free medical books pdf download sites to in-process testing ; european pharmacopoeia 8.0 free download pdf to testing that is to be carried out euroean the manufacturer on the nal article, downloav on european pharmacopoeia 8.0 free download pdf batches or on each batch prior to release. The measurements result in absolute viscosity values, which can be compared with any other absolute values. The examination is carried out in diffused light. Heads of Medicines Agency.">
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European Pharmacopoeia Ph. Advanced embedding details, examples, and help! Topics 01 Collection opensource. There are no reviews yet. Carry out 3 and the chromatographic plate under examination used in a determinations on any given dropper. No result may deviate by pharmacopoeial test should never exceed the distance used to more than 5 per cent from the mean of the 3 determinations. Sieves are constructed of suitable materials with square meshes.
For purposes other than analytical procedures, sieves with circular meshes may be used, the internal diameters of which are 1. There must be no reaction between the material of the sieve and the substance being sifted. Degree of comminution is prescribed in the monograph using the sieve number, which is the size of the mesh in micrometres, given in parenthesis after the name of the substance Table 2.
Wire diameter d : the wire diameters given in Table 2. The nominal sizes of the wire diameters may depart from these values within the limits dmax and dmin. The limits dene a permissible range of choice 15 per cent of the recommended nominal dimensions. The wires in a test sieve shall be of a similar diameter in warp and weft directions.
Table 2. Information on the reactivity for various oils is 2. If the oil used is TESTS not cited in the leaet, the tube manufacturer must verify the reactivity and if necessary provide a tube specic for this oil.
Tubes used for comparative tests are matched tubes of colourless glass with a uniform internal diameter. The base is transparent and at. A column of the liquid is examined down the vertical axis of the tube against a white background, or if necessary, against a black background. The examination is carried out in diffused light.
It is assumed that tubes with an internal diameter of 16 mm will be used. Tubes with a larger internal diameter may be used instead but the volume of liquid examined must then be increased so that the depth of liquid in the tubes is not less than where the prescribed volume of liquid and tubes 16 mm in internal diameter are used.
Gas supply 5. Indicator tube. Figure 2. Apparatus for gas detector tubes Carbon dioxide detector tube. Sealed glass tube containing Gas detector tubes are cylindrical, sealed tubes consisting of adsorbent lters and suitable supports for hydrazine and an inert transparent material and are constructed to allow crystal violet indicators.
The minimum value indicated is the passage of gas. They contain reagents adsorbed onto ppm with a relative standard deviation of at most 15 per inert substrates that are suitable for the visualisation of the cent.
The minimum value indicated is 0. Sealed glass tube containing adsorbent tube. The length of the coloured layer or the intensity of a colour change on a Nitrogen monoxide and nitrogen dioxide detector graduated scale gives an indication of the impurities present. Sealed glass tube containing adsorbent lters and suitable supports for an oxidising layer Cr VI salt and the The calibration of the detector tubes is veried according to diphenylbenzidine indicator.
The minimum value indicated is the manufacturers instructions. Examine according to the manufacturers cent. Sealed glass tube The gas supply is connected to a suitable pressure regulator containing adsorbent lters and suitable supports for di-iodine and needle valve. Connect the exible tubing tted with a pentoxide, selenium dioxide and fuming sulfuric acid Y-piece to the valve and adjust the ow of gas to be examined indicators.
The minimum value indicated is 5 ppm or less, to purge the tubing in order to obtain an appropriate ow with a relative standard deviation of at most 15 per cent.
Prepare the indicator tube and t to the Hydrogen sulde detector tube. Sealed glass tube containing metering pump, following the manufacturers instructions. Connect the open end of the indicator tube to the short leg of adsorbent lters and suitable supports for an appropriate lead salt indicator. The minimum value indicated is 1 ppm or less, the tubing and operate the pump by the appropriate number with a relative standard deviation of at most 10 per cent.
Read the value corresponding to the length Water vapour detector tube. Sealed glass tube containing of the coloured layer or the intensity of the colour on the adsorbent lters and suitable supports for the magnesium graduated scale.
If a negative result is achieved, indicator perchlorate indicator. The minimum value indicated is tubes can be veried with a calibration gas containing the 67 ppm or less, with a relative standard deviation of at most appropriate impurity. Compare the solutions in diffused daylight 5 min after preparation of the reference suspension, viewing vertically against a black background.
The diffusion of light must be such that reference suspension I can readily be distinguished from water R, and that reference suspension II can readily be distinguished from reference suspension I. A liquid is considered clear if its clarity is the same as that of water R or of the solvent used when examined under the conditions described above, or if its opalescence is not more pronounced than that of reference suspension I.
Hydrazine sulfate solution. Dissolve 1. Allow to stand for h. Hexamethylenetetramine solution. In a mL ground-glass-stoppered ask, dissolve 2. Primary opalescent suspension formazin suspension. To the hexamethylenetetramine solution in the ask add Mix and allow to stand for 24 h.
