FERRONYL® IRON

FERRONYL® IRON
Dietary Iron Supplement for Vitamin, Nutritional,
Pharmaceutical and Food Products
INTERNATIONAL SPECIALTY PRODUCTS
A Better Choice

Contents
Introduction 3
Physical and Chemical Properties 4-6
Product Description
Iron Content
Particle Morphology
Particle Size and Particle Size Distribution
Stability
Bioavailability 7
Applications 8-9
Tablets
Liquid Suspensions
Safety and Toxicity Summary 10-13
Poison Control Statistics
Animal Toxicity Studies
Regulatory 14
Summary 15
References 15

Introduction
Iron deficiency continues to be a concern around the
world, especially in women and children, often resulting
in anemia. One approach to prevent iron deficiency is
supplementation of food, vitamins and nutritional
products. In formulating an iron supplement, one must
consider bioavailability, toxicity, side effects, iron content,
stability, taste and ease of formulation when selecting an
iron source. Ferronyl® iron is an ideal source of essentially
pure iron with low toxicity, minimal metallic taste and
excellent bioavailability. Thus, it is the better choice for
iron supplementation.
Ferronyl iron powder is elemental iron (Fe) with high (>
98%) iron content. High iron content results in lower use
levels to achieve same daily intake levels compared to
ferrous (Fe 2+ ) salts (e.g., ferrous sulfate, ferrous fumarate,
or ferrous gluconate). This is important in multivitamin
formulations where smaller tablets are preferred for
consumer compliance, but often difficult to achieve with
the large number of actives in a formulation.
Benefits of Ferronyl Iron Powder
●
Low Use Levels
In addition to the high iron content, a key physical
property of Ferronyl iron is its fine spherical particle size
that results in higher human bioavailability than other
elemental iron forms.
Each year accidental iron overdose accounts for a
significant number of emergency room visits and too
many childhood deaths. Thus, one must consider toxicity
when selecting an iron source for a supplement product.
Ferronyl iron is far less toxic than soluble iron salts, it
causes fewer side effects, and the slow absorption from
the GI tract provides time for clinical intervention in the
event of accidental overdose.
●
●
●
●
●
Low Toxicity
Excellent Bioavailability
Highly Resistant to Oxidation
Easy to Formulate
Generally Recognized as Safe (GRAS)
With its low use level, excellent bioavailability and low
toxicity, Ferronyl iron is a better choice for iron
supplementation, of:
●
●
●
Multivitamin and iron supplement tablets;
Chewable vitamin tablets; and
Liquid suspensions.
A Better Choice 3

Physical & Chemical Properties
Product Description
Ferronyl iron powder is elemental iron manufactured by the chemical decomposition of iron
pentacarbonyl. The resulting iron particles are small, uniform particles of high purity with only traces of
carbon, oxygen and nitrogen.
Chemical Description:
Elemental Iron
CAS Registry Number: 7439-89-6
CAS Registry Name:
Iron
Chemical Formula:
Fe
Synonyms:
Carbonyl iron, carbonyl iron powder (CIP)
Iron Content
With greater than 98% iron, Ferronyl iron has a much higher iron level than ferrous salts, such as ferrous
gluconate, ferrous sulfate and ferrous fumarate (Table 1). As a result, substantially less Ferronyl iron is
required to reach the same unit dose than a ferrous salt, resulting in lower tablet weight. This makes
Ferronyl iron well suited for multivitamin applications with high active levels as Ferronyl iron can reduce
tablet weight.
Table 1. Less Ferronyl iron is required to reach same unit dose compared to other iron sources.
Ferronyl Iron
(Fe)
Ferrous Gluconate
(C 12 H 22 O 19 Fe)
Ferrous Fumarate
(C 4 H 2 FeO 4 )
Ferrous Sulfate
(FeSO 4 )
% Iron 98 12 32 36
Molecular Weight 56 446 170 152
Amount of Iron
Supplement needed to
meet US RDA*
18.4 mg 150.0 mg 54.4 mg 50.0 mg
*RDA (Recommended Daily Allowance) for Adults is 18 mg/day.
4

