Avantor Performance Materials, Inc.

3477 Corporate Parkway,

Suite # 200
Center Valley, PA 18034
U.S.A.
Tel: 1-610-573-2600
Fax: 1-610-573-2610
www.avantormaterials.com

Potassium Bicarbonate
Product Regulatory Data Sheet

Section 1 Product Information

Products Covered

Brand Product Product Description MOC*

Code code
Macron Fine 6732 Potassium Bicarbonate, Granular U.S.P. F.C.C. R
Chemicals
Macron Fine 6736 Potassium Bicarbonate, Powder U.S.P. F.C.C. R
Chemicals
*MOC = Management of Change

Section 2 Manufacturing, Packaging and Release Site Information

The products in Section 1 are manufactured according to current Good Manufacturing

Practices (cGMPs) as set forth by International Pharmaceutical Excipients Council (IPEC)
guidelines.

A number of the cGMP produced products that are sold by Avantor Performance Materials,
Inc. may not be originally manufactured at our sites. However, we perform the analytical and
stability testing for these products and repackage the products where applicable. With ISO
and cGMP procedures in place at our facilities we can ensure, and take complete responsibility
for, the traceability and quality of the finished, packaged product that we offer.

The original manufacturer and address will be referenced on the Certificate of Analysis as an
alpha or alpha-numeric manufacturer code rather than listing the full name and address. This
practice is compliant with both ICH Q7 Good Manufacturing Guidance for Active
Pharmaceutical Ingredients (APIs) and IPEC guidelines and it meets cGMP requirements. For
instructions to decipher the manufacturer reference code please consult our website.
Instructions can be found in the Ask Avantor Q&A Center of the customer support section of
our web site or by directly linking to www.askavantor.com Keyword: Manufacturer Code.

Rev. 4; November 29, 2012 Page 1 of 6 Potassium Bicarbonate

 Avantor Performance Materials, Inc.
3477 Corporate Parkway,
Suite # 200
Center Valley, PA 18034
U.S.A.
Tel: 1-610-573-2600
Fax: 1-610-573-2610
www.avantormaterials.com

Section 3 Physical/Chemical Information

CAS #: 298-14-6

Manufacturing Process: Synthesis

Raw Material Origin: Chemical

Section 4 Regulatory Information

Compendial Compliance: Please see the current product specifications at

www.avantormaterials.com

DMF: Avantor Performance Materials, Inc. does not carry a Drug Master File for these
products

BSE/TSE Status: The subject materials are manufactured from raw materials that contain NO
animal parts, products, and/or by-products nor do they come in contact with animal parts,
products, and/or by-products.

Allergen/Hypersensitivities Information: The products listed do not contain cereals

containing gluten (i.e. wheat, rye, oats, barley, spelt, kamut or their hybridized strains), malt,
triticale, gluten, other grains, corn, soy, soybeans, eggs, yeast, canola, milk, dairy products,
fish, crustacean shellfish, seafood products, tree nuts, peanuts, nut products (i.e. Almond
(Amygdalus communis L.), Hazelnut (Corylus avellana), Walnut (Juglans regia), Cashew
(Anacardium occidentale), Pecan nut (Carya illiniesis (Wangenh.) K. Koch), Brazil nut
(Bertholletia excelsa), Pistachio nut (Pistacia vera), Macadamia nut and Queensland nut
(Macadamia ternifolia)), seed products (sesame seeds and products thereof), natural grape
products, natural flavors, artificial flavors, celery, mustard, lactose, sulfites, elemental sulfur,
preservatives, MSG, disodium guanylate/inosinate, artificial sweeteners, phenylalanine,
additives, colorants, dyes, or natural rubber (latex). These products are manufactured using
cGMP guidelines which provide controls that allow no potential for cross contamination of any
allergens or other products.

GMO Information: The subject materials, including any raw materials and processing aids,
are NOT subject to genetic modification.

