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Ondansetron Hydrochloride Dihydrate is a selective 5-HT₃ receptor antagonist used to prevent and treat nausea and vomiting associated with chemotherapy, radiotherapy, and postoperative recovery. It works by blocking serotonin receptors in the central nervous system and gastrointestinal tract, reducing the emetic response.
At Bluepill Express, we manufacture and export high-quality Ondansetron Hydrochloride Dihydrate API under WHO-GMP, ISO 9001:2015, and cGMP-certified facilities. Our API demonstrates high assay purity (≥99%), excellent crystallinity, and consistent particle size, making it suitable for oral tablets, oral solutions, and injectable formulations.
The API is globally trusted for its stability, reproducibility, and regulatory compliance, ensuring reliable performance in finished pharmaceutical products.
Therapeutic Applications:
- Prevention of chemotherapy-induced nausea and vomiting (CINV)
- Prevention of radiotherapy-induced nausea and vomiting (RINV)
- Management of postoperative nausea and vomiting (PONV)
- Used in oral, intravenous, and combination formulations
Mechanism of Action:
Ondansetron selectively blocks serotonin (5-HT₃) receptors in the chemoreceptor trigger zone and the gastrointestinal tract, preventing signals that induce nausea and vomiting. Its targeted action ensures high efficacy with minimal CNS side effects.
Technical Specifications:
- Chemical Name: (±)-1,2,3,9-Tetrahydro-9-methyl-3-[(2-methyl-1H-imidazol-1-yl)methyl]-4H-carbazol-4-one hydrochloride dihydrate
- Molecular Formula: C₁₈H₁₉N₃O·HCl·2H₂O
- Molecular Weight: 365.82 g/mol
- CAS Number: 99614-02-5
- Appearance: White to off-white crystalline powder
- Assay (on dried basis): NLT 98.0% and NMT 102.0%
- Solubility: Freely soluble in water; soluble in methanol and dilute acids
- Storage Conditions: Store below 25°C, protected from light and moisture
Pharmacological Classification:
- Therapeutic Class: 5-HT₃ Receptor Antagonist / Antiemetic
- Pharmacopoeial Standards: IP / BP / USP / EP
- Dosage Form Applications:
- Oral tablets (4 mg, 8 mg)
- Oral disintegrating tablets (ODT)
- Injectable solutions for intravenous use
Manufacturing & Quality Standards – Bluepill Express:
- Produced under WHO-GMP, ISO, and cGMP certified facilities
- High assay purity (≥99%) with low impurity levels
- Analytical testing by HPLC, FTIR, and UV spectroscopy
- DMF-ready documentation for global regulatory submission
- Batch-to-batch consistency with controlled particle size and stability
- Compliance with ICH Q3A/B and pharmacopeial standards
Advantages of Bluepill Express Ondansetron Hydrochloride Dihydrate API:
- High purity and excellent crystallinity
- Regulatory-compliant API suitable for global markets
- Optimized for oral and injectable formulations
- Stability proven under long-term and accelerated conditions
- Reliable supply and documentation support for exports
Packaging & Export Details:
- Packaging Sizes: 1 kg / 5 kg / 25 kg HDPE drums with double LDPE liners
- Shelf Life: 3 years under recommended storage conditions
- Labeling: Compliant with international pharmacopeial and export standards
- Export Markets: Europe, Africa, Middle East, Latin America, and Asia-Pacific
- Documentation Provided:
- Certificate of Analysis (COA)
- Material Safety Data Sheet (MSDS)
- Drug Master File (DMF)
- Stability and Validation Reports
