Manufacturer
& Exporter of Binding Agent, Lubricants, Solublisers, Coatings,
Disintegrant & Super Disintegrant.
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Manufacturer
& Exporter of Binding Agent, Lubricants, Solublisers, Coatings,
Disintegrant & Super Disintegrant. |
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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| 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 |
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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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| ............. Tablets ............. |
| ............. Liquid ............. |
| ............. Injectable ............. |
| ............. Ointment ............. |
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