Residual Solvents/Organic Volatile Impurities (OVI) Information: The above subject

materials (all lots) comply with the requirements of the ICH Q3C Residual Solvents Guideline

Rev. 4; November 29, 2012 Page 2 of 6 Potassium Bicarbonate

 Avantor Performance Materials, Inc.
3477 Corporate Parkway,
Suite # 200
Center Valley, PA 18034
U.S.A.
Tel: 1-610-573-2600
Fax: 1-610-573-2610
www.avantormaterials.com

and USP<467>Residual Solvents. No Class 1, 2, 3 or other solvents are used or produced in

the manufacturing or purification of the product.

Residual Metallic Catalysts Information: No metallic catalysts, as defined by EMEA

Guideline on the Specification Limits for Residues of Metal Catalysts
(CPMP/SWP/QWP/4446/00), are used in the production of the above subject materials.

Kosher Status: Certified Kosher Pareve for year-round use. Please refer to the customer
support section of our website for our most up to date listing of Kosher products.
(www.askavantor.com Keyword: Kosher)

Halal Status: The subject materials are not Halal Certified. Please refer to the customer
support section of our website for our most up to date listing of Halal products.
(www.askavantor.com Keyword: Halal)

GRAS Status: The United States Food and Drug Administration (FDA) have acknowledged
that the chemical listed in Section 1 is a Direct Food Substances Affirmed As Generally
Recognized as Safe (GRAS) in foods when used in accordance with the requirements and
limitations per 21 CFR parts 184.1613.

Section 5 Miscellaneous Product Information

Certificate of Analysis Date Format: The Manufactured Date and Expiration/Retest Date on
the C of A are reported as YYYY/MM/DD from our ERP system effective April 30, 2012. For
example, the Manufactured Date for October 1, 2012 would be reported as 2012/10/01.

Prior to ERP implementation, the Release Date on the C of A was reported as MM/DD/YYYY.
For example, the Release Date for October 1, 2012 would have been reported as 10/01/2012.

Lot Numbering System and Batch Description: Please refer to the customer support
section of our website for information concerning our lot/batch numbering system.
(www.askavantor.com Keyword: Lot Number)

Shelf Life Information: If a product has an assigned expiration or retest period, the date will
appear on the certificate of analysis. For products that do not have assigned dates please
contact Technical Support through the customer support section of our website for our product
stability profiles. (www.askavantor.com Keyword: Expiration)

Rev. 4; November 29, 2012 Page 3 of 6 Potassium Bicarbonate

 Avantor Performance Materials, Inc.
3477 Corporate Parkway,
Suite # 200
Center Valley, PA 18034
U.S.A.
Tel: 1-610-573-2600
Fax: 1-610-573-2610
www.avantormaterials.com

Nutritional/Supplement Facts Labeling: Bulk food chemicals that are intended for the use in
manufacturing of finished food products or for products that are to be processed, labeled,
and/or repacked at a site other than where its originally processed or packed, are exempt from
the Nutrient Content Evaluation and Nutrient Labeling Requirements. (21 CFR 101.9(j)(9))

Organic Status: The products listed in Section 1 are not certified as organic. However, to the
best of our knowledge, the product is not produced using Ionizing Radiation as described in 21
CFR 179.26 or Sewage Sludge as described in 7 CFR Section 205.2.

Management of Change: Please refer to the customer support section of our website for
information concerning our Management of Change program. (www.askavantor.com
Keyword: MOC)

Rev. 4; November 29, 2012 Page 4 of 6 Potassium Bicarbonate

 Avantor Performance Materials, Inc.
3477 Corporate Parkway,
Suite # 200
Center Valley, PA 18034
U.S.A.
Tel: 1-610-573-2600
Fax: 1-610-573-2610
www.avantormaterials.com