Physical & Chemical Properties
Particle Morphology
Ferronyl carbonyl iron powder (CIP) is a grey powder. When
examined under a scanning electron microscope (SEM),
Ferronyl iron particles are highly spherical (Figure 1). The
spherical particle morphology provides for excellent flow
during manufacturing.
Figure 1. Ferronyl iron particles are
spherical providing good flow properties.
Particle Size and Particle Size Distribution
Ferronyl carbonyl iron has a narrow particle size distribution (Figure 2). The typical average particle size is
about 7 to 9 microns which is smaller than the 10-100 microns of other forms of elemental iron (e.g.,
reduced, electrolytic and atomized). This small particle size contributes to its high bioavailability.
With a narrow particle size distribution, Ferronyl iron does not require additional processing prior to
formulation. Other iron sources can have wide particle size distributions and, thus, must be sieved, milled
or ground prior to use which adds time and cost to the manufacturing process.
Figure 2. Ferronyl carbonyl iron has a narrow particle size distribution and
small particle size.
Typical Average Particle Size = 7-9 µm
10
Volume %
0.1 1.0 10.0 100.0 1000.0
Particle Diameter (µm)
0
A Better Choice 5

Physical & Chemical Properties
Stability
Ferronyl iron is stable without loss of efficacy, even under elevated temperature and humidity.
When Ferronyl iron was formulated with Vitamin C (50:50 blend) and held in a humidity chamber for
several weeks, only slight color changes were noted. This is the result of the Ferronyl carbonyl iron being
relatively impervious to atmospheric oxidation. In contrast to other iron sources, such as ferrous salts,
Ferronyl iron shows significantly less color change at elevated temperature and humidity (Table 2).
Table 2. Ferronyl iron, in combination with Vitamin C, shows minimal color change under elevated temperature
and humidity.
Iron
Source
Ambient
Elevated Temperature
(45 o C)
Elevated Temperature and
Relative Humidity
(45 o C and 75% RH)
Week 1 Week 2 Week 3 Week 1 Week 2 Week 3 Week 1 Week 2 Week 3
Ferronyl
Iron
OK OK OK OK OK OK OK
Very
slightly
off color
Slightly
off color
Ferrous
Fumarate
OK OK OK OK OK OK
Slightly
off color
Dark
Very
Dark
Brown
Ferrous
Sulfate
OK OK OK OK
Slightly
off color
Off color
OK
Slightly
off color
Off
color
Ferrous
Gluconate
OK
Slightly
off color
Off color
OK
Slightly
off color
Off color
OK
Slightly
off color
Black
6

Bioavailability
The amount of iron absorbed by the body per unit dosage from a particular iron source is a function of
several factors - particle size, surface area, ionic charge, iron content. The first three of these factors
contribute to the relative biological value (RBV) of the iron source - a measure of how quickly the iron
enters the blood stream. The iron content is a function of molecular structure, i.e., elemental iron versus
ferrous salts like ferrous sulfate (FeSO 4 ) and is a measure of the percentage of iron in a unit dose.
Multiplying the RBV by the iron content produces the iron absorption per unit dosage. Table 3 shows that
the high iron absorption from Ferronyl iron results from its small particle size, which contributes to a
higher RBV than other forms of elemental iron, and its high iron content relative to ferrous sulfate.
Table 3. The small particle size of Ferronyl iron contributes to its high RBV, which together with its high iron
content leads to high absorption per unit dose.
Iron Source Particle Size, µm RBV, % Iron Content, % Absorption, %
FeSO 4
*
N/A 100 20 20
Reduced Iron 10 - 20 34 96 33
Electrolytic Iron 10 - 20 48 97 47
Ferronyl iron 7 - 9 70 98 69
*FeSO 4
● 4H 2 O
In a study of iron-deficient rats, Sacks and Houchin (1978 a,b) concluded that, for similar iron dosage
levels, carbonyl iron powder was as effective as ferrous sulfate and more so than ferrous pyrophosphate
in restoring normal hematocrit levels (Table 4). Due to its finer particle size, carbonyl iron powder was also
found to be more efficacious than the other forms of elemental iron (e.g., electrolytic and reduced).
Table 4. Effect of various iron supplements on rat hematocrit levels.
Iron Source
Supplement Dose
(mg/kg)
Iron Dose
(mg/kg)
Increase in Hematocrit with 2 weeks
Supplementation
Control (Basal Diet) 0 0 -2
FeSO 4 30 6 4
FeSO 4 60 12 11
FeSO 4 120 24 22
CIP 12 12 6
CIP 24 24 15
A Better Choice 7

