on pharmacy shelves over a century ago, riding the momentum of early amino acid research that disrupted older ideas about basic nutrition. Back in the early 1900s, chemists worked hard to isolate and characterize amino acids using methods that look laborious today. Cysteine emerged as a critical discovery, bringing with it a chance to treat malnutrition, liver problems, and respiratory issues in a direct, reliable way. Over time, pharmaceutical formulation standards evolved under strict pharmacopeias like BP (British Pharmacopoeia), EP (European Pharmacopoeia), and USP (United States Pharmacopeia). These regulatory bodies set the tone for purity and safety benchmarks, making sure what ended up in a vial matched what textbooks and researchers promised. Cysteine hydrochloride’s journey mirrored the transformation in global medicine, from the rough first extractions to present-day tight specs demanded by regulators and clinicians.

Product Overview

Cysteine hydrochloride comes as a pharmaceutical ingredient that brings versatility and proven performance. Created by combining the amino acid L-cysteine with hydrochloric acid, this compound offers water solubility and stability that make it well-suited for intravenous and oral solutions. Its role as a component of total parenteral nutrition (TPN) gives it life-saving significance, especially in neonatal and critical care, where protein synthesis and antioxidant defenses matter every single day. Beyond clinical use, food and biotechnology sectors value its reducing properties and ready reactivity, both of which open up uses from baking to protein processing.

Physical & Chemical Properties

Cysteine hydrochloride typically shows up as a white, crystalline powder sporting a slight sulfur-like odor. It dissolves quickly in water, forming a clear solution, but stays quite insoluble in organic solvents. Chemically, its structure stacks an amino group, a carboxyl group, a thiol side chain, and a hydrochloride moiety. This structure brings about the compound’s reducing power, pivotal in both metabolism and industrial processes requiring breakage or rearrangement of disulfide bonds. With a melting point around 175°C (decomposition) and a pH in aqueous solution near 1.5-2.0, this ingredient plays well in the hands of professionals familiar with complex compounding recipes.

Technical Specifications & Labeling

Pharma grade cysteine hydrochloride never takes shortcuts on its specification sheet. Products lining up under BP, EP, or USP stamps come with rigorous certificate of analysis reports, spelling out minimum purity (often above 98%), specific optical rotation, chloride content, heavy metal thresholds, and microbial limits. Labels warn explicitly against use beyond expiry and flag any deviation from batch quality to prevent dosing errors or contamination. Clear warnings on safe storage — away from moisture and high temperatures — reflect real discomfort from costly batch recalls and safety audits triggered by unstable ingredients.

Preparation Method

Manufacturers begin with fermentation via select microbial strains or hydrolyze animal- or plant-derived proteins under controlled conditions. Following isolation and purification, the cysteine is reacted with hydrochloric acid, yielding cysteine hydrochloride. Process controls wield a major influence here: any slip in pH, reaction time, or temperature throws off yield and purity, risking out-of-spec product. Final purification often employs activated carbon, filtration, and crystallization steps. The sequence has improved year by year as analytical techniques enable near-real-time tracking of impurities and runaways.

Chemical Reactions & Modifications

Cysteine hydrochloride’s value rises from its reactive thiol group. In the lab, this group easily gives up hydrogen atoms, opening doors for reduction of disulfide bonds in peptides and proteins. That same thiol plays a role in Maillard reactions found in food chemistry, giving baked goods and meats richer flavors. Chemists sometimes modify cysteine hydrochloride through alkylation, oxidation, or enzymatic reactions to synthesize therapeutic agents, build protective agents against liver toxicity, or enhance antioxidant power. In diagnostics, derivatives like S-carboxymethylcysteine show up as mucolytics or chelating agents.

Synonyms & Product Names

Pharmaceutical catalogs list cysteine hydrochloride by many aliases. Besides L-cysteine hydrochloride monohydrate, one finds names like 2-amino-3-mercaptopropionic acid hydrochloride, cysteine HCl, or HCl salt of L-cysteine. Trade names and catalog codes often muddy the waters, especially for buyers comparing global sources. This odd linguistic tangle in pharmaceutical commerce means researchers and buyers learn to double-check regulatory monographs and chemical abstracts registry numbers to avoid nasty surprises.

