Simvastatin- A Statin drug

A class of drugs that helps in lowering the cholesterol levels in the blood are known as Statins. By lowering these levels they help in preventing heart attack, stroke and other related cardiovascular diseases.

One of the best-selling statin drugs is SIMVASTATIN, which is marketed under the trade name of Zocor and was developed by Merck. Simvastatin is a semi-synthetic derivative of fungus Aspergillus terreus and it is used for the treatment of dyslipidemia and to prevent atherosclerosis-related complications.

Simvastatin is a semi-synthetic drug and hence its synthesis involves several biocatalytic processes. This, in turn, results in numerous process related impurities of Simvastatin along with degradants and metabolites.

Pharmaffiliates Analytics and Synthetics have identified and synthesized these impurities, metabolites, derivatives and degradants of Simvastatin, which are classified below

1. Simvastatin-impurity A (Simvastatin acid sodium salt) – a sodium salt of Simvastatin metabolite i.e Simvastatin acid, the active form of the drug.
2. Simvastatin-impurity A (free base) - Simvastatin acid, an active form of Simvastatin.
3. Simvastatin-impurity B (4’-acetyl Simvastatin) - an acetate ester present as an impurity.
4. Simvastatin-impurity C (Anhydro Simvastatin) - an impurity formed in commercial preparation.
5. Simvastatin-impurity D - Simvastatin dimer present as an impurity.
6. Simvastatin-impurity E or Lovastatin - a fungal metabolite used in the synthesis of Simvastatin. Lovastatin also belongs to the family of HMG-CoA reductase inhibitors like Simvastatin and it is an antihypercholesterolemic agent.
7. Simvastatin-impurity F (epi Lovastatin) - an epimer of Lovastatin.
8. Simvastatin-impurity G (Simvastatin-3-en) - a 3-methylene Simvastatin impurity.
9. Simvastatin - impurity K (4α,5-dihydro Simvastatin) - an impurity formed in commercial preparation
10. Simvastatin methyl ester – A methyl ester present as an impurity
11. Simvastatin ethyl ester – An ethyl ester present as an impurity
12. Simvastatin glycerol ester – A glycerol ester present as an impurity
13. Simvastatin acid ammonium salt - An ammonium salt of Simvastatin metabolite i.e Simvastatin acid, the active form of the drug.
14. Anhydro Simvastatin acid sodium salt -An impurity formed in the synthesis.
15. (1S,3R,7S,8S,8AR)-8-(2-((2R,4R)-4-Hydroxy-6-oxotetrahydro-2h-pyran-2-yl)ethyl)-3,7-dimethyl-1,2,3,7,8,8a-hexahydronaphthalen-1-yl isobutyrate - An impurity of both Simvastatin and Lovastatin
16. (3S,5S)-Dihydroxy Simvastatin - An impurity formed in the synthesis.

Majority of the above mentioned impurities synthesized at Pharmaffiliates are 98% pure and are available in pack sizes as small as 50mg and 25mg. Customized pack sizes can also be made available as per the customer’s need.

Each of these standards synthesized at Pharmaffiliates are been identified through an elaborate structure elucidation data and certificate of analysis is provided for the same.