This suspension is stable for 2 months, provided it is stored in a glass container free from surface defects. The suspension must not adhere to the glass and must be well mixed before use.
Standard of opalescence. Dilute This suspension is freshly prepared and may be stored for up to 24 h. Reference suspensions. Prepare the reference suspensions according to Table 2. Mix and shake before use.
Turbidity standard. The formazin suspension prepared by mixing equal volumes of the hydrazine sulfate solution and the hexamethylenetetramine solution is dened as a NTU nephelometric turbidity units primary reference standard.
Stabilised formazin suspensions that can be used to prepare stable, diluted turbidity standards are available commercially and may be used after comparison with the standards prepared as described.
Formazin has several desirable characteristics that make it an excellent turbidity standard. It can be reproducibly prepared from assayed raw materials.
The physical characteristics make it a desirable light-scatter calibration standard. The formazin polymer consists of chains of different lengths, which fold into random congurations. This results in a wide assay of particle shapes and sizes, which analytically ts the possibility of different particle sizes and shapes that are found in the real samples. Due to formazins reproducibility, scattering General Notices 1 apply to all monographs and other texts.
For turbidity measurement of coloured samples, ratio turbidimetry and nephelometry with ratio selection are used. The light scattering effect of suspended particles can be measured by observation of either the transmitted light turbidimetry or the scattered light nephelometry. Ratio turbidimetry combines the principles of both nephelometry and turbidimetry. Turbidimetry and nephelometry are useful for the measurement of slightly opalescent suspensions.
Reference suspensions produced under well-dened conditions must be used. For quantitative measurements, the construction of calibration curves is essential, since the relationship between the optical properties of the suspension and the concentration of the dispersed phase is at best semi-empirical.
The determination of opalescence of coloured liquids is done with ratio turbidimeters or nephelometers with ratio selection, since colour provides a negative interference, attenuating both incident and scattered light and lowering the turbidity value.
The effect is so great for even moderately coloured samples that conventional nephelometers cannot be used. The instrumental assessment of clarity and opalescence provides a more discriminatory test that does not depend on the visual acuity of the analyst.
Numerical results are more useful for quality monitoring and process control, especially in stability studies. For example, previous numerical data on stability can be projected to determine whether a given batch of dosage formulation or active pharmaceutical ingredient will exceed shelf-life limits prior to the expiry date.
A certain portion of the light beam entering a turbid liquid is transmitted, another portion is absorbed and the remaining portion is scattered by the suspended particles. If measurement is made at 90 to the light beam, the light scattered by the suspended particles can be used for the determination of their concentration, provided the number and size of particles inuencing the scattering remain constant.
The reference suspension must maintain a constant degree of turbidity and the sample and reference suspensions must be prepared under identical conditions. The Tyndall effect depends upon both the number of particles and their size. Nephelometric measurements are more reliable in low turbidity ranges, where there is a linear relationship between nephelometric turbidity unit NTU values and relative detector signals.
As the degree of turbidity increases, not all the particles are exposed to the incident light and the scattered radiation of other particles is hindered on its way to the detector. The maximum nephelometric values at which reliable measurements can be made lie in the range of NTU. Linearity must be demonstrated by constructing a calibration curve using at least 4 concentrations. This is an expression of the optical property that causes light to be scattered and absorbed rather than transmitted in a straight line through the sample.
The quantity of solid material in suspension can be determined by the measurement of the. A linear relationship between turbidity and concentration is obtained when the particle sizes are uniform and homogeneous in the suspension. This is true only in very dilute suspensions containing small particles. Linearity between turbidity and concentration must be established by constructing a calibration curve using at least 4 concentrations.
This procedure compensates for the light that is diminished by the colour of the sample. The inuence of the colour of the sample may also be eliminated by using an infrared light-emitting diode IR LED at nm as the light source of the instrument. The instruments photodiode detectors receive and measure scattered light at a 90 angle from the sample as well as measuring the forward scatter light reected in front of the sample along with the measurement of light transmitted directly through the sample.
The measuring results are given in NTU ratio and are obtained by calculating the ratio of the 90 angle scattered light measured to the sum of the components of forward scattered and transmitted light values. In ratio turbidimetry the inuence of stray light becomes negligible. Nephelometers are used for measurements of the degree of opalescence of colourless liquids. Measurements of reference suspensions I-IV with a ratio turbidimeter show a linear relationship between the concentrations and measured NTU values see Table 2.
Reference suspensions I-IV Ph. Instrumental methods may also be used for determining compliance with monograph requirements once the suitability of the instrument as described below has been established and calibration with reference suspensions I-IV and with water R or the solvent used has been performed. Ratio turbidimeters or nephelometers with selectable ratio application use as light source a tungsten lamp with spectral sensitivity at about nm operating at a lament colour temperature of K, or IR LED having an emission maximum at nm with a 60 nm spectral bandwidth.