Safety & Operational Standards

Real-life handling of cysteine hydrochloride takes training and respect for established protocols. Dust inhalation or direct skin exposure can prompt irritation and even allergic responses. Personnel stick to gloves, lab coats, and face masks during weighing and transfer, especially in busy compounding labs or large-scale plants. Material safety data sheets back up these practices, carrying details from spill response through disposal. Pharma production floors enforce batch traceability, double-checking every label, log entry, and lot code. Quality assurance teams work overtime to ensure every release meets GMP (Good Manufacturing Practice) rules—not because it’s an abstract requirement, but because actions in the plant ripple all the way down to patient bedsides.

Application Area

Hospitals and compounding pharmacies draw from cysteine hydrochloride’s strengths every day. Pediatric wards depend on it for life-saving TPN regimens, where premature infants cannot take regular feeds. Emergency rooms and ICUs lean on it during acute hepatic failure or acetaminophen overdose, where restoring glutathione levels might tip the balance between recovery and disaster. Food and beverage industries use it to improve dough properties, enhance flavors, and stabilize products; hair care and cosmetics rely on its reductive power during perming and hair-strengthening. In my time working alongside clinical pharmacists, I saw firsthand how every batch, every label check, every dosing calculation performed with cysteine hydrochloride meant one more step toward giving real people a fighting chance.

Research & Development

Cysteine hydrochloride continues to attract research investment, especially where protein engineering or tailored nutrition requirements take center stage. Investigators probe its antioxidant mechanisms, trying to harness or modulate its impact on cell damage and repair. Drug delivery sciences explore prodrug formulations that release cysteine at the right spot in the body, tracking the compound’s journey using advanced imaging and metabolic tracing. Innovations in fermentation and purification cut down on environmental impact and boost yield, reflecting the growing demand and tightening sustainability expectations across the industry.

Toxicity Research

Cysteine itself forms part of human metabolism, but its concentrated pharmaceutical salt form brings risks if misused or overdosed. Toxicology studies nail down safe dosing ranges, flagging risks from excess accumulation like metabolic acidosis, renal burden, or neurological impacts—particularly in those with underlying metabolic disorders. Rodent studies, clinical monitoring, and post-market surveillance programs all feed back crucial data to regulators and practitioners. In the late 20th century, research emerged mapping out safe limits in pediatric populations and for patients on long-term TPN, reshaping treatment protocols and driving home the significance of regular lab monitoring.

Future Prospects

Demand for cysteine hydrochloride continues to rise, both because of the pressures of modern healthcare and expanding food and pharmaceutical production. Biotechnological advances tease out new microbial strains that deliver higher yields with fewer unwanted byproducts, hinting at cheaper, greener methods. Gene editing and enzyme engineering bear potential for even more precise synthesis. The expanding market for individualized medicine and advanced nutraceuticals positions cysteine hydrochloride as more than an afterthought ingredient—it’s a tool with growing scientific and commercial traction, driven by data and a deeper understanding of human metabolism’s complexity.




What is Cysteine Hydrochloride BP EP USP Pharma Grade used for?

Why Cysteine Hydrochloride Matters in Pharmaceuticals

Whenever someone picks up a pack of tablets at the pharmacy, few people think about each molecule inside. Cysteine Hydrochloride Pharma Grade matters far more than most realize. In my view, this amino acid derivative doesn’t just pop up in chemistry textbooks. It shapes the way many medicines work and how they reach their intended effect.

The Building Block With Deep Roots

I have seen cysteine described as a “building block” in health circles, but what does that mean in the real world of medicine? As an amino acid, cysteine forms part of the proteins that keep the body running smoothly. In pharmaceutical production, though, it plays a specific and vital job. The “hydrochloride” part makes it more stable and easier to use in different types of medicine — including injections and oral drugs.

Cysteine Hydrochloride shines most in making injectable solutions. Humans often need amino acids delivered straight into the bloodstream during surgical recovery, trauma, or severe illness. Clinical teams depend on precise control over these solutions, and pharmaceutical manufacturers depend on consistent, high-grade ingredients like this one.

