| Calcium Lactobionate Injection Grade |
| Product name | : | Calcium Lactobionate Injection Grade |
| CAS No. | : | 110638-68-1 |
| Molecular Formula | : | C24 H42CaO24.2H2O |
| Molecular Weight | : | 790.68 |
| Tests | | Specifications | | Reference |
| Appearance
| | White microcrystalline powder,may be partially granular
| | In-house |
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| Odour
| | Odourless | | In-house |
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| Identification
| | | | In-house |
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| A.Calcium | | A white crystalline precipitate of oxalate must be formed,which is soluble in 2N
hydrochloric acid and gets re-precipitated on addition of 2 N ammonium hydroxide solution
| | In-house |
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| B.IR Spectrum
| | IR absorption spectrum exhibits maxima only at same wavelengths as that of Calcium Lactobionate USP,CRS. | | In-house |
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| C.For Lactobionic acid
| | The sample spot
corresponds to the standard spot with
respect to Rf value, colour and intensity
| | In-house |
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| Appearance of an approx.10% aqueous solution
| | Clear or not more
intensely opalescent than the comparison solution.
Colorless or not more intensely colored than very faint yellow,very faint brown or very faint brownish yellow | | In-house |
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| Behaviour on sterilization | | Colourless or not more intensely coloured than very faint yellow, very faint brown or very faint brownish yellow.
| | In-house |
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| pH of the Solution [1 in 20] | | Between 5.5 and 8.0 | | In-house |
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| Reducing Substances | | Not more than 1.0% | | In-house |
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| Specific Rotation | | Between + 22.5º and + 26.5º | | In-house |
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| Chloride
| | Not more than 50 ppm
| | In-house |
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| Sulphate
| | Not more than 50 ppm
| | In-house |
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| Heavy Metals | | Not more than 5 ppm | | In-house |
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| Iron
| | Not more than 10 ppm | | In-house |
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| Phosphate
| | Not more than 100 ppm
| | In-house |
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| Arsenic
| | Not more than 1 ppm
| | In-house |
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| Alkali metals and magnesium | | Not more than 0.5 % | | In-house |
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| Organic volatile impurities | | Shall pass as per USP <467> and ICH Q3C | | In-house |
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| Oxalic acid (by titrimetry method) | | Not more than 100 ppm | | In-house |
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| Assay (Complexometric Titration) | | Not less than 98 % and not more than 102.0 % | | In-house |
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| Count of Organisms
Aerobic organisms
| | Not more than 100 cfu / g | | In-house |
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| Bacterial Endotoxin | | Less than 167 EU/g | | In-house |
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| Storage: | | Store in a well-closed container at a temperature not exceeding 25°C,protected from direct sunlight and Moisture,unless otherwise specified
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| Retest Period: | | 3 years from the date of manufacture
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