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Abacavir Sulfate Ip Usp Bp Ep Manufacturer Supplier - India

price: contact company for price

CERTIFICATE OF ANALYSIS

Product Name Abacavir SulfateUSP CAS No: 188062- 50- 2

Batch No: ABA/ 011114 A. R. No 14/ FP/ ABA/ 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

2. 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) Sulphate : Meets the requirements

3. Water content 0.05% NMT 0.5%

4. Residue on Ignition 0.026% NMT 0.2%

5. Impurities 0.05%

Undetectable

0.01%

0.06%

Descyclopropyl abacavir not more than 0.2%

Trans- abacavir not more than 0.2%

O- Pyrimidinyl derivative abacavir not more than 0.2%

t- Butyl derivative abacavir not more than 0.2%

Unknown impurities not more than 0.1%

Total impurities not more than 0.8%

6. Stereoisomer 0.002% NMT 0.3%

7. Residual solvents

Ethanol

Methanol

Isobutanol

Undetectable

NMT 0.5%

NMT 0.3%

8. Assay ( On dry basis) 99.63% 97.0% ~102.0%

9. Particle size D10: 7.5um

D50: 18.4um

D90: 45.2um Complies


Company Contact:


  • Phone: 912406641875

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

  • Email: Email


Published date: September 3, 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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