Avantor Performance Materials, Inc.

3477 Corporate Parkway,

Suite # 200
Center Valley, PA 18034
U.S.A.
Tel: 1-610-573-2600
Fax: 1-610-573-2650
www.avantormaterials.com

Sodium Bicarbonate
Product Regulatory Data Sheet

Section 1 – Product Information

Products Covered
Brand Product Product Description MOC*
Code code
J.T.Baker® 3509 Sodium Bicarbonate, Powder, U.S.P. - F.C.C. R
J.T.Baker® 3510 Sodium Bicarbonate, Powder, USP, Multi-Compendial R
Macron Fine 7396 Sodium Bicarbonate, Powder, U.S.P. - F.C.C. R
Chemicals™
Macron Fine 7749 Sodium Bicarbonate, Powder, USP - GenAR® R
Chemicals™
Macron Fine 7451 Sodium Bicarbonate, Powder, U.S.P., A.C.S. 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 the International Pharmaceutical Excipients Council
(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 Q&A
Center of the customer support section of our web site or by directly linking to
www.AskAvantor.com Keyword: Manufacturer Code.

Rev. 5; October 21, 2014 Page 1 of 5 SODIUM BICARBONATE

 Avantor Performance Materials, Inc.
3477 Corporate Parkway,
Suite # 200
Center Valley, PA 18034
U.S.A.
Tel: 1-610-573-2600
Fax: 1-610-573-2650
www.avantormaterials.com

Section 3 – Physical/Chemical Information

CAS #: 144-55-8

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, lupine and products thereof, 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.

Rev. 5; October 21, 2014 Page 2 of 5 SODIUM BICARBONATE

 Avantor Performance Materials, Inc.
3477 Corporate Parkway,
Suite # 200
Center Valley, PA 18034
U.S.A.
Tel: 1-610-573-2600
Fax: 1-610-573-2650
www.avantormaterials.com

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

(all lots) comply with the requirements of the ICH Q3C Residual Solvents Guideline 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: No metal catalysts or metal reagents, as defined by EMEA

Guideline on the Specification Limits for Residues of Metal Catalysts or Metal Reagents
(CPMP/SWP/QWP/4446/2000), 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: J.T.Baker® 3509 is 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 substance Generally Recognized as Safe (GRAS) in
foods when used in accordance with the requirements and limitations per 21 CFR parts
184.1736.

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. 5; October 21, 2014 Page 3 of 5 SODIUM BICARBONATE

 Avantor Performance Materials, Inc.
3477 Corporate Parkway,
Suite # 200
Center Valley, PA 18034
U.S.A.
Tel: 1-610-573-2600
Fax: 1-610-573-2650
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 it’s 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)

Section 6 – Revision History

Rev. 0; Oct. 1, 2007 – IPEC EIP format
Rev. 1; Oct. 22, 2008 – Section 4: updated residual solvents information
Rev. 2; Jan. 29, 2010 – Entire document: new letterhead and changed all references of “Solv
IT Center” to “AskMBI.”; Section 7: updated TS manager info. Section 4: added Residual
Metallic Catalysts and GRAS information. (KES)
Rev. 3; July 18, 2011 –Entire document: new letterhead, and changed all references of
“AskMBI” to “AskAvantor.” Updated website links for new website; Section 1: Mallinckrodt
brand name updated to Macron; added MOC codes, removed delisted code Macron 7903;
Section 2: added GMP statement; Section 4: expanded Allergens list; Section 5: Added
Nutritional and Organic status statements; Section 7: updated contact information; minor
formatting. (PH/MCH)
Rev. 4; February 20, 2013 –Entire document: HDQ address change. Section 4: added add’l
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; Added COA Date Format statement; Section 7: removed
contact list table and added CS/TS contact information. (MCH)
Rev. 5: October 21, 2014 – Added code 7451 to product list ; Section 4: Updated EMEA
Residual Metallic statement to reflect current guideline revision. (MCH)

This electronic document is valid without a signature.