More Than Just a Supplement

It’s tempting to lump cysteine with everyday supplements, but what happens in pharma settings takes things up a notch. Manufacturers use strict European (EP), British (BP), and U.S. (USP) pharmacopoeial standards for purity and safety. As someone interested in the medical field, I see why these standards matter — small impurities can cause serious side effects, especially for people with weakened immunity or critical illnesses.

Doctors sometimes rely on cysteine hydrochloride in parenteral nutrition. This isn’t about boosting your daily protein shake. It’s about supporting patients who can’t eat or process food on their own. Babies born premature, for example, depend on nutrients delivered this way in neonatal care. Medicines for chronic conditions may also incorporate cysteine hydrochloride to improve their stability or extend shelf life.

Clearing Up Misconceptions

Some people get nervous when they see complex chemical names on a medicine label. In my experience, education makes the difference. Clear information about the ingredients and roles of compounds like cysteine hydrochloride helps foster trust between healthcare providers and patients. Transparency from pharmaceutical companies goes a long way in building that trust — after all, every milligram in a vial can impact real outcomes.

Challenges and Ways Forward

One persistent issue involves sourcing reliable raw materials. Changes in global supply chains and growing demand from both medicine and food industries put pressure on cysteine hydrochloride production. Experts in the supply chain field have pushed for better traceability, more robust supplier audits, and increased investment in local production infrastructure.

I have heard pharmacists and physicians call for improved training on pharmaceutical-grade amino acids to avoid dosing errors. Hospitals benefit from tighter coordination between purchasing managers, pharmacy teams, and care providers. Consistent guidelines help keep quality high and risk low.

Regulators and industry leaders continue to refine safety and purity requirements. As research marches on, the importance of quality control and ethical sourcing will only grow. In the eyes of the patient, every detail in that little vial matters. That’s why people in science, medicine, and manufacturing have to work together every single step of the way.

What are the specifications and purity levels of this product?

Why Purity Levels Matter

Walk into any lab or factory, and you’ll quickly notice people care about purity like chefs care about their ingredients. Purity in a product separates reliable results from wasted time. In a chemical, for example, an impurity can throw off a reaction or cause unexpected problems down the line. At home, nobody wants to find out their vitamin supplement is mostly filler. Customers have learned—sometimes the hard way—that quality isn’t just a luxury; it protects them, their teams, and often, their businesses.

Diving Into Specifications

Specs spell out exactly what buyers get with a product. For chemicals, this information covers things like molecular weight, assay (which tells us what fraction of the material matches what’s listed), melting and boiling points, plus any key impurities and heavy metals. In industries like food and pharmaceuticals, these numbers aren’t for show. If a product doesn’t meet pharmaceutical grade, it shouldn’t end up in medicine. In manufacturing, minor flaws or unwanted trace elements can mean equipment breakdowns or entire batches going in the trash.

Lab work I’ve done showed how even a half-percent off in purity led to failed tests. Even if the numbers seem small, the results never lie. Take sodium chloride as an example: common table salt needs to be pure enough for eating, but for medical saline, the bar goes higher. Each application has different stakes, and that’s why the listed specifications include everything from percent purity to color, moisture, and limits on lead, arsenic, or other hazards.

Testing and Trust

Trust doesn’t come from labels alone. Companies back up their claims with certificates of analysis (COAs) that lay out test results in black and white. Independent labs verify batch purity using well-established methods—from gas chromatography for organics to ICP-MS for metals. Across industries, regulatory bodies like the FDA, EPA, European Medicines Agency, and ISO help define what’s acceptable. You’ll often see products labeled as “USP grade” or “analytical reagent grade,” signaling they meet these tough standards.

From a business perspective, losing trust means losing customers. Recalls or lawsuits over corners cut can bankrupt even big brands. On an individual level, nobody feels safe using a product from a shady source. This goes for pharmaceuticals, food, industrial chemicals, and more. In my experience, clear and detailed specs go hand in hand with good business practices.

Challenges and Moving Forward

Fakers and shortcuts still show up, especially when demand spikes. Counterfeit or adulterated goods pop up everywhere—from bogus supplements to fake electronics. Technology offers some help. Rapid testing kits and blockchain-based tracking provide stronger ways to trace and verify products, though adoption takes time. Education helps too. When buyers understand how to read a certificate or spot red flags, bad actors find it harder to operate.

