Linaclotide Linaclotide powder 851199-59-2
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Linaclotide is a once-daily, orally administered, first-in-class agonist of guanylate cyclase-C that is minimally absorbed. It is being developed to treat gastrointestinal disorders. Linaclotide has received its first global approval in the US for the treatment of constipation-predominant irritable bowel syndrome (IBS-C) and chronic idiopathic constipation (CIC), and a marketing submission has been filed in the EU for IBS-C. This article summarizes the milestones in the development of linaclotide leading to this first approval for IBS-C and CIC.
Contents of testing |
Specifications |
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Appearance |
White or almost white crystalline powder |
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Identity by HPLC |
The reaction is same with the reference substance |
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Amino Acid Composition |
±20% of theoretical |
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Purity (HPLC) |
≥ 98.0% |
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Related Substance(By HPLC) |
Total Impurities(%)≤ 2.0% Largest Single Impurity(%)≤ 1.0% |
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Acetate Content(By HPLC) |
≤15% |
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Water Content(By HPLC) |
≤5.0% |
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Bacterial Endotoxins |
≤5IU/mg |
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