4 74 Paraffin

Comments Sodium palmitate is used as a surfactant and 5 Japan Pharmaceutical Excipients Council. Japanese Pharmaceutical
emulsifying agent in pharmaceutical formulations. The EINECS Excipients 2004. Tokyo: Yakuji Nippo, 2004; 601.
number for sodium palmitate is 206-988-1.
20 General References
18 Comments
Bhattacharya A, Ghosal SK. Permeation kinetics of ketotifen fumarate alone
A specification for palmitic acid is included in the Food Chemicals and in combination with hydrophobic permeation enhancers through
Codex(4) and in the Japanese Pharmaceutical Excipients 2004 human cadaver epidermis. Boll Chim Farm 2000; 139: 177–181.
(JPE).(5) International Labour Organization. International Chemical Safety Card
The EINECS number for palmitic acid is 200-312-9. The (ICSC) 0530: Palmitic acid, 1997.
PubChem Compound ID (CID) for palmitic acid is 985. Yagi S et al. Factors determining drug residence in skin during transdermal
absorption: studies on beta-blocking agents. Biol Pharm Bull 1998; 21:
19 Specific References 1195–1201.
1 Wang PY. Palmitic acid as an excipient in implants for sustained release
of insulin. Biomaterials 1991; 12: 57–62.
2 Hashizume M et al. Improvement of large intestinal absorption of 21 Author
insulin by chemical modification with palmitic acid in rats. J Pharm H Ito.
Pharmacol 1992; 44: 555–559. .
3 Lewis RJ, ed. Sax’s Dangerous Properties of Industrial Materials, 11th
edn. New York: Wiley, 2004; 2813.
22 Date of Revision
4 Food Chemicals Codex, 6th edn. Bethesda, MD: United States
Pharmacopeia, 2008; 715. 18 February 2009.

Paraffin

1 Nonproprietary Names 8 Description

BP: Hard Paraffin Paraffin is an odorless and tasteless, translucent, colorless, or white
JP: Paraffin solid. It feels slightly greasy to the touch and may show a brittle
PhEur: Paraffin, Hard fracture. Microscopically, it is a mixture of bundles of microcrystals.
P USP-NF: Paraffin
Paraffin burns with a luminous, sooty flame. When melted, paraffin
is essentially without fluorescence in daylight; a slight odor may be
apparent.
2 Synonyms
Hard wax; paraffinum durum; paraffinum solidum; paraffin wax. 9 Pharmacopeial Specifications
See Table I.
3 Chemical Name and CAS Registry Number
Paraffin [8002-74-2] Table I: Pharmacopeial specifications for paraffin.

4 Empirical Formula and Molecular Weight Test JP XV PhEur 6.0 USP32–NF27

Paraffin is a purified mixture of solid saturated hydrocarbons Identification þ þ þ

having the general formula CnH2nþ2, and is obtained from Characters — þ —
Congealing range 50–758C — 47–658C
petroleum or shale oil. Melting point — 50–618C —
Heavy metals 410 ppm — —
5 Structural Formula Arsenic 42 ppm — —
See Section 4. Sulfates þ 4150 ppm þ
Polycyclic aromatic — þ þ
hydrocarbons
6 Functional Category Readily carbonizable þ — þ
Ointment base; stiffening agent. substances
Acidity or alkalinity þ þ þ
7 Applications in Pharmaceutical Formulation or
Technology
Paraffin is mainly used in topical pharmaceutical formulations as a 10 Typical Properties
component of creams and ointments. In ointments, it may be used to Density 0.84–0.89 g/cm3 at 208C
increase the melting point of a formulation or to add stiffness. Melting point Various grades with different specified melting
Paraffin is additionally used as a coating agent for capsules and ranges are commercially available.
tablets, and is used in some food applications. Paraffin coatings can NIR spectra see Figure 1.
also be used to affect the release of drug from ion-exchange resin Solubility Soluble in chloroform, ether, volatile oils, and most
beads.(1) warm fixed oils; slightly soluble in ethanol; practically insoluble
 Paraffin 47 5

1.5 1404
1.6 medicines licensed in the UK. Included in the Canadian List of
1000 × [2nd deriv. log(1/R)]
1678
1239 1349 Acceptable Non-medicinal Ingredients.
1751

