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Compactrol Rev. 02

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Compactrol Rev. 02
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    COMPACTROL   (Calcium Sulfate Dihydrate, NF) Issued March 2003 TDS.QA0.10002.00000.02 Page 1 of 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    DESCRIPTION: Compactrol ® 1   is the dihydrate form of Calcium Sulfate (CaSO 4 ), a white to slightly off-white powder with a median particle size of 120 µm.  APPLICATIONS AND USE: Compactrol ®  is a specially-processed grade of calcium sulfate with a particle size ideally suited for use in pharmaceutical tablets which are made by direct compression. It is an efficient and relatively inexpensive tablet and capsule filler. Compactrol ®  is a non-hygroscopic and free-flowing product that offers excellent long-term stability. The particle size distribution is within the range of a great majority of active ingredients, thereby ensuring uniform blending and close uniformity. Because of its high bulk density and free-flowing characteristics, it imparts a high degree of fluidity which is essential for high-speed compaction and filling.  MONOGRAPH SPECIFICATIONS: Compactrol ®  complies with the monograph for Calcium Sulfate Dihydrate in the NF. 1. Appearance A white to slightly off-white powder. 2. Identification Responds to the tests for Calcium <191> and for Sulfate <191>. 3. Loss on drying 19.0 - 23.0 %   4. Iron Not more than 0.01% 5. Heavy metals Not more than 0.001% 6. Assay 98.0 – 101.0 %  ADDITIONAL SPECIFICATIONS:   1. Lead Not more than 10 ppm 2. Organic Volatile Impurities Meets the requirements 1 Compactrol ®  is a registered trademark of JRS Pharma LP (Rettenmaier)    COMPACTROL   (Calcium Sulfate Dihydrate, NF) Issued March 2003 TDS.QA0.10002.00000.02 Page 2 of 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    ADDITIONAL SPECIFICATIONS (continued): 3. Particle size (by Ro-Tap ® 2 ) Not less than 85.0% is retained on a #140 mesh sieve (100 µm)  Not less than 98.0% passes through a #40 mesh sieve (425 µm) 4. Bulk density Not more than 1.10 g/mL 5. Tapped density 0.90 - 1.35 g/mL Identification and heavy metals: Results shown represent expected results based on historical data. JRS Pharma warrants that this material, if tested, will conform to the specification listed for each test. Assurance that this product meets the Organic Volatile Impurities (OVI) specifications as listed in USP <467> is based on the knowledge that there is no potential for the specific toxic solvents to be present in the material. The product is not exposed to any OVIs during our manufacturing, handling, shipping, and storage. JRS Pharma warrants that this material, if tested, will comply with the established standards.  PACKAGING:   Compactrol ®  is available in 25-kg four-ply bags, including a polyethylene layer.  STORAGE RECOMMENDATIONS: Compactrol ®  should be stored in srcinal, unopened, well-closed containers under conditions that do not typically exceed 30°C and 70% RH. When stored as recommended, Compactrol ®  has a recommended re-evaluation period of three (3) years from the date of manufacture. An additional year can be added if the LOD and assay test within test specifications.  ADDITIONAL TECHNICAL INFORMATION:   Chemical Abstract Service (CAS) Registry number: 10101-41-4  Brussels Nomenclature number: 2520 20 90 0 00   WARRANTY: The information contained in this document is believed to be accurate at the time of issuance and is offered in good faith, with no assumption of liability on the part of JRS Pharma, as a guide to the use and testing of the material, but in no way does this information constitute a performance warranty. JRS Pharma excipients are sold with the understanding that purchasers will determine the suitability of the excipients for their particular applications or purposes. 2   Ro-Tap   is a registered trademark of W.S. Tyler, Inc.  
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