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Not appropriate for regulatory submission. Please visit www.spectrumchemical.com or contact Tech Services for the most up‐to‐date information contained in this information package.
Spectrum Chemical Mfg Corp 769 Jersey Avenue New Brunswick, NJ 08901 Phone 732.214.1300
Ver4.04 05.August.2019
Scientific Documentation KA105, Kaolin, Powder, USP
Dear Customer,
Thank you for your interest in Spectrum’s quality products and services.
Spectrum has been proudly serving the scientific community for over 45 years. It is our mission to manufacture and distribute fine chemicals and laboratory products with Quality and delivery you can count on every time.
To accomplish our mission, Spectrum utilizes our sourcing leverage and supplier qualification expertise in offering one of the industry’s most comprehensive line of fine chemical products under one brand, in packaging configurations designed to meet your research and production requirements. Our product grades include: USP, NF, BP, EP, JP, FCC, ACS, KSA, Reagent grade, as well as DEA controlled substances. We operate facilities in the United States on the East Coast, West Coast, as well as in Shanghai, China in order to provide the best logistical support for our customers.
At Spectrum, Quality is priority number one. Suppliers with the best qualifications are preferred and we employ full-functioning in-house analytical laboratories at each of our facilities. Our facilities and systems are USFDA registered and ISO certified. We frequently host customer audits and cherish opportunities for improvements. Quality is engrained into our culture. Quality is priority number one.
In the following pages, we have designed and prepared documented scientific information to aid you in your initial qualification or your continual use of our products. Please do not hesitate to contact us if further information or the most up-to-date documentation is desired from any of the covered areas.
We appreciate your business and we look forward to hearing from you.
Sincerely,
Michael Dang Director, Quality Systems & GMP Compliance [email protected]
05.August.2019
KA105, Kaolin, Powder, USP
Table of Contents
Product Specification
Safety Data Sheet (SDS)
Manufacturing Process Flowchart
Certification of Quality Management System (QMS)
Certification of current Good Manufacturing Practices (cGMP)
Product BSE/TSE Statement
Product Allergen Statement
Product Aflatoxin Statement
Product Certificate of Analysis Sample(s)
General Label Information – Sample Label
General Lot Numbering System Guidance
Stability – Shelf Life Guidance
Halal Certificate
Specification for Kaolin, Powder, USP (KA105)
Item Number KA105
Item Kaolin, Powder, USP
CAS Number 1332-58-7
Molecular Formula
Molecular Weight
MDL Number
Synonyms China Clay ; White Bole
Test SpecificationMin Max
LOSS ON IGNITION 15.0 %
LEAD 10 ppm
IRON NOT MORE THAN SLIGHTRED TINT
ACID-SOLUBLE SUBSTANCES 2.0 %
CARBONATE NO EFFERVESCENCE
ELEMENTAL IMPURITIES AS REPORTED
MICROBIAL LIMITS (Escherichia coli) NEGATIVE
IDENTIFICATIONGRAY RESIDUE ON
FILTER, POSITIVE FORALUMINUM
RETEST DATE
DATE OF MANUFACTURE
APPEARANCE
RESIDUAL SOLVENTS AS REPORTED
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56,+781�8,+09��:;<=> 56,+781�*/?09��:;@ �#��!@'�AB�C�! DD�E�DD
Spectrum Chemical Mfg Corp
Corporate Headquarters: West Coast Facility: 769 Jersey Ave. 14422 S. San Pedro St. New Brunswick, NJ 08901 Gardena, CA 90248
732.214.1300 310.516.8000
Manufacturing Process Flowchart
Kaolin, Powder, USP - KA105
CentrifugalFractionation
Crude Ore Blending
Crude Ore Dispersion
(High Shear)
Degritting Dragbox, Screens,
Centrifuge, Cyclones
Slurry Blending
Clay Brightening(Differential
Flocculation)
Overflow
Brightening Ozonation, Magnetic
Separation, Leaching
Filtration (Rotary Vacuum Filters)Spray Drying
Pulverization UnderflowDetermination
Packaging Gamma Irradiation (4.0 to 25.0 kGy) Shipping
C O R P O R A T E H E A D Q U A R T E R S
769 Jersey Avenue
New Brunswick, NJ 08901
PHONE 732.214.1300
FAX 732.246.7132
A N I S O 90 0 1 :2 0 15 RE G IS T E RE D COM P A NY