Section 6 Revision History

Rev. 0; Oct. 1, 2007 IPEC EIP format

Rev. 1; Oct. 16, 2008 Section 4: updated residual solvents information
Rev. 2; Oct. 1, 2009 Section 4: Added Residual Metallic Catalyst statement; Section 5:
added GRAS status; Entire document: changed references to Solv IT Center to AskMBI.
(KES)
Rev. 3; Jul. 15, 2011 Entire document: new letterhead and changed all references of
AskMBI to AskAvantor. Updated website links for new website; minor formatting; Section 1:
added MOC codes; changed Mallinckrodt to Macron brand; Section 2: added GMP statement;
Section 4: expanded Allergens list; Section 5: added Nutritional and Organic info; Section 7:
updated contact information. (PH, JLW)
Rev. 4; Nov 29, 2012 HDQ address change, minor formatting. Section 4: added addl allergens
as listed in EU Directive 2003/89/EC; updated Residual Metallic Catalysts statement;
separated Kosher/Halal status and added certification statement; Section 5: added
Management of Change information, Nutritional/Supplement Facts Labeling, Organic Status ;
Added COA Date Format statement; Section 7: removed contact list table and added CS/TS
contact information. (JDR)

This electronic document is valid without a signature.

Rev. 4; November 29, 2012 Page 5 of 6 Potassium Bicarbonate

 Avantor Performance Materials, Inc.
3477 Corporate Parkway,
Suite # 200
Center Valley, PA 18034
U.S.A.
Tel: 1-610-573-2600
Fax: 1-610-573-2610
www.avantormaterials.com

Section 7 Contact Information

Customer Service

Phone: 1-855-282-6867
1-610-573-2600 (outside U.S.)
Fax: 1-610-573-2650

Technical Service

Phone: 1-855-282-6867
1-610-573-2600 (outside U.S.)
Fax: 1-610-573-2650

Rev. 4; November 29, 2012 Page 6 of 6 Potassium Bicarbonate

 Version: 1.0
Revision date: 06-02-2014

SAFETY DATA SHEET

1. Identification

Product identifier: POTASSIUM BICARBONATE

Other means of identification

Product No.: 2940, 6748, 6736, 6732

Recommended use and restriction on use

Recommended use: Not available.
Restrictions on use: Not known.

Manufacturer/Importer/Supplier/Distributor information

Manufacturer
Company Name: Avantor Performance Materials, Inc.
Address: 3477 Corporate Parkway, Suite 200
Center Valley, PA 18034
Telephone:
Customer Service: 855-282-6867
Fax:
Contact Person: Environmental Health & Safety
e-mail: info@avantormaterials.com

Emergency telephone number:

24 Hour Emergency: 908-859-2151

Chemtrec: 800-424-9300

2. Hazard(s) identification

Hazard classification
Not classified

Label elements

Hazard symbol: No symbol

Signal word: No signal word.

Hazard statement: Not applicable

Precautionary statement Not applicable

Other hazards which do not None.

result in GHS classification:

3. Composition/information on ingredients

Substances

Composition comments: The components are not hazardous or are below required disclosure limits.

4. First-aid measures

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General information: Get medical advice/attention if you feel unwell. Show this safety data sheet
to the doctor in attendance.

Ingestion: Rinse mouth thoroughly. Call a POISON CENTER or doctor/physician if

you feel unwell.

Inhalation: Move to fresh air. Get medical attention if symptoms persist.

Skin contact: Wash skin thoroughly with soap and water. Get medical attention if irritation
persists after washing. Wash contaminated clothing before reuse.

Eye contact: Flush thoroughly with water. If irritation occurs, get medical assistance.

Most important symptoms/effects, acute and delayed

Symptoms: May cause irritation to skin, eyes, and respiratory tract.

Indication of immediate medical attention and special treatment needed

Treatment: Treat symptomatically. Symptoms may be delayed.

5. Fire-fighting measures

General fire hazards: The product is non-combustible.

