A Brief Introduction to Epinastine Hydrochloride
Molecular Formula:C16H16ClN3
Molecular Weight:285.77
CAS No.:108929-04-0
Appearance:White to slightly yellowish crystalline powder
Regular commercial package: 25kg/drum
What is Epinastine Hydrochloride?
Epinastine Hydrochloride, also known as Epinastine HCl, is an active pharmaceutical ingredient used in the production of various formulations. It is a white to slightly yellowish crystalline powder and can be used in the manufacture of finished products such as Epinastine Hydrochloride tablets, capsules, and eye drops.
Why choose Highassay?
Highassay, as a supplier of Epinastine Hydrochloride raw materials from China, ensures that our products meet GMP production requirements. We adhere to standard operating procedures from production to testing, and our Epinastine Hydrochloride meets all the standards for appearance, identification, content, and impurities of active pharmaceutical ingredients. As a supplier with stable production capacity, we not only guarantee the quality of our raw materials but also possess a comprehensive management system, advanced technology, and accurate product data and documentation. Choosing Highassay means your finished pharmaceutical products will receive the highest quality assurance.
Benefits of Epinastine Hydrochloride
- Epinephrine Hydrochloride is a drug that does not easily penetrate the blood-brain barrier, thus minimizing side effects such as drowsiness and fatigue.
- This drug has a rapid onset of action and a long duration of effect, whether applied topically or taken orally. For example, eye drops can provide relief for 8 hours, and oral medication can be effective for 24 hours.
- It has a dual mechanism of action: on the one hand, it reduces vasodilation, exudation, and inflammatory responses by preventing histamine from binding to its receptors, thus providing relief. On the other hand, it inhibits the release of inflammatory factors from mast cells, controlling allergic reactions through multiple pathways.
Epinastine Hydrochloride Eye Drops
- Epinastine Hydrochloride eye drops are one of the few products that use Epinastine Hydrochloride as the active ingredient.
- Its main function is to prevent and treat allergic conjunctivitis. Allergic conjunctivitis is a common allergic eye disease that can easily cause discomfort such as itchy, red, and watery eyes, a feeling of a foreign body in the eye, and may even be accompanied by symptoms of allergic rhinitis.
- Epinastine Hydrochloride is an antihistamine medication that can quickly relieve a range of allergic symptoms caused by allergic conjunctivitis.
- The production of Epinastine Hydrochloride eye drops is not simply dissolving the active pharmaceutical ingredient in water or another solution; it involves a sterile manufacturing process with extremely strict requirements regarding process and environment to prevent eye infections.
Oral dosage form of Epinastine Hydrochloride
Although only one formulation of Epinastine Hydrochloride eye drops is currently available in the US market, in other countries and regions, such as China, Japan, and some European countries, Epinastine Hydrochloride is manufactured in other dosage forms, such as oral tablets, syrups, and capsules, and is used to treat various allergic diseases, with a wider range of applications.
As a second-generation antihistamine drug, it is primarily used to treat allergic diseases such as chronic urticaria, allergic rhinitis, eczema, and atopic dermatitis.
Sepcification of Epinastine Hydrochloride
- Sepcification of Epinastine Hydrochloride
- Sepcification of Epinastine Hydrochloride
| Tests | Standards |
| Description | White to off-white crystalline powder |
| Identification | Positive |
| IR | Conforms |
| Color of solution | Colorless to light-yellow and clarity |
| Loss on drying | 0.5% max |
| Water content (K.F) | 1.0% max |
| Heavy metals | 10 ppm max |
| Sulfated ash | 0.1% max |
| Arsenic | 2 ppm max |
| PH | 3.5~5.5 |
| Related substances | Individual impurity 0.5% max |
Total impurity 1.0% max | |
| Assay | 98.5% min |
| Conclusion | Qualified |
| Product Name | Epinastine Hydrochloride |
| Melting Point | 270℃ |
| Boiling Point | 428℃ |
| Flash Point | 212.7℃ |
| Vapor Pressure | 1.56E-07mmHg (25°C) |
| Solubility | Easily soluble in water, methanol, and formic acid |
| Acidity and alkalinity | Its aqueous solution is weakly acidic to nearly neutral |
| Package | 25kg/drum |
| Storage | Store in a dark, sealed, and dry place |
0.05% Epinastine Hydrochloride refers to eye drops containing 0.05% Epinastine Hydrochloride, a topical liquid for ophthalmic use, primarily used to treat allergic conjunctivitis and vernal keratoconjunctivitis.
Antihistamine eye drops are generally used to relieve itching and redness in the eyes caused by allergies, while steroid eye drops are generally used for more serious eye conditions.
The primary function of Epinastine Hydrochloride is to block histamine released during allergic reactions, thereby relieving symptoms such as sneezing, runny nose, and itchy eyes. Ulcers usually refer to gastric ulcers or duodenal ulcers, and Epinastine Hydrochloride has no direct therapeutic effect on them and may even pose potential side effect risks.
Relestat
Regarding Epinastine Hydrochloride Eye Drops
- The concentration of Epinastine Hydrochloride is generally 0.05%, which is effective for treatment while minimizing local irritation.
- The usual dosage is one drop twice a day. It is strictly prohibited for children under 2 years old to use this product without medical supervision.
- Wash your hands thoroughly before use. The bottle opening should not come into contact with anything, including your eyes, to prevent contamination of the eye drops.
- Currently, the only approved formulation of Epinastine Hydrochloride eye drops in the United States is Relestat, manufactured by Allergan.
Precautions for using Epinastine Hydrochloride
- This medication should not be used by pregnant women, breastfeeding women, or children without consulting a doctor.
- This product is strictly contraindicated for individuals allergic to this ingredient or those with severe liver dysfunction.
- Do not take this medication with alcohol or sedatives.
- Although it can be taken long-term, it must be done under the guidance and supervision of a doctor.
