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Rosuvastatin IMpurity (5-Oxo Rosuvastatin tert-Butyl Ester) is a chemical compound that occurs as an impurity in the production of Rosuvastatin, a medication prescribed to reduce cholesterol and triglyceride levels in the blood. This impurity is a derivative of the primary drug and is generated during the manufacturing process. It is crucial to regulate and quantify the presence of this impurity to ensure the safety and effectiveness of the final pharmaceutical product for patient use, adhering to regulatory standards for pharmaceuticals.

854898-53-6

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854898-53-6 Usage

Uses

Used in Pharmaceutical Manufacturing:
Rosuvastatin IMpurity (5-Oxo Rosuvastatin tert-Butyl Ester) is used as a quality control parameter in the pharmaceutical industry for ensuring the purity and safety of the final drug product. It is essential to monitor and control the levels of this impurity to meet regulatory requirements and to maintain the efficacy of Rosuvastatin.
Used in Regulatory Compliance:
In the regulatory compliance sector, Rosuvastatin IMpurity (5-Oxo Rosuvastatin tert-Butyl Ester) is used as a benchmark for assessing the manufacturing process and the final product's adherence to quality standards. Accurate quantification and control of this impurity are necessary to comply with the guidelines set by regulatory bodies for pharmaceutical products.
Used in Research and Development:
In the research and development field, Rosuvastatin IMpurity (5-Oxo Rosuvastatin tert-Butyl Ester) serves as a subject of study for understanding the formation mechanisms of impurities during drug synthesis. This knowledge aids in the development of improved manufacturing processes and the creation of more effective purification techniques to minimize impurities in pharmaceuticals.

Check Digit Verification of cas no

The CAS Registry Mumber 854898-53-6 includes 9 digits separated into 3 groups by hyphens. The first part of the number,starting from the left, has 6 digits, 8,5,4,8,9 and 8 respectively; the second part has 2 digits, 5 and 3 respectively.
Calculate Digit Verification of CAS Registry Number 854898-53:
(8*8)+(7*5)+(6*4)+(5*8)+(4*9)+(3*8)+(2*5)+(1*3)=236
236 % 10 = 6
So 854898-53-6 is a valid CAS Registry Number.

854898-53-6SDS

SAFETY DATA SHEETS

According to Globally Harmonized System of Classification and Labelling of Chemicals (GHS) - Sixth revised edition

Version: 1.0

Creation Date: Aug 17, 2017

Revision Date: Aug 17, 2017

1.Identification

1.1 GHS Product identifier

Product name Benzo[h]quinazoline-6-pentanoic acid, 8-fluoro-5,6-dihydro-β,δ-dihydroxy-4-(1-methylethyl)-2-[methyl(methylsulfonyl)amino]-, (βR,δS,6S)-

1.2 Other means of identification

Product number -
Other names -

1.3 Recommended use of the chemical and restrictions on use

Identified uses For industry use only.
Uses advised against no data available

1.4 Supplier's details

1.5 Emergency phone number

Emergency phone number -
Service hours Monday to Friday, 9am-5pm (Standard time zone: UTC/GMT +8 hours).

More Details:854898-53-6 SDS

854898-53-6Upstream product

854898-53-6Downstream Products

854898-53-6Relevant academic research and scientific papers

A study of photodegradation of drug rosuvastatin calcium in solid state and solution under UV and visible light irradiation: The influence of certain dyes as efficient stabilizers

Litvi?,?mic,Vinkovi?,Filipan-Litvi?

, p. 84 - 92 (2013/03/14)

Photodegradation of rosuvastatin calcium (1) under several radiation wavelengths in solid state and solution in solvents of different polarity has been studied. It was shown that 1 is very sensitive, especially in solution, even to low energy wavelengths and main and almost exclusive degradation pathway includes formation of diastereomeric dihydrophenanthrene derivatives (R,S,R)-2 and (S,S,R)-2. Absolute configurations of isolated diastereomeric photoproducts in forms of respective lactones 3 and 4 have been determined. First partial diastereoselective photocyclization of 1 leading 10.5% d.e. of (R,S,R)-2(S,S,R)-2 has been determined in water as a solvent. To prevent photodegradation of 1 in solution use of brown glass is necessary. Solid formulations of 1 are efficiently protected against photodegradation by the presence of combination of dyes such as yellow iron oxide and pink color E122 or β-carotene inside the formulation or tablet coating.

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