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%
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%
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.
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.
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%
White to offwhite powder, freely soluble in dichloromethane. Identification » 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
Test Specification Appearance : White crystalline powder Solubility : Freely soluble in water & in methanol, very slightly soluble in acetone. Identification » 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 %