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