Sucralose - JK Sucralose Inc.

JK Pharmaceutical Grade Sucralose

JK Sucralose Inc. is the only producer of pharmaceutical grade sucralose in China and is the only manufacturer to obtain the license to produce sucralose for use in pharmaceutical products. JK’s sucralose provides its clients with the highest quality and production experience, on par with the leading producers worldwide. JK has also taken the lead in registering sucralose as an addition to the Chinese Pharmacopeia, with sucralose listed in the 2015 edition as a type of pharmaceutical excipient. JK Sucralose Inc., through the U.S. FDA, had sucralose registered under the DMF number 031633 as a pharmaceutical excipient. JK Sucralose is currently being reviewed for registration under the European Drug Master File (EDMF). JK is also the sole sucralose producer with independently owned ISO Class 5 cleanroom pharmaceutical and GMP certified production facilities rated at 100,000 or less particles per m3. JK currently has the capacity to produce 100 tons of GMP certified sucralose with an additional 1,000 tons of production capacity to be incorporated after the completion of its 3rd Phase Project.

JK currently has the capacity to produce 100 tons of GMP certified sucralose with an additional 1,000 tons of production capacity to be incorporated after the completion of its 3rd Phase Project.

Advantages

Sucralose, with attributes including intense sweetness (roughly 600 times that of sugar by weight), smooth flavor, structural stability, and non-toxicity, is quickly becoming regarded as the pinnacle of non-sugar, zero calorie sweeteners.

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Applications

JK’s sucralose product has been approved as safe for use and consumption in over 3,000 differentiated food, pharmaceutical, and personal care products in many countries and continents around the world.

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Product Knowledge

1.What is sucralose?: Sucralose is a zero calorie High Intensity Sweetener (HIS) synthesized from table sugar (sucrose), so it tastes just like sugar. so it tastes like sugar. It is about 600 times sweeter than sugar and can be used in place of sugar to eliminate or reduce calories in a wide variety of products, including beverages, baked goods, desserts, dairy products, canned fruits, syrups and condiments. Sucralose was discovered in 1976. More than 100 scientific studies conducted over a 20-year period have conclusively demonstrated that sucralose is safe for consumption. In 1990, the Joint FAO/WHO Expert Committee on Food Additives (JECFA) was the first regulatory body to endorse the safety of sucralose. In 1991, Canada’s Health Protection Branch became the first national regulatory agency to endorse sucralose safety and permit its use in foods and beverages. In 1998, the United States Food and Drug Administration (FDA) approved the use of sucralose in 15 food and beverage categories -- the broadest initial approval ever given to a food additive. Then, in August 1999, the FDA extended the approval by permitting sucralose use as a general-purpose sweetener in all foods, beverages, dietary supplements and medical foods. In January 2004, the European Union amended its Sweeteners Directive to permit the use of sucralose in a broad range of food and beverage products. Sucralose is now permitted for use in over 100 countries and is been consumed by millions of people worldwide.

2.What are the advantages of sucralose?

The Only High Intensity Sweetener (HIS) Made from Sugar

Closest Sweetness Profile to Sugar of Any HIS

On Average 600 Times Sweeter Than Sugar by Weight

Very Soluble and Easy to Handle

Extremely Stable

Zero Calories or Carbohydrates

Does Not Cause Tooth Decay

No Effect on Short or Long-Term Blood Glucose Control

No Effect on Carbohydrate Metabolism

No Effect on Male or Female Reproduction

3.What’s the difference from other HIS?

	Sweetness Level	Aftertaste	Carcinogen	Temperature Stability	Shelf-Life
Sucralose	600 X	None	No	Yes	Great
Aspartame	180 X	Metallic	Under investigation	No	Poor
Saccharin	500 X	Bitter	No>Yes>No	Yes	Good
Acesulfame Potassium	200 X	Bitter	No	Yes	Good

4.Products sweetened with sucralose provide good-tasting, lower-calorie alternatives. How much sucralose may people safely consume?: People may consume a varied sucralose-sweetened food and beverage products on a daily basis without concern that they are exceeding a safe intake level. When evaluating the safety of new food ingredients like sucralose, health authorities compare an estimate of the ingredient’s maximum daily intake with the highest daily consumption level consumed in preclinical and clinical studies that was shown to be without harmful effects. Ideally, the intake estimate will be substantially less than the actual consumption levels shown to be without adverse effect in the preclinical and clinical studies. Studies in animals consuming large doses of sucralose on a daily basis over a lifetime and studies in humans who consumed high levels of sucralose for up to six months have shown no harmful effects. The consumption levels in these studies were well in excess of the estimates of maximum potential exposure to sucralose from foods and beverages.

