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Potassium Bicarbonate
Product Regulatory Data Sheet
Products Covered
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.
CAS #: 298-14-6
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.
GMO Information: The subject materials, including any raw materials and processing aids,
are NOT subject to genetic modification.
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.
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)
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)
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
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
Chemtrec: 800-424-9300
2. Hazard(s) identification
Hazard classification
Not classified
Label elements
3. Composition/information on ingredients
Substances
Composition comments: The components are not hazardous or are below required disclosure limits.
4. First-aid measures
General information: Get medical advice/attention if you feel unwell. Show this safety data sheet
to the doctor in attendance.
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.
5. Fire-fighting measures
Specific hazards arising from During fire, gases hazardous to health may be formed.
the chemical:
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.
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.
SDS_US - SDS000001045 2/8
Version: 1.0
Revision date: 06-02-2014
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:
Control parameters
Occupational exposure limits
None of the components have assigned exposure limits.
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.
Skin protection
Hand protection: Wear protective gloves.
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.
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.
SDS_US - SDS000001045 3/8
Version: 1.0
Revision date: 06-02-2014
Dermal
Product: No data available.
Inhalation
Product: No data available.
Skin corrosion/irritation
Product: May cause skin irritation.
Carcinogenicity
Product: This substance has no evidence of carcinogenic properties.
In vivo
Product: No mutagenic components identified
Reproductive toxicity
Product: No components toxic to reproduction
Aspiration hazard
Product: Not classified
Ecotoxicity:
Acute hazards to the aquatic environment:
Fish
Product: No data available.
Aquatic invertebrates
Product: No data available.
Aquatic invertebrates
Product: No data available.
BOD/COD ratio
Product: No data available.
Bioaccumulative potential
Bioconcentration factor (BCF)
Product: No data available on bioaccumulation.
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.
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.
DOT
Not regulated.
IMDG
Not regulated.
IATA
Not regulated.
US federal regulations
Hazard categories
Not listed.
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
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.
NFPA Hazard ID
0 Flammability
1 0 Health
Reactivity
Special hazard.
Hazard rating: 0 - Minimal; 1 - Slight; 2 - Moderate; 3 - Serious; 4 - Severe
Version #: 1.0