488 Part 184—Direct Food
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Product Information Sheet
September 17, 2015 productISOVACTIN information AA PLUS Nutrients 8.5 fl oz (250mL) per 100mL SKU 37002 Calories 186 74 Calories From Fat 57 23 NET WEIGHT 2 GAL (7.5 L) Protein Equivalent, g 20 8 Free Amino Acids, g 22 9 SERVING SIZE 8.5 fl oz (250mL) Carbohydrates, g 13 5 Sugar, g 5 2 SERVINGS PER PACKAGE 30 Sugar Alcohols, g 0 0 Dietary Fiber, g 2.8 1 Fat, g 6 2.4 24359-0702-03 REIMBURSEMENT CODE Saturated Fat, g 0.5 0.2 (for USA only) Trans Fat, g 0.0 0.0 DHA, mg 150.0 60.0 Cholesterol, mg 0.4 0 MEDICAL FOOD PRODUCT Vitamin A, IU 1100.0 440.0 For the dietary management of Isovaleric Acidemia. Dispensed by prescription. Vitamin C, mg 40.0 16.0 Isovactin AA Plus is a ready-to-drink metabolic formula product for Isovaleric Acidemia Vitamin D, IU 620.0 248.0 patients, over 1 year of age. Isovactin contains an advanced fortification blend. Product Vitamin E, IU 10.0 4.0 Vitamin K1, mcg 20.0 8.0 comes in a 250 mL carton. Vitamin K2 (MK-7), mcg 20.0 8.0 Thiamin (B1), mg 0.5 0.2 Riboflavin (B2), mg 0.5 0.2 Niacin (B3), mg 6.6 2.6 PRECAUTIONS For the dietary management of Isovaleric Acidemia (IVA) and Vitamin B6, mg 0.5 0.2 other disorders of leucine metabolism. Use as directed by physician. Must be Folic acid, mcg 186.0 74.4 administered under medical supervision only. -
Brochure-Product-Range.Pdf
PRODUCT RANGE 2015 edition ANSI Standard 60 NSF® CERTIFIED HALAL M ISLAMIC FOOD AND NUTRITION ® COUNCIL OF AMERICA Rue Joseph Wauters, 144 ISO 9001:2008 (Quality) / OHSAS 18001:2007 (Health/ B-4480 Engis Safety) / ISO 14001:2004 (Environment) / ISO 22000:2005 www.globulebleu.com (Food Safety) / FSSC 22000:2013 (Food Safety). Tel. +32 (0) 4 273 93 58 Our food grade phosphates are allergen free, GMO free, Fax. +32 (0) 4 275 68 36 BSE/TSE free. www.prayon.com mail. [email protected] Design by www.prayon.com PRODUCT RANGE | 11 TABLE OF CONTENTS HORTICULTURE APPLICATIONS HORTIPRAY® RANGE FOR HORTICULTURE* FOOD AND INDUSTRIAL APPLICATIONS PRODUCT NAME Bulk density P O pH N-NH Made 2 5 4 MONOAMMONIUM PHOSPHATE - NH4H2PO4 in 3 3 % 1% % Sodium orthophosphates ................................................................................... 03 g/cm lbs/ft indicative indicative indicative Water-soluble fertilisers. Sodium pyrophosphates .................................................................................... 04 HORTIPRAY® MAP Horticultural Grade 0.9 56 61 4.5 12 Sodium tripolyphosphates ................................................................................. 05 HORTIPRAY® MAP 12.60 Horticultural Grade 0.9 56 60 5 12.1 Water-soluble fertilisers; Sodium polyphosphates ..................................................................................... 06 HORTIPRAY® MAP anticalc Horticultural Grade 0.9 56 61 4.5 12 preventive action against clogging. Potassium orthophosphates ............................................................................. -
(12) Patent Application Publication (10) Pub. No.: US 2017/0143022 A1 Wicker Et Al
US 20170143022A1 (19) United States (12) Patent Application Publication (10) Pub. No.: US 2017/0143022 A1 Wicker et al. (43) Pub. Date: May 25, 2017 (54) COMPOSITIONS INCORPORATING AN (52) U.S. Cl. UMLAM FLAVORAGENT CPC ............... A2.3L 27/20 (2016.08); A23L 27/88 (2016.08); A23L 2/56 (2013.01); A23L 2780 (71) Applicant: Senomyx, Inc., San Diego, CA (US) (2016.08); A23L 27/30 (2016.08); A23K 20/10 (2016.05); A23K 50/40 (2016.05); A61K 47/22 (72) Inventors: Sharon Wicker, Carlsbad, CA (US); (2013.01) Tanya Ditschun, San Diego, CA (US) (21) Appl. No.: 14/948,101 (57) ABSTRACT The present invention relates to compositions containing (22) Filed: Nov. 20, 2015 flavor or taste modifiers, such as a flavoring or flavoring agents and flavor or taste enhancers, more particularly, Publication Classification savory (“umami”) taste modifiers, savory flavoring agents (51) Int. Cl. and savory flavor enhancers, for foods, beverages, and other AOIN 25/00 (2006.01) comestible compositions. Compositions comprising an A23K2O/It (2006.01) umami flavor agent or umami taste-enhancing agent in A6 IK 47/22 (2006.01) combination with one or more other food additives, prefer A2.3L 2/56 (2006.01) ably including a flavorant, herb, Spice, fat, or oil, are A23K 50/40 (2006.01) disclosed. US 2017/O 143022 A1 May 25, 2017 COMPOSITIONS INCORPORATING AN tions WO 02/06254, WO 00/63166 art, WO 02/064631, and UMAM FLAVORAGENT WO 03/001876, and U.S. Patent publication US 2003 0232407 A1. The entire disclosures of the articles, patent BACKGROUND OF THE INVENTION applications, -
