Oxytocin API
Product Positioning, Quality & Supply Overview
Product Positioning Overview
In pharmaceutical development, Oxytocin (CAS 50-56-6) is rarely assessed on pharmacology alone. Procurement teams prioritize batch consistency, analytical transparency, and long-term supply reliability, particularly for injectable dosage forms.
This material is supplied strictly as an Active Pharmaceutical Ingredient (API), intended for formulation trials, validation activities, and scalable manufacturing - not as a finished medicinal product.
Identity & Physical Characteristics
▸ Material Name: Oxytocin (synthetic peptide, human sequence)
▸ CAS Number: 50-56-6
▸ Molecular Nature: Nonapeptide hormone
▸ Appearance: White to slightly off-white lyophilized powder
▸ Purity: ≥ 98% (HPLC, lot-specific)
Each batch is released only after identity and purity confirmation against validated analytical standards.
Quality Control Philosophy
Lot-to-Lot Reproducibility
Manufacturing emphasizes repeatable chromatographic behavior, enabling QC teams to benchmark results directly against historical data sets.
Analytical Transparency
Documentation is prepared for technical review rather than marketing purposes. COA values are numerical and traceable, supporting:
▸ Identity confirmation
▸ Purity benchmarking
▸ Impurity trend analysis
This approach reduces repeated qualification during scale-up.
Handling & Stability Considerations
Recommended Storage:
▸ Short-term: 2–8 °C
▸ Long-term: −20 °C
Environmental Sensitivity: Avoid moisture and prolonged light exposure.
Operational Tip: Allow sealed containers to equilibrate before opening to minimize condensation.
Packaging & Supply Execution
Laboratory and commercial-scale quantities
Moisture-protected containers with clear batch identification
Temperature-managed shipping available for sensitive routes
Supply programs support initial evaluation followed by bulk supply, minimizing early-stage inventory pressure.
Typical Use Contexts
▸ Injectable formulation development
▸ Process validation and scale-up studies
▸ Reference material for analytical method verification
Use is restricted to pharmaceutical R&D and manufacturing environments.
Frequently Asked Questions
Q: Is this product suitable for direct clinical use?
A: No. It is supplied strictly as an API for further formulation.
Q: Can we start with a small quantity?
A: Yes. Sample quantities are available for evaluation.
Q: What documentation is provided?
A: COA, MSDS/TDS, and batch traceability records are included.
Q: How is batch traceability handled?
A: Each unit carries a unique lot number linked to production and test data.
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