Product Name: Ruxolitinib Phosphate

CAS No.: 1092939-17-7

Molecular Formula: C17H21N6O4P

Molecular Weight: 404.360201

Brief Introduction:

Ruxolitinib Phosphate is the phosphate form of Ruxolitinib, which is a tyrosine kinase inhibitor and is mainly used clinically to treat myeloproliferative neoplasms such as chronic myeloid leukemia and myelofibrosis.

Drug Category:

JAK Inhibitor: Selectively inhibits JAK1 and JAK2 kinases, works by blocking the JAK-STAT signaling pathway, and regulates immune and inflammatory responses.

Mechanism of Action:

Inhibits the abnormally active JAK-STAT pathway, reduces the production of pro-inflammatory cytokines (such as IL-6, IFN-γ), and thus inhibits inflammation and abnormal cell proliferation.

Specifications of our Ruxolitinib Phosphate:

Appearance		White to almost white powder
Identification		IR: Identical versus reference spectrum
		The retention time of the major peak of the sample solution corresponds to that of the standard solution, as obtained in the assay.
Water		Not more than 0.5%
pH Value		2.5 ~ 4.5
Na		Not more than 100 ppm
Pd		Not more than 10 ppm
PO43- (Anhydrous and no solvent basis)		22.4% ~ 25.1%
Enantiomer		Impurity A: Not more than 0.7%
Related Substances	Impurity C	Not more than 0.15%
	Impurity H	Not more than 0.15%
	Impurity E	Not more than 0.15%
	Impurity D	Not more than 0.15%
	Impurity F	Not more than 0.15%
	Impurity B	Not more than 0.15%
	Individual unspecified impurity	Not more than 0.10%
	Total impurities	Not more than 0.5%
Residual Solvents Ⅰ	Methanol	Not more than 3000 ppm
	Acetone	Not more than 5000 ppm
	2-Propanol	Not more than 5000 ppm
	Dichloromethane	Not more than 600 ppm
	Tert-Butylmethyl ether	Not more than 5000 ppm
	Ethyl acetate	Not more than 5000 ppm
	1,4-Dioxane	Not more than 380 ppm
Residual Solvents Ⅱ	n-Heptane	Not more than 4000 ppm
	N,N-Dimethylformamide	Not more than 880 ppm
	Dimethyl sulfoxide	Not more than 5000 ppm
Residual Solvents Ⅲ	Benzene	Not more than 2 ppm
Microbiological Limits	Total aerobic microbial count	Not more than 1000 CFU/g
	Total combined yeasts & mould count	Not more than 100 CFU/g
	Escherichia coli	Negative
Assay (Anhydrous and no solvent basis)		98.0% ~ 102.0%

Indications:

※ Myelofibrosis: Relieve splenomegaly and related symptoms (e.g., pain, fatigue).

※ Polycythemia Vera: For patients resistant or intolerant to hydroxyurea.

※ Atopic Dermatitis: Topical or systemic treatment of moderate to severe cases.

※ Graft Versus Host Disease (GVHD): Steroid-refractory acute GVHD.

Preparation and Usage:

- Oral Tablets or Topical Application (depending on the indication).

♔ The dosage should be adjusted according to the patient's condition.

Packaging:

10g/Bag, 20g/Bag, 50g/Bag, 100g/Bag, 500g/Bag, 1kg/Bag or according to the specific requirements from customers.

Storage Conditions:

Preserved in unopened original containers in a cool dry place before using; kept away from direct sunlight, heat and moisture.

Shelf Life:

36 months from the date of manufacturing when stored under the above conditions.