Long-Term Calcium-Phosphorus Studies in Confined Dairy Cows
Long-Term Calcium-Phosphorus Studies in Confined Dairy Cows George Ward, Ph.D. E. P. Call, Ph.D. Dept. of Animal Sciences and Insdustry Kansas State University Manhattan, Kansas 66506 Modern dairy cows are under considerable stress ~tudy (Figures 1 and 2). Comparison of Figures 3 and consuming and metabolizing large quantities of feed 4 shows the influence of supplemental vitamin D on and synthesizing large quantities of milk. The calcium utilization. Cows producing more than 15 kg nutrient requirement for peak production in a cow's milk without vitamin D supplement had negative lactation usually exceeds her capacity for feed. The calcium balances with intakes to 250 g/day. We es combination of deficit consumption and obligatory timated the calcium requirement from the balances nutrient balance required for milk synthesis com with cows supplemented with vitamin Da and produc pounds that stress. Attempts to satisfy energy re ing in excess of 15 kg milk in Figure 4. We drew the quirements result in inordinate skewing of the ration requirement line where it included negative balances toward a large proportion of concentrate. above the line equal in number to positive balances Combination of extreme variation among rations below the line (10). This estimate was nearly twice and the vast requirement for nutrients to support the NRC requirement (11). Some of our contem heavy lactation emphasizes the need for adequate in poraries ascribe the deviation to short-time balances formation concerning nutrient requirements, but few longer ones are being reported. Graphic treatment of data from Forbes, et al. (3), availabilities, and interactions. -
Monosodium Phosphate 1 of 9 Anhydrous
SAFETY DATA SHEET Monosodium Phosphate 1 of 9 Anhydrous Complying with 1907/2006/EEC Regulation of 18 December 2006 Section 1. IDENTIFICATION OF THE SUBSTANCE/PREPARATION AND OF THE COMPANY/UNDERTAKING REACH Product name: Monosodium Phosphate Anhydrous Trade names: Monosodium Phosphate Anhydrous; MSP-Gr; MSP-Pw; Hi-C-510; Hi-C-511; Hi-C-512; Hi-C-516. Synonyms: Sodium Phosphate, Monobasic; Monosodium Dihydrogen Phosphate; Phosphoric acid, monosodium salt; MSP Chemical formula: NaH2PO4 Fertilizer formula: Not applicable Product type: Solid (powder or granular) Cas number: 7558-80-7 Use of the substance/preparation: Food processing-buffer, emulsifier. Pharmacopoeia - nutrient, buffer. Industries – water treatment, metal treatment, corrosion control, drilling mud, ceramics, acid-base cleaners. Company/undertaking identification Supplier/Manufacturer: Haifa Chemicals Ltd. P.O.B 10809, Haifa Bay 26120, Israel Tel: +972-4-8469961 Fax: +972-4-8469955 E-mail address of person responsible for this SDS: [email protected] Emergency telephone number: +972-4-8469603/4 (with hours of operation) Section 2. HAZARDS IDENTIFICATION Classification: The substance is not classified as dangerous according to Directive 67/548/EEC and its amendments. Most important hazards: CAUTION! Dust in high concentration may cause eye, skin and respiratory tract irritation. See section 11 for more detailed information on health effects and symptoms. SAFETY DATA SHEET Monosodium Phosphate 2 of 9 Anhydrous Section 3. COMPOSITION/INFORMATION ON INGREDIENTS Substance/preparation: Ingredient name CAS % EC number Classification number Monosodium Phosphate 7558-80-7 100% 231-449-2 - Anhydrous See section 16 for the full text of the R-phrases declared above There are no additional ingredients present which, within the current knowledge of the supplier and in the concentrations applicable, are classified as hazardous to health or the environment and hence require reporting in this section. -
E Number from Wikipedia, the Free Encyclopedia
