IOL Chemicals and Pharmaceuticals Limited

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Mono Chloro Acetic Acid

Acetyl Chloride

Omeparazole

Lansoprazole

Rabeprazole Sodium

Tramadol HCl

Sertraline HCl

Losartan Potassium

Lamotrigine

Fenofibrate

Pantoprazole Na Sesquihyderate / Pantoprazole Sodium

Home » Product Range » Ibuprofen » Ibuprofen Ph.Eur

Ibuprofen Ph.Eur

Ibuprofen BP

Ibuprofen IP

Ibuprofen Ph.Eur

Ibuprofen USP

Molecular Formula :	C₁₃H₁₈O₂
Molecular Wt. :	206.3

NSAID with significant medicinal application.

Ibuprofen manufacturing capacity is 3600 TPA in the current financial year.

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.

Specifications

TEST

UNIT

SPECIFICATIONS

TEST METHOD

Description

White or almost white, crystalline powder or colourless crystals.

TM/IBU-EUR/001

Solubility

Practically insoluble in water, freely soluble in Acetone, in Methanol, and in Methylene chloride. It dissolves in dilute solution of alkali hydroxides and carbonates.

TM/IBU-EUR/002

Identification
1^st Identification A,C
2^nd Identification A,B,D

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.

TM/IBU-EUR/003

Appearance of solution.

10% solution in methanol should be clear & colorless

TM/IBU-EUR/004

Optical rotation

- 0.05⁰ to 0.05⁰

TM/IBU-EUR/005

Sulphated ash(w/w)

% Max.

0.1

TM/IBU-EUR/006

Heavy Metals

Max, ppm

TM/IBU-EUR/007

Loss on drying

% Max.

0.5

TM/IBU-EUR/008

Impurity -F

% Max.

0.1

TM/IBU-EUR/009

Related Substances(By HPLC)

Impurity –A,J,N (for each impurity)

Total Impurity

Unspecified Impurity

% Max

% Max.

0.15

0.2

0.05

TM/IBU-EUR/010

Assay(with reference to the dried substance)

98.5 to 101.0

TM/IBU-EUR/011

Residual Solvents (GC)

Trichloroethylene

Acetone

Isopropyl Alcohol

Hexane

Benzene

ppm

80 Max.

100 Max.

2 Max

TM/IBU-A/001

* 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.

Ibuprofen Ph.Eur