Propylparaben Sodium Excipient | Uses, Suppliers, and Specifications

Propylparaben sodium occurs as a white, crystalline, odorless or almost odorless powder.

Pharmacoepial Specifications

Typical Properties

Acidity/alkalinity pH = 9.5 – 10.5 (0.1% w/v aqueous solution)

Dissociation constant pK_a = 8.4 at 22

Partition coefficient logP (octanol: water) = 3.0

Solubility see Table II

11 Stability and storage conditions

Propylparaben sodium is stable under normal conditions. It decomposes on heating. Store in a tightly closed container.

12 Incompatibilities

The activity of propylparaben sodium can be adversely affected by the presence of other excipients or active ingredients such as atropine, essential oils, iron, magnesium trisilicate, talc, polysorbate 80 and other nonionic surfactants, sorbitol, weak alkalis and strong acids.

13 Method of Manufacture

Propylparaben sodium is produced from benzoic acid

14 Safety

Proylparaben sodium is used in oral pharmaceuticals and cosmetics. The pure form is toxic by the IV route and moderately toxic by ingestion and the IP route. Propylparaben sodium may cause asthma, rashes and hyperactivity.

LD₅₀ (mouse, IP): 0.49g/kg

LD₅₀ (mouse, IV): 0.18g/kg

LD₅₀ (mouse, oral): 3.7g/kg

15 Handling Precautions

Observe normal precautions appropriate to the circumstances and quantity of the material handled. Avoid inhalation or contact with eyes, skin, and clothing. Avoid prolonged or repeated exposure.

Wear suitable protective clothing, gloves, eye/face protection and a respirator

16 Regulatory Status

Included in the FDA Inactive Ingredients Database (oral capsules, tablets, suspensions). Accepted for use as a food additive in Europe. Included in nonparenteral medicines (oral capsules, mixtures, orodispersibel tablets, solutions and suspensions; cutaneous emulsions) licensed in the UK.

17 Related Substances

Butylparaben; ethylparaben; methylparaben; propylparaben