General Pharmacopoeia Monograph "Osmolarity". Unless otherwise specified in the Pharmacopoeia Monograph, pharmaceuti-cal forms designed for infusion should be tested for the presence of bacterial endo-toxins in accordance with the requirements of the General Pharmacopoeia Mono-graph …
Availability And Storage: Each 45 mL of red liquid contains: alcohol 15%, pipradrol HCl 2 mg, thiamine HCl 10 mg, riboflavin 5 mg, pyridoxine HCl 1.9 mg, niacinamide 50 mg, choline 100 mg, inositol 100 mg. Nonmedicinal ingredients: alcohol, artificial date flavor, butylparaben, caramel flavor, cherry flavor, dextrose, FD&C Blue #1, FD&C Red #2, fructose, hydrochloric acid, sodium hydroxide and sorbitol. …
monograph requirements apply and supersede the require-official titles may not be used as substitutes for official titles. ments of the General Notices or the general chapter, Official articles include both official substances and official whether or not the monograph explicitly states the products. An official substance is a drug substance .
METRONIDAZOLE General Monograph, Antibacterial - Antiprotozoal Pharmacology: Metronidazole is amebicidal, trichomonacidal and bactericidal. A chemically reactive, reduced form of metronidazole is thought to be responsible for the drug's activity.
Submission Guideline for Chemical Medicines . G1.06-00 Page 4 of 21 . EFFECTIVE DATE 04/29/2016 • Introduction of new techniques will be considered on a case-by-case basis. It is preferable to start with the development of a general chapter describing the technique before referencing the technique in a monograph. Please contact
USP-NF SF in which S is the volume, in mL, of the Reagent consumed in the second titration; and F is the water equivalence factor of the Reagent. Method Ib (Residual Titration) Principle—See the information given in the section Principle under Method Ia.In the residual titration, excess Reagent is added to the test specimen, sufficient time is allowed for the
698 DELIVERABLE VOLUME. . whether supplied as liquid preparations or liquid preparations that are constituted from solids upon the addition of a designated volume of a specific diluent. They are not required for an article packaged in single-unit containers when the monograph includes the Uniformity of Dosage Units 905 test.
Monographs General Monographs General monographs on dosage forms include requirements of general application and apply to all preparations within the scope of the Introduction section of the general monograph, except where a preamble limits the application. The requirements are not necessarily comprehensive for a given
High-pressure liquid chromatography (HPLC), sometimes called high-performance liquid chromatography, is a separation technique based on a solid stationary phase and a liquid mobile phase. Separations are achieved by partition, adsorption, or ion-exchange processes, depending upon the type of stationary phase used.
2 〈1〉 Injections / General Requirements USP 31 less proscribed in the individual monograph, provided they areContainers for Injections that are intended for use as dialysis, harmless in the amounts administered and do not interfere with thehemofiltration, or irrigation solutions and that contain a volume of
Presentations of powder (usually single-dose presentations, for example, a small sachet) that are intended to be issued to the patient as a powder, to be taken in or with water or another suitable liquid, are outside the scope of this general monograph. Such preparations are controlled by the monograph for Oral powders. Definition
Liquid-In-GlassThermometry JacquelynA.Wise ThisMonograph,whichsupersedesNBSMonograph90,containsinformationofgeneralinterest tomanufacturersandusersofliquid-in .
Questions and Answers on Current Good Manufacturing Practices—Control of Components and Drug Product Containers and Closures. Do the CGMP regulations permit the destruction of an internal .
Get more out of the British Pharmacopoeia with the free 'How to use the BP' guide Get the 'How to use the BP' guide
Literature: Indonesia Pharmacopoeia III. Pastae Pasta. Pasta is a soft mass of the dosage form is intended for external use, is usually created by mixing ingredients in the form of powder in large quantities with petroleum jelly or liquid paraffin or a base material is made fat with glycerol, musilago ataui soap.
There is a possibility that liquid dosage forms of iron may stain teeth. To reduce this possibility, mix each dose with water or fruit juice. If staining occurs, remove by …
monographs and in the general monographSubstances for pharmaceutical use (2034).Specificmonographhe general monograph are complementary: specific monographs prescribe acceptance criteria for impurities whereas the general monograph deals with the need for qualification, identification and reporting of any organic impurities that occur inactive
Monographs: Dosage forms: General monographs: Capsules. The requirements of this monograph do not necessarily apply to preparations that are presented as capsules intended for use other than by oral administration, such as vaginal or rectal capsules or capsules for inhalation. . liquid or of a paste-like consistency. Capsule shells and .
Monographs: Dosage forms: General monographs: Tablets Definition : Tablets are solid dosage forms containing one or more active ingredients. They are obtained by single or multiple compression (in certain cases they are moulded) and may be uncoated or coated.
in General Information ChapterPharmaceutical Dosage Forms h1151i. Collodion Collodion (pyroxylin solution; see USP monograph), is a solution of nitrocellulose in ether and acetone, some-timeswiththeadditionofalcohol.Asthevolatilesolvents evaporate, a dry celluloid-like ﬁlm is left on the skin. Be-cause the medicinal use of a collodion depends on the
Viscosity is a property of liquids that is closely related to the resistance to flow. It is defined in terms of the force required to move one plane surface continuously past another under specified steady-state conditions when the space between is filled by the liquid in question.
In general, transaminase elevations of greater than 3 times the ULN in the presence of elevated bilirubin without an alternative explanation are an important predictor of severe liver injury. Early identification of elevated liver enzymes may decrease the risk of a serious outcome. . For additional information until a more detailed monograph .
formulations of OTC pediatric oral liquid drug products and market only the 160 mg/5 mL 3 For more information about the IAAA monograph, see FDA's Web site at
USP 35 General Requirements / 〈1〉 Injections33 General Chapters General Tests and Assays 1. [DRUG] Injection—Liquid preparations that are drug General Requirements for substances or solutions thereof. 2. [DRUG] for Injection—Dry solids that, upon the addi- Tests and Assays tion of suitable vehicles, yield solutions conforming in all respects to the requirements for Injections.
The specific gravity of the liquid USP29 is the quotient obtained by dividing the weight of the liquid USP29 contained in the pycnometer by the weight of water contained in it, USP29 both determined at 25, unless otherwise directed in the individual monograph.
drug monograph: a statement that specifies the kinds and amounts of ingredients a drug or class of drugs may contain, the directions for the drug's use, the conditions in which it may be used, and the contraindications to its use.
1 A monograph on a herbal drug or a herbal drug preparation is drafted with the same overall 2 structure as a monograph on a chemical substance and both the latest versions of the 3 Technical guide for the elaboration of monographs and of the Style guide apply to 4 monographs on herbal drugs and herbal drug preparations.
USP will maintain one Dextrose monograph to incorporate both the anhydrous and monohydrate forms. Added Infrared, Chromatographic identity, and Water tests for ID test. Removed the ID test by color reaction. Added the new assay test by liquid chromatography. Added the new related substances test by liquid chromatography.
EUROPEAN PHARMACOPOEIA 6.0 2.2.1. 2.2. 2.2.1. VISUAL METHOD Using identical test-tubes of colourless, transparent, neutral glass with a flat base and an internal diameter of 15-25 mm, compare the liquid to be examined with a reference suspension freshly prepared as described below, the depth of the layer being 40 mm.