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Meropenem Usp Ip Bp Ep Manufacturer - India

price: contact company for price

CERTIFICATE OF ANALYSIS

Product Name Meropenem USP CAS No: 119478- 56- 7

Batch No: MER/ 030313 A. R. No 13/ FP/ MER/ 0303

Date of Manufacture Feb- 2013 Date of Analysis 02- 02- 13

Batch Quantity 165 kg Date of Retest Jan- 2016

Sr. No Test Results Acceptance Criteria

1. Appearance

2. Solubility Soluble in dimethyl formamide and in 5% monobasic potassium phosphate solution; sparingly soluble in water; very slightly soluble in alcohol; practically insoluble in acetone and in ether. Soluble in dimethylformamide and in 5% monobasic potassium phosphate solution; sparingly soluble in water; very slightly soluble in alcohol; practically insoluble in acetone and in ether.

3. Identification

Complies By IR Spectrum: The infrared absorption spectrum of the test sample exhibits maxima only at the same wavelengths as that of the working standard.

4. Related Substances

Individual Impurity Total Impurity

0.042%

0.061%

NMT 0.1%

NMT 0.3%

5. Specific Optical Rotation at 20 0 C ( Anhydrous Basis) - 19º Between - 17° to - 21°

6. pH 5.4 Between 4.0–6.0

7. Heavy Metals Complies 10ppm

8. Water Content by KF 12.4% 11.4% –13.4%

9. Residue On Ignition 0.025% NMT 0.1%

10. Assay HPLC 99.46% 98.0% –101.0%

11. Bacterial Endotoxins Test 0.102 EU/ mg NMT 0.125 USP EU/ mg

Meropenem

Meropenem. svg

Meropenem- from- xtal- 1992- 3D- balls. png

Systematic ( IUPAC) name

3- [ 5- ( dimethylcarbamoyl) pyrrolidin- 2- yl] sulfanyl- 6- ( 1- hydroxyethyl) - 4- methyl- 7- oxo- 1- azabicyclo[ 3.2.0] hept- 2- ene- 2- carboxylic acid

Clinical data

Trade names Merrem

AHFS/ Drugs. com monograph

Pregnancy

category

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

Legal status

UK: Prescription- only ( POM)

US: ℞ - only

Routes of

administration IV

Pharmacokinetic data

Bioavailability 100%

Protein binding Approximately 2% .

Biological half- life 1 hour

Excretion Renal

Identifiers

CAS Registry Number 119478- 56- 7 Yes

ATC code J01DH02

PubChem CID: 441130

DrugBank DB00760 Yes

ChemSpider 389924 Yes

UNII FV9J3JU8B1 Yes

KEGG D02222 Yes

ChEBI CHEBI: 43968 Yes

ChEMBL CHEMBL127 Yes

Chemical data

Formula C17H25N3O5S

Molecular mass 383.464 g/ mol


Company Contact:


  • Phone: 912406641875

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

  • Email: Email


Published date: September 10, 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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