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SMAART PHARMACEUTTICALS was founded by a Young Technocrat Mr. Nitten Gavande, a Chemical Engineer & Business Management Graduate, with a steadfast belief that research-based pharmaceutical industry would be the driving force behind innovations in modern healthcare. SMAART PHARMACEUTTICALS manufacturing facility is located at Jalgaon, 400km north of Mumbai, the Economic capital of INDIA & is situated 50km away from the ancient Buddhist cave temples of Ajanta. which were excavated between the 2d century BC and the 5th century AD. This state-of-the-art facility specializes in the manufacture of API's (Active Pharmaceutical Ingredients) ranging from Disinfectants to Cardiovasculars. This facility has Glass Lined Reactors, S.S Reactors, S.S centrifuges, Dryers and varied production equipment. The facilities are versatile and are capable of carrying out varied reactions ranging from -20°c to +150°c. SMAART has the capability to handle highly complex and hazardous reactions with utmost safety and productivity. SMAART’s operations are backed by a full spectrum of utilities, sophisticated quality control equipment and a 'zero discharge' environment-friendly effluent treatment plant. SMAART PHARMACEUTTICALS has established a Trading division to source world class API’s at competitive rates, directly from leading manufacturers in India and providing consistent quality and time bound shipment schedules. This has given us an additional advantage in terms of better understanding of the overseas API market & has offered more exposure in the world market
SMAART PHARMACEUTTICALS
 

NEBIVOLOL HYDROCHLORIDE. IN HOUSE
Post date:2008-04-25

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NEBIVOLOL HYDROCHLORIDE. IN HOUSE Tests Specifications 1 Description White to off white crystalline power 2 Identification: 1) IR spectrum 2) UV spectrum 3) Fluoride 4) HPLC Positive Positive Positive Positive 3 PH 4.5 to 6.5 4 Related substances: NMT 1.0% 5 Loss on drying NMT 0.5% w/w 6 Residue on ignition NMT 0.1% 7 Heavy metals (ppm) NMT 10ppm 8 Ethanol (%) NMT 0.5% 9 Methylene Chloride NMT 0.06% 10 Toluene NMT 0.089% 11 Dimethylsulfoxide NMT 0.088% 12 Assay(On dried basis) It should contain not less than 98.0% & not more than 102% of the C22H26O4NCIF2 calculated on dried basis.

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Minimum order:As required
Certification:fda approud cgmp certified
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Member since: 2005-09-06
Country: India
 Contact details:
Tel: 91 257 3296354
Fax: 91 257 2270141
Website: http://www.smaartpharma.com
Address: B-23, M.I.D.C., AJANTHA ROAD,, JALGAON, MAHARASHTRA - India
425003
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NEBIVOLOL HYDROCHLORIDE. IN HOUSE Tests Specifications 1 Description White to off white crystalline power 2 Identification: 1) IR spectrum 2) UV spectrum 3) Fluoride 4) HPLC Positive Positive Positive Positive 3 PH 4.5 to 6.5 4 Related substances: NMT 1.0% 5 Loss on drying NMT 0.5% w/w 6 Residue on ignition NMT 0.1% 7 Heavy metals (ppm) NMT 10ppm 8 Ethanol (%) NMT 0.5% 9 Methylene Chloride NMT 0.06% 10 Toluene NMT 0.089% 11 Dimethylsulfoxide NMT 0.088% 12 Assay(On dried basis) It should contain not less than 98.0% & not more than 102% of the C22H26O4NCIF2 calculated on dried basis.
NEBIVOLOL HYDROCHLORIDE. IN HOUSE		 CHLORHEXIDINE BASE IN HOUSE Tests Specifications 1 Description A White to almost White powder 2 Identification { By IR} To match with Reference Standard 3 Color Test (20% CHG Sol.) Absorbance not more than 0.03 (Absorbance at 480 nm) 4 Sulphated ash Not more than 0.1% w/w 5 Loss on drying at 105 oC % w/w. Not more than 0.5 % w/w 6 Related substances by HPLC i] Single impurities% w/w ii] Total Impurities % w/w Not more than 0.5 % w/w Not more than 1.0 % w/w 7 Assay By HPLC : Not less than 98% and not more than 102% By TITRATION: Not Less than 98% and note more than 102% 8 Para Chloro Aniline, ppm Not more than 200 ppm
CHLORHEXIDINE BASE IN HOUSE		 FOSINOPRIL SODIUM U.S.P Tests Specifications 1 Description A white to off white crystalline powder. 2 Solubility Soluble in water & in methanol. 3 Identification Complies {IR,Sodium} 4 Loss on Drying 0.1% w/w { NMT 0.5 %} 5 Specific Optical Rotation {0.1% sol. In Chloroform} 4.90 { -4.50 to -6.00 on anhydrous basis} 6 Related substance { TLC } Complies { NMT 0.15 % } 7 Related substance { GC } Complies { NMT 0.15 % } 8 Related substance {HPLC} 0.10% {Fosinoprilat NMT 0.5%} 0.05% {Any Unidentified Impurity NMT 0.10%} 0.24% {Total Impurities NMT 1.0%} 9 Heavy metals Complies {NMT 20 ppm} 10 Assay { on dry basis } 100.2% { Sd be between 98.5 to 101.50% w/w } * No potential for the class-1 solvents as specified by ICH or < 467 > USP to be present in Fosinopril sodium as they are not used in the manufacturing process. The material if tested for these solvents, will comply with the established standards.
FOSINOPRIL SODIUM U.S.P		 CETRIMIDE POWDER I. P . / B. P Tests Specifications 1 DESCRIPTION A White or almost white, voluminous, free-flowing powder, freely soluble in water & in alcohol. 2 IDENTIFICATION {A,B,C,D,E } TO COMPLY THE TEST 3 SOLUBILITY FREELY SOLUBLE IN WATER, IN ETHANOL {95%}, & IN CHLOROFORM. PRACTICALLY INSOLUBLE IN ETHER 4 ACIDITY OR ALKALINITY NMT. 0.1ML SOLUTION REQUIRED. 5 CLARITY & COLOUR OF SOLUTION 2.0% W/V SOLUTION IS CLEAR & COLOURLESS 6 AMINE SALTS TO COMPLY THE TEST 7 SULPHATED ASH NMT 0.5% 8 LOSS ON DRYING NMT 2% 9 ASSAY{ON D.B} BETWEEN 96% TO 101%
CETRIMIDE POWDER I. P . / B. P
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  NEBIVOLOL HYDROCHLORIDE. IN HOUSE Tests Specifications 1 Description White to off white crystalline power 2 Identification: 1) IR spectrum 2) UV spectrum 3) Fluoride 4) HPLC Positive Positive Positive Positive 3 PH 4.5 to 6.5 4 Related substances: NMT 1.0% 5 Loss on drying NMT 0.5% w/w 6 Residue on ignition NMT 0.1% 7 Heavy metals (ppm) NMT 10ppm 8 Ethanol (%) NMT 0.5% 9 Methylene Chloride NMT 0.06% 10 Toluene NMT 0.089% 11 Dimethylsulfoxide NMT 0.088% 12 Assay(On dried basis) It should contain not less than 98.0% & not more than 102% of the C22H26O4NCIF2 calculated on dried basis.  
     
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