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Alfuzosin Hydrochloride Usp Api Manufacturer - India

price: contact company for price

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- 2019

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: 917387999183

  • Address: PLOT NO: 04, MAYUR PARK, HARSOOL, AURANGABAD, AURANGABAD, India

  • Email: Email


Published date: October 1, 2014 -

  • Business Description: 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 ISO 9001:2008 Certified and we are specializes in sales and marketing of Pharmaceutical Finished products, Pharmaceutical Active Ingredients (API's), Intermediates and Herbal Extracts, 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.
    Send us your enquiries on Email: sales@swapnroopdrugs.com
    or Call us on Tel: +91 240 6641875, Mob:+91 7387999183
    Contact Persons:
    1. Dulal Mohato (Sales & Marketing Manager) Tel:0240 6641875, Mob:+91 7387999183
    Email: sales@swapnroopdrugs.com Whatsapp Mobile No: +91 7387999183
    Skype: dulalmohato
    Website:www.swapnroopdrugs.com

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