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Active Pharmaceutical Ingredients

With our years of industrial experience, we are to offer a wide range of APIs (Active Pharmaceutical Ingredients). Used as prominent ingredient in various medicines, these helps in curing health related problems. We conduct stringent quality checking throughout our manufacturing process in order to offer these APIs according to the industrial regulatory norms. Further, we also take utmost care to safeguard these products from any sort of contamination after being processed. We offer the following products under this category:

Dexchlorpheniramine Maleate

CAS No: 2438-32-6

Molecular Formula: C16 H19 CIN2 C4 H4 O4

Molecular Weight: 390.86 g/mole

We have been engaged in processing Dexchlorpheniramine Maleate, offered to our clients with maximum advantageous properties. It is an odorless, white colored powder, which is freely soluble in water. Further, manufactured using excellent ingredients, these products offer efficiency in their usage. We store these in light-resistant and tight containers, so as to avoid any chances of contamination.

Test	Specification
Characters	A white crystalline powder.
Solubility	Very soluble in water, freely soluble in alcohol, in methanol and in methylene chloride
Identification	Test A,C and E OR Tests A,B,D and E.
Identification A	It should comply with the test for specific optical rotation.
Identification B ( Melting Range)	110.00C to 115.00C.
Identification C	The Infra red absorption spectrum should concordant with the spectrum obtained from Dexchlorpheniramine Maleate working Standard.
Identification D	The chromatogram obtained with the test solution should show two clearly separated spots. The upper spot should be similar in position and size to the spot in the chromatogram obtained with reference solution.
Identification E	The solution should give the reaction of chlorides
Appearance of solution	The solution should be clear and not more Intensely coloured than reference solution BY6.
pH	4.50 to 5.50.
Specific optical rotation	+22.000 to +23.000 on dried basis
Related substance (By GC ) :	Any individual impurity: Not more than 0.40%. Total impurity: Not more than 1.00%.
Enantiomeric Purity ( By HPLC )	(R) Enantiomer: Not more than 2.00%. Any Other Individual Enantiomer: Not more than 0.50%.
Heavy metals	Not more than 20ppm.
Loss On Drying (At 65.00C)	Not more than 0.50%w/w
Sulfated Ash	Not more than 0.100 %w/w
Assay	98.00% to 100.50% w.r.t. dried substance.

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Ketoconazole

CAS No: 65277-42-1

Molecular Formula: C26 H28 Cl2 N4 O4

Molecular Weight: 531.43g/mole

Apart from these products, clients can also avail from us an important array of Ketoconazole. It is freely soluble in dichloromethane and sparingly soluble in ethanol (95%). The melting point of this product ranges from 148.00°C to 152.00°C. Having all the required properties, our range is widely used in catering the needs of pharmaceutical industries. There are many other specifications offered by our processed range.

Test	Specification
Characters	A white or almost white powder.
Solubility	Practically insoluble in water, freely soluble in methylene chloride, soluble in methanol, sparingly soluble in alcohol.
Identification	Test B OR Tests A, C and D.
Identification A (Melting point)	148.00C to 152.00C
Identification B	The Infra red absorption spectrum should concordant with the spectrum obtained from Ketoconazole or with the Reference Infra red spectrum graph.
Identification C	The principal spot in the chromatogram obtained with test solution should be similar in position, colour and size to the principal spot in the chromatogram obtained with reference solution (a). The test should not valid unless the chromatogram obtained with reference solution (b) shows two clearly separated spots.
Identification D	The solution gives reaction (a) of chlorides.
Appearance of solution	The 10%w/v solution in methylene chloride should be clear and not more intensely coloured than reference solution BY4.
Optical rotation	- 0.100 to + 0.100
Related substance	Total impurities NMT 0.50%.
Heavy metals	NMT 20 ppm
Loss on drying	NMT 0.50%w/w
Sulphated ash	NMT 0.100%w/w
Assay	99.00% to 101.00%w/w on dried substance.

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Clotrimazole

CAS No: 23593-75-1

Molecular Formula: C22 H17 ClN2

Molecular Weight: 344.84g/mole

We have been indulged in offering Clotrimazol, to our huge clientèle. A white to pale yellow crystalline powder, it has the melting point at about 1420 with decomposition. Processed in bulk quantities our range is assured for its quality features. We have achieved a strong market position owing to our excellent range of products.

Test	Specification
Characters	A white or almost white powder.
Solubility	Practically insoluble in water, freely soluble in methylene chloride, soluble in methanol, sparingly soluble in alcohol.
Identification	Test B OR Tests A, C and D.
Identification A	148.00C to 152.00C
Identification B	The Infra red absorption spectrum should concordant with the spectrum obtained from Ketoconazole or with the Reference Infra red spectrum graph.
Identification C	The principal spot in the chromatogram obtained with test solution should be similar in position, colour and size to the principal spot in the chromatogram obtained with reference solution (a). The test should not valid unless the chromatogram obtained with reference solution (b) shows two clearly separated spots.
Identification D	The solution gives reaction (a) of chlorides.
Appearance of solution	The 10%w/v solution in methylene chloride should be clear and not more intensely coloured than reference solution BY4.
( 2-Chlorophenyl ) diphenylmethanol (ByTLC)	- 0.100 to + 0.100
Imidazole	Total impurities NMT 0.50%.
Loss on drying	NMT 20 ppm
Sulphated Ash	NMT 0.50%w/w
Assay	NMT 0.100%w/w
	99.00% to 101.00%w/w on dried substance.

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Carbamazepine

Chemical Specification

•    Chemical Name : Carbamazepine
•    Molecular Formula : C15H12N2O
•    Description : White to Off White Crystalline Powder
•    Purity : 97 to 103 %
•    LOD : NMT 0.5 %
•    Melting Point : 189 to 193 oC

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Mr. Kirit Shah / Mr. Bipin Parikh
405 - 408, Navbharat Estate, 4th Floor, "B" Wing, Sewri (West)
Mumbai, Maharashtra - 400 015, India
Telephone: +(91)-(22)-24158860

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