Factory Price Olopatadine HCl - Low MOQ & Fast Delivery for Global Buyers
Property Description
Chemical Name:(Z)-11-[(3-Dimethylamino)propylidene]-6,11-dihydrodibenz[b,e]oxepin-2-acetic acid hydrochloride
Molecular Formula C<sub>21</sub>H<sub>23</sub>NO<sub>3</sub>·HCl
CAS:140462-76-6
Molecular Weight:373.88 g/mol
Appearance:White to off-white crystalline powder
Solubility:Freely soluble in water, methanol, and ethanol; slightly soluble in acetonitrile
Melting Point:~245–250 °C (with decomposition)
pKa:~4.5 (carboxylic acid group), ~9.5 (tertiary amine group)
Partition Coefficient (LogP)：~1.8 (predicted for the free base)
Storage Conditions ：Store at room temperature (15–30 °C), protect from light and moisture
Stability：Stable under recommended storage conditions
Pharmacological Class：Selective H<sub>1</sub>-antihistamine, mast cell stabilizer
Therapeutic Use：Treatment of allergic conjunctivitis and allergic rhinitis
Brief Introduction:
Olopatadine hydrochloride is a dual-action anti-allergic agent that functions as both a selective histamine H<sub>1</sub> receptor antagonist and a mast cell stabilizer. It is widely used in ophthalmic solutions (e.g., Pataday®) and nasal sprays (e.g., Patanase®) to relieve symptoms of allergic conjunctivitis and allergic rhinitis. Its mechanism involves inhibiting the release of inflammatory mediators (e.g., histamine, leukotrienes) from mast cells, providing rapid and long-lasting relief from itching, redness, and nasal congestion.
Certificate of Analysis (COA) – Olopatadine Hydrochloride
| Parameter | Specification | Test Method | Result |
|---|
| Product Name | Olopatadine Hydrochloride | — | Complies |
| CAS No. | 140462-76-6 | — | Complies |
| Molecular Formula | C₂₁H₂₃NO₃·HCl | — | Complies |
| Appearance | White to off-white crystalline powder | Visual inspection | Complies |
| Identification (HPLC/IR) | Matches reference standard | HPLC / FTIR | Complies |
| Assay (Purity) | ≥98.5% (HPLC) | USP <621> / EP 2.2.29 | 99.2% |
| Water Content | ≤0.5% | Karl Fischer titration | 0.3% |
| Residue on Ignition | ≤0.1% | USP <281> | 0.05% |
| Heavy Metals (Pb) | ≤10 ppm | ICP-MS / USP <231> | <5 ppm |
| Related Substances | Total impurities ≤1.0% | HPLC (USP/EP) | 0.6% |
| Single Maximum Impurity | ≤0.5% | HPLC | 0.2% |
| Solubility | Freely soluble in water, methanol | — | Complies |
| Microbial Limits | Meets USP <61> requirements | Microbial enumeration | Complies |
| Storage Conditions | 15–30°C, protected from light/moisture | — | — |
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