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Cefepime Hcl Usp Ip Ep Bp Manaufacturer - India

price: contact company for price

CERTIFICATE OF ANALYSIS

Product Name Cefepime HCL CAS No:

Batch No: CEF/ 011114 A. R. No 14/ FP/ CEF/ 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 to slightly yellow powder

2. Identification Complies The infrated absorption spectrum is concordant with the reference spectrum of cefepime HCL.

3. Crystallinity Complies It should meet the requirements

4. Water 3.2% 3.0% to 4.5%

5. Related substances

Compound A

Compound B

Other impurity

0.03%

0.1%

0.1%

NMT 0.3%

NMT 0.2%

NMT 0.1%

6. Residue on ignition 0.05% NMT 0.1%

7. Heavy metals Complies NMT 20 PPM

8. N- methylpyrrolidine 0.01% NMT 0.3%

9. Bacterical endotoxin Complies NMT 0.040EU/ mg

10. Sterility Complies Should meet the std.

11. Assay 88.5% 82.5% to 91.1%

. .

Cefepime

Cefepime2DCSD. svg

Cefepime ball- and- stick. png

Systematic ( IUPAC) name

( 6R, 7R, Z) -

7- ( 2- ( 2- aminothiazol- 4- yl) - 2- ( methoxyimino) acetamido) -

3- ( ( 1- methylpyrrolidinium- 1- yl) methyl) - 8- oxo- 5- thia-

1- aza- bicyclo[ 4.2.0] oct- 2- ene- 2- carboxylate

Clinical data

Trade names Maxipime

AHFS/ Drugs. com monograph

MedlinePlus a698021

Pregnancy

category

AU: B1

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

Legal status

AU: Prescription Only ( S4)

CA: ℞ - only

UK: Prescription- only ( POM)

US: ℞ - only

Routes of

administration Intravenous, intramuscular

Pharmacokinetic data

Bioavailability 100% ( IM)

Metabolism Hepatic 15%

Biological half- life 2 hours

Excretion Renal 70–99%

Identifiers

CAS Registry Number 88040- 23- 7 Yes

ATC code J01DE01

PubChem CID: 5479537

DrugBank DB01413 Yes

ChemSpider 4586395 Yes

UNII 807PW4VQE3 Yes

KEGG D02376 Yes

ChEBI CHEBI: 478164 Yes

ChEMBL CHEMBL186 Yes

Chemical data

Formula C19H24N6O5S2

Molecular mass 480.56 g/ mol


Company Contact:


  • Phone: 912406641875

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

  • Email: Email


Published date: September 6, 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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