Suitable (and unsuitable) extinguishing media

Suitable extinguishing Use fire-extinguishing media appropriate for surrounding materials.

media:

Unsuitable extinguishing None known.

media:

Specific hazards arising from During fire, gases hazardous to health may be formed.
the chemical:

Special protective equipment and precautions for firefighters

Special fire fighting Move containers from fire area if you can do so without risk. Use water
procedures: spray to keep fire-exposed containers cool. Cool containers exposed to
flames with water until well after the fire is out.

Special protective equipment Firefighters must use standard protective equipment including flame
for fire-fighters: retardant coat, helmet with face shield, gloves, rubber boots, and in
enclosed spaces, SCBA.

6. Accidental release measures

Personal precautions, Keep unauthorized personnel away. Use personal protective equipment.
protective equipment and See Section 8 of the MSDS for Personal Protective Equipment.
emergency procedures:

Methods and material for Ventilate the area. Sweep up and place in a clearly labeled container for
containment and cleaning chemical waste. Clean surface thoroughly to remove residual
up: contamination.

Notification Procedures: Prevent entry into waterways, sewer, basements or confined areas. Inform
authorities if large amounts are involved.

Environmental precautions: Prevent further leakage or spillage if safe to do so. Avoid discharge into
drains, water courses or onto the ground.
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7. Handling and storage

Precautions for safe handling: Use personal protective equipment as required. Avoid contact with eyes,
skin, and clothing. Avoid inhalation of dust. Wash thoroughly after handling.

Conditions for safe storage, Keep containers tightly closed. Store in cool, dry place. Store in a well-
including any ventilated place.
incompatibilities:

8. Exposure controls/personal protection

Control parameters
Occupational exposure limits
None of the components have assigned exposure limits.

Appropriate engineering No data available.

controls

Individual protection measures, such as personal protective equipment

General information:
Good general ventilation (typically 10 air changes per hour) should be used.
Ventilation rates should be matched to conditions. If applicable, use
process enclosures, local exhaust ventilation, or other engineering controls
to maintain airborne levels below recommended exposure limits. If
exposure limits have not been established, maintain airborne levels to an
acceptable level.

Eye/face protection: Use tight fitting goggles if dust is generated.

Skin protection
Hand protection: Wear protective gloves.

Other: Wear suitable protective clothing.

Respiratory protection: In case of inadequate ventilation use suitable respirator.

Hygiene measures: Always observe good personal hygiene measures, such as washing after
handling the material and before eating, drinking, and/or smoking. Routinely
wash work clothing and protective equipment to remove contaminants.
Provide eyewash station and safety shower.

9. Physical and chemical properties

Appearance
Physical state: Solid
Form: Crystals
Color: White
Odor: Odorless
Odor threshold: No data available.
pH: No data available.
Melting point/freezing point: 100 C
Initial boiling point and boiling range: No data available.
Flash Point: No data available.
Evaporation rate: No data available.
Flammability (solid, gas): No data available.
Upper/lower limit on flammability or explosive limits
Flammability limit - upper (%): No data available.
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Flammability limit - lower (%): No data available.

Explosive limit - upper (%): No data available.
Explosive limit - lower (%): No data available.
Vapor pressure: Estimated < 0.01 kPa (25 C)
Vapor density: No data available.
Relative density: 2.17 (20 C)
Solubility(ies)
Solubility in water: 360 g/l
Solubility (other): No data available.
Partition coefficient (n-octanol/water): No data available.
Auto-ignition temperature: No data available.
Decomposition temperature: No data available.
Viscosity: No data available.

10. Stability and reactivity

Reactivity: No dangerous reaction known under conditions of normal use.

Chemical stability: Material is stable under normal conditions.

Possibility of hazardous Hazardous polymerization does not occur.

reactions:

Conditions to avoid: Heat, sparks, flames.

Incompatible materials: Strong oxidizing agents.

Hazardous decomposition Thermal decomposition may release oxides of carbon.

products:

11. Toxicological information

Information on likely routes of exposure

Ingestion: May cause irritation of the gastrointestinal tract.

Inhalation: May cause irritation to the respiratory system.

Skin contact: May cause irritation.

