1,2-Propanediol is used in pharmaceutical products as an excipient solvent in oral, topical and injectable drug products. It is an organic compound and colourless liquid without odour. It has a slightly sweet taste and chemically classed as a diol.
Characters | Unit | Specification |
---|---|---|
Appearance | viscous, clear, colourless, hygroscopic liquid | |
Identification A (IR) | complies | |
Identification B (Limit of Ethylene glycol) | % | max. 0.10 |
Identification B (Limit of Diethylene glycol) | % | max. 0.10 |
Identification C (GC Scan) | complies | |
Assay | % | min. 99.5 |
Residue on Ignition (USP) | mg/50g | max. 3.5 |
Sulphated ash (EP) | % | max. 0.01 |
Chloride | ppm | max. 70 |
Sulphate | ppm | max. 60 |
Specific gravity (25°C/25°C) | 1.035 – 1.037 | |
Relative density (20°C/20°C) | 1.035 – 1.040 | |
Acidity (USP) | ml of 0.10 N NaOH | max. 0.20 |
Acidity (EP) | ml of 0.1 M NaOH | max. 0.05 |
Water | % | max. 0.20 |
Refractive index | 1.431 – 1.433 | |
Oxidizing substances | ml of 0.05M Na2S2O3 | max. 0.2 |
Reducing substances | complies | |
Heavy metals | complies | |
Total aerobic microbial count | cfu/g | max. 100 |
Total yeasts and moulds count | cfu/g | max. 50 |
E.coli | cfu/g | absent in 1g |
Pseudomonas aeruginosa | cfu/g | absent in 1g |
Staphylococcus aureus | cfu/g | absent in 1g |
Salmonella | cfu/g | absent in 25g |
Shelf Life/Retest Date: 1,2 Propylene Glycol can be kept for at least 2 years if stored under recommended conditions.
Storage/Shipping Conditions:
Pack Sizes: 5 Kg