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Butylparaben
Categories:
Pharmaceutical Excipients

Butylparaben

Alias
Butylparaben / Butyl parahydroxybenzoate / Butyl p-hydroxybenzoate / Butyl 4-hydroxybenzoate / 4-Hydroxybenzoic acid butyl ester / Nipabutyl
CAS No.
Molecular Formula
C11H14O3
Structure
Butylparaben Chemical Structure
Product Details

Product Overview

Product Summary

Butylparaben, also known as butyl p-hydroxybenzoate and Nipabutyl, is the ester of p-hydroxybenzoic acid and n-butanol, with molecular formula C11H14O3, molecular weight 194.23 and CAS number 94-26-8. It is a white or off-white crystalline powder at room temperature with an assay (on dried basis) of 98.0-102.0% (see specifications); its melting point of 68-71°C sits in the lower range among the four paraben esters (methyl, ethyl, propyl and butyl). Published literature reports that paraben antimicrobial activity and oil solubility both increase with carbon chain length (order methyl < ethyl < propyl < butyl), and butylparaben has the longest chain of the four; it covers molds, yeasts and certain bacteria, is commonly used in semi-solid topical preparations with oily bases (subject to formulation verification) and is often combined with methylparaben, propylparaben and other parabens. These are factory control items; this product is not registered as a pharmaceutical excipient - suitability for pharmaceutical use is assessed by the buyer under applicable drug regulations.

Usage

A raw material for antimicrobial preservatives in pharmaceutical formulations. Published literature reports that paraben bacteriostatic activity and oil solubility both increase with carbon chain length (order methyl < ethyl < propyl < butyl), with activity against molds, yeasts and certain bacteria. Downstream applications include topical ointments, creams, gels and suppositories, commonly semi-solid preparations with oily bases (based on its oil solubility, subject to formulation verification). Often combined with other parabens (such as methylparaben and propylparaben) to balance water solubility and antimicrobial efficacy.
Applications

Applications by Industry

Topical Preparations with Oily Bases

Per published literature, paraben oil solubility increases with carbon chain length and butylparaben has the longest chain of the four esters, with comparatively good oil solubility (see Usage); it is commonly used in semi-solid topical preparations with oily bases such as ointments and creams, subject to formulation verification. In systems with a high oil phase, dissolution and dispersion of the preservative component is a typical formulation concern. Specification review points include assay (98.0-102.0%), melting point (68-71°C) and heavy metals (≤20 ppm) on this page.

Gels and Suppositories

In gels and suppositories, butylparaben serves as an antimicrobial preservative; base materials and processes differ across these dosage forms, and selection is confirmed through formulation verification, with impurity and heavy-metal limits checked against this page's specifications (related substances individual ≤0.4%, total ≤0.8%).

Preservative Component in Combined Systems

Butylparaben is often combined with other parabens such as methylparaben and propylparaben to balance water solubility and antimicrobial efficacy; blend ratios are set by the formulation owner and verified in the actual system.
Specifications

Technical Specifications

Product Specifications
Appearance White or off-white crystals or crystalline powder
Content (on dried basis) 98.0%–102.0%
Melting point 68–71°C
Acidity Compliant (0.1 mol/L NaOH consumption ≤0.1 mL)
Solution clarity and color Clear and colorless
Chloride (Cl) ≤0.035%
Sulfate (as SO₄) ≤0.024%
Related substances Individual impurity ≤0.4%, total impurities ≤0.8%
Loss on drying ≤0.5% (silica gel desiccator, vacuum dried to constant weight)
Residue on ignition ≤0.1%
Heavy metals ≤20 ppm
Arsenic ≤0.0002%
Logistics

Packaging, Storage & Transport

Packaging

25 kg fiber drum with double polyethylene liner; custom packaging available upon request. Sample arrangements and order quantities can be discussed during inquiry.

Storage

Store tightly closed in a cool, dry, well-ventilated place

Transport

Transport classification follows the goods transport appraisal report and the carrier's requirements; protect from moisture, sunlight and physical damage; keep packaging intact

FAQ

Frequently Asked Questions

Where does the oil solubility of butylparaben show up?
Per published literature, paraben oil solubility increases with carbon chain length and butylparaben has the longest chain of the four esters, with comparatively good oil solubility, which is why it is commonly used in semi-solid preparations with oily bases; dissolution and dispersion in the oil phase should be verified in the actual formulation.
What are the assay and key specifications?
Assay (on dried basis) 98.0-102.0%, melting point 68-71°C, acidity compliant, a clear and colorless solution, heavy metals ≤20 ppm and arsenic ≤0.0002%; related substances controlled at individual ≤0.4% and total ≤0.8% (see specifications).
The melting point is low - anything to note in storage and transport?
Butylparaben melts at 68-71°C, lower than the other paraben esters. Standard storage is tight-sealed in a cool, dry, well-ventilated place; transport protects from moisture, sunlight and damage, and in hot seasons prolonged exposure to sun or heat sources should be avoided.
Which products is it commonly blended with?
It is often combined with methylparaben, propylparaben and other parabens to balance water solubility and antimicrobial efficacy; blend ratios follow each formulation.
What packaging and order quantities are available?
Standard packaging is a 25 kg fiber drum with a double polyethylene liner, and custom packaging is available. Sample arrangements and order quantities can be discussed during inquiry; regular batches are produced against the order schedule.
How do I verify the product name in procurement?
Common aliases include butyl p-hydroxybenzoate, 4-hydroxybenzoic acid butyl ester and Nipabutyl. The four paraben esters (methyl, ethyl, propyl and butyl) carry similar names, so quoting CAS number 94-26-8 in inquiries is recommended.