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Cefaclor Usp Ip Bp Ep Manufacture - India

price: contact company for price

CERTIFICATE OF ANALYSIS

Product Name Cefaclor USP CAS No: 53994- 73- 3

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.

4. Related Substances

Individual Impurity Total Impurity

0.32 %

1.1%

NMT 0.5%

NMT 2.0%

5. pH 3.4 Between 3.0–4.5

6. Water Content by KF 4.7% 3.0% –6.5%

7. Crystallinity Complies Meets the requirements

8. Assay HPLC 982µg/ mg 950 mg/ mg–1020 mg/ mg

. .

Cefaclor

Cefaclor. svg

Systematic ( IUPAC) name

( 6R, 7R) - 7- { [ ( 2R) - 2- amino- 2- phenylacetyl] amino} - 3- chloro- 8- oxo- 5- thia- 1- azabicyclo[ 4.2.0] oct- 2- ene- 2- carboxylic acid

Clinical data

Trade names Biocef, Ceclor, Distaclor, Keflor, Raniclor

AHFS/ Drugs. com monograph

MedlinePlus a682729

Pregnancy

category

AU: B1

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

Legal status

℞ ( Prescription only)

Routes of

administration Oral

Pharmacokinetic data

Bioavailability Well absorbed, independent of food intake

Metabolism 15% to 40%

Biological half- life 0.6 to 0.9 hours

Excretion Renal

Identifiers

CAS Registry Number 53994- 73- 3 Yes

ATC code J01DC04

PubChem CID: 51038

DrugBank DB00833 Yes

ChemSpider 46260

UNII 3Z6FS3IK0K Yes

KEGG D00256 Yes

ChEMBL CHEMBL8867

Chemical data

Formula C15H14ClN3O4S

Molecular mass 367.808 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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