| Calcium Glubionate Injection Grade |
| Product name | : | Calcium Glubionate Injection Grade |
| CAS No. | : | 12569-38-9 |
| Molecular Formula | : | (C12 H21 O12. C6 H11 O7) Ca. H2O |
| Molecular Weight | : | 610.52 |
| Tests | | Specifications | | Reference |
| Description (Appearance) | | White or yellowish white powder | | In-house |
| | | | |
| Odour
| | Odourless | | In-house |
| | | | |
| Behaviour on sterilization
| | Colourless or not more intensely colored than very faint yellow or very faint brown or very faint
brownish yellow. | | In-house |
| | | | |
| Identification | | | | In-house |
| | | | |
| A.Calcium | | Positive for Calcium | | In-house |
| | | | |
| B.Gluconic acid (by TLC) | | Positive for Gluconic acid | | In-house |
| | | | |
| C.Lactobionic acid (by TLC) | | Positive for Lactobionic acid | | In-house |
| | | | |
| Appearance of the solution in water (20 in 80 parts of boiling water,cooled to 20°C)
| | | | In-house |
| | | | |
| a.Clarity | | Should not be more opalescent than the comparison solution
| | In-house |
| | | | |
| b.Colour | | Should not be more intensely colored than the comparison solution
| | In-house |
| | | | |
| Loss on Drying (On 0.5 g at 105°C for 6 hrs.)
| | Not more than 7% w/w | | In-house |
| | | | |
| pH of the solution | | Between 6.0 and 8.2 | | In-house |
| | | | |
| Heavy metals
| | Not more than 10 ppm | | In-house |
| | | | |
| Iron
| | Not more than 5 ppm | | In-house |
| | | | |
| Oxalic Acid
| | Not more than 70 ppm
| | In-house |
| | | | |
| Assay (Complexometric)
(On dried basis) | | Not less than 98.0% and not more than 102.0% | | In-house |
| | | | |
| Count of Organisms | | | | In-house |
| | | | |
| a.Aerobic Microbial count | | Not more than 100 cfu / g | | In-house |
| | | | |
| b.Bacterial Endotoxin test | | 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. |
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| Retest Period: | | 3 years from the date of manufacture. |
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