Applications
As Ferronyl iron is easily formulated into tablets and liquid suspensions, it is a better choice for iron
supplements, including multivitamin tablets, chewable tablets and liquid suspensions.
One advantage of formulating with Ferronyl iron is that it does not require further processing prior to
formulation, thus reducing manufacturing time and costs. With its narrow particle size distribution and
spherical particle morphology, Ferronyl iron can be formulated as supplied.
Tablets
Since less Ferronyl iron is required to achieve the unit dose, compared to ferrous salts, smaller tablets are
achieved. Hence, Ferronyl iron is ideally suited for multivitamin formulations containing iron to reduce
tablet weight compared to ferrous salts. High tablet weight can lead to difficult to swallow tablets that
result in poor consumer compliance.
In recent studies, tablets of equivalent weight containing the recommended daily allowance (RDA) of iron
for adults of Ferronyl iron, ferrous sulfate and ferrous fumarate with equal parts lactose and dicalcium
phosphate with small amounts of lubricant were evaluated for hardness and friability over a range of
compression forces. Ferronyl iron provided tablets of equivalent hardness and friability to ferrous sulfate
and ferrous fumarate. (Figure 3)
Figure 3. Ferronyl iron provides tablets of similar hardness to tablets with ferrous sulfate and ferrous fumarate.
40
35
Hardness (kP)
30
25
20
15
10
5
0
2000 3000 4000 5000 6000 7000 8000
Compression Force (lbs)
Ferronyl Iron
Ferrous Sulfate
Ferrous Fumarate
8

Applications
Liquid Suspensions
For some consumers, like children, it may be difficult to swallow tablets; therefore a liquid dosage form
may be preferred. As Ferronyl iron is compatible with commonly used excipients and additives, it can be
formulated into stable liquid formulations.
One example of a stable liquid suspension with Ferronyl iron is shown in Table 5. After 3 months at 40 o C
and 75% relative humidity, the formulation was white and pH was unchanged.
Table 5. Stable Suspension with Ferronyl Iron
Ingredient Wt. % Supplier
Water 90.25
Polyplasdone® INF-10 Crospovidone 5.00 ISP
Manucol® LKX sodium alginate 2.00 ISP
EDTA 1.88 Sigma
Ferronyl iron 0.36 ISP
Tert-butyl-hydroquinone (TBHQ) 0.01 Eastman Chemical
Methylparaben 0.40 ISP
Proplyparaben 0.10 ISP
TOTAL: 100.00
Procedure:
1. Prepare a 2% solution of Manucol LKX in water using a suitable stirrer.
2. Add methyl and propyl paraben, EDTA and Polyplasdone INF-10 to the alginate while stirring.
3. Add Ferronyl iron and TBHQ to the mixed solution, then homogenize for 3 minutes.
9

Safety & Toxicity Summary
The primary reason Ferronyl iron is offered as an alternative to ferrous salts is the inherent safety (30 - 150
fold reduction in toxicity) that results from the rate limiting conversion of elemental iron to ferrous ion via
gastric acid. As a result of the slow gastrointestinal oxidation, toxic effects resulting from accidental
overdose of carbonyl iron take longer to materialize; a window of time allowing clinical intervention. Both
historic and more recently expanded acute oral toxicity studies in several animal models support these
claims. In addition, statistics compiled by the American Association of Poison Control Centers show both
fewer and less severe incidences of toxic exposure resulting from accidental overdose of carbonyl iron
powder versus ferrous salts. This inherently safe material is one effective and demonstrable way iron
supplementation does not become iron overdose and death.
Poison Control Statistics
In statistics compiled through the American Association of Poison Control Centers' Toxic Exposure
Surveillance System (AAPCC TESS) carbonyl iron powder had substantially fewer and less severe signs and
symptoms of toxicity than ferrous salts both on an absolute basis and relative to the total number of
reported incidences (Table 6). Furthermore, the same AAPCC TESS database shows that carbonyl iron
powder is significantly safer than ibuprofen, a common over the counter drug not subject to the
packaging and labeling requirements of iron supplements. Another finding from these data is that the
AAPCC documented the length of time these overdose signs and symptoms persisted in the ferrous salt
and carbonyl iron powder overdose situations. With iron salt overdoses, the majority of the symptoms for
both moderate and severe effects lasted over 24 hours and some as long as one month. In the two
reported cases of carbonyl iron powder overdoses there was complete recovery within 8 hours.
Table 6. Carbonyl iron powder (CIP) caused fewer and less severe incidences of toxicity than ferrous
salts or ibuprofen.
Iron Salts
(1995)
Iron Salts
(1996)
Ibuprofen
(1995)
Ibuprofen
(1996)
CIP
(1995)
CIP
(1996)
Moderate Effect 155 117 17 29 1 1
Major Effect 14 5 1 2 0 0
Death 2 2 0 0 0 0
Total 171 124 18 31 1 1
Reported Exposures 21,643 22,382 18,333 21,970 1527 1252
>Moderate Effect 0.79% 0.55% 0.10% 0.14% 0.06% 0.08%
10

