鏂规璇︽儏锛欬/div>

娆ф床鑽吀锛欬/span>

Clarity and degree of opalescence of liquids

VISUAL METHOD涓€鑸柟娉旤/span>

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. 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.

鍦ㄥ唴寰?5锝?5mm锛屽钩搴曪紝鏃犺壊銆侀€忔槑銆佷腑鎬х幓鐠冪涓紝鍔犲叆绛夐噺鐨勪緵璇曟憾娑蹭笌娴婂害鏍囧噯娑诧紝浣挎恫浣嶇殑娣卞害閮戒负40mm锛屾寜濡備笅鎵€杩版柟娉曡繘琛屾瘮杈冦€傛祳搴︽爣鍑嗘恫鍒跺5鍒嗛挓鍚庯紝浠ヨ壊鏁ｈ嚜鐒跺厜鐓у皠娴婂害鏍囧噯婧舵恫鍜屼緵璇曟憾娑诧紝鍦ㄩ粦鑹茶儗鏅笅浠庡瀭鐩存柟鍚戣瀵熴€佹瘮杈冩緞娓呭害鎴朁/span>

娴戞祳绋嬪害銆傝壊鏁ｈ嚜鐒跺厜蹇呴』杈冨鏄撳尯鍒嗘祳搴︽爣鍑嗘憾娑测厾涓庢按锛屾祳搴︽爣鍑嗘憾娑测叀涓庢祳搴︽爣鍑嗘憾娑测厾

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.

濡傛灉渚涜瘯婧舵恫鐨勬緞娓呫€侀€忔槑绋嬪害涓庢按鐩稿悓锛屾垨鑰呬笌鎵€鐢ㄦ憾鍓傜浉鍚岋紝鎴栬€呭叾婢勬竻搴︿笉瓒呰繃鈪犲彿娴婂害鏍囧噯婧舵恫锛岄偅涔堝彲鍒ゅ畾璇ユ憾娑蹭负婢勬竻銆侟/span>

Hydrazine sulfate solution. Dissolve 1.0 g of hydrazine sulfate R in water R and dilute to 100.0 mL with the same solvent. Allow to stand for 4-6 h.

纭吀鑲兼憾娑诧細鍙?.0g纭吀鑲兼憾浜庢按锛屽姞姘寸█閲婅嚦100.0ml锛岄潤缃?锝?灏忔椂銆侟/span>

Hexamethylenetetramine solution. In a 100 mL ground-glass-stoppered flask, dissolve 2.5 g of hexamethylenetetramine R in 25.0 mL of water R.

涔屾礇鎵樺搧锛堝叚浜氱敳鍩哄洓鑳猴級婧舵恫 锛氬湪100ml瀹归噺鐡朵腑锛屼互25.0ml姘存憾瑙?.5g涔屾礇鎵樺搧銆侟/span>

Primary opalescent suspension (formazin suspension).

To the examethylenetetramine solution in the flask add 25.0 mL of the hydrazine sulfate solution. 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.

娴婂害鏍囧噯璐娑诧細鍦ㄥ瓨鏀句箤娲涙墭鍝佹憾娑茬殑100ml瀹归噺鐡朵腑锛屽姞25.0ml鐨勭～閰歌偧婧舵恫銆傛贩鍚堬紝闈欑疆24灏忔椂锛岃串瀛樺湪鏃犺〃闈㈣姹傜殑鐜荤拑瀹瑰櫒涓紝鍙湪2涓湀鍐呬娇鐢ㄣ€傝娴婂害娑蹭笉寰楅粡闄勭幓鐠冿紝鐢ㄥ墠蹇呴』鍏呭垎鎽囧寑銆侟/span>

Standard of opalescence. Dilute 15.0 mL of the primary opalescent suspension to 1000.0 mL with water R. This suspension is freshly prepared and may be stored for up to 24 h.

娴婂害鏍囧噯鍘熸恫锛氬彇娴婂害鏍囧噯璐娑?5ml锛屽姞姘寸█閲娿€佸畾瀹硅嚦1000ml銆傝娑蹭复鐢ㄥ墠鍒跺锛岃嚦澶氫繚瀛?4灏忔椂銆侟/span>

Reference suspensions. Prepare the reference suspensions according to Table 2.2.1.-1. Mix and shake before use.

娴婂害鏍囧噯娑诧細鐢辨祳搴︽爣鍑嗗師娑蹭笌姘存寜琛?-1閰嶅埗,鍗冲緱銆傛湰娑插簲涓寸敤鍓嶉厤鍒躲€侟/span>

Table 1.-1

Turbidity standard. The formazin suspension prepared by mixing equal volumes of the hydrazine sulfate solution and the hexamethylenetetramine solution is defined as a 4000 NTU (nephelometric turbidity units) primary reference standard. Reference suspensions I, II, III and IV have values of 3 NTU, 6 NTU, 18 NTU and 30 NTU respectively. 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.

