This document provides analytical test results and certification for a lot of iron oxide pigment. It details the product tested, manufacturing site, lot number, date of manufacture, expiration date, and recommended re-evaluation date. It also includes results for various assays and tests for elements, heavy metals, microbiological analysis, and certification statements regarding standards and approvals.
This document provides analytical test results and certification for a lot of iron oxide pigment. It details the product tested, manufacturing site, lot number, date of manufacture, expiration date, and recommended re-evaluation date. It also includes results for various assays and tests for elements, heavy metals, microbiological analysis, and certification statements regarding standards and approvals.
Original Description:
pigmentos aula dermofarmácia e cosmética FFUL - exemplos
This document provides analytical test results and certification for a lot of iron oxide pigment. It details the product tested, manufacturing site, lot number, date of manufacture, expiration date, and recommended re-evaluation date. It also includes results for various assays and tests for elements, heavy metals, microbiological analysis, and certification statements regarding standards and approvals.
This document provides analytical test results and certification for a lot of iron oxide pigment. It details the product tested, manufacturing site, lot number, date of manufacture, expiration date, and recommended re-evaluation date. It also includes results for various assays and tests for elements, heavy metals, microbiological analysis, and certification statements regarding standards and approvals.
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
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
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
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.