E number From Wikipedia, the free encyclopedia E numbers are codes for substances which can be used as food additives for use within the European Union[1] and Switzerland (the "E" stands for "Europe").[2] They are commonly found on food labels throughout the European Union.[3] Safety assessment and approval are the responsibility of the European Food Safety Authority.[4] Having a single unified list for food additives was first agreed upon in 1962 with colours. In 1964, the directives for preservatives were added, 1970 for antioxidants and 1974 for the emulsifiers, stabilisers, thickeners and gelling agents.[5] Contents A solution of E101 riboflavin (also 1 Numbering scheme known as Vitamin B2) 2 Colloquial use 3 Classification by numeric range 4 Full list 4.1 E100–E199 (colours) 4.2 E200–E299 (preservatives) 4.3 E300–E399 (antioxidants, acidity regulators) 4.4 E400–E499 (thickeners, stabilizers, emulsifiers) 4.5 E500–E599 (acidity regulators, anti-caking Crystals of E621 Monosodium glutamate, a flavour enhancer agents) 4.6 E600–E699 (flavour enhancers) 4.7 E700–E799 (antibiotics) 4.8 E900–E999 (glazing agents and sweeteners) 4.9 E1000–E1599 (additional chemicals) 5 See also 6 Notes 7 External links Numbering scheme The numbering scheme follows that of the International Numbering System (INS) as determined by the Codex Alimentarius committee,[6] though only a subset of the INS additives are approved for use in the European Union as food additives. E numbers are also encountered on food labelling in other jurisdictions, including the Cooperation Council for the Arab States of the Gulf, Australia, New Zealand[7] and Israel. -
Section 13. Disposal Considerations Disposal Methods : the Generation of Waste Should Be Avoided Or Minimized Wherever Possible
SAFETY DATA SHEET Sodium Phosphate, Monobasic, Monohydrate Section 1. Identification GHS product identifier : Sodium Phosphate, Monobasic, Monohydrate Code : 20233 Other means of : Sodium dihydrogenorthophosphate monohydrate; Monosodium phosphate, identification monohydrate; Monosodium dihydrogen phosphate Supplier/Manufacturer : 3420 Central Expressway, Santa Clara CA 95051 3420 Central Expressway, Santa Clara CA 95051 In case of emergency : Chemtrec: 1 800 424 9300 Outside USA & Canada: +1 703 527 3887 Section 2. Hazards identification OSHA/HCS status : While this material is not considered hazardous by the OSHA Hazard Communication Standard (29 CFR 1910.1200), this MSDS contains valuable information critical to the safe handling and proper use of the product. This MSDS should be retained and available for employees and other users of this product. Classification of the : Not classified. substance or mixture GHS label elements Signal word : No signal word. Hazard statements : No known significant effects or critical hazards. Precautionary statements Prevention : Not applicable. Response : Not applicable. Storage : Not applicable. Disposal : Not applicable. Hazards not otherwise : None known. classified Section 3. Composition/information on ingredients Substance/mixture : Substance Ingredient name % CAS number Phosphoric acid, monosodium salt, monohydrate 99.99 - 100 10049-21-5 Any concentration shown as a range is to protect confidentiality or is due to batch variation. There are no additional ingredients present which, within the current knowledge of the supplier and in the concentrations applicable, are classified as hazardous to health or the environment and hence require reporting in this section. Occupational exposure limits, if available, are listed in Section 8. Section 4. First aid measures Description of necessary first aid measures Eye contact : Immediately flush eyes with plenty of water, occasionally lifting the upper and lower eyelids. -
F1y3x CHAPTER 29 ORGANIC CHEMICALS VI 29-1 Notes 1
)&f1y3X CHAPTER 29 ORGANIC CHEMICALS VI 29-1 Notes 1. Except where the context otherwise requires, the headings of this chapter apply only to: (a) Separate chemically defined organic compounds, whether or not containing impurities; (b) Mixtures of two or more isomers of the same organic compound (whether or not containing impurities), except mixtures of acyclic hydrocarbon isomers (other than stereoisomers), whether or not saturated (chapter 27); (c) The products of headings 2936 to 2939 or the sugar ethers and sugar esters, and their salts, of heading 2940, or the products of heading 2941, whether or not chemically defined; (d) Products mentioned in (a), (b) or (c) above dissolved in water; (e) Products mentioned in (a), (b) or (c) above dissolved in other solvents provided that the solution constitutes a normal and necessary method of putting up these products