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Pharmaceutical Raw Materials Baricitinib for Rheumatoid arthritis 1187594-09-7

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Abstract

CAS:1187594-09-7
MF:C16H17N7O2S
MW:371.41688
EINECS:1592732-453-0
Certification: ISO 9001, USP, BP
Suitable for: Adult
State: Solid
Purity: >99%

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Pharmaceutical Raw Materials Baricitinib for Rheumatoid arthritis 1187594-09-7

Abstract

CAS:1187594-09-7
MF:C16H17N7O2S
MW:371.41688
EINECS:1592732-453-0
Certification: ISO 9001, USP, BP
Suitable for: Adult
State: Solid
Purity: >99%

Description

In February 2017, Baricitinib was approved for second-line treatment in adults with moderate to severe active rheumatoid arthritis in the European Union, either alone or in combination with methotrexate.
Baricitinib received the FDA’s CRL in April 2017. The letter indicates that the US Food and Drug Administration is unable to approve the current form of application. Specifically, the FDA noted that more clinical data is needed to determine the most appropriate dose and that more data is needed to further clarify safety issues in the treatment sector.
On April 23, 2018, the FDA advisory committee recommended the approval of baricitinib 2mg for the treatment of rheumatoid arthritis, but 4mg was not recommended for serious adverse events. On May 31, 2018, the FDA approved Barictinib for the treatment of adult patients with moderate to severe rheumatoid arthritis who were not responding to one or more TNF antagonists.

COA

Batch No. HF161208 Quantity 55.2kgs
Mfg. Date Dec. 08, 2016 Package As required
Rep. Date Oct. 23, 2016 Exp. Date Oct. 19, 2018
Items Standards Results
Appearance White or off-white powder Complies
Identification By IR Complies
By HPLC Complies
Loss on Drying ≤ 0.50% 0.31%
Heavy Metals ≤ 10ppm Complies
Residue on Ignition ≤ 0.10% 0.09%
Related Substances Maximum single impurity: ≤0.50% 0.13%
Total impurities: ≤1.00% 0.63%
Purity No less than 99% 99.47%
Reference Standard In-house Standard
Conclusion The product complied to In-house standard.
Storage Preserve in tight,light-resistant containers in a cool place

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