People often overlook the work that goes into delivering a reliable product. Quality costs money and time, but cutting corners isn’t worth it in the long run. In my work, I’ve seen that high standards not only reduce risk but let everyone down the chain sleep easier. Groups that share honest data, make tech upgrades for quality control, and reward rigorous suppliers will shape the future, pushing out those who play fast and loose with their specs or purity claims.

Is it suitable for pharmaceutical and food industry applications?

Getting Down to the Basics in Manufacturing Safety and Purity

Folks in the pharmaceutical and food industry know safety matters more than anything else. Every day, a single misstep can ripple from a lab bench or factory floor right into someone’s home or hospital bed. Protecting consumers relies on consistency, purity, and trust—not just buzzwords, but real results we can stand behind.

I think back to my days visiting small pharmaceutical plants, watching operators in hairnets carefully measure out each ingredient with an eye trained by years of routine. Those quiet rooms demanded more than good intentions: they needed materials free from contaminants, meeting strict regulatory standards set by groups like the FDA or EFSA. In the food and pharma game, “close enough” won’t cut it—you’re either safe or you’re not.

Meeting Quality Standards Every Time

The pharmaceutical industry carries the weight of people's health. Any excipient, raw powder, or active compound must prove its safety, chemical stability, and traceability. Consumers count on their tablet, cough syrup, or vaccine batch knowing each contains exactly what the label promises. There’s no room for shortcuts when testing for heavy metals, residual solvents, or microbial contamination; labs run through certificate after certificate, batch after batch, to catch even the smallest slip.

Food producers live that reality too. Contamination scandals—salmonella in peanut butter, listeria in frozen veggies—can shake up trust for years. Food-grade ingredients and additives need to align with HACCP plans and ISO norms. Tracing every scoop, every shipment, and every batch guards consumers and brands alike. Today’s consumers want to recognize what’s in their food, so transparency drives ingredient choice as much as shelf life.

Supporting Innovation and Real-World Demands

Pharmaceutical and food innovation thrives when companies can depend on materials that do their job reliably. I recall my cousin, who works in R&D for a global snack company, mentioning how changing a minor ingredient sometimes derails an entire project. A replacement needs not only sensory properties that pass consumer panels, but a supply chain with fewer suprises and a specification sheet any auditor can trust. Even in product launches, small changes—like ingredient origin or mixing process—mean serious paperwork and validation.

The big push for natural and plant-sourced blends makes this even more urgent. Pharmaceutical and food industries face requests for allergen labeling, non-GMO certification, and even animal cruelty standards. Brands now make traceability a selling point with QR codes or online batch lookups. Some companies invest in blockchain or AI-driven tracking software, so no step in the process gets lost or hidden. Experience tells me that whatever the label claims, companies must prove it with documented analysis and real testing.

Getting It Right Is Not Just a Box to Check

My own experience in compliance reviews showed me the pressure teams operate under. A single out-of-spec raw material can spark a recall, cause profit losses, even endanger lives. Strong supplier relationships help—frank communication, supplier audits, and third-party verification all build a safety net. I’ve seen companies expand on-site testing, train teams to spot inconsistencies, and download supplier documentation before even receiving a pallet.

Regulatory bodies such as the FDA or EFSA don’t stop at checking boxes on paperwork—they want to see real, traceable proof that products meet standards from start to finish. Industry players invest in robust documentation systems, analytical equipment, and continuous education to maintain this reputation for safety. Nobody building a pharmaceutical pipeline or food portfolio can cut corners and hope not to get burned. Quality assurance means real work, constant vigilance, and never losing sight of what’s at stake—real lives, real trust, real progress.

What is the recommended storage condition and shelf life?

Everyday Decisions, Long-Term Impact

Most folks toss containers into a cupboard or stock up on sales without much thought about where things sit. Food, medicine, and even household cleaners react to their environment every day. Heat, light, and moisture chip away at what’s inside, sometimes making it less effective, sometimes making it unsafe. That container of flour in a steamy kitchen? The potency drops faster than you think. Vitamins on a sunny windowsill? Potency loss starts within weeks.

