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Calcium Pitavastatin Usp Ip Ep Bp Manufacturer - India

price: contact company for price

CERTIFICATE OF ANALYSIS

Product Name Calcium pitavastatin CAS No:

Batch No: CAL/ 011114 A. R. No 14/ FP/ CAL/ 0111

Date of Manufacture Nov- 2014 Date of Analysis 02- 11- 14

Batch Quantity 100 kg Date of Retest Jan- 2017

Sr. No Test Results Acceptance Criteria

1. Appearance complies White or almost white powder or crystalline powder

2. Specific optical rotation +21.9º +18.5º to +23.5º

3. Identification Complies

UV

4. Water 2.1% NMT 5.0%

5. Ca 4.53% 4.3% to 4.8%

6. Enantiomric purity 0.10% NMT 1.0%

7. Diastereomeric purity 0.28% NMT 1.0%

8. Related substances 0.46% NMT 1.0%

9. Heavy metals Complies NMT 20 PPM

10. Chloride Complies NMT 0.1%

11. Content 99.5% 99.0% to 101.0%

12. Residual absorption Complies Complies

.

Pitavastatin

Pitavastatin2DCSD. svg

Pitavastatin3Dan. gif

Systematic ( IUPAC) name

( 3R, 5S, 6E) - 7- [ 2- cyclopropyl- 4- ( 4- fluorophenyl) quinolin- 3- yl] - 3, 5- dihydroxyhept- 6- enoic acid

Clinical data

Trade names Livalo

AHFS/ Drugs. com monograph

MedlinePlus a610018

Licence data US FDA: link

Pregnancy

category

AU: D

US: X ( Contraindicated)

Legal status

AU: Prescription Only ( S4)

CA: ℞ - only

UK: Prescription- only ( POM)

US: ℞ - only

Routes of

administration Oral

Pharmacokinetic data

Bioavailability 60%

Protein binding 96%

Metabolism minimally CYP2C9

Biological half- life 11 hours

Excretion Faeces

Identifiers

CAS Registry Number 147511- 69- 1

ATC code C10AA08

PubChem CID: 5282452

IUPHAR/ BPS 3035

ChemSpider 4445604 Yes

UNII M5681Q5F9P Yes

ChEBI CHEBI: 32020

ChEMBL CHEMBL1201753

Chemical data

Formula C25H24FNO4

Molecular mass 421.461


Company Contact:


  • Phone: 912406641875

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

  • Email: Email


Published date: September 5, 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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