娴婂害鏍囧噯锛氫钩鍏夋偓娴婅串澶囨恫[纭吀鑲兼憾娑插拰涔屾礇鎵樺搧锛堝叚浜氱敳鍩哄洓鑳猴級婧舵恫浠ョ瓑閲忎綋绉贩鍚圿瀹氫负4000NTU锛堟瘮娴婃祴瀹氭硶鐨勬祳搴﹀崟浣嶏級鍌ㄥ娑插鐓ф爣鍑?娴婂害鏍囧噯娑睮, II, III 鍜?nbsp;IV鐩稿簲鐨凬TU鍊煎垎鍒槸3 NTU, 6 NTU, 18 NTU 鍜?nbsp;30 NTU銆傜ǔ瀹氱殑涔冲厜鎮祳璐娑插彲鐢ㄤ簬绋€閲婂埗澶囨祳搴︽爣鍑嗭紝鍏锋湁鐜板疄鐨勫晢涓氫环鍊硷紝涔熷彲浠ヤ笌涓婅堪鐨勬爣鍑嗗寲鍒跺杩涜杈冦€侟/span>

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 configurations. This results in a wide assay of particle shapes and sizes, which analytically fits the possibility of different particle sizes and shapes that are found in the real samples. Due to formazin鈥檚 reproducibility, scattering characteristics and traceability, instrument calibration algorithms and performance criteria are mostly based on this standard.

鍥犵椹皵鑲煎叿鏈変竴浜涙垜浠墍甯屾湜鐨勭壒鎬э紝鎵€浠ュ畠鏄竴绉嶉潪甯镐紭鑹殑娴婂害鏍囧噯鐗┿€傚畠鍙互浠庤娴嬪師鏂欎腑鍙嶅鍒跺銆傚叿鏈夋墍鎯宠鐨勫厜闂皠鏍℃鏍囧噯鍖栫殑鐗╃悊鐗规€с€傜椹皵鑲艰仛鍚堢墿鐢变笉鍚岄暱搴︾殑閾剧粍鎴愶紝浠栦滑鍙互鎶樻垚鍚勭褰㈢姸锛屽簲姝ゅ彲浠ュ垎鏋愪笉鍚屽ぇ灏忓拰褰㈢姸鐨勭矑瀛愩€傝繖涓€鐗规€т娇寰楁垜浠彲浠ュ鐜板疄鏍峰搧涓墍鍏锋湁鐨勪笉鍚屽ぇ灏忓強鎬х姸鐨勭矑瀛愯繘琛屾祴瀹氥€傜敱浜庛€傜椹皵鑲煎叿鏈夊彲閲嶅鎬с€佸厜鏁ｅ皠鎬с€佸彲鎻忕粯鎬с€佷华鍣ㄦ牎鍑嗗彲绠楀拰鎿嶄綔鏍囧噯鍖栫殑鐗规€э紝浣垮叾鎴愪负浜嗘祳搴︽爣鍑嗙墿銆侟/span>

instrumental methods Introduction

浠櫒鏂规硶绠€浠婞/span>

The degree of opalescence may also be determined by instrumental measurement of the light absorbed or scattered on account of submicroscopic optical density inhomogeneities of opalescent solutions and suspensions. 2 such techniques are nephelometry and turbidimetry. For turbidity measurement of coloured samples, ratio turbidimetry and nephelometry with ratio selection are used.

璇ヤ华鍣ㄦ槸鏍规嵁娴戞祳娑插拰鎮祳娑蹭簹鏄惧井闀滃厜瀵嗗害鐨勪笉鍧囦竴鎬ф潵娴嬮噺鍏夌殑鍚告敹鎴栧厜鐨勬暎灏勶紝鍗虫暎灏勬祴娴婃硶鍜岄€忓皠娴嬫祳娉曘€傚浜庢湁鑹叉牱鍝佺殑娴婂害娴嬭瘯娉曪紝瑕佺敤鍒版瘮鐜囬€忓皠姣旀祳娉曞拰鍙€夋嫨姣旂巼鐨勬暎灏勬瘮娴婃硶銆侟/span>

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-defined 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.