Eye contact: May cause temporary eye irritation.

Information on toxicological effects

Acute toxicity (list all possible routes of exposure)
Oral
Product: No data available.

Dermal
Product: No data available.

Inhalation
Product: No data available.

Repeated dose toxicity

Product: No data available.

Skin corrosion/irritation
Product: May cause skin irritation.

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Serious eye damage/eye irritation

Product: May irritate eyes.

Respiratory or skin sensitization

Product: Not a skin sensitizer.

Carcinogenicity
Product: This substance has no evidence of carcinogenic properties.

IARC Monographs on the Evaluation of Carcinogenic Risks to Humans:

No carcinogenic components identified

US. National Toxicology Program (NTP) Report on Carcinogens:

No carcinogenic components identified

US. OSHA Specifically Regulated Substances (29 CFR 1910.1001-1050):

No carcinogenic components identified

Germ cell mutagenicity

In vitro
Product: No mutagenic components identified

In vivo
Product: No mutagenic components identified

Reproductive toxicity
Product: No components toxic to reproduction

Specific target organ toxicity - single exposure

Product: No data available.

Specific target organ toxicity - repeated exposure

Product: No data available.

Aspiration hazard
Product: Not classified

Other effects: None known.

12. Ecological information

Ecotoxicity:
Acute hazards to the aquatic environment:
Fish
Product: No data available.

Aquatic invertebrates
Product: No data available.

Chronic hazards to the aquatic environment:

Fish
Product: No data available.

Aquatic invertebrates
Product: No data available.

Toxicity to Aquatic Plants

Product: No data available.

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Persistence and degradability

Biodegradation
Product: There are no data on the degradability of this product.

BOD/COD ratio
Product: No data available.

Bioaccumulative potential
Bioconcentration factor (BCF)
Product: No data available on bioaccumulation.

Partition coefficient n-octanol / water (log Kow)

Product: No data available.

Mobility in soil: No data available.

Other adverse effects: The product components are not classified as environmentally hazardous.
However, this does not exclude the possibility that large or frequent spills
can have a harmful or damaging effect on the environment.

13. Disposal considerations

Disposal instructions: Discharge, treatment, or disposal may be subject to national, state, or local
laws.

Contaminated packaging: Since emptied containers retain product residue, follow label warnings even
after container is emptied.

14. Transport information

DOT
Not regulated.

IMDG
Not regulated.

IATA

Not regulated.

15. Regulatory information

US federal regulations

TSCA Section 12(b) Export Notification (40 CFR 707, Subpt. D)

US. OSHA Specifically Regulated Substances (29 CFR 1910.1001-1050)
None present or none present in regulated quantities.

CERCLA Hazardous Substance List (40 CFR 302.4):

None present or none present in regulated quantities.

Superfund amendments and reauthorization act of 1986 (SARA)

Hazard categories
Not listed.

SARA 302 Extremely hazardous substance

None present or none present in regulated quantities.

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SARA 304 Emergency release notification

None present or none present in regulated quantities.

SARA 311/312 Hazardous chemical

None present or none present in regulated quantities.

SARA 313 (TRI reporting)

None present or none present in regulated quantities.

Clean Water Act Section 311 Hazardous Substances (40 CFR 117.3)
None present or none present in regulated quantities.

Clean Air Act (CAA) Section 112(r) Accidental Release Prevention (40 CFR 68.130):
None present or none present in regulated quantities.

US state regulations

US. California Proposition 65

No ingredient regulated by CA Prop 65 present.

US. New Jersey Worker and Community Right-to-Know Act

No ingredient regulated by NJ Right-to-Know Law present.

US. Massachusetts RTK - Substance List

No ingredient regulated by MA Right-to-Know Law present.

US. Pennsylvania RTK - Hazardous Substances

No ingredient regulated by PA Right-to-Know Law present.

US. Rhode Island RTK

No ingredient regulated by RI Right-to-Know Law present.

