Calcium Chloride 2-Hydrate
EP, USP + LEC + Microbiological requirements
CAS #:
10035-04-8
Molecular Formula:
CaCl2.2H2O
Synonym:
N/A
Molecular Weight:
147.02 g/mol
Overview
Calcium Chloride, Dihydrate, USP, EP is used in treatment of hypocalcaemia, electrolyte depletion, and hyperkalaemia. It is an analytical grade chemical that is packaged in laboratory size bottles to production drum quantities. Calcium Chloride, Dihydrate is a white deliquescent compound which is commonly used as a reagent in biochemistry. Biological processes, including signal transduction, muscle contraction, maintenance of cell membranes and cell wall stability rely on calcium ions.
| Characters | Unit | Specification |
|---|---|---|
| Identity (EP<2.2.24>) (USP<197K>) | IR | |
| Identity (EP<2.2.27>) | TLC | |
| Identity (EP<2.2.7>) | Sp. Rot., [α]D: +23° to 25° | |
| Identity (EP<2.2.14>) (USP<741>) | °C | MP: 165-170 °C |
| Appearance | White microcryst. solid | |
| Solubility | Freely soluble in water, practically insoluble in Ethanol (96%) | |
| Appearance of solution (EP) (USP) | Clear (2.2.1), colorless (2.2.2, Method II) solution | |
| Conductivity (EP<2.2.38>) (USP) | 20 pScm-1 | |
| Assay (EP<2.2.29>) (USP) | % | 97 - 102 |
| Related Substances (EP<2.2.29>) (USP) | ||
| Impurity A (D-Sorbitol) | % | ≤ 2 |
| Impurity B (D-Malttitol) +Impurity C (Isomalt) | % | ≤ 2 |
| Unknown impurities | % | ≤ 0.1 |
| Total impurities | % | ≤ 2 |
| Reducing Sugars | USP, EP | |
| LOD (EP<2.2.32>) (USP<731>) | % | 0.5 |
| Residual Solvents (USP) | Meets USP <467> specifications | |
| Heavy metals (Pb) (EP) | ppm | ≤ 5 |
| Ni (EP<2.4.15>) (AAS : USP<852>) | ppm | ≤ 1.0 |
| Microbiological Specifications | ||
| Total Aerobic (EP<2.6.12>) (USP<62>) | CFU/g | ≤ 100 |
| E Coli | Negative | |
| Salmonella | Negative | |
| Staphylococcus aureus | Negative | |
| Pseudomonas | Negative | |
| Mold and Yeast (EP<2.6.13>) (USP<62>) | CFU/g | ≤100 |
| Endotoxin Level+ (EP <2.6.14>)(USP<85>)* | IU/g | ≤ 4 |
| Endotoxin Level+ (EP <2.6.14>) (USP<85›)** | IU/g | ≤ 2.5 |
| +If intended for use in the manufacture of parenteral dosage forms without a further appropriate procedure for the removal of bacterial endotoxins. | ||
| * - For parenteral dosage forms having a concentration of 100 WI. or less of Mannitol. | ||
| ** - For parenteral dosage forms having a concentration of more than 100 of Mannitol. | ||
Shelf Life/Retest Date: Calcium Chloride Di-hydrate can be kept for at least 5 years if stored in a cool and dry place.
Storage/Shipping Conditions:
- Keep the container tightly closed in a cool, well ventilated place.
- Storage temperature recommended: < 25°C
Pack Sizes: 0.5 Kg and 5 Kg
