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2MS521 ~ Di~s ~

Page 1 of 3
Date: March 30, 2011
Version: 001

R0dub0uim~

~
Colors

PIGMENTS
Systems Solutions

CERTIFICATE OF ANALYSIS
Rockwood Italia S.p.A. Divisione Silo
Via G. Reiss Romoli 44112, 1-10148 Torino (ltaly)
Phone: (+39) 011 2280501

Fax: (+39) 011 2269275

Product:

Iron Oxide Sicovit Red 30 E172

Manufacturing Site:

Turin, ltaly

Lot Number: W795A

Date of Manufacture: 0410812011

Expiration Date: 0310812016

Recommended Re-Evaluation Date: annually

Pharmacopeial Designation:

Ferric Oxide (USP-NF), Red Ferrie Oxide (JPE),

Iron Oxide Red (E172)

Analytical Results
Test
Appearance
Identification
~
Assay (Fe)
Assay (Fe203)
Arsenic As
Barium Ba
Cadmium Cd
Chromium Cr
Copper Cu
Lead Pb
Mercury Hg
Nickel Ni
Zino Zn
Antimony Sb
Selenium
Heavy Metais (as Pb)
Loss on lgnition
Organio Coiours and
Lakes
~le
~a
Coiour Shade AE
Mass tone
Colour Shade AE
Tint
Tinting Strength
pH
Loss on Drying

Specification

Test Method

Source

Results

Red powder
Complies
0.3%

Visual Examination
LO-46
LO-36

E172/JPE
JPE/IJSP
LJSP

Complies
Complies
0.14%

68%
100.5%
1 ppm
30 ppm
1 ppm
30 ppm
30 ppm
7 ppm
0.5 ppm
70 ppm
50 ppm
5 ppm
1 ppm
30 ppm
2.0%

LO-16
LO-41
LO-27
LO-27
LO-27
LO-27
LO-7
LO-27
LO-27
LO-27
LO-27
LO-27
LO-27
External Laboratory
LO-34

E172
USP!JPE
USP/JECFA
USP/JECFA
USP/JECFA
USP/JECFA
USP/JECFA
USP/JECFA
USP/JECFA
IJSP/JECFA
USP/JECFA
IJSP/JECFA
USP/JECFA
JPE
JPE

68.58%
98.1%
<1 ppm
4 ppm
<1 ppm
16 ppm
6 ppm
1 ppm
<0.2 ppm
43 ppm
24 ppm
<1 ppm
<1 ppm
<30 ppm
0.49%

Complies
0.75%

External Laboratory
LOG-04

USP
JPE

Complies
0.3%

1.0%

LOG-04

USP

0.3%

s 1.5

LO-53

Internal

1.49

s 1.0
100 5%
6.0 8.0
1%

LO-54
LO-54
L0-06
LOG-25

lnternal
Internal
EN 50 787-9
EN 50 787-2

0.73
100.4%
6.25
0.43%

98.0

4I~)flhIkLi

ROCIWOOD

Page 2 of 3
Date: March 30, 2011
Version: 001

Colors

PIGMENTS
Systems Solutions

CERTIFICATE OF ANALYSIS
Rockwood Italia S.p.A. Divisione Silo
Via G. Reiss Romoli 44112, 1-10148 Torino (ltaly)
Product:

Iron Oxide Sicovit Red 30 E172

Lot Number:

W795A

Microbiological Analysis Data

Test Parameter

Unit

Sample

Total viable aerobic count

cfu/g

<10

max. 1,000

Yeasts and moulds

cfu/g

<10

max. 100

Enterobacteria

Passed

negative in 1 g

Escherichia coli

Passed

negative in 1 g

Pseudomonas aeruginosa

Passed

negative in 1 g

Candida albicans

Passed

negative in 1 g

Staphylococcus aureus

Passed

negative in 1 g

Pseudomonaceae

Passed

negative in 1

Salmonelia

Passed

negative in 10 g

ROCIWOOD

Page 3 of 3
Date: March 30, 2011
Version: 001

Colors

PIGMENTS
Systems Solutions

CERTIFICATE OF ANALYSIS
Rockwood Italia S.p.A. Divisione Silo
Via G. Reiss Romoli 44112, 1-1 0148 Torino (Italy)
Product:

Iron Oxide Sicovit Red 30 E172

Lot Number:

W795A

Certification and Compliance Statements

Pharmacopeial Standards
This iot of Iron Oxide Sicovit Red 30 E172 comphes with ali of the current requirements listed in the
Japanese Pharmaceutical Excipients (JPE) and the United States Pharmacopoeia (USP-NF).
GMP Compliance
This iot of iron Oxide Sicovit Red 30 E172 was produced according to the actual valid Joint IPEC-PQG
Good Manufacturing Practices Guide for Pharmaceutical Excipients.
Residual Solvents (ICH Q3C)
This lot of iron Oxide Sicovite Red 30 E172 does neither contam any Class 1 2 or 3 residual solvents nor
was any of Class 1, 2 or 3 residual soivents used in the manufacturing process as defined in the ICH Q3C
Guidehne on Residual Solvents.
Other Certification Statements
This lot of iron Oxide Sicovit~ Red 30 E172 complies with the requirements of EC directive 2008/128/EC
(E172), 21 CFR 73.200, 21 CFR 73.1200, 21 CFR 73.2250, 21 CFR 73.3125, JECFA and WHOIFAO. iron
Oxide Sicovit5 Red 30 E172 is Kosher certified.

Approvai

Quality Assurance

Date of Approval
2310812011

os

pq~aTos
OUMCOS. LOA.
A Ab AIb~ 25 5~
IS. Osisigos de reis

Page 1 of 3
Date: December 1,2010
Version: 000

Produlosousmicos

PIGMENTS
Solutions

Eei~:digafleeca

Systems

Colors

CERTIFICATE OF ANALYSIS
Rockwood Italia S.p.A. Divisione Silo
Via G. Reiss Romoli 44/12, 1-10148 Torino (ltaly)
Phone: (+39) 011 2280 501

Fax: (+39) 011 22 69275

Product

Iron Oxide Sicovit Brown 70 E172

Manufacturing Site:

Turin, ltaly

Lot Number: W703

Date of Manufacture: 06/03/2009

Expiration Date: 05/0312014

Recommended Re-Evaluation Date: annually

Pharmacopeial Designation:

Not existent; mix of Red Iron Oxide (JPE, E172,

USP-NF), Yellow lron Oxide (JPE, E172, USP
NF), and Black Iron Oxide (JPE, E172)

Analytical Results
Test
Appearance
Identification
Assay (Fe)
Assay (Fe20,)
Arsenic As
Barium Ba
Cadmium Cd
Chromium Cr
Copper Cu
Lead Pb
Mercury Hg
Nickel Ni
Zinc Zn
Antimony Sb
Selenium
Heavy MetaIs (as Pb)
WaterSoluble
~ E
Colour Shade AE, tint
Tinting Stren~th
pH
Loss on Drying

Specification
Brown powder

Test Method
Visual Examination

Comphes
60%
98.0 100.5%
1 ppm
30 ppm
1 ppm
30 ppm
s 30 ppm
7 ppm
S 0.5 ppm
100 ppm
50 ppm
S 5 ppm
1 ppm
30 ppm
0.75%

Source

Results

1.0-46
LO-is
LO41
LO-27
LO-27
LO-27
LO-27
L0-27
LO-27
L0-27
LO-27
LO-27
L0-27
LO-27
External Laboratory
LOG-04

E172/JPE
JPE
E172
USP/JPE
USPIJECFA
USP/JECFA
USP/JECFA
USP/JECFA
USP!JECFA
USP/JECFA
(JSP/JECFA
USP!JECFA
USP/JECFA
USP/JECFA
USP!JECFA
JPE
JPE

Compiles
Compiles
68.5%
Not availabie
<1 ppm
4 ppm
<1 ppm
8 ppm
1 ppm
1 ppm
<0.2 ppm
50 ppm
33 ppm
<1 ppm
<1 ppm
Not available
016%

