Pharmaceutical Raw Material Agomelatine

Product Description

Agomelatine

Brief Description Product name:agomelatine

Synonyms:n-(2-(7-methoxynaphth-1-yl)ethyl)acetamide

CAS No.:138112-76-2

Molecular weight:243.30

Molecular Formula:C15H17NO2

Melting Point:107-109 °C

Boiling point:478.8 °C at 760 mmHg

Appearance:white powder

Competitive price with high quality

Conforms to BP/USP/EP/FCC

Agomelatine COA

ITEM STANDARD RESULTS

Appearance White to almost white crystalline powder white crystalline powder

Solubility This product is soluble in DMF, methanol, ethanol, water and 0.1mol/L hydrochloric acid solution almost not 108.4-108.5 C

UV Has an absorption maximum at 230nm Conforms

IR Corresponding to reference spectrum Conforms

HPLC Should the retention time of the main peak of the reference solution Conforms

Chloride ≤0.01% Conforms

Single impurity ≤0.5% 0.049%

Total impurity ≤0.1% 0.06%

Impurities I ≤0.1% Not detected

Impurities II ≤0.1% Not detected

N-hexane ≤0.029% 0.0002%

Ethanol ≤0.5% 0.1%

Dichloromethane ≤0.06% Not detected

Ethyl acetate ≤0.5% Not detected

Tetrahydrofuran ≤0.072% Not detected

Toluene ≤0.089% Not detected

Chloroform ≤0.006% 0.001%

Loss on drying ≤0.5% 0.002%

Residue on ignition ≤0.1% 0.06%

Heavy metal ≤20ppm Conforms

Assay ≥99.0% 99.52%

Conclusion Qualified

Medical uses

Major depressive disorder

Agomelatine is indicated for the treatment of major depressive episodes in adults.Ten placebo controlled trials have been performed to investigate the short term efficacy of agomelatine in major depressive disorder. At the end of treatment, significant efficacy was demonstrated in six of the ten short-term double-blind placebo-controlled studies.Two were considered "failed" trials, as comparators of established efficacy failed to differentiate from placebo. Efficacy was also observed in more severely depressed patients in all positive placebo-controlled studies.The maintenance of antidepressant efficacy was demonstrated in a relapse prevention study.

Results of the meta-analysis of three positive, randomized, double-blind, placebo controlled studies in 357 patients treated with agomelatine and 360 patients treated with placebo show that agomelatine is effective in treating severe depression. Its antidepressant effect is greater for more severe depression. In patients with a greater baseline score (>30 on HAMD17 scale), the agomelatine-placebo difference was of 4.53 points.Controlled studies in humans have shown that agomelatine is at least as effective as the SSRI antidepressants paroxetine, sertraline, escitalopram, venlafaxine and fluoxetine in the treatment of major depression.

A large meta-analysis of 20 trials with 7460 participants found agomelatine to be as effective as standard antidepressants.

A small open-label study has suggested efficacy in the treatment of atypical and melancholic depression.Well-designed clinical trials have demonstrated efficacy in the treatment of anxious depression.Agomelatine’s onset of action has been reported to occur as early as the first week of treatment.

Packaging & Shipping Agomelatine Packaging: 25kg/bag or according to client request

Agomelatine  Delivery Detail: 1~2 weeks after confirm order.Some of the products can be supplied within 7 days on the strength of EDC warehouse.

Our Services

1. Complex chemical supplier in China with over 5 years of experience.

2. Arrange the orders and shipping with cus requests in time, According to the different countries export policy provide complete customs clearance documents..

3. Variety of high quality chemical products with competitive price.

Company Information

Hubei Ocean Biotechnology has concentrated on food additives,Vitamins,and some relative chemicals for over 20 years domestic experience and 5 years of international experience.

FAQ

1. What's your payment terms?

T/T or L/C.

2. What's your delivery time?

Usually we will arrange the shipment in 7 -15 days,due to different products you choose.

3. How about the packing?

Usually we provide the packing as 25 kg / bag or carton,and also as your request bag.

4. How about the validity of the products?

According to the products you ordered.

5. What documents you provide?

Usually, we provide Commerical Invoice,  Packing List, Bill of loading, COA , Health certificate and Origin certificate. If your markets have any special requirements, let us know.

6. What is loading port?

Usually is Shanghai,Qingdao or Tianjin.