1 Nonproprietary Names

BP: Purified Talc

JP: Talc

PhEur: Talc

USP: Talc

2 Synonyms

Altalc; E553b; hydrous magnesium calcium silicate; hydrous

magnesium silicate; Imperial; Luzenac Pharma; magnesium hydrogen metasilicate; Magsil Osmanthus; Magsil
Star; powdered talc;

purified French chalk; Purtalc; soapstone; steatite; Superiore;

talcum.

3 Chemical Name and CAS Registry Number

Talc [14807-96-6]

4 Empirical Formula and Molecular Weight

Talc is a purified, hydrated, magnesium silicate, approximating to

the formula Mg6(Si2O5)4(OH)4. It may contain small, variable

amounts of aluminum silicate and iron.

5 Structural Formula

See Section 4.

6 Functional Category

Anticaking agent; glidant; tablet and capsule diluent; tablet and

capsule lubricant.

7 Applications in Pharmaceutical Formulation or

Technology

Talc was once widely used in oral solid dosage formulations as a

lubricant and diluent, see Table I,(1–3) although today it is less

commonly used. However, it is widely used as a dissolution

retardant in the development of controlled-release products.(4–6)

Talc is also used as a lubricant in tablet formulations;(7) in a novel

powder coating for extended-release pellets;(8) and as an adsorbant.(9)

In topical preparations, talc is used as a dusting powder,

although it should not be used to dust surgical gloves; see Section

14. Talc is a natural material; it may therefore frequently contain

microorganisms and should be sterilized when used as a dusting

powder; see Section 11.

Talc is additionally used to clarify liquids and is also used in

cosmetics and food products, mainly for its lubricant properties.

Table I: Uses of talc.

Use Concentration (%)

Dusting powder 90.0–99.0

Glidant and tablet lubricant 1.0–10.0

Tablet and capsule diluent 5.0–30.0

8 Description

Talc is a very fine, white to grayish-white, odorless, impalpable,

unctuous, crystalline powder. It adheres readily to the skin and is

soft to the touch and free from grittiness.

9 Pharmacopeial Specifications

See Table II. See also Section 18.

10 Typical Properties

Acidity/alkalinity pH = 7–10 for a 20% w/v aqueous dispersion.

Hardness (Mohs) 1.0–1.5

Moisture content Talc absorbs insignificant amounts of water at

258C and relative humidities up to about 90%.

NIR spectra see Figure 1.

Particle size distribution Varies with the source and grade of

material. Two typical grades are 599% through a 74 mm (#200

mesh) or 599% through a 44 mm (#325 mesh).

Test JP XV PhEur 6.3 USP 32

Identification þþ þ

Characters þ þ —

Acid-soluble substances 42.0% — 42.0%

Acidity or alkalinity — þ þ

Production — þ —

pH — — —

Water-soluble substances — 40.2% 40.1%

Aluminum — 42.0% 2.0%

Calcium — 40.9% 0.9%

Iron — 40.25% 0.25%

Lead — 410 ppm 40.001%

Magnesium — 17.0–19.5% 17.0–19.5%

Loss on ignition 45.0% 47.0% 47.0%

Microbial contamination — þ 4500 cfu/g

Aerobic bacteria — 4102 cfu/g 102 cfu/g(a)

103 cfu/g(b)

Fungi — 4102 cfu/g 50 cfu/g(a)

102 cfu/g(b)

Acid and alkali-soluble

substances

44.0 mg — 42.0%

Water-soluble iron þ — —
Arsenic 44 ppm — 43 ppm

Heavy metals — — 40.004%

Absence of asbestos — — þ

(a) If intended for topical administration.

(b) If intended for oral administration.

3.0

0.0

−5.0

1000

× [2nd deriv. log(1/R)

0.2

1392

1405
1379 2276

2300

2408

2335

2288

2230

2392

2312

2466

log(1/R)

−0.2

Wavelength/nm

1100 1300 1500 1700 1900 2100 2300 2500

Figure 1: Near-infrared spectrum of talc measured by reflectance.

11 Stability and Storage Conditions

Talc is a stable material and may be sterilized by heating at 1608C

for not less than 1 hour. It may also be sterilized by exposure to

ethylene oxide or gamma irradiation.(10)

Talc should be stored in a well-closed container in a cool, dry

place.