Safety & Toxicity Summary
Animal Toxicity Studies
The relative safety advantage of carbonyl iron powder over ferrous sulfate has been known for over fifty
years. Acute oral toxicity studies done in several different laboratory animal species show that for the
same iron dosage, carbonyl iron powder is 30-150 times safer (Table 7).
Table 7. For the same iron dosage, carbonyl iron powder is significantly safer than ferrous sulfate.
Study
Species
FeSO 4 LD 50
(mg/kg)
Fe 2+ LD 50
(mg /kg)
CIP LD 50
(mg/kg)
Shelanski, 1950; Boyd & Shanas, 1963 Rat 1490-5000 298-1000 30,000
Shelanski, 1950; Boyd & Shanas, 1963 Guinea Pig 1500-1750 300-350 20,000
GAF, 1990 Dog 800 160 >25,000
ISP, 1997a Young Rat 950 190 19,000
In the 1997 study on young rats (ISP 1997a,b), the research also looked at the time to expiration for
animals given a toxic iron dose. When treated with 1000 mg/kg ferrous ion, 60% of the animals expired
within 2 hours and the remainder within 4 hours. For animals treated with 100 times more Ferronyl iron;
all lived at least 4 hours, half lived at least 24 hours and some lived for as long as 5 days (Table 8). This time
differential is directly related to the rise in free plasma iron and suggests that the oxidation of Ferronyl
iron to ferrous ion and subsequent movement of the ion across the mucosal cell is significantly slower
than the simple transport of the ferrous ion derived from ferrous sulfate. The slower increase in toxicity
provides time for clinical intervention in the case of accidental Ferronyl iron overdose that is not available
in the event of iron salt overdose.
Table 8. The toxic effects of iron overdose from Ferronyl iron take longer to develop than those of ferrous salts
despite the higher dosage.
Time (Hours)
Mortalities / Treated
(100,000 mg Ferronyl iron/kg)
Mortalities / Treated
(1000 mg Fe 2+ (as FeSO 4 )/kg)
1 0 / 10 1 / 10
2 0 / 10 6 / 10
4 0 / 10 10 / 10
24 5 / 10 ---
48 8 / 10 ---
72 9 / 10 ---
120 10 / 10 ---
T 50 24.57 1.4
11

Safety & Toxicity Summary
In rats given a LD 90 dose of iron (ISP 1997c), Ferronyl iron treated animals had lower plasma iron after 1
hour and no visibly detected gastrointestinal tract erythema, despite about 100 and 290 times higher
dosages of iron in male and female rats, respectively, than the ferrous sulfate treated animals (Table 9).
This corroborates the previous finding that Ferronyl iron entered the vascular space more slowly than
ferrous ion.
Table 9. The low toxicity of Ferronyl iron results from the controlled release of iron into the blood stream.
Iron Source
Iron Dose
(mg/kg)
Plasma Iron (µg / dl) 1
Hour Post-Dosing
Stomach & Intestine;
Gross Pathological
Examination
FeSO 4
240 (1200 FeSO4) Male;
220 (1100 FeSO4) Female
993 + 638
Erythema
“slight - pronounced”
Ferronyl
23,000 Male;
64,000 Female
438 + 22
No Erythema
“black granular [test]
material”
In a study of young swine (ISP 1998), all of the animals lived, but the physiologic response to a noxious
insult (vomiting and diarrhea) was less severe for the highest dose of Ferronyl iron than the lowest dose
of FeSO 4 (a 750-fold difference in iron content) (Table 10).
Table 10. Despite significantly lower dosages of ferrous sulfate, the reaction to Ferronyl iron in young swine
was significantly less severe than to ferrous sulfate.
Iron Source
Dose of Test Substance
(mg/kg)
Dose of Iron
(mg Fe/kg)
Mortalities Vomiting Diarrhea
FeSO 4 100 20 None Severe Severe
FeSO 4 250 50 None Severe Severe
FeSO 4 500 100 None Severe Severe
Ferronyl 500 500 None None Moderate
Ferronyl 5,000 5,000 None Minimal Moderate
Ferronyl 15,000 15,000 None Minimal Moderate
12

