Physical and Chemical Properties
Common Name
Rosuvastatin calcium
Chemical Name
Molecular Formula
C44H54CaF2N6O12S2
Molecular Weight
1001.14
CAS No.
147098-20-2
EINECS No.
Product Specification
Appearance
White or yellow powder
Purity
98.0%
Shelf life
2 years
Quality Standard
In-house
Certification
In process of applying for GMP and ISO 9001
Product Description
Rosuvastatin is a member of the drug class of statins, used to treat high cholesterol and related conditions, and to prevent cardiovascular disease.
Rosuvastatin was initially developed by Shionogi in the late 1980s; the original development number is S-4522. In June, 1998, the development, market and sales rights were in-licensed to AstraZeneca. Rosuvastatin was approved for the first time in Holland on November 7, 2002, and then was approved in Canada in Feb, 2003. Approval in the United States by the FDA came on August 12, 2003.
Rosuvastatin is a competitive inhibitor of the enzyme HMG-CoA reductase, having a mechanism of action similar to that of other statins. Its approximate elimination half life is 19 hours and its time to peak plasma concentration is reached in 3–5 hours following oral administration.
We manufacture and supply APIs and relative intermediates of Statin series for cardiovascular disease, including Pitavastatin, Rosuvastatin, Atorvastatin and Fluvastatin.
TECHNICAL DATA SHEET
Item
Specification
Appearance
White to yellow powder
Identification
IR-Spectrum
UV
Calcium content
3.5%-4.5%
Water
≤5.0%
Specific Rotation
14.0-20.0
Heavy Metals
≤0.002%
Relative Substance
Diastereomer ≤0.30%
Rosuvastatin lactone ≤0.20%
Diene ≤0.30%
Unknown single impurity ≤0.20%
Total impurity ≤1.0%
Assay (On dry basis)
98.0-102.0%
Packaging & Shipping
Packaging Spec.
1kg/bag, 25kg/drum
Shipping Mode
Air or express
Loading Port
Nanjing, Shanghai or other China main ports
Delivery Time
Depending upon the order volume
Payment
Payment Mode
T/T, L/C, D/P, D/A and others
Note: For small value order, we always require 100% T/T in advance as payment term.