Bulk drug Ranitidine Hydrochloride manufacturer and exporter

Manufacturer and Exporter of Ranitidine Hydrochloride


	Ranitidine Specifications

	Production Department

	Packaging Department

	Utilities

STANDARD SPECIFICATIONS

	PRODUCT : RANITIDINE HYDROCHLORIDE USP 27 / PH EUR IV – D.C. GRADE \|
	PRODUCT : RANITIDINE HYDROCHLORIDE USP 27 / PH EUR IV – CRYSTALLINE POWDER \|
	PRODUCT : RANITIDINE HYDROCHLORIDE USP 27 / PH EUR IV – INJECTION GRADE \|

PRODUCT : RANITIDINE HYDROCHLORIDE USP 27 / PH EUR IV – DC GRADE
No	TEST	L I M I T S USP 27 // PH EUR IV	SPECIFICATION (ORCHEV)
1	DESCRIPTION	WHITE TO PALE YELLOW, PRACTICALLY ODOURLESS, CRYSTALLINE POWDER	ALMOST WHITE, PRACTICALLY ODOURLESS,GRANULES
2	SOLUBILITY	FREELY SOLUBLE IN WATER & METHANOL & SPARINGLY SOLUBLE IN ETHANOL	FREELY SOLUBLE IN WATER, & METHANOL & SPARINGLY SOLUBLE IN ETHANOL
3	IDENTIFICATION	IR, UV, TLC AND CHLORIDES	CONFORMS
4	pH(1 in 100)	4.5 TO 6.0	5.0 TO 5.8
5	APPEARANCE OF SOLN.	AS PER PH EUR IV	CONFORMS
6	RELATED SUBSTANCES (TLC)	IMPURITY B // A.. NMT 0.5% ANY OTHER IMPURITY NMT 0.3% ONE OTHER IMPURITY NMT 0.2% TWO OTHER IMPURITY NMT 0.1% UNIDENTIFIED IMPURITY NMT 0.1% ------------- TOTAL IMPURITIES NMT 1.0%	COMPLIES COMPLIES COMPLIES COMPLIES COMPLIES ---------------- COMPLIES
7	HEAVY METALS	NMT 20 ppm	NMT 20 ppm
8	LOSS ON DRYING	NMT 0.75%	NMT 0.25%
9	SULPHATED ASH	NMT 0.10%	NMT 0.04%
10	ASSAY USP (DRY BASIS) PH EUR III	(97.5% - 102%) (98.5% - 101%)	(98.0% - 101%) (99.0% - 100.5%)
11	ORGANIC VOLATILE IMPURITIES (in ppm)	1. CHLOROFORM NMT 60 2. BENZENE NMT 02 3. 1,4 DIOXAN NMT 380 4. METHYLENE CHLORIDE NMT 600 5. TRICHLOROETHYLENE NMT 80	NMT 05 NOT USED IN PROCESS NOT USED IN PROCESS NOT USED IN PROCESS NOT USED IN PROCESS

1*	RESIDUAL SOLVENTS	ISOPROPANOL - NMT 1800 ppm M.I.B.K. - NOT USED IN PROCESS TOLUNE - NOT USED IN PROCESS METHANOL - NOT USED IN PROCESS
2*	MELTING POINT ( °C )	ABOUT 140
3*	COLOUR OF 10% SOLN :430 nm ABSORBANCE / TRANSMISSION	NMT 0.07 // NLT 83.0%
4*	BULK DENSITY (GM/ML) UNTAPPED // TAPPED	(0.5 +/- 0.1) // (0.75 +/- 0.1)
5*	PARTICLE SIZE: MORE THAN 500 micron (30#) MORE THAN 250 micron (60#) LESS THAN 90 micron (170#)	NMT 5% (BY WEIGHT) NMT 55% (BY WEIGHT) NMT 15% (BY WEIGHT)
6*	EXTRANEOUS MATTER	1. Should not have any extraneous matter 2. Filter Paper should not be change to black

NOTE : ALL SPECIFIC USERS WHO WOULD LIKE TO HAVE D.C. GRADE MATERIAL OF EVEN HIGHER BULK DENSITY I.E. DENSITY ABOVE 0.8 GM/CC, MAY KINDLY LET US KNOW THEIR SPECIAL BULK DENSITY REQUIREMENT TO ENABLE US TO OFFER ACCORDINGLY.

