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Oxytocin powder (CAS 50-56-6) is a core polypeptide active pharmaceutical ingredient for the genitourinary system. It is a synthetic cyclic nonapeptide hormone. Oxytocin API is a key raw material for the production of clinical drugs for obstetrics and reproductive systems, with irreplaceable clinical value in labor induction, labor augmentation, postpartum hemostasis, and lactation promotion. 50-56-6 serves as its unique chemical identifier, ensuring uniqueness and traceability in global R&D, production, and registration. Oxytocin features precise targeting, rapid onset, clear metabolic pathways, and mild systemic side effects compared with ordinary uterotonic agents. The product is compatible with the development of injections, nasal preparations, lyophilized preparations and other dosage forms, and is a core raw material for safe obstetric medications and reproductive health drug R&D.
Technical Specifications
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Product Name |
Oxytocin |
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Synonyms |
CAS 50-56-6, 50-56-6, Oxytocin API, Oxytocin powder |
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Characteristic |
White to off-white lyophilized powder |
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CAS Number |
50-56-6 |
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Assay |
≥98.5% (HPLC, Subject to the COA) |
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Formula |
C43H66N12O12S2 |
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Package |
Technical Package |
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Storage |
Store at -20℃ |
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Structure |
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We focus on the global supply of high-quality Oxytocin API. Supported by GMP, CEP, and FDA certified partner factories, we provide global pharmaceutical companies with Oxytocin API that meets CP, USP, and EP standards with stable production capacity, strict quality control, and complete registration documentation.
Product Characteristics
High Purity and Compliance with International Pharmacopeia Standards
Oxytocin API (CAS 50-56-6) is produced through solid-phase synthesis, multi-stage chromatographic purification, and sterile lyophilization. Production, subpackaging, and packaging are fully completed in Class D clean areas to control impurities such as peptide fragments, deamidation products, residual solvents, heavy metals, and microorganisms from the source. Core quality specifications: assay ≥98.5%, maximum single impurity ≤0.3%, total impurities ≤0.8%, bacterial endotoxins <1.0 EU/mg, moisture ≤5.0%. These key indicators fully exceed the requirements of Chinese Pharmacopoeia, European Pharmacopoeia, and United States Pharmacopeia, making it suitable for high-safety preparations such as injectable products.
Stable Physicochemical Properties and Wide Compatibility for Formulation Development
Oxytocin powder is a white to off-white loose lyophilized powder, odorless and non-caking, with excellent water solubility. It dissolves quickly in water for injection, buffers and other common pharmaceutical excipients, facilitating formulation preparation, prescription screening, and industrial production. The product has uniform crystal form and stable particle size distribution, and is compatible with sterile lyophilization, injection preparation, nasal spray and other processes.
Metabolic Characteristics
It has a half-life of 1–6 minutes and is rapidly metabolized by the liver and kidneys without accumulation risk. The incidence of adverse reactions is <3%, and the reactions are mostly mild-to-moderate uterine hyperstimulation and nausea, which can be relieved quickly after symptomatic treatment. It is well-tolerated by pregnant and lying-in women.
Full-Cycle Quality Control and Stable Quality
Full-Process Traceability Management
We work closely with GMP-, CEP-, and FDA-certified partner factories to implement full-chain traceability management for Oxytocin API, covering starting materials, peptide synthesis, cleavage and purification, lyophilization, sterile sieving, subpackaging, packaging, and finished product inspection. Each batch of Oxytocin powder (CAS 50-56-6) is assigned a unique batch number. Production processes are recorded in real time, and key process parameters, intermediate testing, and finished product inspection data are retained for at least 5 years, enabling full traceability, verification, and retesting. Complete quality documents are provided with delivered products, including COA, HNMR, LC-MS, and HPLC chromatograms, endotoxin test, and microbial limit test to ensure transparent and reliable quality.
Strict Standard and Compliance Assurance
Oxytocin API is manufactured in strict accordance with ICH Q7, GMP, USP, EP, and CP standards. A full-dimensional testing scheme for injectable polypeptides is implemented. Quality indicators are fully aligned with mainstream international pharmacopeias, supporting drug registration and filing in major global markets including China, the United States, Europe, Japan, and Southeast Asia.
Continuous Quality System Optimization
Supported by continuous technological upgrading of partner factories, we keep optimizing the synthesis and purification processes of Oxytocin API to improve purity and yield while reducing impurity levels and production costs. A complete system is established for deviation handling, change control, stability testing, and annual quality review. Process validation and international benchmarking are conducted regularly to ensure consistent and stable quality of every batch.
