Anti Ulcer Medicine | Acid Discrete Agents

Ranitidine Hydrochloride I.P.

Certificate of Analysis ( Ranitidine Hydrochloride I.P. )

No.	Test	Specification	Result
1	Description	White to Pale Yellow Crystalline Powder	White Crystalline Powder
2	Solubility	Freely Soluble in Water, Methanol and Ethanol (95%), Saparingly soluble in ethanol, very slightly soluble in Chloroform and in Dichloro Methane.	Complies
3	Identification	A. IR B. Related Substances (TLC) C. Chlorides (AS PER IP)	IR : Complies TLC : Complies Chlorides : Complies
4	Ph (1% w/v Soln in water)	4.5 to 6.0	5.10
5	Clarity & Colour of Solution	1.0% w/v solution is clear and not More intensely coloured than RS BY55	Complies
6	Related Substacne	As Per IP	Complies
7	Sulphated Ash	Not more than 0.1% w/w	0.031%
8	Loss on Drying	Not more then 0.75% w/w	0.15%
9	Assay / HPCL (Dry Basis)	97.5% to 102.0%	99.73%

Additional Tests

Certificate of Analysis ( Ranitidine Hydrochloride USP 27 / PH EUR IV )

No.	Test	Specification		Result
No.	Test	USP 27	PH EUR IV	Result
1	Description	White	off White, Odourless, Powder or Granules	Almost White, Particularly Odourless, Powder
2	Solubility	Freely Soluble In Water And Methanol Sparingly Soluble In Ethanol		Complies
3	Identification	IR, UV, TLC & Chlorides		Complies
4	pH (1 in 100)	4.5 to 6.0		5.10
5	Appearance of Soln.	As Per PH EUR III		Complies
6	Related Substacne (TLC)	Impurity B // A Any Other Impurity One Other Impurity Two Other Impurity Unidentified Impurity Total Impurities	NMT 0.5% NMT 0.3% NMT 0.2% NMT 0.1% NMT .01% NMT 1.0%	0.25% 0.20% 0.10% 0.05% NIL 0.60%
7	Heavy Metals	NMT 20 ppm		Complies
8	Loss on Drying	NMT 0.75%		0.15%
9	Sulphated Ash (Roi)	NMT 0.01%		0.031%
10	Assay (Dry Basis)	(97.5% - 102%)	(98.5% - 101%)	99.73% // 99.50%
11	Organic Volatile Impurities (In Ppm)	Chloroform Benzene 1, 4 Dioxan Methylene Chloride Trichloroethylene	NMT 60 NMT 02 NMT 380 NMT 600 NMT 80	02 Nil Nil Nil Nil

No.	Test	Specification		Result
No.	Test	USP 27	PH EUR IV	Result
1 *	Residual Solvents	ISO Propanol	NMT 1500 ppm	1280
2 *	Melting Range	136 to 142 (Degree Centigrade)		140
3 *	Clarity : 10% Soln. Nm Absorbance /Transmission	NMT 0.07	NLT 85%	0.04 / 91.3%
4 *	Bulk Density (Gm/Cc) (Tapped)	Powder 0.5 to 0.68 Granules 0.7 to 0.8		0.55
5 *	Granulometry Test	NLT 100% Passes Through 80//		Passes (100% Through 80//)
6 *	Extraneous Matter	(As per Customer Specification) 1. Should not have any extraneous matter 2. Filter Paper should not be changed to black after filtration.		Complies Complies

Note : (*) indicates the House Limits

Home | Profile | Contact Us | Enquiry