Inventory Status:
Australia AICS: On or in compliance with the inventory
Canada DSL Inventory List: On or in compliance with the inventory
EINECS, ELINCS or NLP: On or in compliance with the inventory
Japan (ENCS) List: On or in compliance with the inventory
China Inv. Existing Chemical Substances: Not in compliance with the inventory.
Korea Existing Chemicals Inv. (KECI): On or in compliance with the inventory
Canada NDSL Inventory: Not in compliance with the inventory.
Philippines PICCS: On or in compliance with the inventory
US TSCA Inventory: On or in compliance with the inventory
New Zealand Inventory of Chemicals: On or in compliance with the inventory
Japan ISHL Listing: On or in compliance with the inventory
Japan Pharmacopoeia Listing: Not in compliance with the inventory.

16.Other information, including date of preparation or last revision

NFPA Hazard ID

0 Flammability
1 0 Health
Reactivity
Special hazard.
Hazard rating: 0 - Minimal; 1 - Slight; 2 - Moderate; 3 - Serious; 4 - Severe

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Issue date: 06-02-2014

Revision date: No data available.

Version #: 1.0

Further information: No data available.

Disclaimer: THE INFORMATION PRESENTED IN THIS MATERIAL SAFETY DATA

SHEET (MSDS/SDS) WAS PREPARED BY TECHNICAL PERSONNEL
BASED ON DATA THAT THEY BELIEVE IN THEIR GOOD FAITH
JUDGMENT IS ACCURATE. HOWEVER, THE INFORMATION PROVIDED
HEREIN IS PROVIDED AS IS, AND AVANTOR PERFORMANCE
MATERIALS MAKES AND GIVES NO REPRESENTATIONS OR
WARRANTIES WHATSOEVER, AND EXPRESSLY DISCLAIMS ALL
WARRANTIES REGARDING SUCH INFORMATION AND THE PRODUCT
TO WHICH IT RELATES, WHETHER EXPRESS, IMPLIED, OR
STATUTORY, INCLUDING WITHOUT LIMITATION, WARRANTIES OF
ACCURACY, COMPLETENESS, MERCHANTABILITY, NON-
INFRINGEMENT, PERFORMANCE, SAFETY, SUITABILITY, STABILITY,
AND FITNESS FOR A PARTICULAR PURPOSE, AND ANY WARRANTIES
ARISING FROM COURSE OF DEALING, COURSE OF PERFORMANCE,
OR USAGE OF TRADE. THIS MSDS/SDS IS INTENDED ONLY AS A
GUIDE TO THE APPROPRIATE PRECAUTIONARY HANDLING OF THE
MATERIAL BY A PROPERLY TRAINED PERSON USING THIS PRODUCT,
AND IS NOT INTENDED TO BE COMPREHENSIVE AS TO THE MANNER
AND CONDITIONS OF USE, HANDLING, STORAGE, OR DISPOSAL OF
THE PRODUCT. INDIVIDUALS RECEIVING THIS MSDS/SDS MUST
ALWAYS EXERCISE THEIR OWN INDEPENDENT JUDGMENT IN
DETERMINING THE APPROPRIATENESS OF SUCH ISSUES.
ACCORDINGLY, AVANTOR PERFORMANCE MATERIALS ASSUMES NO
LIABILITY WHATSOEVER FOR THE USE OF OR RELIANCE UPON THIS
INFORMATION. NO SUGGESTIONS FOR USE ARE INTENDED AS, AND
NOTHING HEREIN SHALL BE CONSTRUED AS, A RECOMMENDATION
TO INFRINGE ANY EXISTING PATENTS OR TO VIOLATE ANY FEDERAL,
STATE, LOCAL, OR FOREIGN LAWS. AVANTOR PERFORMANCE
MATERIALS REMINDS YOU THAT IT IS YOUR LEGAL DUTY TO MAKE
ALL INFORMATION IN THIS MSDS/SDS AVAILABLE TO YOUR
EMPLOYEES.

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