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Ambroxol Hydrochloride


Ambroxol is a clinically proven systematically active mucolytic agent. When administered orally onset of action occurs after about 30 minutes. The breakdown of acid mucopolysaccharide fibers make the sputum thinner and less viscous and therefore more easily removed by coughing. Although sputum volume eventually decreases, its viscosity remains low for as long as treatment is maintained.



Test Specification
Description : White or almost white crystals or crystalline powder.
Solubility : Freely soluble in water and in ethanol (96%); slightly soluble in glycerol and in liquid paraffin.
Identification : A. The infrared absorption spectrum, is concordant with the reference spectrum of bronopol (RS 031).

B. Dissolve 0.1 g in 10 ml of water , add 10 ml of 7.5M sodium hydroxide and, carefully with constant stirring and cooling, 0.5 g of nickel-aluminium alloy. Allow the reaction to subside, filter and carefully neutralise with nitric acid. The resulting solution yields reaction A characteristic of bromides,

C. Melting point, after drying over phosphorus pentoxide at a pressure not exceeding 0.7 kPa, about 130 ºC
P H : Between 5.0 to 7.0
Sulphated Ash : NMT 0.10 % w/w
Water : NMT 0.50% w/w
Related substances by HPLC
» Single Impurity :

NMT 0.50%
» Total Impurities : NMT 1.00%
Assay (on anhydrous basis) : NLT 99.0% and NMT 101.0%

Clopidogrel Bisulphate


Test Specification
Description : White to off-white powder
Identification by IR : To concordant with working standard
Solubility : Freely soluble in methanol
Specific optical rotation
(At 25°C in methanol medium) : Should be between +50° and +58°
Loss on drying : NMT 0.5 % w/w
Heavy Metals : NMT 20 ppm
Residue on ignition : NMT 0.1% w/w
Related compounds ( by HPLC)
» Clopidogrel related compound A : NMT 0.2%
» Clopidogrel related compound B : NMT 0.3%
» Clopidogrel related compound C : NMT 1.0%
» Any other impurity : NMT 0.1%
» Total impurities : NMT 1.5%
Assay (by HPLC) : NLT 97.0% and NMT 101.5%

Closantel Sodium


an anthelmintic used mostly in domestic animals, it is used as a dewormer for cattle, sheep, horse, pig, dog, camel, deer and ostrich etc.
It is highly effective against itch-mite, mange, fascioliasis, sheepnose fly, cowskin fly, fascioliasis, gastrointestinal nematode and demodicidosis etc.



Test Specification
Description : A white crystalline Powder
Clarity and colour of solution : The Solution is Clear and Colourless.
Identification : As per standard specification
» By IR : The Infra red absorption spectrum of the sample should exhibit maximum only at the same wavelengths as that of a similar preparation of FLUCONAZOLE working standard
Melting Range : 138ºC - 142ºC
Loss On Drying : NMT 0.50%
Residue on Ignition : NMT 0.10%
Iron Content : NMT 0.002%

Related Compounds (Test - 1)

» Impurity at RRT 0.6 : NMT 1.00%
» Impurity at RRT 0.5 or 0.9 : NMT 0.20%
» Any other individual Impurities : NMT 0.10%
» Total Other impurity : NMT 0.20%
» Total Impurities : NMT 1.20%
Assay by Chemical : NLT 98.00 % and NMT 102.00 %



Niclosamide is used to treat broad or fish tapeworm, dwarf tapeworm, and beef tapeworm infections. Niclosamide may also be used for other tapeworm infections as determined by your doctor. It will not work for other types of worm infections (for example, pinworms or roundworms)

Niclosamide works by killing tapeworms on contact. The killed worms are then passed in the stool. However, you may not notice them since they are sometimes destroyed in the intestine.



Oxyclozanide is salicylanilide anthelmintic and is used for the treatment and control of fascioliasis in cattle, sheep and goats

Oxyclozanide is a chemical substance used to expel or destroy tapeworms in domestic animals. It is an anthelmintic used in grazing animals for fasciola and cestode infestations



Anthelmintic (also spelled anthelminthic) is a chemical substance used to expel or destroy tapeworms in domestic animals It is used as a fasciolicide in cattle,sheep,goats and horses.it is also active against gastrointestinalnematodesand against the sheep nasal bot fly.

Sertraline Hcl


Test Specification
Description : Off-White to white crystalline powder.
Solubility : Sparingly Soluble in Methanol. Slightly soluble in Dimethyl formamide
Identification : The IR spectrum of sample d should be concordant with the spectrum of reference standard
Melting Range : Between 245 - 250°C
Loss On Drying : NMT 0. 50 % w/w
Sulphated Ash : NMT 0.10 % w/w
Heavy Metals : NMT 20 ppm
Optical Rotation : + 38 to + 42°
Related substances by HPLC
» Single Impurity :

NMT 0.20%
» Total Impurities : NMT 0.50%
» Individual impurity : NMT 0.10%
Assay (on anhydrous basis) : NLT 98.0% and NMT 102.0%

Residual solvents

Ethanol NMT 5000ppm

Ethylacetate NMT 5000ppm
IPA NMT 5000ppm







White to offwhite powder, freely soluble in dichloromethane.
» A) By IR :
The infrared absorption spectrum of substance being
examined must be concordant with the IR spectrum
obtained from the Topiramate working standard.
» B) By HPLC :
The retention time of the major peak in the
Chromatograph of the assay preparation of substance
being examined corresponds to that in the major peak
obtained from assay preparation of Topiramate
working standard.
Specific Optical Rotation : Between -29.0° and -35.0°
Water Content : Not more than 0.50% w/w
Residue on ignition : Not more than 0.20% w/w
Related substances by HPLC
» Topiramate related compound A.Fractose : Not more than 0.30%
» Single impurity : Not more than 0.10%
» Total Impurities : Not more than 0.50%
Assay (on anhydrous basis) : Not less than 98.0% and Not more than 102.0% w/w

Tramadol Hcl


Test Specification
Appearance : White crystalline powder
Solubility : Freely soluble in water & in methanol, very slightly soluble in acetone.
» Melting Point : 180 0 C to 184 0
» Infrared Absorption Spectrum : To be concordant with standard Spectrum
» TLC To be corresponds with reference std. Chromatogram.
» Chloride Test : It gives reaction of chlorides
Appearance of Solution : Solution S is to be clear and colourless


NMT 0.4 ml of 0.01M NaOH is required
Optical Rotation :

0.1 ° to + 0.1 °
Impurity E by TLC : NMT 0.2 %
Related Substance by HPLC
» Impurity A : NMT 0.2%
» Any other impurity : NMT 0.1%
» Total impurities : NMT 0.4 %
Heavy Metals : NMT 20 ppm
Water : NMT 0.5 %

To,Konar Organics Limited

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