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Alfuzosin Hydrochloride Usp - India

price: contact company for price

PRODUCT CODE: SDPAPI0068

PRODUCT NAME: Alfuzosin HCl

CAS NO: 81403- 68- 1

USES: Prostatic hyperplasia

MOLECULAR WEIGHT: 425.91

MOLECULAR FORMULA: C19H27N5O4 · HCl

CHEMICAL NAME: N- ( 3- ( ( 4- Amino- 6, 7- dimethoxy- 2- quinazolinyl) methylamino) propyl) tetrahydro- 2- furancarboxamide hydrochloride, Uroxatral hydrochloride

CERTIFICATE OF ANALYSIS

Product Name Alfuzosin Hydrochloride USP CAS No: 81403- 68- 1

Batch No: ALF/ 030313 A. R. No 13/ FP/ ALF/ 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. 1. Appearance

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

alcohol, practically insoluble in methylene chloride. Freely soluble in water, sparingly soluble in alcohol, practically insoluble in methylene chloride.

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) 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:

3. 4. Specific Optical Rotation at 20 0 C ( Anhydrous Basis) +2.5º Between - 10° to +10°

4. 6. Water Content by KF 0.23% NMT 0.5%

10. Residue On Ignition 0.04% NMT 0.1%

Remarks: The values in the results has been obtained from Manufacturer' s COA.

5. 9. Related Substance by HPLC

9.1 Impurity- A 0.026% NMT 0.05 %

9.2 Impurity- B 0.031% NMT 0.05 %

9.3 Impurity- C 0.034% NMT 0.05%

9.7 Total Impurities 0.15% NMT 0.30 %

10. Assay by HPLC ( On anhydrous basis) 99.5% NLT 99.0 % w/ w and NMT 101.0 % w/ w

Note:

Impurity Name Chemical Name

Impurity- A N- [ 3- [ ( 4- Amino- 6, 7- dimethoxyquinazolin- 2- Organic Impurities

yl) ( methyl) amino] propyl] furan- 2- carboxamide.

Impurity- B Impurity A, a component of USP Alfuzosin System Suitability Mixture RS, is not a specified impurity.

Impurity- C N- ( 4- Amino- 6, 7- dimethoxyquinazolin- 2- yl) - N- methylpropane- 1, 3- diamine.


Company Contact:


  • Phone: 912406641875

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

  • Email: Email


Published date: September 4, 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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