Amlodopinebesilate Bp Usp Manufacturer Supplier - Indiaprice: contact company for price
Product Name Amlodopinebesilate CAS No:
Batch No: AML/ 011114 A. R. No 14/ FP/ AML/ 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 Complies White to off white crystalline powder
IR spectrum should be concordant with the amlodipine besilate working standard
The Principal spot in the chromatogram obtained with the test solution ( b) corresponds to that in the chromatogram obtained with reference solution ( b) by TLC in test A for related substances.
The specific absorbance at the maximum is 113 to 121
IR spectrum concordant with the Amlodipine besilate working standard.
Matching the standard
Meet the requirement
3. Solubility Complies Slightly soluble in water freely soluble in methanol sparingly soluble in ethanol slightly soluble in 2- propanol
4. Optical rotation 0.00° - 0.10° to +0.10° determined in a 1.0% w/ v solution in methanol
5. Relative substances
A by TLC
Number of spots of >0.10% and <0.30%
B by HPLC
BDL ( 0.03% )
NMT 2 spot
6. Sulphated ash 0.06% NMT 0.20% w/ w
7. Water content 0.09% NMT 0.50% w/ w
8. Assay by HPLC 99.59% 97.0% to 102.0% w/ w on anhydrous basis
9. Residual solvents
NMT 1000 PPM
NMT 290 PPM
NMT 500 PPM
10. Microbial analysis
Total aerobic microbial count
Total combined yeast and mold count
10 cfu/ g
NMT 1000 cfu/ g
NMT cfu/ g
- Posted By: SWAPNROOP DRUGS AND PHARMACEUTICALS
- Phone: 912406641875
- Address: PLOT NO: 04 JALGAON ROAD, HARSOOL, AURANGABAD, India
- Website: http://www.apisupplier.com
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
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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