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Cefradine 65288 Micronized 65289 Usp Ip Ep Bp Manufacturer - India

price: contact company for price

CERTIFICATE OF ANALYSIS

Product Name Cefradine( Micronized) 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 White or slightly yellow powder, hygroscopic

powder.

2. Solubility Complies Slightly soluble in water, practically insoluble in

ethanol 96 percent and in hexane.

3. Indentification Complies IR spectrum should match with that of standard

4. Clarity of solution Complies Solution S is not more opalescent than reference

suspension II

5. Absorbance at 450 nm 0.2 NMT 0.6

6. PH 4.8 3 to 6

7. Specific optical rotation +85° Between +80.0°and +90.0°( anhydrous substance)

8. Related substances

Impurity B

Impurities A, C, D, E, F, G

Any other impurity

Total impurities

Complies

Complies

NMT 0.25%

NMT 2.0%

9. Acetone Complies NMT 5000 PPM

10. Mc Complies NMT 600 PPM

11. DMF Complies NMT 880 PPM

12. Water 4.2% NMT 6.0%

13. Sulphated ash 0.1% NMT 0.2%

14. cefradine 97.6% NLT 90.0%

15. cefalexin 1.3% NLT 5.0%

16. 4′ , 5′ - dihydrocefradine 0.3% NMT 2.0%

17. Sum of cefradine, cefalexin

and 4′ , 5′ - dihydrocefradine 99.2% 96.0% to 102.0%

18. Density 0.43g/ ml -

. .

Cefradine

Cefradine. svg

Systematic ( IUPAC) name

( 6R, 7R) - 7- { [ ( 2R) - 2- amino- 2- ( 1- cyclohexa- 1, 4-

dienyl) acetyl] amino} - 3- methyl- 8- oxo- 5- thia-

1- azabicyclo[ 4.2.0] oct- 2- ene- 2- carboxylic acid

Clinical data

Trade names Intracef, Velocef

AHFS/ Drugs. com International Drug Names

MedlinePlus a601206

Legal status

℞ ( Prescription only)

Routes of

administration Oral, IM, IV

Pharmacokinetic data

Bioavailability Well absorbed

Protein binding <10%

Metabolism Nil

Biological half- life 0.9 hours

Excretion Renal, unchanged

Identifiers

CAS Registry Number 38821- 53- 3 Yes

ATC code J01DB09

PubChem CID: 38103

IUPHAR/ BPS 4830

DrugBank DB01333 Yes

ChemSpider 34933 Yes

UNII 9YA6SX5S4D Yes

KEGG D00264 Yes

ChEBI CHEBI: 3547 Yes

ChEMBL CHEMBL1604 Yes

Chemical data

Formula C16H19N3O4S

Molecular mass 349.406 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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