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Amlodopinebesilate Bp Usp Manufacturer Supplier - India

price: contact company for price

CERTIFICATE OF ANALYSIS

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

2. Identification

A

B

C

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

Total Impurity

Number of spots of >0.10% and <0.30%

B by HPLC

Impurity D

Total impurities

0.3%

2

BDL ( 0.03% )

0.04%

NMT 0.3%

NMT 2 spot

NMT 0.30%

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

Methanol

Hexane

Ethyl acetate

Toluene

3.96 PPM

0.59 PPM

3.07 PPM

1.4 PPM

NMT 1000 PPM

NMT 290 PPM

NMT 500 PPM

10. Microbial analysis

Total aerobic microbial count

Total combined yeast and mold count

Escherichia coli

10 cfu/ g

Absent

NMT 1000 cfu/ g

NMT cfu/ g

Absent

. .


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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