1, 2, Propylene Glycol
EP, USP (Tested for Endotoxin & Microbes)
CAS #:
57-55-6
Molecular Formula:
C3H8O2
Synonym:
Propylenglykol 1,2, Propane-1,2-diol
Molecular Weight:
76.10 g/mol
Overview
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:
- Protect against electrostatic charges.
- Keep ignition sources away - Do not smoke.
- Protect from heat.
- The product forms flammable fumes when heated.
- Fumes can combine with air to form an explosive mixture.
- Store away from oxidizing agents.
- Keep container tightly sealed.
- This product is hygroscopic.
Pack Sizes: 5 Kg