W E S T C O A S T F A C I L I T Y
14422 South San Pedro Street
Gardena, California 90248
PHONE 310.516.8000
FAX 310.516.9843
w w w . s p e c t r u m c h e m i c a l . c o m
January 08, 2019 Certification of Compliance with current Good Manufacturing Practices Dear Valued Customer: Spectrum Chemical Mfg Corp certifies that our USP, NF, FCC, EP, BP, JP, and food grade products are produced, processed, packaged and held in compliance with current Good Manufacturing Practices (cGMP) in accordance with the applicable parts of 21 CFR, parts 210 and 211 and parts 110 and 111 of the Code of Federal Regulations, respectively. Spectrum is an FDA registered and inspected Drug Establishment. Our United States Food and Drug Administration (USFDA) Registration numbers are as follows: Spectrum Gardena, California: 2020632 Spectrum New Brunswick, New Jersey: 2246824 Thank you for your interest in Spectrum products. Please feel free to contact me at 310-516-8000, extension 5610 or via email at [email protected] if I may be of further assistance. Sincerely,
Michael Dang Director, Quality Systems & GMP Compliance
August 05, 2019
Certification of Compliance with current Good Manufacturing Practices
Dear Valued Customer:
Spectrum Chemical Mfg Corp certifies that the following product(s) is produced, processed, packaged and held in compliance with current Good Manufacturing Practices (cGMP) in accordance with the applicable parts of 21 CFR, parts 210 and 211 of the Code of Federal Regulations.
Catalog Number Product Name KA105 Kaolin, Powder, USP
Spectrum is an FDA registered and inspected Drug Establishment. Our United States Food and Drug Administration (USFDA) Registration numbers are as follows:
Spectrum-Gardena, CA: 2020632 Spectrum-New Brunswick, NJ: 2246824 Spectrum-Shanghai, China: 03006174778
Thank you for your interest in Spectrum products. If we may be of further assistance, please feel free to contact the Quality Assurance department at 310-516-8000 or via email at [email protected]
Sincerely,
Oralia Chavez Quality Assurance Specialist
April 27, 2016 Re: Kaolin, Powder, USP-KA105 To Whom It May Concern: Thank you for your interest in Spectrum high quality chemicals. We at Spectrum Chemical Mfr. Corp. understand the concern regarding Bovine Spongiform Encephalopathy (BSE). Please be assured that the chemical Kaolin, Powder, USP-KA105 is BSE/TSE free. If you have any further questions, please contact Tech Services at (310) 516- 8000 Extension 5471, or by email at [email protected]. Sincerely, Darlene Dagdag-Lyudmirskiy Technical Services Spectrum Chemical Mfr. Corp. This document has been produced electronically and is valid without a signature
April 27, 2016 Re: Kaolin, Powder, USP-KA105 To Whom It May Concern: Thank you for your interest in Spectrum high quality chemicals. We at Spectrum Chemical Mfr. Corp. understand the concern regarding the presence of allergens in raw materials. Please be assured that the following chemical does not contain (Milk; Egg; Fish; Shellfish; Sulfur dioxide and sulfites at concentrations of more than 10 mg/kg or 10 mg/liter expressed as SO2; Tree nuts; Wheat; Peanuts; Soy; Cereals containing Gluten; Celery; Mustard; Sesame Seed). Kaolin, Powder, USP-KA105
If you have any further questions, please contact Tech Services at (310) 516- 8000 Extension 5471, or by email at [email protected]. Sincerely, Darlene Dagdag-Lyudmirskiy Technical Services Spectrum Chemical Mfr. Corp. This document has been produced electronically and is valid without a signature
April 27, 2016 Re: Kaolin, Powder, USP-KA105 To Whom It May Concern: Thank you for your interest in Spectrum high quality chemicals. We at Spectrum Chemical Mfg. Corp. understand the concern regarding Aflatoxins in raw materials. To the best of our knowledge, the product listed below is not contaminated with Aflatoxins. Aflatoxins are not used in production. The following product does not come in contact with Aflatoxins at any stage of production. Kaolin, Powder, USP-KA105 If you have any further questions, please contact Tech Services at (310) 516- 8000 Extension 5471, or by email at [email protected]. Sincerely, Darlene Dagdag-Lyudmirskiy Technical Services Spectrum Chemical Mfr. Corp. This document has been produced electronically and is valid without a signature