Rev. 5; October 21, 2014 Page 4 of 5 SODIUM BICARBONATE

 Avantor Performance Materials, Inc.
3477 Corporate Parkway,
Suite # 200
Center Valley, PA 18034
U.S.A.
Tel: 1-610-573-2600
Fax: 1-610-573-2650
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. 5; October 21, 2014 Page 5 of 5 SODIUM BICARBONATE

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Revision date: 06-05-2014

SAFETY DATA SHEET

1. Identification

Product identifier: Sodium Bicarbonate

Other means of identification

Product No.: 7451, 7751, 7752, 7750, 7749, 7412, 7396, 3510, 3509, 3506, 7903

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: No hazardous ingredients.

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.

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

Most important symptoms/effects, acute and delayed

Symptoms: May cause skin and eye irritation.

Indication of immediate medical attention and special treatment needed

Treatment: Symptoms may be delayed. Treat symptomatically.

5. Fire-fighting measures

General fire hazards: No unusual fire or explosion hazards noted.

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. Ventilate closed spaces before
protective equipment and entering them. Use personal protective equipment. See Section 8 of the
emergency procedures: MSDS for Personal Protective Equipment.

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

Notification Procedures: Inform authorities if large amounts are involved.

Environmental precautions: Do not contaminate water sources or sewer. Prevent further leakage or
spillage if safe to do so.

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7. Handling and storage

Precautions for safe handling: Avoid contact with eyes, skin, and clothing. Wash hands thoroughly after
handling. See Section 8 of the MSDS for Personal Protective Equipment.

Conditions for safe storage, Keep container tightly closed. Store in a dry place. Store in a well-ventilated
including any 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. An eye wash and safety shower must be available in the
immediate work area.

Eye/face protection: Wear safety glasses with side shields (or goggles).

Skin protection
Hand protection: Wear protective gloves.

Other: Wear suitable protective clothing.

Respiratory protection: In case of inadequate ventilation use suitable respirator. During dust-raising
work: Dust mask/respirator.

Hygiene measures:
Provide eyewash station and safety shower. 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. Wash contaminated clothing
before reuse.

9. Physical and chemical properties

Appearance
Physical state: Solid
Form: powder
Color: White
Odor: Odorless
Odor threshold: No data available.
pH: 8.3 (25 °C) (0.1 molar aqueous solution)
Melting point/freezing point: 50 °C
Initial boiling point and boiling range: No data available.
Flash Point: Not applicable
Evaporation rate: No data available.
Flammability (solid, gas): No data available.

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Upper/lower limit on flammability or explosive limits

Flammability limit - upper (%): No data available.
Flammability limit - lower (%): No data available.
Explosive limit - upper (%): No data available.
Explosive limit - lower (%): No data available.
Vapor pressure: No data available.
Vapor density: No data available.
Relative density: 2.2 (20 °C)
Solubility(ies)
Solubility in water: Soluble
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.

Other information
Molecular weight: 84.01 g/mol (CH2O3.Na)

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: Excessive heat. Moisture.

Incompatible materials: Acids. Strong oxidizing agents.

Hazardous decomposition Carbon dioxide Carbon monoxide Sodium oxides

products:

11. Toxicological information

Information on likely routes of exposure

Ingestion: May be harmful if swallowed.

Inhalation: Dust may irritate respiratory system.

Skin contact: None under normal conditions.

Eye contact: May irritate eyes.

Information on toxicological effects

Acute toxicity (list all possible routes of exposure)
Oral
Product: LD 50 (Rat): 4,220 mg/kg

Dermal
Product:
No data available.

Inhalation
Product: No data available.
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Repeated dose toxicity

Product: No data available.

Skin corrosion/irritation
Product: May cause skin irritation.

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: None known.

Specific target organ toxicity - repeated exposure

Product: None known.

Aspiration hazard
Product: Not classified

Other effects: None known.

12. Ecological information

Ecotoxicity:
Acute hazards to the aquatic environment:
Fish
Product: LC 50 (Western mosquitofish (Gambusia affinis), 96 h): 7,550 mg/l

Aquatic invertebrates
Product: No data available.

Chronic hazards to the aquatic environment:

Fish
Product: No data available.

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Aquatic invertebrates
Product: No data available.

Toxicity to Aquatic Plants

Product: No data available.

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.

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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.

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: On or 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

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NFPA Hazard ID

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

Issue date: 06-05-2014

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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