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Clarithromycin Usp Ip Bp Ep Manufacturer - India

price: contact company for price

CERTIFICATE OF ANALYSIS

Product Name Clarithyromycin CAS No:

Batch No: CLA/ 011114 A. R. No 14/ FP/ CLA/ 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 almost white crystalline powder.

2. Solubility Complies Practically insoluble in water, soluble in acetone and in methylene chloride, slightly soluble in methanol.

3. Identification Complies IR: Conforms to the Clarithromycin CRS spectrum.

4. Specific optical rotation - 98º - 94° to - 102°

5. Crystallinity Complies Meets the requirements

6. PH 8.2 8.0 to 10.0

7. Water 0.18% NMT 2.0%

8. Residue on ignition 0.02% NMT 0.2%

9. Heavy metals Complies NMT 20 PPM

10. Related substances

Single impurity

Any impurities MT 0.4%

Total impurities

0.72%

1

1.4%

NMT 1.0%

NMT 4

NMT 3.5%

11. Residual solvents

Ethanol

Pyridine

Not detected

Not detected

NMT 5000 PPM

NMT 200 PPM

12. Assay 98.2% 96.0% to 102.0%

Clarithromycin

Clarithromycin structure. svg

Clarithromycin ball- and- stick. png

Systematic ( IUPAC) name

( 3R, 4S, 5S, 6R, 7R, 9R, 11S, 12R, 13S, 14S) - 6- { [ ( 2S, 3R, 4S, 6R) - 4- ( dimethylamino) - 3- hydroxy- 6- methyloxan- 2- yl] oxy} - 14- ethyl- 12, 13- dihydroxy- 4- { [ ( 2R, 4S, 5S, 6S) - 5- hydroxy - 4- methoxy- 4, 6- dimethyloxan- 2- yl] oxy} - 7 - methoxy- 3, 5, 7, 9, 11, 13- hexamethyl - 1- oxacyclotetradecane- 2, 10- dione

Clinical data

Trade names Biaxin

AHFS/ Drugs. com monograph

MedlinePlus a692005

Pregnancy

category

C ( USA)

B3 ( Aus)

Legal status

prescription only

Routes of

administration oral, intravenous

Pharmacokinetic data

Bioavailability 50%

Protein binding low binding

Metabolism hepatic

Biological half- life 3–4 h

Identifiers

CAS Registry Number 81103- 11- 9 Yes

ATC code J01FA09

PubChem CID: 5284534

DrugBank DB01211 Yes

ChemSpider 21112273

UNII H1250JIK0A Yes

KEGG D00276 Yes

ChEMBL CHEMBL1741

Chemical data

Formula C38H69NO13

Molecular mass 747.953 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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