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| Powder: | Yes |
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Product Name: Olopatadine hydrochloride;
Synonyms: OLOPATADINE HCL;OLOPATADINE HYDROCHLORIDE;OLOPATDINEHYDROCHLORIDE;OLOPATADINE HYDROCHLORIDE AND THE INTERMEDIATES;(Z)-11-[3-(Dimethylamino)propylidene]-6,11-dihydrodibenz[b,e]oxepin-2-acetic acid hydrochloride;OLAPATADINE HCL;Olopatadine Hydrochloride (150 mg);Olopatadin HCL;
CAS: 140462-76-6;
MF: C21H24ClNO3;
MW: 373.87;
Product Categories: Pharmaceutical material and intermeidates;APIs;Olopatadine;Amines;Heterocycles;Intermediates & Fine Chemicals;Pharmaceuticals;Opatanol, Pataday, Patanase, Allelock;API;
Melting point: 242-245 ºC;
storage temp.: Refrigerator;
Purity:99%
Apperance:white powderOlopatadine hydrochloride is an antihistamine (as well as anticholinergic and mast cell stabilizer), sold as a prescription eye drop manufactured by Alcon in one of three strengths: 0.7% solution or Pazeo in the US, 0.2% solution or Pataday (also called Patanol S in some countries), and 0.1% or Patanol (also called Opatanol in some countries). It is used to treat itching associated with allergic conjunctivitis (eye allergies). A decongestant nasal spray formulation is sold as Patanase, which was approved by the FDA on April 15, 2008. It is also available as an oral tablet;
It should not be used to treat irritation caused by contact lenses. The usual dose for Patanol is 1 drop in each affected eye 2 times per day, with 6 to 8 hours between doses. Both Pazeo and Pataday are dosed 1 drop in each eye daily.
There is potential for Olopatadine as a treatment modality for steroid rebound (red skin syndrome).
| Items | Standards | Results | |
| Appearance | White or off-white solid powder | Complies | |
| Identification | By IR | Complies | |
| By HPLC | Complies | ||
| Melting Point | 95ºC~105ºC | 101ºC~102ºC | |
| Loss on Drying | ≤ 1.00% | 0.12% | |
| Heavy Metals | ≤ 20ppm | Complies | |
| Residue on Ignition | ≤ 0.10% | 0.05% | |
| Isomer | ≤ 0.15% | ND | |
| Related Substances | Any single impurity: ≤0.50% | 0.45% | |
| Total Impurities: ≤1.00% | 0.67% | ||
| Purity(HPLC) | ≥ 99.00% | 99.33% | |
| Reference Standard | In-house Standard | ||
| Conclusion | The product complied to In-house standard. | ||
| Storage | Preserve in tight,light-resistant containers in a cool place | ||
Olopatadine is a potent, selective antagonist of the H1 histamine receptor (Ki = 16-41.1 nM), with much lower affinities for the H2 and H3 receptors (Ki = 43.4 and 172 μM, respectively). It blocks histamine-induced phosphoinositide turnover in isolated cells (IC50 = 9.5-39.9 nM) and prevents passive cutaneous anaphylaxis in rats (ED50 = 49 μg/kg) and anaphylactic bronchoconstriction in guinea pigs (ID50 = 30 μg/kg). Olopatadine is effective in treating allergic rhinitis and conjunctivitis. It also suppresses itch in patients with well-controlled chronic urticaria. In humans, this antihistamine does not cause cognitive or psychomotor impairment at therapeutic doses.
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