(*) indicates Customers Requirement if any / In-House Limits                                                   Prepared By : Mr. G.K. Bera
                                                                                                                                                         Title : Q.C. Incharge
                                                                                                                                                           Date : 04.10.2003

PRODUCT : RANITIDINE HYDROCHLORIDE USP 27 / PH EUR IV– POWDER
No	TEST	L I M I T S USP 27 // PH EUR IV	SPECIFICATION (ORCHEV)
1	DESCRIPTION	WHITE TO PALE YELLOW, PRACTICALLY ODOURLESS, CRYSTALLINE POWDER	ALMOST WHITE, PRACTICALLY ODOURLESS, CRYSTALLINE POWDER
2	SOLUBILITY	FREELY SOLUBLE IN WATER, & METHANOL & SPARINGLY SOLUBLE IN ETHANOL	FREELY SOLUBLE IN WATER, & METHANOL & SPARINGLY SOLUBLE IN ETHANOL
3	IDENTIFICATION	IR, UV, TLC AND CHLORIDES	CONFORMS
4	pH(1 in 100)	4.5 TO 6.0	5.0 TO 5.8
5	APPEARANCE OF SOLN.	AS PER PH EUR IV	CONFORMS
6	RELATED SUBSTANCES (TLC)	COMPOUND B // A.. NMT 0.5% ANY OTHER IMPURITY NMT 0.3% ONE OTHER IMPURITY NMT 0.2% TWO OTHER IMPURITY NMT 0.1% UNIDENTIFIED IMPURITY NMT 0.1% --------------- TOTAL IMPURITIES NMT 1.0%	COMPLIES COMPLIES COMPLIES COMPLIES COMPLIES ---------------- COMPLIES
7	HEAVY METALS	NMT 20 ppm	NMT 20 ppm
8	LOSS ON DRYING	NMT 0.75%	NMT 0.25%
9	SULPHATED ASH	NMT 0.10%	NMT 0.04%
10	ASSAY USP DRY BASIS PH EUR III	(97.5% - 102%) (98.5% - 101%)	(98.0% - 101%) (99.0% - 100.5%)
11	ORGANIC VOLATILE IMPURITIES (in ppm)	1. CHLOROFORM NMT 60 2. BENZENE NMT 02 3. 1,4 DIOXAN NMT 380 4. METHYLENE CHLORIDE NMT 600 5. TRICHLOROETHYLENE NMT 80	NOT MORE THAN 03 NOT USED IN PROCESS NOT USED IN PROCESS NOT USED IN PROCESS NOT USED IN PROCESS

1*	RESIDUAL SOLVENTS	ISOPROPANOL - NMT 1500 ppm M.I.B.K. - NOT USED IN PROCESS TOLUNE - NOT USED IN PROCESS
2*	MELTING POINT ( °C )	ABOUT 140
3*	COLOUR OF 10% SOLN :430 nm ABSORBANCE / TRANSMISSION	NMT 0.08 // NLT 83.0%
4*	BULK DENSITY (GM/ML) UNTAPPED // TAPPED	(0.4 +/- 0.1) // (0.55 +/- 0.1)
5*	PARTICLE SIZE	NLT 90 % PASS THROUGH 80#
6*	EXTRANEOUS MATTER	1. Should not have any extraneous matter 2. Filter Paper should not be change to black after filteration.

