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SUGARTAB®

(Compressible Sucrose)

DESCRIPTION:
Sugartab is a white, free-flowing, sugar product with an agglomerated median particle size of ca. 300 µm (by sieve analysis) comprising approximately 90 - 93% sucrose with the balance being invert sugar.
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APPLICATIONS AND USE:
When Sugartab is simply blended with the active component plus a suitable lubricant and compressed, it can be directly compressed to produce hard, nonfriable, pharmaceutically elegant tablets which offer the palatability and mouth-feel characteristics desirable in chewable and other water soluble tablets. Sugartab is an excellent vehicle for direct compression. It offers good flow characteristics, excellent compressibility and numerous additional beneficial properties including flavor-masking, relatively low hygroscopicity, chemical stability, non-cloying sweetness, a wide range of compatibilities, smooth disintegration and pleasant aftertaste. Sugartab has been used extensively in vitamin formulations where the coarse mesh size makes it an excellent carrier for material which may have certain inherent compression problems.

PRODUCT SPECIFICATIONS:
1. 2. 3. 4. Appearance pH Loss on drying Particle size (by Ro-Tap )
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Practically white, crystalline, odorless powder. 3.8 - 7.5 Not more than 2.0% Not more than 50.0% is retained on a #20 mesh sieve (850 µm) Not more than 30.0% passes through a #80 mesh sieve (180 µm)

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Tapped density

0.6 - 0.8 g/mL

MICROBIOLOGICAL SPECIFICATIONS:
1. Total aerobic microbial count Not more than 1000/g

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Sugartab® is a registered trademark of JRS Pharma (Rettenmaier) ® Ro-Tap is a registered trademark of W.S. Tyler, Inc.
TDS.QA0.10041.00000.02 Page 1 0f 2 US Office: Phone 845-878-3414 • 1-800-431-2457 • Fax 845-878-3484 UK Office: Phone +44 1737 222323 • Fax +44 1737 222545

Issued March 2003

10041. as a guide to the use and testing of the material.02 Page 2 0f 2 . with no assumption of liability on the part of JRS Pharma.SUGARTAB® (Compressible Sucrose) PACKAGING: Sugartab is available in 100-kg drums. well-closed containers under conditions that do not typically exceed 30°C and 70% RH. Issued March 2003 US Office: Phone 845-878-3414 • 1-800-431-2457 • Fax 845-878-3484 UK Office: Phone +44 1737 222323 • Fax +44 1737 222545 TDS. unopened. An additional year can be added if the Loss on Drying tests within specification. Very soluble in water. ADDITIONAL TECHNICAL INFORMATION: Nutritional information: 100% carbohydrate with a caloric content of 4 kcal/g.00000. WARRANTY: The information contained in this document is believed to be accurate at the time of issuance and is offered in good faith. JRS Pharma excipients are sold with the understanding that purchasers will determine the suitability of the excipients for their particular applications or purposes. STORAGE RECOMMENDATIONS: Sugartab should be stored in original. but in no way does this information constitute a performance warranty. Sugartab has a recommended reevaluation period of three (3) years from the date of manufacture. slightly soluble in alcohol.QA0. When stored as recommended.