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Carbamazepine Usp Bp Ip Ep Manufacturer - India

price: contact company for price

CERTIFICATE OF ANALYSIS

Product Name Carbamazepine USP CAS No:

Batch No: CAR/ 030313 A. R. No 13/ FP/ CAR/ 0303

Date of Manufacture Feb- 2013 Date of Analysis 02- 02- 13

Batch Quantity 165 kg Date of Retest Jan- 2016

Sr. No Test Results Acceptance Criteria

1. Appearance

2. Solubility

3. Identification

Complies By IR Spectrum: The infrared absorption spectrum of the test sample exhibits maxima only at the same wavelengths as that of the working standard.

4. Related Substances

Individual Impurity Total Impurity

0.08 %

0.21%

NMT 0.2%

NMT 0.5%

5. Loss On Drying 0.17% NMT 0.5%

6. X- Ray Diffraction Complies The X- ray diffraction pattern conforms to that of USP Carbamazepine RS, similarly determined.

7. Heavy Metals Complies NMT 10 ppm

8. Residue On Ignition 0.05% NMT 0.1%

9. Assay HPLC 99.54% 98.0 to 102.0

.

Carbamazepine

Carbamazepine. svg

Carbamazepine 3D. png

Systematic ( IUPAC) name

5H- dibenzo[ b, f] azepine- 5- carboxamide

Clinical data

Trade names Tegretol

AHFS/ Drugs. com monograph

MedlinePlus a682237

Licence data US Daily Med: link

Pregnancy

category

AU: D

US: D ( Evidence of risk)

Legal status

AU: Prescription Only ( S4)

CA: ℞ - only

UK: Prescription- only ( POM)

US: ℞ - only

Routes of

administration Oral

Pharmacokinetic data

Bioavailability ~100% [ 1]

Protein binding 70- 80% [ 1]

Metabolism Hepatic—by CYP3A4, to active epoxide form ( carbamazepine- 10, 11 epoxide) [ 1]

Biological half- life 36 hours ( single dose) , 16- 24 hours ( repeated dosing) [ 1]

Excretion Urine ( 72% ) , feces ( 28% ) [ 1]

Identifiers

CAS Registry Number 298- 46- 4 Yes 85756- 57- 6

ATC code N03AF01

PubChem CID: 2554

IUPHAR/ BPS 5339

DrugBank DB00564 Yes

ChemSpider 2457 Yes

UNII 33CM23913M Yes

KEGG D00252 Yes

ChEBI CHEBI: 3387 Yes

ChEMBL CHEMBL108 Yes

Chemical data

Formula C15H12N2O

Molecular mass 236.269 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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