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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