1.5

LO-53

Internal

0.96

S 1.0
100 5%
6.0 8.0
1%

LO-54
LO-54
L0-06
LOG-25

internai
Internal
EN 50 787-9
EN lSO 787-2

0.60
104.8%
6.7
0.6%

R CIc~lI.
PIGMENTS

Page2of3
Date: Decemberi, 2010
Version: 000

Colors

Systems

Solutions

CERTIFICATE OF ANALYSIS
Rockwood Italia S.p.A. Divisione Silo
Via G. Reiss Romoli 44112, 1-10148 Torino (ltaly)
Product:

Iron Oxide Sicovit Brown 70 E172

Lot Number:

W703

Microbiological Analysis Data

(in accordance with Ph. Lur. 2.6.12B, 2.6.13B, harmonized EP, JP, USP)
Test Parameter

Unit

Sample

Specificaton

Total viable aerobic count

cfulg

10

max. 1,000

Yeasts and moulds

cfu/g

20

max. 100

Enterobacteria

Passed

negative in 1 g

Escherichia coli

Passed

negative in 1 g

Pseudomorias aeruginosa

Passed

negative in 1 9

Candida albicans

Passed

negative in 1 9

Staphylococcus aureus

Passed

negative in 1

Pseudomonaceae

Passed

negative in 1

Salmoneila

Passed

negative

~fl

109

Page 3 of 3
Date: December 1, 2010
Version: 000

Colors

III
PIGMENTS
Systems Solutians

CERTIFICATE OF ANALYSIS
Rockwood Italia S.p.A. Divisione Silo
Via G. Reiss Romoli 44/12, 1-1 0148 Torino (ltaly)
Product:

Iron Oxide Sicovit Brown 70 E172

Lot Number:

W703

Certification and Compliance Statements

Pharmacopeial Standards
This lot of iron Oxide Sicovit Brown 70 E172 cornplies with ali of the current requirements hsted in the
United States Pharmacopeia (USP-NF) and the Japanese Pharmaceutical Excipients (JPE) for the singie
components of the biend.
GMP Compliance
This iot of iron Oxide sicovite~ Brown 70 E172 was produced according to the actual vahd Joint IPEC-POG
Good Manufacturing Practices Guide for Pharmaceuticai Excipients.
Residual Solvents (ICH Q3C)
This lot of iron Oxide Sicovit Brown 70 El 72 does neither contam any Ciass 1, 2 or 3 residual solvents nor
was any of Class 1, 2 or 3 residual solvents used in the manufacturing process as defined in the ICH 03C
Guidehne on Residual Solvents.
Other Certification Statements
This Iot of Iron Oxide Sicovit Brown 70 El 72 compiles with the requirements of EC directive 200811 281EC
(E172), 21 CFR 73.200, 21 CFR 73.1200,21 CFR 73.2250, 21.CFR.73.3125, JECFA and WHOIFAO. Iron
Oxide Sicovit Brown 70 E172 is Kosher certifled.

Approval

urance
Date of Approval
0110912011

DS

Page 1 of 3
Date: December 1, 2010
Version: 000

Produtos Qumicos

CoIors

P16 ME 1V T S
System$ Srslutions

CERTIFICATE OF ANALYSIS
Rockwood Italia S.p.A. Divisione Silo
Via G. Reiss Romoli 44112, 1-10148 Torino (ltaly)
Phone: (+39) 011 2280501

Fax: (+39) 011 2269275

Product:

Iron Oxide Sicovit Black 80 E172

Manufacturing Site:

Turin, ltaly

Lot Number: W778

Date of Manufacture: 1911212010

Expiration Date: 1811212015

Recommended Re-Evaluation Date: annually

Pharmacopeial Designation:

Black tron Oxide (JPE), Iron Oxide Black (E172)

Analytical Results
Test
Appearance
Identification
Assay (Fe)
Arsenic As
Barium Ba
Cadmium Cd
Chromium Cr
Copper Cu
Lead Pb
Mercury Hg
Nickel Ni
Zinc Zn
Antimony Sb
Selenium
Heavy Metais (as Pb)
Loss on Ignition
Wat:rSduble

