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Cefotaxime Sodium Usp Ip Bp Ep Manufacturer - India

price: contact company for price

CERTIFICATE OF ANALYSIS

Product Name Cefotaxime Sodium USP CAS No: 64485- 93- 4

Batch No: CEF/ 030313 A. R. No 13/ FP/ CEF/ 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

3. Identification

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

Complies b) By HPLC: Retention time of the principle peak in the chromatogram obtained with sample solution should match with that of the principle peak in chromatogram obtained with standard solution.

Complies c) By Sodium: Meets the requirements.

4. Related Substances

Individual Impurity Total Impurity

0.7 %

1.33%

NMT 1.0%

NMT 3.0%

5. Specific Optical Rotation at 20 0 C ( Anhydrous Basis) +59º Between +58° to +64°

6. pH in a solution ( 1 in 10) 5.2 Between 4.5–6.5

7. Loss on drying 1.18% NMT 3.0%

8. Bacterial Endotoxins Test 0.09EU/ mg NMT 0.2 EU/ mg

9. Assay HPLC 934µg/ mg 916–964 mg/ mg

. .

Cefotaxime

Cefotaxime. svg

Cefotaxime ball- and- stick. png

Systematic ( IUPAC) name

( 6R, 7R, Z) - 3- ( Acetoxymethyl) - 7- ( 2- ( 2- aminothiazol- 4- yl) - 2- ( methoxyimino) acetamido) - 8- oxo- 5- thia- 1- azabicyclo[ 4.2.0] oct- 2- ene- 2- carboxylic acid

Clinical data

Trade names Claforan ; Cefatam ( LGls)

AHFS/ Drugs. com monograph

MedlinePlus a682765

Pregnancy

category

AU: B1

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

Legal status

AU: Prescription Only ( S4)

Routes of

administration Intravenous and Intramuscular

Pharmacokinetic data

Bioavailability n/ a

Metabolism Hepatic

Biological half- life 0.8–1.4 hours

Excretion 50–85% renal

Identifiers

CAS Registry Number 63527- 52- 6 Yes

ATC code J01DD01

PubChem CID: 5479527

DrugBank DB00493 Yes

ChemSpider 4586392 Yes

UNII N2GI8B1GK7 Yes

KEGG D07647 Yes

ChEMBL CHEMBL102 Yes

Chemical data

Formula C16H17N5O7S2

Molecular mass 455.47 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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