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Ritonavirm Ip Bp Ep Manfuacturer - India

price: contact company for price

CERTIFICATE OF ANALYSIS

Product Name Ritonavir CAS No:

Batch No: RIT/ 011114 A. R. No 14/ FP/ RIT/ 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 to off- white powder

2. Identification Complies

Complies HPLC: The retention time of the major peak of the Sample solution is within 2% of the retention time of the major peak of the Standard solution, as obtained in the Assay.

IR: The infrared absorption spectrum of the test sample is concordant with the spectrum of reference standard

3. Water content by KF 0.06% NMT 0.50%

4. Residue on ignition 0.04% NMT 0.20%

5. Heavy metals Complies NMT 20 PPM

6. Organic impurities

( by HPLC)

Impurity E

Impurity O

Impurity T

Individual impurity

Total impurities

Not detected

0.096%

0.27%

NMT 0.30%

NMT 0.20%

NMT 0.10%

NMT 1.0%

7. Assay 98.44% 97.0% to 102.0%

8. Residual solvents

MTBE

Methanol

Toulene

Tetrahydrofuran

Ethyl acetate

Heptane

2- propanol

Ethanol

325 PPM

245 PPM

Not detected

NMT 5000 PPM

NMT 890 PPM

NMT 720 PPM

Ritonavir

Ritonavir. svg

Ritonavir ball- and- stick. png

Systematic ( IUPAC) name

1, 3- thiazol- 5- ylmethyl N- [ ( 2S, 3S, 5S) - 3- hydroxy- 5- [ ( 2S) - 3- methyl- 2- { [ methyl( { [ 2- ( propan- 2- yl) - 1, 3- thiazol- 4- yl] methyl} ) carbamoyl] amino} butanamido] - 1, 6- diphenylhexan- 2- yl] carbamate

Clinical data

Trade names Norvir

AHFS/ Drugs. com monograph

MedlinePlus a696029

Pregnancy

category

AU: B3

US: B ( No risk in non- human studies)

Legal status

AU: Prescription Only ( S4)

CA: ℞ - only

UK: Prescription- only ( POM)

US: ℞ - only

Routes of

administration oral

Pharmacokinetic data

Protein binding 98- 99%

Metabolism Hepatic

Biological half- life 3- 5 hours

Excretion mostly fecal

Identifiers

CAS Registry Number 155213- 67- 5 Yes

ATC code J05AE03

PubChem CID: 392622

DrugBank DB00503 Yes

ChemSpider 347980 Yes

UNII O3J8G9O825 Yes

KEGG D00427 Yes

ChEBI CHEBI: 45409

ChEMBL CHEMBL163 Yes

NIAID ChemDB 028478

Chemical data

Formula C37H48N6O5S2

Molecular mass 720.946 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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