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Antiseptic

Chlorhexidine Gluconate 20% Solution. B.P / U.S.P / E.P / I.P

Chlorhexidine Base. In House

Chlorhexidine Acetate. B.P

Chlorhexidine Hydrochloride. B.P

Strong Cetrimide Solution. B.P

Cetrimide. B.P

Benzalkonium Chloride 50% Solution. B.P / I.P

Benzalkonium Chloride 80% Solution. In House

Cardiovasculars

Fosinopril Sodium U.S.P

Nebivolol Hydrochloride. In House

FDA Approved

CGMP Certified

Manufacturing Company

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.