(*) indicates Customers Requirement if any / In-House Limits                                                   Prepared By : Mr. G.K. Bera
                                                                                                                                                         Title : Q.C. Incharge
                                                                                                                                                           Date : 04.10.2003

PRODUCT : RANITIDINE HYDROCHLORIDE USP 27 / PH EUR IV– INJECTION GRADE
No	TEST	L I M I T S USP 27 // PH EUR IV	SPECIFICATION (ORCHEV)
1	DESCRIPTION	WHITE TO PALE YELLOW, PRACTICALLY ODOURLESS, CRYSTALLINE POWDER	ALMOST WHITE, PRACTICALLY ODOURLESS, CRYSTALLINE POWDER
2	SOLUBILITY	FREELY SOLUBLE IN WATER, & METHANOL & SPARINGLY SOLUBLE IN ETHANOL	FREELY SOLUBLE IN WATER, & METHANOL & SPARINGLY SOLUBLE IN ETHANOL
3	IDENTIFICATION	IR, UV, TLC AND CHLORIDES	CONFORMS
4	pH(1 in 100)	4.5 TO 6.0	5.0 TO 5.8
5	APPEARANCE OF SOLN.	AS PER PH EUR IV	CONFORMS
6	RELATED SUBSTANCES (TLC)	COMPOUND B // A.. NMT 0.5% ANY OTHER IMPURITY NMT 0.3% ONE OTHER IMPURITY NMT 0.2% TWO OTHER IMPURITY NMT 0.1% UNIDENTIFIED IMPURITY NMT 0.1% --------------- TOTAL IMPURITIES NMT 1.0%	COMPLIES COMPLIES COMPLIES COMPLIES COMPLIES ---------------- COMPLIES
7	HEAVY METALS	NMT 20 ppm	NMT 20 ppm
8	LOSS ON DRYING	NMT 0.75%	NMT 0.25%
9	SULPHATED ASH	NMT 0.10%	NMT 0.04%
10	ASSAY USP 27 DRY BASIS PH EUR IV	(97.5% - 102%) (98.5% - 101%)	(98.0% - 101%) (99.0% - 100.5%)
11	ORGANIC VOLATILE IMPURITIES (in ppm)	1. CHLOROFORM NMT 60 2. BENZENE NMT 02 3. 1,4 DIOXAN NMT 380 4. METHYLENE CHLORIDE NMT 600 5. TRICHLOROETHYLENE NMT 80	NOT MORE THAN 03 NOT USED IN PROCESS NOT USED IN PROCESS NOT USED IN PROCESS NOT USED IN PROCESS

1*	RESIDUAL SOLVENTS		ISOPROPANOL - NMT 1500 ppm M.I.B.K. - NOT USED IN PROCESS TOLUNE - NOT USED IN PROCESS
2*	MELTING POINT ( °C )		ABOUT 140
3*	COLOUR OF 10% SOLN :430 nm ABSORBANCE / TRANSMISSION		NMT 0.06 // NLT 87.0%
4*	BULK DENSITY (GM/ML) UNTAPPED // TAPPED		(0.4 +/- 0.1) // (0.55 +/- 0.1)
5*	PARTICLE SIZE		NLT 90 % PASS THROUGH 80#
6*	EXTRANEOUS MATTER		1. Should not have any extraneous matter 2. Filter Paper should not be change to black after filteration.
7*	BACTERIAL ENDOTOXIN	NOT MORE THAN 7 EU/MG	LESS THAN 7 EU/MG
8*	E-COLLI, SALMONELLA	MUST BE ABSENT IN 1 GM	ABSENT
9*	BACTERIAL COUNT	NMT 1000 cfu/gm	COMPLIES
10*	MOULD COUNT	NMT 100 cfu/gm	COMPLIES

	PRODUCT : RANITIDINE HYDROCHLORIDE USP 27 / PH EUR IV – D.C. GRADE \|
	PRODUCT : RANITIDINE HYDROCHLORIDE USP 27 / PH EUR IV – CRYSTALLINE POWDER \|
	PRODUCT : RANITIDINE HYDROCHLORIDE USP 27 / PH EUR IV – INJECTION GRADE \|

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Ranitidine Specifications