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 |
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 |
|
| No. |
Test |
Specification |
Result |
| 1 |
Melting Range |
136 to 142 (Degree Centigrade) |
140 C |
| 2 |
Bulk Density |
0.50 to 0.80 |
0.55 gm/cc |
|
Certificate
of Analysis ( Ranitidine Hydrochloride USP 27 / PH EUR IV ) |
|
| No. |
Test |
Specification
|
Result |
| USP 27 |
PH EUR IV |
| 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 |
| USP 27 |
PH EUR IV |
| 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 |
|
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