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Esomeprazole Magnesium Dihydrate Usp Ip Bp Ep Manfuacturer - India

price: contact company for price

CERTIFICATE OF ANALYSIS

Product Name Esomeprazole magnesium dihydrate CAS No:

Batch No: ESO/ 011114 A. R. No 14/ FP/ ESO/ 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 Off white to slightly pale colored powder

2. IDENTIFICATION

IR Complies The infrared absorption spectrum of sample should be concurrent with the spectrum obtained with esomeprazole WS.

3. Solubility Complies

Soluble in DMSO, slightly soluble in water insoluble in heptane

4. Colour of solution 0.07 Absorbance no greater than 0.2

5. Specific rotation at 20°C - 133.19°

- 128° to - 135°

6. Water content 4.75% 4.5% to 6.0%

7. Chromatographic purity

N oxide

Related compound A

Any individual impurity

Total impurities

Not detected

0.03%

0.06%

0. . 16%

NMT 0.10%

NMT 0.20%

NMT 0.50%

8. Enantiomeric purity R- enantiomer 0.03% NMT 0.20%

9. Content of magnesium ( on anhydrous basis) 3.38% 3.30% to 3.55%

10. Assay by HPLC 99.32% 98.0% to 102.0%

.

Esomeprazole

Esomeprazole 2D structure. svg

Esomeprazole ball- and- stick model. png

Systematic ( IUPAC) name

( S) - 5- Methoxy- 2- [ ( 4- methoxy- 3, 5- dimethylpyridin- 2- yl) methylsulfinyl] - 3H- benzoimidazole

Clinical data

Trade names Nexium, many others[ 1]

AHFS/ Drugs. com monograph

MedlinePlus a699054

Licence data US FDA: link

Pregnancy

category

AU: B3

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

Legal status

AU: Prescription Only ( S4)

UK: General sales list ( GSL, OTC)

US: Rx only IV OTC oral

Routes of

administration Oral, IV

Pharmacokinetic data

Bioavailability 50 to 90%

Metabolism Hepatic ( CYP2C19, CYP3A4)

Biological half- life 1–1.5 hours

Excretion 80% Renal

20% Faecal

Identifiers

CAS Registry Number 119141- 88- 7

ATC code A02BC05

PubChem CID: 9579578

DrugBank DB00736 Yes

ChemSpider 7843323

UNII N3PA6559FT Yes

KEGG D07917 Yes

ChEBI CHEBI: 50275 Yes

ChEMBL CHEMBL1201320

Chemical data

Formula C17H19N3O3S

Molecular mass 345.417 g/ mol


Company Contact:


  • Phone: 912406641875

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

  • Email: Email


Published date: September 8, 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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