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Benazepril Hydrochloride Usp Bp Ip Ep Maufacturer - India

price: contact company for price

CERTIFICATE OF ANALYSIS

Product Name Benazepril Hydrochloride USP CAS No: 86541- 74- 4

Batch No: BEN/ 030313 A. R. No 13/ FP/ BEN/ 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 a) By IR Spectrum: The infrared absorption spectrum of the test sample exhibits maxima only at the same wavelengths as that of the working standard.

Complies b) By HPLC: Retention time of the principle peak in the chromatogram obtained with sample solution should match with that of the principle peak in chromatogram obtained with standard solution.

Complies c) By chloride test: Meets the requirements.

4. Related Substances

Individual Impurity Total Impurity

0.07 %

0.31%

NMT 0.3 %

NMT 0.5 %

5. Specific Optical Rotation at 20 0 C ( Anhydrous Basis) - 126.02 Between - 125 0 to - 138 0

6. pH ( Solubility of 0.1 g in 50 ml) 4.52 Between 3.9 and 4.6

7. Water Content by KF 3.70 % w/ w NMT 4.5 % w/ w

8. Sulphated Ash 0.05 % w/ w NMT 0.1 % w/ w

10. Heavy Metals Complies NMT 20 ppm

11. Residue On Ignition NMT 0.1%

12. Assay HPLC 100.4% 98.0 to 102.0%

Melting Temperature

. .

Benazepril

Benazepril. svg

Benazepril- 3D- balls. png

Systematic ( IUPAC) name

2- [ ( 3S) - 3- { [ ( 2S) - 1- ethoxy- 1- oxo- 4- phenylbutan- 2- yl] amino} -

Clinical data

Trade names Lotensin

AHFS/ Drugs. com monograph

MedlinePlus a692011

Pregnancy

category

D

Legal status

℞ ( Prescription only)

Routes of

administration Oral

Pharmacokinetic data

Protein binding 96.7%

Metabolism Hepatic glucuronidation

Biological half- life 10- 11 hours

Excretion Renal and biliary

Identifiers

CAS Registry Number 86541- 75- 5 Yes

ATC code C09AA07

PubChem CID: 5362124

IUPHAR/ BPS 6374

DrugBank DB00542 Yes

ChemSpider 4514935 Yes

UNII UDM7Q7QWP8 Yes

ChEBI CHEBI: 3011 Yes

ChEMBL CHEMBL838 Yes

Chemical data

Formula C24H28N2O5

Molecular mass 424.49 g/ 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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