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Bromfenac Sodium Usp Ip Ep Manufacturer - India

price: contact company for price

CERTIFICATE OF ANALYSIS

Product Name Bromfenac Sodium CAS No:

Batch No: BRO/ 011114 A. R. No 14/ FP/ BRO/ 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 Yellowish- orange to orange crystalline powder. No

Visible evidence of contamination for foreign matter. Odorless.

2. Solubility Complies Freely soluble in water, sparingly soluble in methanol,

practically insoluble in ethyl acetate.

3. Identification Complies

Complies

Complies 1. Max. absorption exhibited at 268nm to 379nm

2. The infrared absorption spectrum corresponds to that

of reference standard

3. The identification of sodium salt is positive reaction

4. PH 8.9 8.3 to 9.5

5. Chlorides 0.05% NMT 0.05%

6. Loss on drying 7.16% 6.50% to 7.50%

7. Heavy metals ( USP) 10 PPM NMT 10 PPM

8. Heavy metals ( EP) 10 PPM NMT 10 PPM

9. Related substances Impurity A≤ 0.10% , LOD=0.0014% , LOQ=0.0043%

Impurity B≤ 0.10% , LOD=0.00092% , LOQ=0.0028%

Impurity C≤ 0.10% , LOD=0.0022% , LOQ=0.0065%

Impurity D≤ 0.10% , LOD=0.00097% , LOQ=0.0030%

Max other single impurity≤ 0.10%

Total impurities≤ 0.50% 0.18% NMT 0.0014%

NMT 0.068%

NMT 0.0022%

NMT 0.00097%

NMT 0.055%

NMT 0.18%

10. Residual solvents Methyl benzene≤ 890ppm

<Dichloromethane≤ 600ppm

Diisopropyl ether≤ 500ppm

Ethanol≤ 3000ppm

Methanol ≤ 3000ppm

2- methoxyethanol≤ 50ppm

Acetone≤ 3000ppm

Benzene ≤ 2ppm NMT 14.6 PPM

NMT 23 PPM

NMT 19.8 PPM

NMT 21.9 PPM

NMT 8 PPM

NMT 1 PPM

NMT 142 PPM

NMT 0.15 PPM

. .

Bromfenac

Bromfenac. svg

Systematic ( IUPAC) name

2- [ 2- amino- 3- ( 4- bromobenzoyl) phenyl] acetic acid

Clinical data

Trade names Bromday, Prolensa

AHFS/ Drugs. com monograph

MedlinePlus a611018

Pregnancy

category

C

Legal status

US: ℞ - only

Routes of

administration Oral ( discontinued)

ophthalmic

Identifiers

CAS Registry Number 91714- 94- 2 Yes

ATC code S01BC11

PubChem CID: 60726

IUPHAR/ BPS 7131

DrugBank DB00963 Yes

ChemSpider 54730 Yes

UNII 864P0921DW Yes

KEGG D07541 Yes

ChEBI CHEBI: 240107 Yes

ChEMBL CHEMBL1077 Yes

Chemical data

Formula C15H12BrNO3

Molecular mass 334.16g/ mol


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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