E,
Colour Shade ~E, tint
Tinting Strength
p11
Loas on Dryinq

Speciflcation

Test Method

Source

Results

Biack powder
Complies
68%
1 ppm
30 ppm
1 ppm
30 ppm
s 30 ppm
7 ppm
0.5 ppm
150 ppm
s 50 ppm
5 ppm
1 ppm
30 ppm
2.0%
s 0.75%

Visual Examination
LO-46
LO-16
LO-27
LO-27
LO-27
LO-27
LO-27
LO-27
LO-27
LO-27
LO-27
LO-27
LO-27
External Laboratoiy
LO-34
LOG-04

E172/JPE
JPE
172
USP/JECFA
USP/JECFA
USP/JECFA
USP/JECFA
USP/JECFA
USP/JECFA
USP/JECFA
USP/JECFA
USP/JECFA
USP/JECFA
USP/JECFA
JPE
For Information only
JPE

Compiles
Complies
70.6%
<1 ppm
4 ppm
<1 ppm
21 ppm
9 ppm
<1 ppm
<0.2 ppm
121 ppm
30 ppm
<1 ppm
<1 ppm
<30 ppm
0.2%
0.32%

2.4
1.0
100 5%
6.5 8.5
1%

LQ-53
LO-54
LO-54
LO-06
LOG-25

Internal
Internal
Internal
EN ISO 787-9
EN ISO 787-2

2.22
0.46
102%
8.2
0.45%

*CI~~VOOD

Page2of3
Date: December 1,2010
Version: 000

Colors

PIGMENTS
Systems Solutions

CERTIFICATE OF ANALYSIS
Rockwood Italia S.p.A. Divisione Silo
Via G. Reiss Romoli 44112, 1-10148 Torino (Italy)
Product:

Iron Oxide Sicovit Black 80 E172

Lot Number:

W778

Microbiological Analysis Data

(in accordance with Ph. Eur. 2.6.12B, 2.6.13B, harmonized EP, JP, USP)
Test Parameter

1 Unit

Sample

Specification

Total viable aerobic count

c~/g

max. 1,000

Yeasts and moulds

cfu/g

max. 100

Enterobacteria

Passed

negative in 1 g

Escherichia coli

Passed

negative in 1 g

Pseudomonas aeruginosa

Passed

negative in 1 g

Candida albicans

Passed

negative in 1 g

Staphylococcus aureus

Passed

negative in 1 g

Pseudomonaceae

Passed

negative in 1 g

Salmonelia

Passed

negative in 109

.*~

Page3of3
Date: December 1, 2010
Version: 000

Colors

P1 G ME N TS
Systems Solutions

CERTIFICATE OF ANALYSIS
Rockwood Italia S.p.A. Divisione Silo
Via G. Reiss Romoli 44112, 1-1 0148 Torino (Italy)
Product:

Iron Oxide Sicovit Black 80 E172

L.ot Number:

W778

Certification and Compliance Statements

Pharmacopeial Standards
This iot of Iron Oxide Sicovit Black 80 E172 complies with ali of the current requirements Iisted in the
United States Pharmacopeia (USP-NF) and the Japanese Pharmaceutical Excipients (JPE) for the single
components of the blend.
GMP Compliance
This iot of Iron Oxide Sicovit Black 80 E172 was produced according to the actual valid Joint iPEC-PQG
Good Manufacturing Practices Guide for Pharmaceuticai Excipients.
Residual Soivents (1CH 03C)
This lot of Iron Oxide sicovit Black 80 E172 does neither contam any Class 1, 2 or 3 residual solvents nor
was any of Class 1, 2 or 3 residual solvents used in the manufacturing process as defined in the iCH 03C
Guideline on Residual Solvents.
Other Certification Statements
This lot of iron Oxide Sicovit Black 80 E172 complies with the requirements of EC directive 2008/128/EC
(E172), 21 CFR 73.200,21 CFR 73.1200,21 CFR 73.2250, 21.CFR.73,3125, JECFA and WHO/FAO. Iron
Oxide Sicovit Black 80 E172 is Kosher certifled.

Approval
O

Date of Approvai
1210112011

Conroi