Calcium Lactobionate Injection Grade
| Product Name: | Calcium Lactobionate Injection Grade |
| Product Formula: | C24 H42CaO24.2H2O |
| Molecular Weight: | 790.68 |
| CAS Number: |
| No. | Tests | Specifications | Reference |
|---|---|---|---|
| 1 | Appearance | White microcrystalline powder, may be partially granular | In-house |
| 2 | Odour | Odourless | In-house |
| 3 | Identification : A. Calcium B. IR Spectrum C. For Lactobionic acid |
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 IR absorption spectrum exhibits maxima only at same wavelengths as that of Calcium Lactobionate USP, CRS. The sample spot corresponds to the standard spot with respect to Rf value, colour and intensity. |
In-house |
| 4 | 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 |
| 5 | Behaviour on sterilization | Colourless or not more intensely coloured than very faint yellow, very faint brown or very faint brownish yellow | In-house |
| 6 | pH of the Solution [1 in 20] | Between 5.5 and 8.0 | In-house |
| 7 | Reducing Substances | Not more than 1.0% | In-house |
| 8 | Specific Rotation | Between + 22.5° and + 26.5° | In-house |
| 9 | Chloride | Not more than 50 ppm | In-house |
| 10 | Sulphate | Not more than 50 ppm | In-house |
| 11 | Heavy Metals | Not more than 5 ppm | In-house |
| 12 | Iron | Not more than 10 ppm | In-house |
| 13 | Phosphate | Not more than 100 ppm | In-house |
| 14 | Arsenic | Not more than 1 ppm | In-house |
| 15 | Alkali metals and magnesium | Not more than 0.5 % | In-house |
| 16 | Organic volatile impurities | Shall pass as per USP <467> and ICH Q3C | In-house |
| 17 | Oxalic acid (by titrimetry method) | Not more than 100 ppm | In-house |
| 18 | Assay (Complexometric Titration) | Not less than 98 % and not more than 102.0 % | In-house |
| 19 | Count of Organisms Aerobic organisms | Not more than 100 cfu / g | In-house |
| 20 | Bacterial Endotoxin | Less than 167 EU/g | In-house |
Storage: Store in a well-closed container at a temperature not exceeding 25°C, protected from direct sunlight and Moisture, unless otherwise specified.
Retest Period: 3 years from the date of manufacture.
