Calcium Glubionate Injection Grade
| Product Name: | Calcium Glubionate Injection Grade |
| Product Formula: | (C12 H21 O12. C6 H11 O7) Ca.H2O |
| Molecular Weight: | 610.52 |
| CAS Number: |
| No. | Tests | Specifications | Reference |
|---|---|---|---|
| 1 | Description (Appearance) | White to Yellow-tinged white crystalline powder. | In-house |
| 2 | Odour | Odourless | In-house |
| 3 | Behavior on sterilization | Colourless or not more intensely colored than very faint yellow or very brown or very faint brownish yellow | In-house |
| 4 | Identification A. Calcium B. Gluconic acid (by TLC) C. Lactobionic acid (by TLC) |
Positive for Calcium Positive for Gluconic acid Positive for Lactobionic acid |
In-house |
| 5 | Appearance of the solution in water (20 in 80 parts pf boiling water, cooled to 20°C) a. Calrity b. Colour |
Should not be more opalescent than the comparison solution Should be more intensely colored than the comparison solution |
In-house |
| 6 | Loss on Drying (On .05g at 105°C for 6 hrs) |
Not more than 7% w/w | In-house |
| 7 | pH of the solution | Between 6.0 and 8.2 | In-house |
| 8 | Heavy metal | Not more that 10 ppm | In-house |
| 9 | Iron | Not more than 5 ppm | In-house |
| 10 | Oxalic Acid | Not more than 70 ppm | In-house |
| 11 | Assay (Complexometric) (on dried basis) |
Not less than 98.0% and notr more than 102.0% | In-house |
| 12 | Count of Organism a.Aero Microbial count b.Bacterial Exdotoxin test |
Not more than 100 cfu/g 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.