Application Scenarios
Oxytocin API is only used as an active pharmaceutical ingredient. It must be manufactured into pharmaceutical products through formulation processes before clinical use. Core applications are as follows:
Labor Induction and Augmentation Preparations
Oxytocin injections prepared with Oxytocin (CAS 50-56-6) as the active ingredient are first-line drugs for term labor induction and labor augmentation due to uterine atony. They take effect immediately after intravenous infusion, and uterine contraction frequency and intensity stabilize gradually within 15–60 minutes, peaking at term pregnancy. They simulate natural labor rhythm, effectively reduce labor induction failure rate, and achieve a labor induction success rate of over 85%, significantly lowering the cesarean section rate and ensuring safe delivery.
Postpartum Hemorrhage Control Preparations
Postpartum hemostatic products made from Oxytocin API are used for uterine hemorrhage caused by uterine atony or poor involution after delivery or abortion. They are recommended as first-choice hemostatic drugs in global obstetric guidelines. Clinical data show that intramuscular injection of 5–10 IU after placental delivery reduces the incidence of postpartum hemorrhage by more than 60% within 24 hours. Standard use reduces the average 24-hour postpartum bleeding by more than 500 mL, greatly lowering postpartum hemorrhage mortality. They are suitable for vaginal delivery, cesarean section and other modes of delivery.
Lactation Promotion Preparations
Oxytocin nasal spray and nasal drops prepared from Oxytocin powder are used for postpartum lactation disturbance. Administered nasally before breastfeeding, they take effect in 3–5 minutes, promoting milk ejection without increasing milk production, with outstanding safety. They act directly on mammary smooth muscle, gently promoting lactation, relieving breast distension and galactostasis, and improving breastfeeding success rate.
Innovative Drug R&D for Reproductive System
With a clear mechanism of action and good safety, Oxytocin API can be used in the R&D of targeted preparations, extended-release preparations, compound preparations and other innovative drugs for the reproductive system. It has broad application potential in uterine function regulation, reproductive rehabilitation, assisted reproduction and other fields, supporting high-quality raw material supply for genitourinary drug development.
Packaging and Transportation
Professional Packaging Solution
Oxytocin API is vacuum-sealed in pharmaceutical-grade low-adsorption peptide-specific bottles or aluminum foil bags with desiccant and light protection. It is further packed with insulated and shock-resistant outer packaging to provide light, moisture, oxidation, and degradation protection, maximizing stability. Customized packaging is available in 10g, 100g, 1kg, 5kg and other specifications.
Compliant Cold-Chain Logistics
Logistics strictly follows pharmaceutical and cold-chain transportation standards. International transportation complies with UN regulations and cold-chain requirements, offering air freight and international express with full temperature monitoring and trackable routes for safe and on-time delivery. We have complete export qualifications, customs clearance documents, and freight forwarding resources to ensure efficient and compliant global logistics services.
Our Advantages
High Standard Quality Assurance
Oxytocin API is supplied by GMP, CEP, and FDA certified partner factories with full strict quality inspection. Assay is stably ≥98.5% with strict impurity control, providing core support for formulation safety, R&D success, and registration approval. Each batch of Oxytocin powder (50-56-6) is provided with a complete test report with traceable and retestable quality.
Flexible Supply and Global Service
As a reliable China Oxytocin supplier, we have extensive global export experience and a complete system for customs declaration, inspection, logistics, and documentation. We can supply Oxytocin API to Europe, the United States, Japan, South Korea, Southeast Asia, the Middle East, South America and other regions. We provide 7×12-hour multilingual rapid response, sufficient in-stock inventory, and support for bulk Oxytocin procurement. Oxytocin in stock ensures fast delivery and stable production for customers.
R&D Support and Customized Services
We provide Oxytocin Free Sample for potential R&D customers for prescription screening, method development, preliminary pharmacological tests and other early-stage applications. Samples are consistent with bulk goods in purity and quality. Customized Oxytocin services are available for purity, particle size, and packaging specifications, with one-on-one technical support to meet diverse customer needs.
Full-Process Registration Document Support
We provide complete compliant registration documents including COA, HNMR, LC-MS, HPLC chromatograms, residual solvents, elemental impurities, microbiological test, stability data, and manufacturing process overview, supporting global drug registration and reducing R&D costs.
FAQ
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