5.Can people with diabetes use sucralose?: Yes. Clinical studies have shown that sucralose can be safely consumed by people with diabetes. Sucralose is not recognized by the body as sugar or as a carbohydrate. It is not metabolized by the body for energy and does not affect blood glucose levels. Sucralose has no effect on blood glucose utilization, carbohydrate metabolism or insulin production. Products sweetened with sucralose provide good-tasting, lower-calorie alternatives for people with diabetes who are interested in reducing their caloric or sugar intake. As with any nutritional concerns, people with diabetes should consult their doctor or diabetes healthcare professional for advice on an individualized dietary plan.

6.Can pregnant and breastfeeding women consume sucralose?: Yes. Sucralose can be used by everyone, including pregnant women and breastfeeding mothers. Although sucralose may be used as part of a healthy pre- and post-natal diet, women who are pregnant or breastfeeding should talk to their doctor or nutritionist about foods to eat to support their health, and their baby’s health.

7.Is sucralose safe for children?: Yes. Sucralose may be safely used by everyone, including children. Sucralose can be a great addition to healthful meal plans designed for children’s needs.

8.What is the role of sucralose in a healthful diet?: Sucralose may be used as part of a healthy diet that includes a variety of nutritious foods in moderate portions. Because sucralose tastes like sugar, has no calories, and is ideal for cooking and baking, it helps meet consumer demand for good-tasting foods and beverages without the calories of sugar.

9.The end product?: Types of products that contain sucralose makes a wide variety of calorie-reduced products possible, including soft drinks, ice cream, dairy products and baked goods. One of the unique attributes of sucralose is that it can be used almost anywhere sugar is used. It does not lose its sugar-like sweetness even in applications that require heat or that are subjected to long shelf-storage. Thus, products made with sucralose maintain their sweetness during cooking, baking, and throughout their shelf-life. In the United States, the FDA has granted approval for the use of sucralose as a general purpose sweetener, which covers all conventional foods and beverages, dietary supplements, and medical foods. In fact, sucralose is the sweetening ingredient in over 3,500 products worldwide, and may be used across a broad range of major categories including:

10.What is sucralose made of?: Sucralose is derived from sugar through a patented, multi-step process that selectively substitutes three chlorine atoms for three hydrogen-oxygen groups on the sugar molecule. The tightly bound chlorine atoms create a molecular structure that is exceptionally stable.

11.Which regulatory bodies reviewed the safety profile of sucralose?: Among the regulatory bodies that have evaluated the safety of sucralose are the U.S. FDA, the Joint FAO/WHO Expert Committee on Food Additives (JECFA); the Health Protection Branch of Health and Welfare Canada; Food Standards Australia /New Zealand, the European Union’s Scientific Committee on Food, and a host of others in South America and Asia. Sucralose is now permitted for use in over 60 countries.

12. Do products sweetened with sucralose carry any warning labels or information statements?: No. None of the regulatory agencies and scientific review bodies that have confirmed the safety of sucralose require any warning information to be placed on the labels of products sweetened with sucralose.

13. Does sucralose provide calories?: Sucralose is non-caloric and, thus, adds no calories to the foods and beverages it is used to sweeten. Products made withsucralose may contain calories from other nutritive ingredients that provide carbohydrates, protein and fat.

14.How is sucralose handled by the body?: Although sucralose is made from a process that starts with sugar, it is not a sugar nor does the body recognize it as a carbohydrate. Sucralose is not broken down for energy in the body so it has no calories. The sucralose molecule passes through the body unchanged, is not metabolized, and is eliminated after consumption.

15.Is the chlorine in sucralose potentially harmful?: No. Chlorine in the form of chloride is a safe and natural element present in many of the foods and beverages that we eat and drink every day. It is in most natural water supplies, and is also found in lettuce, tomatoes, mushrooms, melons, peanut butter, and table salt. In the case of sucralose, the addition of chlorine to the sucralose molecule is what makes sucralose free of calories. Sucralose is an essentially inert molecule and it passes through the body without being broken down for calories.

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Approved Countries

Sucralose is consumed by millions of people worldwide and is approved for consumption and use in over 100 countries, listed below:

North America:: Canada United States of America

Latin America:: Argentina Bolivia Brazil Chile Colombia Costa Rica Ecuador Guatemala Honduras Mexico Nicaragua Panama Paraguay Peru Uruguay Venezuela

Caribbean:: Bahamas Barbados Bermuda Cayman Islands Curaso Dominican Republic Guyana Jamaica Trinidad & Tobago

Africa:: Egypt South Africa Tanzania Swaziland

Middle East:: Bahrain Israel Jordan

Kuwait Lebanon Qatar Saudi Arabia United Arab Emirates

Europe/CIS：: Croatia European Union France Germany Italy Lithuania Macedonia Malta Norway Romania Russia Serbia Slovakia Spain Switzerland Turkey

Asia Pacific:: Australia China Hong Kong India Indonesia Japan Malaysia New Zealand Pakistan Philippines Singapore South Korea Sri Lanka Taiwan Thailand Vietnam