adopted solely for reasons of safety or for transport and that the solvent does not render the product particularly suitable for specific use rather than for general use; (f) The products mentioned in (a), (b), (c), (d) or (e) above with an added stabilizer necessary for their preservation or transport; (g) The products mentioned in (a), (b), (c), (d), (e) or (f) above with an added antidusting agent or a coloring or odoriferous substance added to facilitate their identification or for safety reasons, provided that the additions do not render the product particularly suitable for specific use rather than for general use; (h) The following products, diluted to standard strengths, for the production of azo dyes: diazonium salts, couplers used for these salts and diazotizable amines and their salts. -
Bulk Drug Substances Nominated for Use in Compounding Under Section 503B of the Federal Food, Drug, and Cosmetic Act
Updated June 07, 2021 Bulk Drug Substances Nominated for Use in Compounding Under Section 503B of the Federal Food, Drug, and Cosmetic Act Three categories of bulk drug substances: • Category 1: Bulk Drug Substances Under Evaluation • Category 2: Bulk Drug Substances that Raise Significant Safety Risks • Category 3: Bulk Drug Substances Nominated Without Adequate Support Updates to Categories of Substances Nominated for the 503B Bulk Drug Substances List1 • Add the following entry to category 2 due to serious safety concerns of mutagenicity, cytotoxicity, and possible carcinogenicity when quinacrine hydrochloride is used for intrauterine administration for non- surgical female sterilization: 2,3 o Quinacrine Hydrochloride for intrauterine administration • Revision to category 1 for clarity: o Modify the entry for “Quinacrine Hydrochloride” to “Quinacrine Hydrochloride (except for intrauterine administration).” • Revision to category 1 to correct a substance name error: o Correct the error in the substance name “DHEA (dehydroepiandosterone)” to “DHEA (dehydroepiandrosterone).” 1 For the purposes of the substance names in the categories, hydrated forms of the substance are included in the scope of the substance name. 2 Quinacrine HCl was previously reviewed in 2016 as part of FDA’s consideration of this bulk drug substance for inclusion on the 503A Bulks List. As part of this review, the Division of Bone, Reproductive and Urologic Products (DBRUP), now the Division of Urology, Obstetrics and Gynecology (DUOG), evaluated the nomination of quinacrine for intrauterine administration for non-surgical female sterilization and recommended that quinacrine should not be included on the 503A Bulks List for this use. This recommendation was based on the lack of information on efficacy comparable to other available methods of female sterilization and serious safety concerns of mutagenicity, cytotoxicity and possible carcinogenicity in use of quinacrine for this indication and route of administration. -
![Dimethylethanolamine (DMAE) [108-01-0] and Selected Salts](https://docslib.b-cdn.net/cover/5743/dimethylethanolamine-dmae-108-01-0-and-selected-salts-2695743.webp)
Dimethylethanolamine (DMAE) [108-01-0] and Selected Salts
Dimethylethanolamine (DMAE) [108-01-0] and Selected Salts and Esters DMAE Aceglutamate [3342-61-8] DMAE p-Acetamidobenzoate [281131-6] and [3635-74-3] DMAE Bitartrate [5988-51-2] DMAE Dihydrogen Phosphate [6909-62-2] DMAE Hydrochloride [2698-25-1] DMAE Orotate [1446-06-6] DMAE Succinate [10549-59-4] Centrophenoxine [3685-84-5] Centrophenoxine Orotate [27166-15-0] Meclofenoxate [51-68-3] Review of Toxicological Literature (Update) November 2002 Dimethylethanolamine (DMAE) [108-01-0] and Selected Salts and Esters DMAE Aceglutamate [3342-61-8] DMAE p-Acetamidobenzoate [281131-6] and [3635-74-3] DMAE Bitartrate [5988-51-2] DMAE Dihydrogen Phosphate [6909-62-2] DMAE Hydrochloride [2698-25-1] DMAE Orotate [1446-06-6] DMAE Succinate [10549-59-4] Centrophenoxine [3685-84-5] Centrophenoxine Orotate [27166-15-0] Meclofenoxate [51-68-3] Review of Toxicological Literature (Update) Prepared for Scott Masten, Ph.D. National Institute of Environmental Health Sciences P.O. Box 12233 Research Triangle Park, North Carolina 27709 Contract No. N01-ES-65402 Submitted by Karen E. Haneke, M.S. Integrated Laboratory Systems, Inc. P.O. Box 13501 Research Triangle Park, North Carolina 27709 November 2002 Toxicological