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Simvastatin Usp Ip Bp Ep Manufacturer - India

price: contact company for price

CERTIFICATE OF ANALYSIS

Product Name Simvastatin USP CAS No: 79902- 63- 9

Batch No: SIM/ 030313 A. R. No 13/ FP/ SIM/ 0303

Date of Manufacture Feb- 2013 Date of Analysis 02- 02- 13

Batch Quantity 165 kg Date of Retest Jan- 2016

Sr. No Test Results Acceptance Criteria

1. Appearance

2. Solubility

3. Identification

Complies a) By IR Spectrum: The infrared absorption spectrum of the test sample exhibits maxima only at the same wavelengths as that of the working standard.

Complies b) By HPLC: Retention time of the principle peak in the chromatogram obtained with sample solution should match with that of the principle peak in chromatogram obtained with standard solution.

4. Related Substances

Individual Impurity Total Impurity

0.41 %

0.57%

NMT 1.0%

5. Specific Optical Rotation at 20 0 C ( Anhydrous Basis) +291º Between +285° to +298°

6. Loss on drying 0.23% NMT 0.5% .

7. Heavy Metals Complies NMT 20ppm

8. Residue On Ignition 0.04% NMT 0.1%

9. Assay HPLC 99.37% 98.0% –101.0%

Simvastatin. svg

Simvastatin3Dan. gif

Systematic ( IUPAC) name

( 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 2, 2- dimethylbutanoate

Clinical data

Trade names Zocor

AHFS/ Drugs. com monograph

MedlinePlus a692030

Licence data US FDA: link

Pregnancy

category

AU: D

US: X ( Contraindicated)

Legal status

AU: Prescription Only ( S4)

UK: Pharmacy medicines when ≤ 10 mg/ day, POM when >10 mg/ day.

US: ℞ - only

Routes of

administration Oral

Pharmacokinetic data

Bioavailability 5%

Protein binding 95%

Metabolism Hepatic ( CYP3A4)

Biological half- life 2 hours for simvastatin and 1.9 hours for simvastatin acid

Excretion Renal 13% , faecal 60%

Identifiers

CAS Registry Number 79902- 63- 9 Yes

ATC code C10AA01

PubChem CID: 54454

IUPHAR/ BPS 2955

DrugBank DB00641 Yes

ChemSpider 49179 Yes

UNII AGG2FN16EV Yes

KEGG D00434 Yes

ChEBI CHEBI: 9150 Yes

ChEMBL CHEMBL1064 Yes

Chemical data

Formula C25H38O5

Molecular mass 418.566 g/ mol


Company Contact:


  • Phone: 912406641875

  • Address: PLOT NO: 04 JALGAON ROAD, HARSOOL, AURANGABAD, India

  • Email: Email


Published date: September 14, 2015 -

  • Business Description: We, at SWAPNROOP, are committed to providing affordable Drugs &

    Pharmaceuticals of global quality standards to Pharma Companies all over

    the world. In our warehouse facilities, approved by FDA. we supply

    Pharmaceutical Finished products, Dental products and Active

    Pharmaceutical Ingredients.

    We, at SWAPNROOP, are committed to providing affordable Drugs & Pharmaceuticals of global quality standards to Pharma Companies all over the world. Our warehouse facilities is approved by FDA and we are specializes in sales and marketing of Pharmaceutical Finished products, Pharmaceutical Active Ingredients (API's) and Dental products, providing a wide range of quality and affordable products to a large number of pharmaceutical companies, reputed private and government/semi government organizations/ research centers as well as universities.

    We supply and market over 500 molecules and their combinations in multiple dosage forms, catering to patient needs in various therapies. These include Anti infectives, Cardiovascular, Pain management, Central Nervous System (CNS), Gastrointestinal, Respiratory, Dermatology, Orthopaedics, Nutritionals, Urology and Dental.

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