Item	FCCVII	USP34-NF29	JP	GB25531	JK Standard
Appearance	White crystalline powder	——	White crystalline powder	White crystalline powder	White crystalline powder
Identification	The retention time of the major peak (excluding the so -lvent peak) in the liquid chromatogr am of the sample solution is the sam -eas that of the st -andard solution obtained in the assay	The retention time of the major peak (excluding the so lvent peak) in the liquid chromatogra -m of the sample solution is the sam -e as that of the standard solution obtained in the assa	——	——	The retention time of the major peak (excluding the so -lvent peak) in the liquid chromatogr am of the sample solution is the sam -eas that of the st -andard solution obtained in the assay
Assay(calcu -lated with reference to the dried substance)	98.0%-102.0%	98.0%-102.0%	98.0%-102.0%	98.0%-102.0%	98.0%-102.0%
Mesh	——	——	——	——	——
Specific Rotation	+84.0°~ +87.5°	+84.0°~ +87.5°	+84.0°~ +87.5°	+84.0°~ +87.5°	+84.0°~ +87.5°
Moisture	+84.0°~ +87.5°	+84.0°~ +87.5°	+84.0°~ +87.5°	+84.0°~ +87.5°	+84.0°~ +87.5°
PH of 10% Aqueous Solution	——	——	——	——	5-8
Methanol	0.1% Max	0.1% Max	≤0.1%	0.1% Max	0.1% Max
Arsenic (As)	——	——	4mg/Kg Max	——	3mg/Kg Max
Lead	1mg/kg Max	——	1mg/kg Max	1mg/kg Max	1mg/kg Max
Copper	——	——	——	——	10mg/kg Max
Iron	——	——	——	——	10mg/kg Max
Ignited Residue	0.7% Max	0.7% Max	≤0.7%	0.7% Max	0.7% Max
Hydrolysis Products (Chlorinated monosac charides)	0.1% Max	0.1% Max	≤0.16%	——	0.1% Max
RelatedSub stance (Oth erchlorinated disacchar ides)	0.5% Max	0.5% Max	≤0.5%	——	0.5% Max
Heavy Metal	——	10mg/kg Max	——	——	10mg/kg Max
Triphenylph osphine oxide	——	——	150mg/kg Max	——	150mg/kg Max
Total Aerobic Count	——	——	——	——	250cfu/g Max
E.Coli	——	——	——	——	MPN/g<3.0
S.Aureus	——	——	——	——	Negative
Salmonella	——	——	——	——	Negative
Yeasts & Molds	——	——	——	——	50cfu/g Max

Sucralose

Sucralose is the latest generation of sweetener in the world and the only one synthesized using sucrose as the main raw ingredient. Sucralose is the best non sugar, zero calorie sweetener currently available on the market, with a wide range of uses, and the biggest potential for future development. It is also a great tasting, safe, and reliable sweetener with great structural and heat stability as well as providing zero calories when consumed. It is considered the preeminent and most promising sweetener by many global companies for improving their product formulas and developing new products.

Product Name : Sucralose
Chemical Name : 1',6'–Dichloro-1', 6'–dideoxy–β–D-fructofuranosyl–4–chloro–4–deoxy–α–D–galactopyranoside
Synonyms : TGS; 4, 1', 6' – Trichlorogalactosucrose; Trichlorogalactosucrose
CAS No. : [56038-13-2]
Molecular Formula : C₁₂H₁₉O₈Cl₃

Functions & Properties: Approximately 600 times sweeter than sugar by weight.; The only high intensity sweetener that is made from sugar and tastes like sugar.; Great heat stability and is particularly stable in acidic/alkaline products.; Safe Accepted Daily Intake Value (ADI) of 5mg/kg of bodyweight.; Non-toxic, no calories or carbohydrates, and no effect on carbohydrate metabolism.

Superior Taste: Because it is made from sugar. Additionally, Sucralose has a well-rounded sweetness and very close to the taste of sugar, with almost none bitterness or astringency associated with other non-sugar sweeteners.

High Intensity: Sucralose is around 600 times sweeter than sugar, although its intensity does fluctuate depending on the type of food to which it is applied.

Excellent stability: Sucralose shows excellent stability in both powder and aqueous form. It is especially stable in aqueous solution at a pH of 7.0 or lower. Its high stability in foods with long shelf lives has been confirmed. It remains stable under high-temperature processing conditions such as retort sterilization. The excellent stability of sucralose makes it the sweetener of choice for a wide range of food products and manufacturing processes.; For example, the natural sugar-esque sweetness of sucralose can be used to make rich, tasty sausages, drawing out the meatiness and accentuating the herbal and spicy flavors. As sucralose is a high intensity sweetener, little else is needed to benefit from its advantages. Additionally, it is both resistant to heat in acidic to neutral conditions and stable through prolonged storage. Sucralose will not be broken down or deteriorate in quality from heat sterilization during the production process.

Application: Sucralose is currently used in over 3,000 products and approved