Other suitable light sources may also be used. Silicon photodiodes and photomultipliers are commonly used as detectors and record changes in light scattered or transmitted by the sample. The light scattered at 90 2. Other detectors are those to detect back and forward scatter as well as transmitted light. The instruments used are calibrated against standards of known turbidity and are capable of automatic determination of turbidity. The test results expressed in NTU units are obtained directly from the instrument and compared to the specications in the individual monographs.
Instruments complying with the following specications are suitable. Measuring units : NTU. NTU is based on the turbidity of a primary reference standard of formazin. These units are used in all 3 instrumental methods nephelometry, turbidimetry and ratio turbidimetry. Measuring range : 0. Resolution : 0. The instrument is calibrated and controlled with reference standards of formazin. Repeatability : NTU : 0. Calibration : with 4 reference suspensions of formazin in the range of interest.
Reference suspensions described in this chapter or suitable reference standards calibrated against the primary reference suspensions may be used. Instruments complying with the above characteristics and veried using the reference suspensions described under Visual method may be used instead of visual examination for determination of compliance with monograph requirements.
Instruments with range or resolution, accuracy and repeatability capabilities other than those mentioned above may be used provided they are sufciently validated and are capable for the intended use. The instrument and methodology should be consistent with the attributes of the product to be tested. A solution is colourless if it has the appearance of water R or the solvent or is not more intensely coloured than reference solution B9.
Compare the colours in diffused daylight, viewing horizontally against a white background. METHOD II Using identical tubes of colourless, transparent, neutral glass with a at base and an internal diameter of 15 mm to 25 mm, compare the liquid to be examined with water R or the solvent or the reference solution see Tables of reference solutions prescribed in the monograph, the depth of the layer being 40 mm.
Compare the colours in diffused daylight, viewing vertically against a white background. Dissolve 46 g of ferric chloride R in about mL of a mixture of 25 mL of hydrochloric acid R and mL of water R and dilute to Titrate and adjust the solution to contain Protect the solution from light. Red solution. Dissolve 60 g of cobalt chloride R in about mL of a mixture of 25 mL of hydrochloric acid R and mL of water R and dilute to Place in a mL conical ask tted with a ground-glass stopper, Titrate the liberated iodine with 0.
Place in a mL conical ask tted with a ground-glass stopper, 5. Boil gently for 10 min, allow to cool and add 60 mL of dilute sulfuric acid R and 2 g of potassium iodide R.
Close the ask and dissolve the precipitate by shaking gently. The end-point is reached when the solution turns pink. Blue primary solution. Dissolve 63 g of copper sulfate R in about mL of a mixture of 25 mL of hydrochloric acid R and mL of water R and dilute to The end-point is reached when the solution shows a slight pale brown colour. Standard solutions Using the 3 primary solutions, prepare the 5 standard solutions as follows Table 2. Reference solutions for Methods I and II Using the 5 standard solutions, prepare the following reference solutions.
General Notices 1 apply to all monographs and other texts. Storage For Method I, the reference solutions may be stored in sealed tubes of colourless, transparent, neutral glass of 12 mm external diameter, protected from light.
Unless otherwise prescribed in the monograph, all measurements are made at the same temperature C. For the temperature correction, when necessary, follow the manufacturers instructions.
The apparatus is calibrated with the buffer solution of potassium hydrogen phthalate primary standard and 1 other buffer solution of different pH preferably one shown in Table 2. The pH of a third buffer solution of intermediate pH read off on the scale must not differ by more than 0.
Immerse the electrodes in the solution to be examined and take the reading in the same conditions as for the buffer solutions. When the apparatus is in frequent use, checks must be carried out regularly. If not, such checks should be carried out before each measurement.
All solutions to be examined and the reference buffer solutions must be prepared using carbon dioxide-free water R. For Method II, prepare the reference solutions immediately before use from the standard solutions. Dissolve Filter or decant. Prepare immediately before use. The pH is a number which represents conventionally the hydrogen ion concentration of an aqueous solution.
For practical purposes, its denition is an experimental one. The pH of a solution to be examined is related to that of a reference solution pHs by the following equation :. Potassium dihydrogen citrate 0. Potassium hydrogen phthalate 0. Potassium dihydrogen phosphate 0. Dissolve 3. The potentiometric determination of pH is made by measuring the potential difference between 2 appropriate electrodes immersed in the solution to be examined : 1 of these electrodes is sensitive to hydrogen ions usually a glass electrode and the other is the reference electrode for example, a saturated calomel electrode.
The measuring apparatus is a voltmeter with an input resistance at least times that of the electrodes used. It is normally graduated in pH units and has a sensitivity such that discrimination of at least 0. More information is available on the European Pharmacopoeia 10th Edition website. Council for europe portal. Language : en Search Choose language.
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