API and Chiral Products
Active pharmaceutical intermediate molecules or API’s are the biologically active, highly potent ingredients in pharmaceutical drugs. These potent ingredients are usually present in enantiomeric form and in most cases one enantiomeric form may be harmful while the other form is the intended active ingredient for the drug. Therefore it is imperative that the intended active pharmaceutical intermediate is present in pure form in the drug. Orochem Technologies Inc. SMB chromatography purification process allows for a high purity and high recovery separation of the active pharmaceutical intermediate. For this reason, Orochem Technologies Inc. is at the forefront of API purification, we have purification process for several enantiomers (montelukast, s-valsartan, gemcitabine, and atorvastin) and pharmaceutical grade API (EPA, phosphotidyl choline, and phytonadione). We are dedicated to helping our customers worldwide in achieving this goal.
MontelukastMontelukast is a leukotriene receptor antagonist and an inhibitor of leukotriene biosynthesis. Montelukast sodium is used in the treatment of asthma. Orochem Technologies Inc developed a continuous SMB process for the purification of a crude Montelukast sodium mixture comprising Montelukast sodium-trans, impurities, an organic solvent, and water. The final montelukast sodium-trans product has a montelukast purity of at least 99.5 wt-%.
s-ValsartanChiral Separation of s-Valsartan from racemic mixture using Chiral SMB Technology Valsartan (Angiotan or Diovan) is an angiotensin II receptor antagonist. Valsartan dilates blood vessels and reduces blood pressure. In the US, valsartan is indicated for treatment of high blood pressure, congestive heart failure(CHF), or post-myocardial infarction. In 2005, Angiotan was prescribed more than 12 million times in the United States and global sales were approximately $6.1 billion in 2010. Traditional purification method involves a numerous purification step i.e. stage wise crystallization in ethyl acetate from a crude which has 95% S-Valsartan and 5 % R-Valsartan with about 50% loss of S-Valsartan in the mother liquor. ChiroSEP SMB system is being commercialized by Orochem Technologies Inc, to obtain high purity s-Valsartan crystals at production scale of 100kg /Day based upon CSP-1C chiral stationary phase developed by Orochem Technologies Inc.
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