17 Related Substances
0.0
Light mineral oil; microcrystalline wax; petrolatum; synthetic

1og(1/R)
2142
paraffin.
2012 Synthetic paraffin
1765
1541 Molecular weight 400–1400
Appearance A hard, odorless, white wax consisting of a mixture
1416 1693 of mostly long-chain, unbranched, saturated hydrocarbons
1216 along with a small amount of branched hydrocarbons.
1392 Melting point 96–1058C
−3.0 0.3 Viscosity (dynamic) 5–15 mPa s (5–15 cP) at 1358C.
1100 1300 1500 1700 1900 2100 2300 2500
Comments The USP32–NF27 states that synthetic paraffin is
Wavelength/nm synthesized by the Fischer–Tropsch process from carbon
monoxide and hydrogen, which are catalytically converted to a
Figure 1: Near-infrared spectrum of paraffin measured by reflectance. mixture of paraffin hydrocarbons. The lower molecular weight
fractions are removed by distillation and the residue is
in acetone, ethanol (95%), and water. Paraffin can be mixed with hydrogenated and further treated by percolation through
most waxes if melted and cooled. activated charcoal. This mixture may be fractionated into its
components by a solvent-separation method. Synthetic paraffin
11 Stability and Storage Conditions may contain not more than 0.005% w/w of a suitable
antioxidant.
Paraffin is stable, although repeated melting and congealing may
alter its physical properties. Paraffin should be stored at a
18 Comments
temperature not exceeding 408C in a well-closed container.
The more highly purified waxes are used in preference to paraffin in
12 Incompatibilities many applications because of their specifically controlled physical
properties such as hardness, malleability, and melting range.
— A specification for synthetic paraffin is contained in the Food
Chemicals Codex (FCC).(8)
13 Method of Manufacture The EINECS numbers for paraffin are 232-315-6 and 265-154-
Paraffin is manufactured by the distillation of crude petroleum or 5.
shale oil, followed by purification by acid treatment and filtration.
Paraffins with different properties may be produced by controlling 19 Specific References
the distillation and subsequent congealing conditions. 1 Motyckas S, Nairn J. Influence of wax coatings on release rate of anions
Synthetic paraffin, synthesized from carbon monoxide and
P
form ion-exchange resin beads. J Pharm Sci 1978; 67: 500–503.
hydrogen is also available; see Section 17. 2 Crosbie RB, Kaufman HD. Self-inflicted oleogranuloma of breast. Br
Med J 1967; 3: 840–841.
14 Safety 3 Bloem JJ, van der Waal I. Paraffinoma of the face: a diagnostic and
therapeutic problem. Oral Surg 1974; 38: 675–680.
Paraffin is generally regarded as an essentially nontoxic and 4 Greaney MG, Jackson PR. Oleogranuloma of the rectum produced by
nonirritant material when used in topical ointments and as a Lasonil ointment. Br Med J 1977; 2: 997–998.
coating agent for tablets and capsules. However, granulomatous 5 Pujol J et al. Interstitial pulmonary disease induced by occupation
reactions (paraffinomas) may occur following injection of paraffin exposure to paraffin. Chest 1990; 97: 234–236.
into tissue for cosmetic purposes or to relieve pain. Long-term 6 Goh D, Buick R. Intestinal obstruction due to ingested Vaseline. Arch
inhalation of aerosolized paraffin may lead to interstitial pulmonary Dis Child 1987; 62: 1167–1168.
disease. Ingestion of a substantial amount of white soft paraffin has 7 Health and Safety Executive. EH40/2005: Workplace Exposure Limits.
led to intestinal obstruction in one instance.(2–6) Sudbury: HSE Books, 2005 (updated 2007). http://www.hse.gov.uk/
See also Mineral Oil for further information. coshh/table1.pdf (accessed 5 February 2009).
8 Food Chemicals Codex, 6th edn. Bethesda, MD: United States
Pharmacopeia, 2008; 717.
15 Handling Precautions
Observe normal precautions appropriate to the circumstances and 20 General References
quantity of material handled. In the UK, the recommended —
workplace exposure limits for paraffin wax fumes are 2 mg/m3
long-term (8-hour TWA) and 6 mg/m3 short-term.(7)
21 Author
16 Regulatory Status AH Kibbe.
Accepted in the UK for use in certain food applications. Included in
the FDA Inactive Ingredients Database (oral capsules and tablets, 22 Date of Revision
topical emulsions, and ointments). Included in nonparenteral 5 February 2009.