Lessons From Home and Work

I’ve learned a thing or two from watching milk spoil and aspirin turn to powder on old shelves. Most products carry instructions for a reason. Aspirin, for example, should stay in a cool, dry spot away from light. Even small temperature swings speed up breakdown. Food is no different. A bag of rice left open for a month takes on moisture, inviting mold and bugs. Professional suppliers know this, so warehouses use climate control and monitor humidity day and night.

How Storage Outlasts Expiration Dates

Manufacturers set shelf life by testing how their products hold up under stress — hot days, cold storage, even rough shipping conditions. They stamp an expiration date that assumes proper storage. Use the right space, and you might gain a few extra weeks’ quality. Ignore it, and shelf life drops fast.

Take antibiotics. The World Health Organization recommends storing them below 25°C, away from light. Ignoring those steps means the medicine loses strength sooner or may not work at all. Food labeling laws push companies to be specific, using “best by” or “use by” dates. Even so, eggs last weeks past the date in a fridge but go bad in days if left out. That’s more about condition than just time.

Solving Storage Slip-Ups

Getting storage right doesn’t take much. Dark cabinets for spices and vitamins, tight lids on grains, low temps for perishables — these habits pay off. In the workplace, stores lean on temperature logs and sealed bins. At home, a thermometer in the pantry or a dehumidifier can make a big difference.

Smart companies have started adding time-temperature strips to packaging, letting folks know if the goods got too warm during shipping. Pharmacies now brief patients about storage when handing over new prescriptions. These steps all help, but real change starts with paying attention at home.

Improving the System for Everyone

Food banks and hospitals sometimes get hit hardest by poor storage. Donations spoil because no one checked the room. Medicine loses value on the shelf. Clearer labeling with icons, public education about what storage means, and more robust mobile cold-chain units can help. For communities dealing with limited refrigeration, low-cost coolers and solar-powered fridges open new doors.

Trust in food and medicine grows when folks know how to store items and when to use them. It comes down to everyday choices — keep things cool, watch out for moisture, and pay attention to labels. Sometimes the difference between fresh and spoiled, safe and unsafe, sits right there on your pantry shelf.

Is the product certified and compliant with BP, EP, and USP standards?

Understanding What BP, EP, and USP Really Mean

Walking into a pharmacy, most people don’t think about where the contents of each bottle come from or who checks if what’s inside is pure and safe. In the pharmaceutical world, it comes down to standards—specifically BP (British Pharmacopoeia), EP (European Pharmacopoeia), and USP (United States Pharmacopeia). Each sets a high bar for quality, safety, and chemical consistency of medicines and raw materials. Companies promising their products meet these benchmarks have shown a real commitment to public health.

Importance of Certification

Growing up with a family member taking daily medication, I remember how much trust went into each pill. People rely on pills to control blood pressure, manage diabetes, or ease pain. No one has time for doubts about what they’re swallowing. A product that passes BP, EP, and USP inspections has gone through a maze of tests—identity, purity, content, and more. These checks block dangerous impurities from ever reaching patients. In a market crammed with new ingredients and manufacturers, certifications give peace of mind and protection against shortcuts.

The Cost of Skipping Proper Checks

Stories pop up every year about recalls, contaminated medicines, or headlines about counterfeit drugs. One of the biggest recalls in the past decade involved drugs tainted with impurities believed to cause cancer, traced back to suppliers skimping on standards or skipping critical tests. A product missing these certifications raises a red flag—its path from lab to market might not have met the safety steps that regulators and patients count on.

Why Certification Takes Real Work

Getting certified isn’t just ticking boxes. It means repeated lab testing, batch after batch, under watchful eyes. Each standard—BP, EP, USP—lays out step-by-step checks: Is the compound as pure as claimed? Are all impurities below safe limits? Does it dissolve as it should? These rules aren’t always the same, and sometimes a company must test a product to multiple standards, adjusting methods and paperwork for each. This level of attention to detail separates trusted suppliers from those cutting corners.

