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Lopinavir Usp Ip Bp Ep Manufacturer - India

price: contact company for price

CERTIFICATE OF ANALYSIS

Product Name Lopinavir CAS No:

Batch No: LOP/ 011114 A. R. No 14/ FP/ LOP/ 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 A white or almost white power

2. Identification Complies

Complies HPLC: The retention time of the test sample corresponds to that of the reference standard

IR: The infrared absorption spectrum of the test sample is

concordant with the spectrum of reference standard.

3. Water content 2.0% NMT 4.4%

4. Sulphated ash 0.06% NMT 0.20%

5. Heavy metals Complies NMT 20 PPM

6. Residual solvents

Ethanol

Ethyl acetate

Dimethylformamide

N- hepatane

Triethylamine

380 PPM

ND

140 PPM

ND

NMT 1000 PPM

NMT 880 PPM

NMT 500 PPM

7. Related substances

Impurity B

Impurity C

Impurity I

Other impurity

0.02%

0.08%

NMT 0.20%

NMT 0.10%

8. Any other impurity

Total impurities 0.08%

0.44% NMT 0.10%

NMT 0.7%

9. Assay 100.9% 98% to 102%

.

Lopinavir

Lopinavir. svg

Lopinavir ball- and- stick. png

Systematic ( IUPAC) name

( 2S) - N- [ ( 2S, 4S, 5S) - 5- [ 2- ( 2, 6- dimethylphenoxy) acetamido] - 4- hydroxy- 1, 6- diphenylhexan- 2- yl] - 3- methyl- 2- ( 2- oxo- 1, 3- diazinan- 1- yl) butanamide

Clinical data

AHFS/ Drugs. com International Drug Names

MedlinePlus a602015

Pregnancy

category

US: C ( Risk not ruled out)

Legal status

UK: Prescription- only ( POM)

US: ℞ - only

Routes of

administration Oral

Pharmacokinetic data

Bioavailability Unknown

Protein binding 98- 99%

Metabolism Hepatic

Biological half- life 5 to 6 hours

Excretion Mostly fecal

Identifiers

CAS Registry Number 192725- 17- 0 Yes

ATC code J05AR10 ( with ritonavir)

PubChem CID: 92727

DrugBank DB01601 Yes

ChemSpider 83706 Yes

UNII 2494G1JF75 Yes

KEGG D01425 Yes

ChEMBL CHEMBL729 Yes

Chemical data

Formula C37H48N4O5

Molecular mass 628.810 g/ mol


Company Contact:


  • Phone: 912406641875

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

  • Email: Email


Published date: September 9, 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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