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Colistin Sulphate Usp Ip Bp Ep Manufacturer - India

price: contact company for price

CERTIFICATE OF ANALYSIS

Product Name Colistin sulphate CAS No:

Batch No: COL/ 011114 A. R. No 14/ FP/ COL/ 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 powder

2. Identification Complies As per EP

3. PH 4.6 4.0 to 6.0

4. Loss on drying 1.7% NMT 3.5%

5. Specific optical rotation - 72º - 63º to - 73º

6. Sulphated ash 0.2% NMT 1.0%

7. Sulphate 16.9% 16.0% to 18.0%

8. Content

Colistin E1

Colistin E3

Colistin E1

0.5%

3.2%

3.3%

89.4%

NMT 10.0%

NLT 77.0%

9. Related substances

Any impurity

Total impurities

2.4%

12.6%

NMT 4.0%

NMT 23.0%

10. Potency 22608 IU/ mg NLT 19000 IU/ mg

.

Colistin

Colistin. svg

Systematic ( IUPAC) name

N- ( 4- amino- 1- ( 1- ( 4- amino- 1- oxo- 1- ( 3, 12, 23- tris( 2- aminoethyl) - 20- ( 1- hydroxyethyl) - 6, 9- diisobutyl- 2, 5, 8, 11, 14, 19, 22- heptaoxo- 1, 4, 7, 10, 13, 18- hexaazacyclotricosan- 15- ylamino) butan- 2- ylamino) - 3- hydroxybutan- 2- ylamino) - 1- oxobutan- 2- yl) - N, 5- dimethylheptanamide

Clinical data

Trade names Coly- mycinm; Coly- monas( India)

Pregnancy

category

C

Legal status

PoM ( UK) , not available in US

Routes of

administration topical, oral, intravenous, inhaled

Pharmacokinetic data

Bioavailability 0%

Biological half- life 5 hours

Identifiers

CAS Registry Number 1264- 72- 8 Yes

ATC code A07AA10 J01XB01 QJ51XB01

PubChem CID: 5311054

DrugBank DB00803 Yes

ChemSpider 4470591 Yes

UNII WP15DXU577

KEGG D02138 Yes

ChEMBL CHEMBL501505

Chemical data

Formula C52H98N16O13

Molecular mass 1155.4495 g/ mol


Company Contact:


  • Phone: 912406641875

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

  • Email: Email


Published date: September 7, 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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