The Broader Impact of Compliance

On the industry side, a certified product fits seamlessly into global commerce. Hospitals, clinics, and pharmacies in different countries all speak the same language of safety when they see the BP, EP, or USP label. Insurance companies and governments show preference for proven products, reducing risk and potential cost from dangerous recalls. Doctors and patients find comfort knowing regulators around the world have signed off on each batch.

Building Trust with Transparency

Companies can’t just claim compliance and call it a day. Real trust comes from sharing detailed reports and certifications, responding to audits, and keeping the process transparent. Customers can ask for documentation and cross-check supplier details. Anyone in the supply chain carrying out these practices builds lasting credibility. I believe that a proven track record and an open approach to certification matter more than flashy packaging or big marketing budgets.

Moving Forward: Raising the Bar

Instead of treating certification as a box to check, companies can see it as a chance to distinguish themselves. Investing in proper testing methods, hiring and training skilled chemists, and routinely checking for compliance turn a product from a commodity into a promise. For end users like my family, or yours, this promise means safer, better care.

Cysteine Hydrochloride BP EP USP Pharma Grade
Names
Preferred IUPAC name 2-amino-3-sulfanylpropanoic acid hydrochloride
Other names Cysteine HCl
L-Cysteine hydrochloride
L-Cysteine HCl
Cysteine monohydrochloride
Cysteine hydrochloride monohydrate
Pronunciation /ˈsɪs.ti.iːn haɪˌdrɒk.ləˈraɪd biː piː iː piː juː ɛs piː ˈfɑː.mə ɡreɪd/
Identifiers
CAS Number 52-89-1
3D model (JSmol) `C([C@@H](CS)N)Cl`
Beilstein Reference 1713613
ChEBI CHEBI:61043
ChEMBL CHEMBL1386
ChemSpider 21544760
DrugBank DB00120
ECHA InfoCard 03b9c454-3a7d-4a42-9faf-2fd177a64f8a
EC Number 52-89-1
Gmelin Reference 8735
KEGG C00097
MeSH D-Cysteine Hydrochloride: "D02AE01" L-Cysteine Hydrochloride: "D02AA27" Cysteine: "D02AA" Cysteine Hydrochloride: "D02AA27
PubChem CID 62638
RTECS number WL7000000
UNII 6M2Q3988VF
UN number UN3077
CompTox Dashboard (EPA) DTXSID20897404
Properties
Chemical formula C3H7NO2S·HCl
Molar mass 175.64 g/mol
Appearance White crystalline powder
Odor Odorless
Density 1.33 g/cm³
Solubility in water Soluble in water
log P -3.4
Acidity (pKa) 8.3
Basicity (pKb) pKb ≈ 7.6
Magnetic susceptibility (χ) Diamagnetic
Dipole moment 9.2 D
Thermochemistry
Std molar entropy (S⦵298) 176.9 J·mol⁻¹·K⁻¹
Std enthalpy of formation (ΔfH⦵298) -206.0 kJ/mol
Std enthalpy of combustion (ΔcH⦵298) -1967 kJ/mol
Pharmacology
ATC code A16AA04
Hazards
Main hazards Hazardous if swallowed, causes skin and eye irritation, may cause respiratory irritation.
GHS labelling GHS07, GHS05
Pictograms GHS05,GHS07
Signal word Warning
Hazard statements Hazard Statements: Causes serious eye irritation.
Precautionary statements Keep container tightly closed. Store in a cool, dry place. Avoid contact with eyes, skin, and clothing. Wash thoroughly after handling. Use with adequate ventilation. In case of insufficient ventilation, wear suitable respiratory equipment.
NFPA 704 (fire diamond) NFPA 704: 1-0-0
Autoignition temperature 260°C
Lethal dose or concentration LD50 (oral, rat): 1890 mg/kg
LD50 (median dose) LD50 (median dose): 1890 mg/kg (Oral, Rat)
NIOSH MW3675000
PEL (Permissible) 10 mg/m³
REL (Recommended) Cysteine Hydrochloride BP EP USP Pharma Grade has a Recommended Exposure Limit (REL) of 5 mg/m³ (as total dust), 8-hour TWA.
IDLH (Immediate danger) 100 mg/m³
Related compounds
Related compounds Cystine
Cysteinamide
N-Acetylcysteine
L-Methionine
Cysteine methyl ester
Homocysteine