12 Incompatibilities

Incompatible with quaternary ammonium compounds.

13 Method of Manufacture

Talc is a naturally occurring hydropolysilicate mineral found in

many parts of the world including Australia, China, Italy, India,

France, and the USA.(11)

The purity of talc varies depending on the country of origin. For

example, Italian types are reported to contain calcium silicate as the

contaminant; Indian types contain aluminum and iron oxides;

French types contain aluminum oxide; and American types contain

calcium carbonate (California), iron oxide (Montana), aluminum

and iron oxides (North Carolina), or aluminum oxide (Alabama).(12)

Naturally occurring talc is mined and pulverized before being

subjected to flotation processes to remove various impurities such as

asbestos (tremolite); carbon; dolomite; iron oxide; and various

other magnesium and carbonate minerals. Following this process,

the talc is finely powdered, treated with dilute hydrochloric acid,

washed with water, and then dried. The processing variables of

agglomerated talc strongly influence its physical characteristics.(13–15)

14 Safety

Talc is used mainly in tablet and capsule formulations. Talc is not

absorbed systemically following oral ingestion and is therefore

regarded as an essentially nontoxic material. However, intranasal or

intravenous abuse of products containing talc can cause granulomas in body tissues, particularly the
lungs.(16–18) Contamination of

wounds or body cavities with talc may also cause granulomas;

therefore, it should not be used to dust surgical gloves. Inhalation of

talc causes irritation and may cause severe respiratory distress in

infants;(19) see also Section 15.

Although talc has been extensively investigated for its carcinogenic potential, and it has been suggested
that there is an increased

risk of ovarian cancer in women using talc, the evidence is

inconclusive.(20,21) However, talc contaminated with asbestos has

been proved to be carcinogenic in humans, and asbestos-free grades

should therefore be used in pharmaceutical products.(22)

Also, long-term toxic effects of talc contaminated with large

quantities of hexachlorophene caused serious irreversible neurotoxicity in infants accidentally exposed

to the substance.(23)

15 Handling Precautions

Observe normal precautions appropriate to the circumstances and

quantity of material handled. Talc is irritant if inhaled and

prolonged excessive exposure may cause pneumoconiosis.

In the UK, the workplace exposure limit for talc is 1 mg/m3 of

respirable dust long-term (8-hour TWA).(24) Eye protection, gloves,

and a respirator are recommended.

16 Regulatory Status
Accepted for use as a food additive in Europe. Included in the FDA

Inactive Ingredients Database (buccal tablets; oral capsules and

tablets; rectal and topical preparations). Included in nonparenteral

medicines licensed in the UK. Included in the Canadian List of

Acceptable Non-medicinal Ingredients.

17 Related Substances

Bentonite; magnesium aluminum silicate; magnesium silicate;

magnesium trisilicate.

18 Comments

Talc is one of the materials that have been selected for harmonization by the Pharmacopeial Discussion
Group. For further information see the General Information Chapter <1196> in the USP32–

NF27, the General Chapter 5.8 in PhEur 6.0, along with the ‘State

of Work’ document on the PhEur EDQM website, and also the

General Information Chapter 8 in the JP XV.

Various grades of talc are commercially available that vary in

their chemical composition depending upon their source and

method of preparation.(11,25,26)

Talc derived from deposits that are known to contain associated

asbestos is not suitable for pharmaceutical use. Tests for amphiboles

and serpentines should be carried out to ensure that the product is

free of asbestos.

A specification for talc is contained in the Food Chemicals

Codex (FCC).(27)

The EINECS number for talc is 238-877-9. The PubChem

Compound ID (CID) for talc includes 26924, 443754 and

16211421.
19 Specific References

1 Dawoodbhai S, Rhodes CT. Pharmaceutical and cosmetic uses of talc.

Drug Dev Ind Pharm 1990; 16: 2409–2429.

2 Dawoodbhai S et al. Optimization of tablet formulations containing

talc. Drug Dev Ind Pharm 1991; 17: 1343–1371.

