Meanings of terms
Alcohol: The term “alcohol” without qualification means ethanol (95 percent). Other dilutions of ethanol are indicated by the term “ethanol” or “alcohol” followed by a statement of the percentage by volume of ethanol (CZH60) required.
Desiccator: A tightly closed container of suitable size and design that maintains an atmosphere of low moisture content by means of silica gel or phosphorus pentoxide or another suitable desiccant.
Drying and ignition to constant weight: Two consecutive weighings after the drying or igniting operations do not differ by more than 0.5 mg, the second weighing following an additional period of drying or of ignition respectively appropriate to the nature and quantity of the residue.
Ethanol: The term “ethanol” without qualification means anhydrous ethanol or absolute alcohol.
Filtration: Unless otherwise stated, filtration is the passing of a liquid through a suitable filter paper or equivalent device until the filtrate is clear.
Freshly prepared: Made not more than 24 hours before it is issued for use. ‘
Label: Any printed packing material, including package inserts that provide information on the article.
Negligible. A quantity not exceeding 0.50 mg.
Solution: Where the name of the solvent is not stated, “solution” implies a solution in water. The water used complies with the requirements of the monograph on Purified Water. The term ‘distilled water’ indicates Purified Water prepared by distillation.
Temperature: The symbol ‘0’ used without qualification indicates the use of the Celsius thermometric scale.
Water: If the term is used without qualification it means Purified Water of the Pharmacopoeia. The term ‘distilled water indicates Purified Water prepared by distillation.
Water-bath: Abath of boiling water unless water at another temperature is indicated. Other methods of heating may be used provided the required temperature is approximately maintained but not exceeded.
ProvisionsApplicableToMonographs and test methods
Expression of Contents: Where the content of a substance is defined, the expression “percent” is used according to circumstances with OI~e of two meanings:
- Percent w/w (percentage, weight in weight) expressing the number of grams of substance in 100 grams of final
- Per cent v/v (percentage, volume in volume) expressing the number ofmillilitres ofsubstance in 100 millilitres of final product.
The expression “parts per million” refers to the weight in weight, unless otherwise stated.
Where the content of a substance is expressed in terms of the chemical formula for that substance an upper limit exceeding 100 percent may be stated. Such an upper limit applies to the result of the assay calculated in terms of the equivalent content of the specified chemical formula. For example, the statement ‘contains not less than 99.0 percent and not more than 101.0 percent of C7H60 Z implies that the result of the assay is not less than 99.0 percent and not more than 101.0 percent, calculated in terms of the equivalent content of C7H6O2.
Where the result of an assay or test is required to be calculated with reference to the dried, anhydrous, ignited substance or the substance-free from solvent, the determination of loss on drying, water content, loss on ignition, the content of the specified solvent respectively is carried out by the method prescribed in the relevant test in the monograph.
Expression of Concentrations:
The following expressions in addition to the ones ‘given under Expression of Content are also used:’
- Percent w/v (percentage, weight in volume) expressing the number of grams of substance in 100 milliliters of
- Percent v/w (percentage, volume in weight) ~xpressing the number of in millilitres of substance in 100 grams of
Usually, the strength of solutions of solids in liquids is expressed as percentage weight in volume, of liquids in liquids
as percentage volume in volume, of solids in semi-solid bases (e.g. creams), and of gases in liquids as percentage weight in weight. ‘
When the concentration of a solution is expressed as, parts of dissolved substance in parts of the solution, it means parts by weight (g) of a solid in parts by volume (ml) of the final solution as parts by weight (g) of gas in parts by weight (g) of the final solution.
When the concentration of a solution is expressed in molarity designated by the symbol M preceded by a number, it denotes the number of moles of the stated solute that contained insufficient Purified Water (unless otherwise stated) to produce 1 liter of solution.
Abbreviated Statements: Incomplete sentences are employed in parts of the monographs for directness and brevity (for example, Iodine Value. Not more than…………………. Relative Density …….to …………..) Where the tests are abbreviated, it is to be understood that the test method referred to in brackets provides the method to be followed and that the values specified are the applicable limits.
Weights and Measures: The metric system of weights and measures is employed in Pharmacopoeia. All measures are required to be graduated at 25° C and all measurements in tests and assays, unless otherwise stated, are to be made at that temperature.
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During his career, he work in quality assurance department with multinational company’s i.e Zydus Cadila Ltd, Unichem Laboratories Ltd, Indoco remedies Ltd, Panacea Biotec Ltd, Nectar life Science Ltd. During his experience, he face may regulatory Audit i.e. USFDA, MHRA, ANVISA, MCC, TGA, EU –GMP, WHO –Geneva, ISO 9001-2008 and many ROW Regularities Audit i.e.Uganda,Kenya, Tanzania, Zimbabwe. He is currently leading a regulatory pharmaceutical company as a head Quality. You can join him by Email, Facebook, Google+, Twitter and YouTube