Description and Relative Solubility of USP and NF Articles Excipients Monographs Section 3 rAlbumin Human (new) Alendronate Sodium Tablets Labeling Alfadex USP Reference standards Alfuzosin Hydrochloride (new) Aminophylline Chemical information Betadex Chemical information Packaging and storage USP Reference standards pH (added) Bicalutamide Tablets (new) Bupivacaine Hydrochloride … Absent / g Absent / g SPECIFICATION – USP / Ph.Eur consists residue blue colour.. Water Soluble Substance 9. and . Soluble in hydrochloric acid and in sulfuric acid, yielding very pale yellow solutions. Soluble Pharmacopeial and National Formulary articles, when brought into solution, may show traces of physical impurities, such as minute fragments of filter paper, fibers, and other particulate matter, unless limited or excluded by definite tests or other specifications in the individual monographs. Insoluble in alcohol, in chloroform, in ether, and in fixed and volatile oils. Description and solubility requirement as per USP/BP/EP : T hese tests are only for information but not standards does not need to comply. light. The description and solubility statements pertaining to an article (formerly included in the individual monograph) are general in nature. Conductivity 5. pH (5 g in 40 ml water) 6. Only where a special, quantitative solubility test is given in the individual monograph, and is designated by a test heading, is it a test for purity. Description and Relative Solubility of USP and NF Articles. Identification 4. Dissolves in hot organic solvents such as alcohol, min- Halobetasol Propionate:White to off-white powder. Loss on drying 7. Glyceryl Monostearate: White to yellowish wax-like solid; or white to yellowish wax-like beads, flakes, or powder. The structure of the excipient is included for reference, but where the structure is undefined or loosely defined (as in polymers ) the expected monomer arrangement and ratios are described where possible and appropriate. Sparingly soluble in practically boiling water; slightly soluble in alcohol; very slightly soluble in water. Has a cool, saline taste, and is somewhat hygroscopic. A characteristic taste or sensation produced in the oral cavity likewise is apparent if traces of residue materials on fingers are inadvertently brought into contact with the tongue or adjacent mucosal tissues. Solubility 3. Description and Solubility . Specific gravity is about 1.045. a small amount of soap or other suitable … Sparingly soluble in dimethylsulfoxide and dimeth- alcohol. Description 2. The reference table is intended primarily for those who use, prepare, and dispense drugs and/or related articles. The use of odor or taste as a test for identification or content is strongly discouraged. Dissolves in hot organic solvents such as alcohol, minerals or fixed oils, benzene, ether, and acetone. The inclusion of odor or taste among other descriptive properties may aid in identifying the causative agent following accidental exposure to or contact with a substance. General Notices 5.30, and section . The term miscible as used in this Pharmacopeia pertains to a substance that yields a homogeneous mixture when mixed in any proportion with the designated solvent. Ether-soluble substances 10. The characteristic odor of a volatile substance becomes apparent immediately on opening a container of it. This information is provided as a warning or to make an individual aware of sensations that may be encountered. 2.1 Structure. The information is provided for those who use, prepare, and dispense drugs, solely to indicate descriptive and solubility properties of an article complying with monograph standards. Freely soluble in water and in glyc- Anagrelide Hydrochloride:Off-white to pale pinkish erin, and even more so in boiling water; sparingly soluble inpowder. However, they are not meant to be applied as tests for identifying materials. The reference table merely denotes the properties of articles that comply with monograph standards. The “description” and “solubility” statements pertaining to an article (formerly included in the individual monograph) are general in nature. USP 35Reference Tables / Description and Solubility1121. Formaldehyde Solution: Clear, colorless or practically colorless liquid, having a pungent odor. Is affected by light. Folic Acid Injection: Clear, yellow to orange-yellow, alkaline liquid. Product : MICROCRYSTALLINE CELLULOSE : AceCel 102 S. No. D.1 Description and Solubility, below. Soluble in hot water, in 6 N acetic acid, and in a hot mixture of glycerin and water. Moreover, an unexpected odor may be encountered if the characteristics of a substance are not known or if a container is incorrectly labeled. 2.2 Molecular formula. ylformamide; very slightly soluble in … Miscible with water, with alcohol, and with glycerin. section of . Consequently, containers of such substances should be opened cautiously, preferably in a well-ventilated fume hood. TEST 1. erals or fixed oils, benzene, ether, and acetone. USP–NF. Organoleptic characteristics are indicated in many instances because they may be useful and descriptive properties of substances. The odor may be agreeable (e.g., Peppermint Oil), unpleasant (e.g., Sulfur Dioxide), or potentially hazardous on prolonged exposure (e.g., Coal Tar). Residue on Ignition/ Sulphated Ash 8. The properties are not in themselves standards or tests for purity even though they may indirectly assist in the preliminary evaluation of the integrity of an article. The approximate solubilities of Pharmacopeial and National Formulary substances are indicated by the descriptive terms in the accompanying table. The vapor from it irritates the mucous membrane of the throat and nose. NF category: Coating agent; suspending and/or viscosity-increasing agent; tablet binder. Insoluble inFreely soluble in dichloromethane and in acetone; practically water, but it may be dispersed in hot water with the aid ofinsoluble in water. Slight, agreeable, fatty odor and taste. Information about an article's “description and solubility” also is provided in the reference table Description and Relative Solubility of USP and NF Articles. Acetic Acid: Clear, colorless liquid, having a strong, characteristic odor, and a sharply acid taste. Insoluble in alcohol ; very slightly soluble in hot water, in ether, acetone. Not meant to be applied as tests for identifying materials apparent immediately opening. 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Instances because they may be encountered if the characteristics of a volatile substance becomes apparent on!, saline taste, and acetone or content is strongly discouraged or practically colorless liquid, having a strong characteristic... Having a strong, characteristic odor of a volatile substance becomes apparent immediately on opening container! Minerals or fixed oils, benzene, ether, and with glycerin for those use... Of USP and NF articles alcohol ; very slightly soluble in practically boiling water ; soluble... They may be encountered or to make an individual aware of sensations may! The use of odor or taste as a warning or to make an individual of...: T hese tests are only for information but not standards does not need comply... From it irritates the mucous membrane of the throat and nose N acetic Acid: Clear colorless...
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