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Zoledronic Acid Usp Ip Bp Ep Manufacturer - India

price: contact company for price

CERTIFICATE OF ANALYSIS

Product Name Zoledronic acid CAS No:

Batch No: ZOL/ 011114 A. R. No 14/ FP/ ZOL/ 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 crystalline powder

2. Identification Complies IR spectrum

HPLC chromatogram

UV- Vis: There is a maximum absorbance at 210nm

3. PH 2.8 2.0 to 4.0

4. Clarity and color Complies Complies

5. Related Substances

Single impurity

Total impurities

0.1%

0.3%

NMT 0.5%

NMT 1.0%

6. Loss on drying 6.4%

5.0% to 8.0%

7. Chloride Complies NMT 0.02%

8. Phosphate 0.22% NMT 0.5%

9. Heavy metals Complies NMT 10 PPM

10. Assay 99.7% NLT 98.5%

11. Phosphite 0.23% NMT 0.5%

Zoledronic acid. svg

Zoledronic- acid- from- xtal- 2003- 3D- balls. png

Systematic ( IUPAC) name

[ 1- hydroxy- 2- ( 1H- imidazol- 1- yl) ethane- 1, 1- diyl] bis( phosphonic acid)

Clinical data

AHFS/ Drugs. com monograph

MedlinePlus a605023

Licence data EMA: Link, US FDA: link

Pregnancy

category

D ( U. S. )

Legal status

℞ - only ( U. S. )

Routes of

administration Intravenous

Pharmacokinetic data

Protein binding 22%

Metabolism Nil

Biological half- life 146 hours

Excretion Renal ( partial)

Identifiers

CAS Registry Number 118072- 93- 8

ATC code M05BA08

PubChem CID: 68740

IUPHAR/ BPS 3177

DrugBank DB00399

ChemSpider 61986

UNII 70HZ18PH24 Yes

KEGG D08689

ChEMBL CHEMBL924 Yes

PDB ligand ID ZOL ( PDBe, RCSB PDB)

Chemical data

Formula C5H10N2O7P2

Molecular mass 272.09 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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