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Cabazitaxel Usp Bp Ip Ep Manufacturer - India

price: contact company for price

CERTIFICATE OF ANALYSIS

Product Name Cabazitaxel CAS No: 183133- 96- 2

Batch No: CAB/ 011114 A. R. No 14/ FP/ CAB/ 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

2. Identification Complies

Complies FT- IR

HPLC

3. Water 0.9% NMT 3.0%

4. Melting Point 153°C 148°C to 158°C

5. Residue on Ignition 0.02% NMT 0.1%

6. Heavy metals 10 PPM NMT 20 PPM

7. Residual Solvents

Acetone

Dichlorimethane

n- Hexane

Acetic acid

Ethyl acetate

Tetrahydrofuran

Ethanol

104 PPM

86 PPM

2 PPM

Not detected

985 PPM

NMT 5000 PPM

NMT 600 PPM

NMT 290 PPM

NMT 720 PPM

8. Related substances

7- demethyl- cabazitaxel

10-

10- DABIII

Any single impurity

Total impurities

0.07%

0.16%

NMT 0.3%

NMT 0.1%

NMT 1.0%

9. Purity 99.84% NLT 99.0%

.

Cabazitaxel

Cabazitaxel. png

Systematic ( IUPAC) name

( 1S, 2S, 3R, 4S, 7R, 9S, 10S, 12R, 15S) - 4- ( Acetyloxy) - 15- { [ ( 2R, 3S) - 3- { [ ( tert- butoxy) carbonyl] amino} - 2- hydroxy- 3- phenylpropanoyl] oxy} - 1- hydroxy- 9, 12- dimethoxy tetramethyl- 11- oxo- 6- oxatetracycloheptadec- 13- ene- 2- yl benzoate

Clinical data

Trade names Jevtana

AHFS/ Drugs. com Consumer Drug Information

MedlinePlus a611009

Licence data EMA: Link, US FDA: link

Pregnancy

category

US: D ( Evidence of risk)

Legal status

UK: Prescription- only ( POM)

US: ℞ - only

Routes of

administration Intravenous

Identifiers

CAS Registry Number 183133- 96- 2

ATC code L01CD04

PubChem CID: 9854073

IUPHAR/ BPS 6798

DrugBank DB06772 Yes

ChemSpider 8029779 Yes

UNII 51F690397J Yes

ChEBI CHEBI: 63584

ChEMBL CHEMBL1201748

Chemical data

Formula C45H57NO14

Molecular mass 835.93 g/ mol


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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