Pharmaceutical CAS 147098-20-2 Rosuvastatin Calcium

• Function: Antibiotic and Antimicrobial Agents
• Certification: GMP
• Grade Standard: Medicine Grade
• Type: Chemical Reagent
• State: Solid
• Volatile: Not Volatile
• Model NO.: BP/USP/EP
• Application: Medicine
• Transport Package: 25kg/Drum
• Specification: USP/BP
• Trademark: SINOAH
• Origin: China
• HS Code: 2933990099
• Production Capacity: 5mt/Month

Product Description

GMP manufacturer of pharmaceutical Rosuvastatin Calcium CAS 147098-20-2

Rosuvastatin calcium CAS 147098-20-2
                   

Tests	Specifications	Results
Appearance	A White to off-white powder	Complies
Specific Rotation	+17°~+21°	+20°
Identification	A. Meets the requirement B. UV: λmax=243nm C. IR: similar to Reference Substance D.X-ray: similar to Reference Substance	Complies Complies Complies Complies
Chloride	≤0.1%	Complies
Sulphate	≤0.1%	Complies
Enantiomer	≤0.15%	Undetected
Calcium	3.9%~4.3%	4.1%
Related substances	Diastereomer≤0.15%	0.06%
	5-oxo-Rosucastatin≤0.15%	Undetected
	Photo degradation 1≤0.15%	Undetected
	Photo degradation 2≤0.15%	Undetected
	Rosuvastatin lactone≤0.15%	Undetected
	Rosuvastatin methyl ester≤0.15%	Undetected
	Rosuvastatin isoamyl ester≤0.15%	Undetected
	Any unknown impurity≤0.10%	0.05%
	Total impurities≤0.75%	0.28%
Water	≤3.0%	2.1%
Isoamyl Bromide	≤37.5ppm	≤37.5ppm
Residual solvents	Ethyl ether≤300ppm Undetected	Complies
	Acetonitrile≤410ppm Undetected	Undetected
	Isoamyl alcohol≤5000ppm Undetected	Undetected
	DMF≤880ppm Undetected	Undetected
Assay	98.5%~102.0%( caculated on the anhydrous basis)	99.8%