Summary for Dimethylethanolamine and Selected Salts and Esters 11/2002 Executive Summary Nomination Dimethylethanolamine (DMAE) was nominated by the NIEHS for toxicological characterization, including metabolism, reproductive and developmental toxicity, subchronic toxicity, carcinogenicity and mechanistic studies. The nomination is based on the potential for widespread human exposure to DMAE through its use in industrial and consumer products and an inadequate toxicological database. Studies to address potential hazards of consumer (e.g. dietary supplement) exposures, including use by pregnant women and children, and the potential for reproductive effects and carcinogenic effects are limited. -
DART-04: Prenatal Development Studies of Dimethylaminoethanol
NTP DEVELOPMEntAL And REprODUCTIVE TOXICITY TECHNICAL REPOrt ON THE PRENATAL DEVELOPMEnt STUDIES OF DIMETHYLAMINOETHANOL BITArtrATE (CASRN 5988-51-2) IN SprAGUE DAWLEY (Hsd:SprAGUE DAWLEY® SD®) RAts (GAVAGE STUDIES) NTP DART 04 JUNE 2020 NTP Developmental and Reproductive Toxicity Technical Report on the Prenatal Development Studies of Dimethylaminoethanol Bitartrate (CASRN 5988-51-2) in Sprague Dawley (Hsd:Sprague Dawley® SD®) Rats (Gavage Studies) DART Report 04 June 2020 National Toxicology Program Public Health Service U.S. Department of Health and Human Services ISSN: 2690-2052 Research Triangle Park, North Carolina, USA Dimethylaminoethanol Bitartrate, NTP DART 04 Foreword The National Toxicology Program (NTP), established in 1978, is an interagency program within the Public Health Service of the U.S. Department of Health and Human Services. Its activities are executed through a partnership of the National Institute for Occupational Safety and Health (part of the Centers for Disease Control and Prevention), the Food and Drug Administration (primarily at the National Center for Toxicological Research), and the National Institute of Environmental Health Sciences (part of the National Institutes of Health), where the program is administratively located. NTP offers a unique venue for the testing, research, and analysis of agents of concern to identify toxic and biological effects, provide information that strengthens the science base, and inform decisions by health regulatory and research agencies to safeguard public health. NTP also works to develop and apply new and improved methods and approaches that advance toxicology and better assess health effects from environmental exposures. The NTP Technical Report series for developmental and reproductive toxicity studies began in 2019. -
485 Part 184—Direct Food Sub- Stances Affirmed As
Food and Drug Administration, HHS Pt. 184 § 182.8217 Calcium phosphate. § 182.8988 Zinc gluconate. (a) Product. Calcium phosphate (a) Product. Zinc gluconate. (mono-, di-, and tribasic). (b) Conditions of use. This substance (b) Conditions of use. This substance is generally recognized as safe when is generally recognized as safe when used in accordance with good manufac- used in accordance with good manufac- turing practice. turing practice. § 182.8991 Zinc oxide. § 182.8223 Calcium pyrophosphate. (a) Product. Zinc oxide. (a) Product. Calcium pyrophosphate. (b) Conditions of use. This substance (b) Conditions of use. This substance is generally recognized as safe when is generally recognized as safe when used in accordance with good manufac- used in accordance with good manufac- turing practice. turing practice. § 182.8994 Zinc stearate. § 182.8250 Choline bitartrate. (a) Product. Zinc stearate prepared (a) Product. Choline bitartrate. from stearic acid free from chickedema (b) Conditions of use. This substance factor. is generally recognized as safe when (b) Conditions of use. This substance used in accordance with good manufac- is generally recognized as safe when turing practice. used in accordance with good manufac- turing practice. § 182.8252 Choline chloride. § 182.8997 Zinc sulfate. (a) Product. Choline chloride. (b) Conditions of use. This substance (a) Product. Zinc sulfate. is generally recognized as safe when (b) Conditions of use. This substance used in accordance with good manufac- is generally recognized as safe when turing practice. used in accordance with good manufac- turing practice. § 182.8778 Sodium phosphate. (a) Product. Sodium phosphate PART 184—DIRECT FOOD SUB- (mono-, di-, and tribasic).