3 Wang DP et al. Formulation development of oral controlled release

pellets of diclofenac sodium. Drug Dev Ind Pharm 1997; 23: 1013–

1017.

4 Fassihi RA et al. Potential use of magnesium stearate and talc as

dissolution retardants in the development of controlled release drug

delivery systems. Pharm Ind 1994; 56: 579–583.

5 Fassihi R et al. Application of response surface methodology to design

optimization in formulation of a typical controlled release system.

Drugs Made Ger 1996; 39(Oct–Dec): 122–126.

6 Schultz P et al. New multiparticulate delayed release system. Part 2.

Coating formulation and properties of free films. J Control Release

1997; 47: 191–199.

7 Oetari RA et al. Formulation of PGV-O a new antiinflammatory agent

as a tablet dosage form. Indonesian J Pharm 2003; 14(4): 160–168.

8 Pearnchob N, Bodmeier R. Dry powder coating of pellets with

micronized Eudragil (R) RS for extended drug release. Pharm Res

2003; 20(12): 1970–1976.

9 Mani N et al. Microencapsulation of a hydrophilic drug into a

hydrophobic matrix using a salting-out procedure: II. Effects of

adsorbents on microsphere properties. Drug Dev Ind Pharm 2004;

30(1): 83–93.

10 Bubik JS. Preparation of sterile talc for treatment of pleural effusion

[letter]. Am J Hosp Pharm 1992; 49: 562–563.

11 Grexa RW, Parmentier CJ. Cosmetic talc properties and specifications.

Cosmet Toilet 1979; 94(2): 29–33.

12 Hoepfner EM et al, ed. Fiedler Encyclopedia of Excipients for

Pharmaceuticals, Cosmetics and Related Areas, 5th edn, vol. II:

Aulendorf: Editio Cantor Verlag, 2002; 1556–1559.

13 Lin K, Peck GE. Development of agglomerated talc. Part 1. Evaluation

of fluidized bed granulation parameters on the physical properties of

agglomerated talc. Drug Dev Ind Pharm 1995; 21: 447–460.

14 Lin K, Peck GE. Development of agglomerated talc. Part 2. Optimization of the processing parameters
for the preparation of granulated talc.

Drug Dev Ind Pharm 1995; 21: 159–173.

15 Lin K, Peck GE. Development of agglomerated talc. Part 3.

Comparisons of the physical properties of the agglomerated talc

prepared by three different processing methods. Drug Dev Ind Pharm

1996; 22: 383–392.

16 Schwartz IS, Bosken C. Pulmonary vascular talc granulomatosis. J Am

Med Assoc 1986; 256: 2584.

17 Johnson DC et al. Foreign body pulmonary granulomas in an abuser of

nasally inhaled drugs. Pediatrics 1991; 88: 159–161.

18 Sparrow SA, Hallam LA. Talc granulomas [letter]. Br Med J 1991; 303:

58.

19 Pairaudeau PW et al. Inhalation of baby powder: an unappreciated

hazard. Br Med J 1991; 302: 1200–1201.

20 Longo DL, Young RC. Cosmetic talc and ovarian cancer. Lancet 1979;

ii: 349–351.

21 Phillipson IM. Talc quality [letter]. Lancet 1980; i: 48.

22 International Agency for Research on Cancer/World Health Organization. Silica and Some Silicates:
IARC Monographs on the Evaluation of

the Carcinogenic Risk of Chemicals to Humans. Geneva: WHO, 1987:

42.

23 Anonymous. Long-term sequelae of hexachlorophene poisoning.

Prescrire Int 1992; 1: 168.

24 Health and Safety Executive. EH40/2005: Workplace Exposure Limits.

Sudbury: HSE Books, 2005 (updated 2007). http://www.hse.gov.uk/

coshh/table1.pdf (accessed 3 February 2009).

25 Phadke DS et al. Evaluation of batch-to-batch and manufacturer-tomanufacturer variability in the

physical properties of talc and stearic
acid. Drug Dev Ind Pharm 1994; 20: 859–871.

26 Lin K, Peck GE. Characterization of talc samples from different sources.

Drug Dev Ind Pharm 1994; 20: 2993–3003.

27 Food Chemicals Codex, 6th edn. Bethesda, MD: United States