Certificate Of Analysis
Item Number KA105 Lot Number 2IG0160
Item Kaolin, Powder, USP Manufacturer Lot MCN1905160704
CAS Number 1332-58-7 Manufacturer Code 258
Molecular Formula Molecular Weight
Test Specification Resultmin max
15.0 % 13.2 %
10 ppm <10 ppm
NOT MORE THANSLIGHT RED TINT
NOT MORE THANSLIGHT RED TINT
2.0 % 0.6 %
NOEFFERVESCENCE
NOEFFERVESCENCE
AS REPORTED COMPLIES WITHSTANDARD
NEGATIVE NEGATIVE
GRAY RESIDUE ONFILTER, POSITIVEFOR ALUMINUM
GRAY RESIDUE ONFILTER, POSITIVEFOR ALUMINUM
15-MAY-2024
16-MAY-2019
OFF WHITE TOBROWNISH
POWDER
AS REPORTED NO RESIDUALSOLVENTS USED
Spectrum Chemical Mfg Corp
755 Jersey Avenue
New Brunswick 08901 NJ
All pharmaceutical ingredients are tested using current edition of applicable pharmacopeia.
Read and understand label and SDS before handling any chemicals. All Spectrum's chemicals are for manufacturing, processing,repacking or research purposes by experienced personnel only. It is the customer's responsibility to provide adequate hazardousmaterial training and ensure that appropriate Personal Protective Equipment (PPE) is used before handling any chemical.
The Elemental Impurities standards implemented by USP and other Pharmaceutical Compendia reflect a growing understandingof the toxicology of trace levels of elemental impurities that can remain in drug substances originating from either raw materials ormanufacturing processes. Identifying and quantifying impurities can be critical to predicting the best possible patient outcomes.Elemental Impurities has been a requirement of all products meeting USP/NF, EP and BP monographs since January 1, 2018.More information can be found in USP sections <232> Elemental Impurities – Limits and <233> Elemental Impurities –Procedures. Data for drug substances furnished by Spectrum Chemical Mfg. Corp can be used to ensure that patient dailyexposures by oral administration to the selected elements are not exceeded in the formulation of pharmaceutical products.
Spectrum Chemical Mfg. Corp. repackages Active Pharmaceutical Ingredient chemicals provided by other manufacturers andsuppliers. For traceability purposes, Spectrum's Certificate of Analysis contains an identifier code unique to each manufacturer orsupplier, as well as the chemical's lot number provided on the original manufacturer Certificate of Analysis. Test results for theoriginal Certificate of Analysis are available upon request from your Spectrum Sales Representative or by calling Spectrum'sQuality Department at 1-800-772-8786.
SPECTRUM CHEMICAL MFG. CORP. Gardena, CA 90248 • New Brunswick, NJ 08901
Chemical Emergency: (800)424-9300*49452KA105062233LVA* KA105 12 KG
Kaolin(China Clay)
PowderU.S.P.
CAS 1332-58-7CAUTION: For manufacturing, processing or repacking. Read and understand the label and Safety Data Sheet (SDS) prior to use.
USE CARE: This material has been evaluated per GHS/OSHA criteria and is not classified as hazardous. All chemicals may pose unknown hazards and must be used with caution. Use personal protection and safe handling methods consistent with proper workplace safety practices. Consult SDS for additional properties and precautions. If adverse reaction occurs seek medical attention.
KEEP FROM CHILDREN
G 9/E2GHS A Lot No. 062233
Kaolin is a native hydrated aluminum silicate, powdered and freed from gritty particles by elutriation.
MAXIMUM LIMITSLoss on Ignition ......................................... 15.0%Lead ......................................................... 0.001%Iron ....................................................To pass testAcid-Soluble Substances ............................. 2.0%Carbonate ...........................................To pass testResidual Solvents ..............................To pass testMicrobial Limit (Escherichia coli) .......To pass test
WARNING: This product contains a chemical known to the State of California to cause cancer.
