SYNCAL® Saccharin- Questions Answered
SYNCAL® brand saccharin products meet very exacting standards as specified by
the FDA and are suitable for food and drug applications. SYNCAL® Saccharin is
made in the United States by PMC Specialties Group. We are the only
manufacturer of saccharin in the USA. A certificate of analysis is sent along
with a current MSDS for every lot of SYNCAL® Saccharin that we ship.
Below are answer some frequently asked questions about SYNCAL® Saccharin:
What is SYNCAL® Saccharin? [top]
SYNCAL® Saccharin is available as three different molecules:
Calcium Saccharin
Sodium Saccharin
Insoluble Saccharin
Each of these is a highly purified single molecule. Each is an alternate
sweetener, not a formulation. These are each based on synthetic ingredients and
contain no natural products derived from plants or animals.
What is the nutritional status of SYNCAL® Saccharin?
[top]
SYNCAL® Saccharin has no nutritional value or calories. Studies have
shown saccharin passes through the body unchanged, Therefore, saccharin is not
an energy source. Saccharin contains no protein, carbohydrate, fat, fatty acid,
fiber, or vitamins.
BSE – Bovine Spongiform Encephalopathy “Mad Cow Disease” Statement
[top]
None of the raw materials that are used in the manufacturing of SYNCAL®
® Sodium Saccharin are of animal or human origin. The equipment used in the
manufacturing process, including packaging, is not also used for the
manufacture or packaging of animal origin products or products containing
ingredients of animal origin.
Food Grade Status [top]
SYNCAL® Saccharin products meet or exceed Food Chemical Codex (FCC)
specification required by the Food and Drug Administration. (21 CFR, revised as
of 4/1/80, Section 180.37)
Genetically Modified Organism Status [top]
SYNCAL® Saccharin products are made entirely from synthetic chemical
sources. They contain no genetically modified organisms.
Ruminant Derived Protein Status [top]
SYNCAL® Saccharin products are made entirely from synthetic chemical
sources. No ruminant derived protein is used to make these products.
Subject: Good Manufacturing Practices for SYNCAL® Sodium Saccharin
[top]
SYNCAL® Saccharin products are produced exclusively by PMC Specialties
Group, a Division of PMC, Inc. at the Cincinnati Plant. SYNCAL® is produced
under Good Manufacturing Practices as mandated by the FDA in 21 CFR, Parts 20,
110, and 211.
Lot Identification and Recallability for SYNCAL® Saccharin products
[top]
SYNCAL® products are made in a continuous process. Product is packed
out in sequential batches, which are identified as lots. Samples are taken of
each lot according to a sampling plan. These samples are analyzed to provide
the data for the Certificate of Analysis for each lot.
Samples from each lot are retained. These retains can be re-analyzed in the
future if there is any question about a given lot meeting the specifications.
All product is identified with a lot number. Only lots which have been analyzed
and shown to meet all specifications are approved for shipment. A Certificate
of Analysis is sent for each lot delivered to a customer.
Our inventory system provides a record of all customers who are shipped a given
lot of SYNCAL® Saccharin. If we were to need to recall a lot of product, the
inventory system would provide a list of customers to contact.
Organic Volatile Impurities (OVI) in Saccharin (all forms)
[top]
SYNCAL® Sodium Saccharin products produced by PMC Specialties Group, Inc., a
Division of PMC, Inc., meet the requirements of Organic Volatile Impurities as
specified in United States Pharmacopeia (USP-27)/National Formulary (NF-22),
and the ICH Guideline for Residual Solvents (CPMP/ICH/283/95).
SYNCAL® also meets the organic volatile impurity (OVI) requirement of section
<467> as described in the First Supplement to the USP-27/NF-22 for Class 1,
Class 2, Class 3, and “other residual solvents” listed. We use none of the OVI
solvents in our process. Based on knowledge of the manufacturing process and
controlled handling, shipping, and storage of the SYNCAL® products, we believe
there is no potential for the OVI’s or the ICH residual solvents to be present
and that our product, if tested, will comply with established standards.
OVI tests are run in accordance with a reduced testing protocol, and a statement
of conformance is included on all Certificates of Analysis.
Allergen Statement – SYNCAL® [top]
Our SYNCAL® Sodium Saccharin is not adulterated with any other material
including wheat, fish/shellfish, eggs, milk, sesame seeds, tree nuts, peanuts,
lactose, gluten, artificial color or flavor, starch, barley, rye, oats, spelt,
corn.
Allergen |
Does Product Contain
Yes/No |
Does Product Share Equipment
Yes/No |
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Milk ( includes buttermilk, casein, margarine, milk chocolate, custard, Malted
milk, nougat, sodium caseinate, sour cream, whey, and yogurt.
|
No
|
No
|
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Egg Products ( includes
egg solids, egg white, albumin, mayonaise, meringue, ovalbumin).
|
No
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No
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Peanuts of Peanut
Products ( includes peanut butter, peanut flour, protein, peanut oil).
|
No
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No
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Tree Nuts (includes
almond, Brazil, cashew, chestnut, hazeknut, macadamia, pecan, pine,
pistachio, walnut).
|
No
|
No
|
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Fish (any type including
derivatives).
|
No
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No
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Shellfish (includes
crustaceans, mollusks, clam, crab, crayfish, lobster, oyster, scallop, and
shrimp).
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No
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No
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Shellfish (includes
crustaceans, mollusks, clam, crab, crayfish, lobster, oyster, scallop, and
shrimp).
|
No
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No
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Wheat Products (includes
bran, any bread or cake product, cracker meal, pre-gelatinized starch,
cereal extracts, farina, graham flour, malt, semolina, wheat flour, wheat
germ, wheat starch).
|
No
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No
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Seeds (includes
cottonseed, poppy seed, sesame seed, sunflower seed, excludes oils).
|
No
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No
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Soybean or Soybean
products (includes miso, tofu, soy, proteins, flavors containing soy or soy
sauce, excludes soybean oil).
|
No
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No
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Celery (includes root,
leaves, stalk, excludes seeds).
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No
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No
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Sulfites (as measured by
the Modified Monier-Williams test).
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No
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No
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FD&C Yellow #5.
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No
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No
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Certificate of Guarantee [top]
In regards to a Certificate of Guarantee, PMC will guarantee that all
our SYNCAL® Saccharin products meet or exceed Food Chemical Codex (FCC), United
States Pharmacopeia (USP) specifications and European Pharmacopeia standards
and will not ship unless all specifications are met.
Shelf Life Documentation [top]
PMC Specialties Group recommends storing SYNCAL® Saccharin products in
a warehouse that is of normal ambient temperature and humidity. Our stability
tests of these products indicate the products remain stable for more than five
years when stored in their sealed container in a non-air-conditioned warehouse.
Ambient conditions of:
Average monthly temperature = 64º F, standard deviation =
18.
Average Dew point = 44º F, standard deviation = 15.
Animal Testing [top]
The testing for Saccharin was performed by the International Life
Sciences Institute at the University of Nebraska Medical Center in Omaha,
Nebraska from 1979 thru 1987. The researcher in charge was Dr. Samuel Cohen who
conducted testing on rats. Additional testing by NCI involved orangutans,
specia monkeys, and chimpanzees to determine that saccharin does NOT cause
cancer in primates. Tests are complete and not ongoing. Products containing
Saccharin no longer require a warning label per the Sweetest Act of 2000.
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