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Diclofenac Diethylamine Usp Ip Bp Ep Manufacturer - India

price: contact company for price

CERTIFICATE OF ANALYSIS

Product Name Diclofenac diethylamine CAS No:

Batch No: DIC/ 011114 A. R. No 14/ FP/ DIC/ 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 slightly yellowish crystalline

powder, slightly hygroscopic

2. Identification Complies

Complies IR- Spectrum

TLC chromatogram

3. PH 7.3 6.4 to 8.4

4. APPEARANCE OF

SOLUTION Complies

0.020% CLEAR

Absorption at 440nm max 0.05

5. Heavy metals Complies NMT 10 PPM

6. Single substance 0.48% NMT 1.0%

7. Related substances

Single impurity

Total impurities

Complies

Complies

NMT 0.2%

NMT 0.5%

8. Sulphated substances Complies NMT 0.1%

9. Loss on drying 0.05% NMT 0.5%

10. Assay 99.43% 99.0% to 101.0%

. .

Diclofenac

Diclofenac. svg

Clinical data

Trade names Aclonac, Cataflam, Voltaren

AHFS/ Drugs. com monograph

MedlinePlus a689002

Pregnancy

category

AU: C

US: C ( Risk not ruled out) in 1st and 2nd trimester, D in 3rd trimester

Legal status

AU: Pharmacy Only ( S2) – S4

UK: Prescription- only ( POM) ( P for topical formulation)

℞ - only in most preparations/ countries, limited OTC in some countries, manufacture and veterinary use is banned in India, Nepal, and Pakistan due to imminent extinction of local vultures

Routes of

administration oral, rectal, intramuscular, intravenous ( renal- and gallstones) , topical

Pharmacokinetic data

Protein binding More than 99%

Metabolism hepatic, no active metabolites exist

Biological half- life 1.2- 2 hr ( 35% of the drug enters enterohepatic recirculation)

Excretion 40% biliary 60% urine

Identifiers

CAS Registry Number 15307- 86- 5 Yes

ATC code D11AX18 M01AB05, M02AA15, S01BC03

PubChem CID: 3033

IUPHAR/ BPS 2714

DrugBank DB00586

ChemSpider 2925 Yes

UNII 144O8QL0L1 Yes

KEGG D07816 Yes

ChEBI CHEBI: 47381 Yes

ChEMBL CHEMBL139 Yes

PDB ligand ID DIF ( PDBe, RCSB PDB)

Chemical data

Formula C14H11Cl2NO2

Molecular mass 296.148 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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