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Azithromycin Dihydrate Usp Ip Bp Ep Manufacturer - India

price: contact company for price

CERTIFICATE OF ANALYSIS

Product Name Azithromycin Dihydrate CAS No:

Batch No: AZI/ 011114 A. R. No 14/ FP/ AZI/ 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 crystalline Powder

2. Identification

IR

HPLC

Complies

Complies

A. Conforms to the reference spectrum

B. Similar in retention time and size to the principal peak of the reference

3. Specific optical rotation - 47.0° - 45° to - 49°

4. Clarity of solution Complies Not more intensely turbid than reference suspensions II

5. PH 9.9 9.0 to 11.0

6. Crystallinity Complies Should conforms to requirements

7. Related substances

Desosaminylazithromycin

N- demothylazithromycin

Other impurity

Total impurity

0.07%

0.35%

0.34%

1.1%

NMT 0.3%

NMT 0.7%

NMT 1.0%

NMT 3.0%

8. Water content 4.5% 4.0% to 5.0%

9. Residue on Ignition 0.03% NMT 0.3%

10. Heavy metals 20 PPM NMT 25 PPM

11. Undue toxicity Complies Should conforms to requirements

12. Assay 967.0μ g/ mg 945μ g/ mg~1030μ g/ mg

. .

Azithromycin

Azithromycin structure. svg

Azithromycin 3d structure. png

Systematic ( IUPAC) name

( 2R, 3S, 4R, 5R, 8R, 10R, 11R, 12S, 13S, 14R) - 2- ethyl- 3, 4, 10- trihydroxy- 3, 5, 6, 8, 10, 12, 14- heptamethyl- 15- oxo- 11- { [ 3, 4, 6- trideoxy- 3- ( dimethylamino) - β - D- xylo- hexopyranosyl] oxy} - 1- oxa- 6- azacyclopentadec- 13- yl 2, 6- dideoxy- 3- C- methyl- 3- O- methyl- α - L- ribo- hexopyranoside

Clinical data

Trade names Zithromax, Azithrocin, others

AHFS/ Drugs. com monograph

MedlinePlus a697037

Licence data US FDA: link

Pregnancy

category

AU: B1

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

Legal status

US: ℞ - only

Routes of

administration Oral ( capsule, tablet or suspension) , intravenous, ophthalmic

Pharmacokinetic data

Bioavailability 38% for 250 mg capsules

Metabolism Hepatic

Biological half- life

11–14 h ( single dose)

68 h ( multiple dosing)

Excretion Biliary, renal ( 4.5% )

Identifiers

CAS Registry Number 83905- 01- 5 Yes

ATC code J01FA10 S01AA26

PubChem CID: 55185

IUPHAR/ BPS 6510

DrugBank DB00207 Yes

ChemSpider 10482163 Yes

UNII J2KLZ20U1M Yes

KEGG D07486 Yes

ChEBI CHEBI: 2955 Yes

ChEMBL CHEMBL529 Yes

NIAID ChemDB 007311

Synonyms 9- deoxy- 9a- aza- 9a- methyl- 9a- homoerythromycin A

Chemical data

Formula C38H72N2O12

Molecular mass 748.984 g· mol− 1


Company Contact:


  • Phone: 912406641875

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

  • Email: Email


Published date: September 5, 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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