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Ibuprofen Ph.Eur This non-steroidal anti-inflammatory drug( NSAID ) is used as an analgesic to provide relief from body pain and to treat ailments such as arthritis, dysmenorrhoea etc. Ibuprofen is known to reduce hormones causing inflammation and pain in the body.
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Molecular Formula
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C13H18O2
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Molecular Wt.
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206.3
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- NSAID with significant medicinal application.
- Ibuprofen manufacturing capacity is 3600 TPA in the current financial year.
Technical Specifications
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Test
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Unit
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Specifications
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Test Method
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Description
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White or almost white, crystalline powder or colourless crystals.
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TM/IBU-IP/001
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Solubility
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Practically insoluble in water, freely soluble in Acetone, in Methanol, and in Methylene chloride. It dissolves in dilute solution of alkali hydroxides and carbonates.
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TM/IBU-EUR/002
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Identification
1st Identification A,C
2nd Identification A,B,D
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Melting point 75.0-78.0
By UV Exhibits 2 absorption maxima, at 264 nm and 272 nm. The ratio of the absorbance measured at the maximum at 264 nm to that measured at the shoulder at 258 nm is 1.20 to 1.30. The ratio of the absorbance measured at the maximum at 272 nm to that measured at the shoulder at 258 nm is 1.00 to 1.10.
By IR The infra-red absorbance spectrum obtained from the sample should be concordant with spectrum obtained from the CRS.
By TLC The principal spot in the chromatogram obtained with the test solution is similar in position, colour and size to the principal spot in the chromatogram obtained with the reference solution.
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TM/IBU-EUR/003
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Appearance of solution
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10% solution in methanol should be clear & colorless
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TM/IBU-EUR/004
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Optical rotation
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0.05o to 0.05o
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TM/IBU-EUR/005
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Sulphated ash(w/w)
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% Max
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0.1
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TM/IBU-EUR/006
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Heavy Metals
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Max, ppm
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10
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TM/IBU-EUR/007
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Loss on drying
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% Max.
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0.5
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TM/IBU-EUR/008
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Impurity -F
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% Max.
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0.1
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TM/IBU-EUR/009
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Related Substances(By HPLC) Impurity –A,J,N (for each impurity)
Total Impurity
Unspecified Impurity
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% Max
% Max.
% Max.
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0.15
0.2
0.05
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TM/IBU-EUR/010
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Assay(with reference to the dried substance)
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%
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98.5 to 101.0
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TM/IBU-EUR/011
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Residual Solvents (GC)
Trichloroethylene
Acetone
Isopropyl Alcohol
Hexane
Benzene |
ppm
ppm
ppm
ppm
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80 Max.
100 Max.
100 Max.
100 Max.
2 Max |
TM/IBU-A/001
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Benzene is not used in Manufacturing Process
- Storage Condition: Keep in Tight Containers
- Standard packing size: The material is packed in a standard pack size of 40Kg and 50Kg. However, packing size can vary depending upon the customer's requirements.
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