Safety & Toxicity Summary
Plasma iron levels increased for all FeSO 4 and Ferronyl iron treatment groups. The plasma iron levels for
swine receiving the highest dose of Ferronyl iron (15,000 mg/kg) were comparable to those that received
the lowest dose of FeSO 4 (20 mg Fe 2+ /kg). These findings, like those of the previously mentioned rat study,
suggest that although iron crosses the wall of the GI tract, there is a barrier to the movement of large
amounts of Ferronyl iron into the blood stream in a short period of time. Histopathological staining of key
organs for iron deposits reinforced this observation. Again the amounts found in the lowest dose of
ferrous sulfate were comparable to the amounts of iron found with the highest dose of carbonyl iron
powder. A 14-day recovery period indicated that iron stores in liver and spleen returned to normal in
Ferronyl iron treated animals versus those that received FeSO 4 .
A Better Choice 13

Regulatory
Ferronyl iron is an elemental iron that is generally recognized as safe (GRAS) under title 21 Code of Federal
Regulations, Parts:
184.1375 - Nutrient for human consumption
582.5375 - Nutrient and/or dietary supplement in animal feed
Ferronyl iron meets the US Food Chemical Codex specifications for Iron, carbonyl.
14

Summary
Each year accidental iron overdose accounts for a significant number of emergency room visits and too
many cases of childhood death. In developing effective products for iron supplementation, care must be
taken not to increase the incidences of toxic exposure. Ferronyl carbonyl iron powder represents an
opportunity to correct a fundamental problem with iron supplementation - the toxicity of currently used
iron salts. Ferronyl is far less toxic than soluble iron salts, it causes fewer side effects, and the slow
absorption from the GI tract provides time for clinical intervention in the event of accidental overdose.
Combined with its high bioavailability, lower use levels and bland taste, Ferronyl iron is a better choice for
iron supplementation.
References
Boyd & Shanas, The Acute Oral Toxicity of Reduced Iron, Canad. Med. Assn. J. 89, 171-175, 1963.
Crosby, W. H., Prescribing Iron? Think Safety. Arch. Intern. Med., 138, 766-767, 1978.
GAF, Acute Oral Toxicity in the Dog: Carbonyl Iron vs. Ferrous Sulfate, GAF Unpublished data, 1990.
ISP, Single Dose Oral Toxicity in Rats / LD50 in Rats; Carbonyl Iron Powder, ISP Unpublished data, 1997a.
ISP, Single Dose Oral Toxicity in Rats / LD50 in Rats; Ferrous Sulfate (Iron II) Sulfate, ISP Unpublished data, 1997b.
ISP, Single Dose (LD90) Oral Toxicity in Rats; Carbonyl Iron Powder and Ferrous Sulfate (Iron II) Sulfate, ISP
Unpublished data, 1997c.
ISP, Food Additive Safety Study with Carbonyl Iron and Ferrous Sulfate in Young Swine, ISP Unpublished data, 1998.
Sacks, P. V. and D. N. Houchin, Comparative Bioavailability of Elemental Iron Powders for Repair of Iron Deficiency
Anemia in Rats. Studies of Efficacy and Toxicity of Carbonyl Iron, Am. Jrnl. Clin. Nutrition, 31(4), 566-571, 1978a.
Sacks, P. V. and D. N. Houchin, Elemental Iron Powders for Food Enrichment. Acid Solubility as a Predictor of
Bioavailability, Am. Jrnl. Clin. Nutrition, 31(4), 571-576, 1978b.
Shelanski, H. A. Acute and Chronic Toxicity Tests on Carbonyl Iron Powder, GAF Unpublished data, 1950.
A Better Choice 15

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The information contained in this brochure and the various products described are intended for use only by persons having technical skill and at their own discretion and risk after they have performed necessary technical investigations,
tests and evaluations of the products and their uses. While the information herein is believed to be reliable, we do not guarantee its accuracy and a purchaser must make its own determination of a product’s suitability for purchaser’s
use, for the protection of the environment, and for the health and safety of its employees and the purchasers of its products. Neither ISP nor its affiliates shall be responsible for the use of this information, or of any product, method,
formulation, or apparatus described in this brochure. Nothing herein waives any of ISP’s or its affiliates’ conditions of sale, and WE MAKE NO WARRANTY, EXPRESS OR IMPLIED, OF MERCHANTABILITY OR FITNESS OF ANY PRODUCT
FOR A PARTICULAR USE OR PURPOSE. We also make no warranty against infringement of any patents by reason of purchaser’s use of any information, product, method or apparatus described in this brochure.