WARNING: This product contains a chemical known to the State of California to cause birth defects or other reproductive harm.
www.SpectrumChemical.com
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Empirical Formula, Formula Weight and Technical Specifications Panel
Expiration Information
Lot Number
Kosher Certified by Kosher Supervision of America (KSA).
Bar CodeGHS Hazard PictogramsWarning, Safety Data and Precautionary InformationProduct Catalog NumberItem Name, Form, Grade
Size/Quantity
Chemical Abstracts Service (CAS) Registry Number
Caution Information
DOT Shipping Information
Toll-Free 24-Hour Chemical Emergency Telephone Number
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YELLOW: Oxidizer
RED: Flammable
GREEN: General Storage
BLUE: Health Hazard
WHITE: Corrosive
Storage Color Band
This color-coded band indicates the hazard most likely to be posed by that material under storage conditions. The criteria used to assign band colors have been established by the Storage Code working group of the Society for Chemical Hazard Communication (SCHC). It is recommended that like colors be stored together, unless otherwise stated, based on the color codes indicated to the right. However, it is the responsibility of the customer to check with their local fire department for possible conflicts with our recommendations when storing hazardous chemicals.
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The Spectrum label presents technical and safety information in an easily understood format. Our technical specialists stay abreast of the latest requirements of the Globally Harmonized System for Classification and Labelling of Chemicals (GHS), as well as the Occupational Safety and Health Administration (OSHA), the Food and Drug Administration (FDA) and other government regulatory agencies in order to ensure compliance, accuracy and concise hazard communication.
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Spectrum Chemical Mfg Corp
Corporate Headquarters: West Coast Facility:
769 Jersey Ave. 14422 S. San Pedro St.
New Brunswick, NJ 08901 Gardena, CA 90248
732.214.1300 310.516.8000
Label Information
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C O R P O R A T E H E A D Q U A R T E R S
769 Jersey Avenue
New Brunswick, NJ 08901
PHONE 732.214.1300
FAX 732.246.7132
A N I S O 90 0 1 :2 0 15 RE G IS T E RE D COM P A NY
W E S T C O A S T F A C I L I T Y
14422 South San Pedro Street
Gardena, California 90248
PHONE 310.516.8000
FAX 310.516.9843
w w w . s p e c t r u m c h e m i c a l . c o m
February 1, 2019 RE: Lot Numbering System Dear Valued Customer: This letter is to inform you of Spectrum Chemicals and Laboratory Products’ Lot Numbering System. The system is based on an alpha-numerical sequence which provides the month, year and location of production. The lot numbering system utilized until 2010 is a sequence of six characters, two letters followed by four numbers. The first letter represents the year, for example, Y denotes 2009 and Z denotes 2010. The second letter represents the month and site, for example, A-L denotes January through December at Spectrum’s Gardena, CA facility, while M-X denotes January through December at the New Brunswick, NJ facility. The following four numbers are sequentially assigned. Example: ZI0928 = The 928th material produced in California in September 2010 The lot numbering system utilized for 2011 and forward, is a sequence of seven characters. The first character, a number, represents the production facility: 1 = Gardena, CA Facility 2 = New Brunswick, NJ Facility 3 = China Facility 4 = Pharmacy, NJ Facility The second character, a letter, represents the year. For example, A denotes 2011 and B denotes 2012. The third character, a letter, represents the month, with A denoting January and L denoting December. The following four numbers are sequentially assigned. Example: 2AA0706 = The 706th material produced in New Jersey in January 2011 Thank you for your interest with Spectrum products. Please feel free to contact us at 310-516-8000 or via email at [email protected] if we may be of further assistance.
Sincerely,
Howard Lau, Quality Assurance Specialist
05.August.2019
Stability – Shelf Life Guidance Product Covered: KA105, Kaolin, Powder, USP Spectrum Chemical’s manufacturing partner has assigned the following shelf life guidance for the product listed above. The product, KA105, Kaolin, Powder, USP, is assigned a 60 months shelf life from date of manufacturing. The quality and integrity of the chemical depends on the handling and storage conditions. Please refer to the Safety Data Sheet for proper storage and handling procedures. Adan R. Hernandez Quality Control Manager
Corporate Headquarters 769 Jersey Avenue New Brunswick, NJ 08901-3605
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