閫氳繃鎶曞皠鍏夛紙鎶曞皠姣旀祳娉曪級鎴栨暎灏勫厜锛堟暎灏勬瘮娴婃硶锛夋潵娴嬮噺娣锋偓绮掑瓙鐨勫厜鏁ｅ皠鏁堣兘銆傛祳搴︽瘮鐜囩粨鍚堜簡閫忓皠姣旀祳娉曞拰鏁ｅ皠姣旀祳娉曚簩鑰呯殑鍘熺悊銆傞€忓皠姣旀祳娉曞拰鏁ｅ皠姣旀祳娉曠敤浜庢祴閲忓叿鏈夎交寰钩鍏夌殑娣锋偓娑层€傚繀椤讳娇鐢ㄥ湪鐨勬潯浠朵笅鍒跺緱鐨勬爣鍑嗘贩鎮恫銆傚洜涓烘贩鎮恫鐨勫厜瀛︽€ц川涓庡垎鏁ｇ浉鐨勬祿搴︿箣闂寸殑鍏崇郴澶氭槸涓€涓崐缁忛獙鍊硷紝鎵€浠ュ畾閲忔祴瀹氫富瑕佷娇鐢ㄦ爣鍑嗘洸绾挎硶銆侟/span>

The determination of opalescence of colored liquids is done with ratio turbidimeters or nephelometers with ratio selection, since color provides a negative interference, attenuating both incident and scattered light and lowering the turbidity value. The effect is so great for even moderately colored samples that conventional nephelometers cannot be used.

鍥犱负婧舵恫棰滆壊浼氫骇鐢熻礋骞叉壈锛岃“鍑忓叆灏勫厜鍜屾暎灏勫厜骞堕檷浣庢祳搴﹀€硷紝鐢ㄦ瘮鐜囬€忓皠娴婂害娉曞拰鍙€夋嫨姣旂巼鐨勬暎灏勬祳搴︽硶娴嬪畾鏈夎壊婧舵恫鐨勪钩鍏夈€傚浜庢濂介€傚害鐨勬湁鑹叉牱鍝侊紝鏁堟灉闈炲父濂斤紝浠ヨ嚦浜庡父瑙勭殑娴婂害浠笉鍐嶄娇鐢ㄣ€侟/span>

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.

鐢ㄤ华鍣ㄦ潵鍒ゆ柇婢勬竻搴﹀拰涔冲厜锛岃瘯楠屾墍鎻愪緵鐨勫垎杈ㄨ兘鍔涙洿寮猴紝涓嶅啀渚濋潬鍒嗘瀽鑰呯殑瑙嗚鏁忛攼鎬ф潵鍒ゆ柇銆傚浜庡畾鎬х洃鎺у拰杩囩▼鎺у埗锛岀壒鍒槸绋冲畾鎬х爺绌讹紝鏁板瓧鍖栫粨鏋滄洿鏈夌敤銆備緥濡傦紝涔嬪墠鎵€寰楃殑鍏充簬绋冲畾鎬х殑鏁板瓧鍖栬祫鏂欑敤浜庡垽鏂竴涓粰瀹氭壒鍙风殑鍓傞噺鎴愬垎鎴栨椿鎬ц嵂鐗╃粍鍒嗘槸鍚﹁秴杩囦簡璐瓨鏈熼檺鎴栬€呮病杩囨湁鏁堟湡銆侟/span>

Nephelometry

When a suspension is viewed at right angles to the direction of the incident light, the system appears opalescent due to the reflection of light from the particles of the suspension (Tyndall effect). 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掳 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 influencing 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 1750-2000 NTU. Linearity must be demonstrated by constructing a calibration curve using at least 4 concentrations.

鏁ｅ皠姣旀祳娉曞綋娣锋偓娑插湪鍨傜洿浜庡叆灏勫厜鐨勬柟鍚戣瀵燂紝鍥犳贩鎮恫绮掑瓙浜х敓鐨勫弽灏勶紝绯荤粺鍑虹幇涔冲厜 (涓佽揪灏旀晥搴?.銆傝繘鍏ヤ竴涓祽娴婃恫鐨勫厜鏉燂紝涓€閮ㄥ垎琚€忚繃锛屼竴閮ㄥ垎琚惛鏀讹紝鍓╀綑閮ㄥ垎琚偓娴婄矑瀛愭暎灏勩€傚鏋滃湪涓庡厜鏉?0掳鐨勬柟鍚戞娴嬶紝鍋囧绮掑瓙鏁伴噺鍜屽ぇ灏忓鏁ｅ皠鐨勫奖鍝嶇淮鎸佸父鏁帮紝鍙互鐢ㄦ偓娴婄矑瀛愮殑鍏夋暎灏勬潵娴嬪畾浠栦滑鐨勬祿搴︺€傜収婧舵恫鐨勬祳搴﹀繀椤讳繚鎸佷笉鍙橈紝骞朵笖鏍峰搧鍜屽鐓ф贩鎮恫鍦ㄤ竴鏍风殑鏉′欢涓嬪埗澶囥€備竵杈惧皵鏁堝簲)渚濊禆浜庣矑瀛愮殑澶у皬鍜屾暟閲忋€傚湪浣庢祳搴﹁寖鍥达紝鍏夋暎灏勬祳搴︽硶鏇村彲闈狅紝鏁ｅ皠娉曟祳搴﹀崟浣嶅€煎拰鏈夊叧妫€娴嬪櫒淇″彿鎴愮嚎鎬с€傞殢娴婃祳搴︾殑澧炲姞锛屼笉鏄墍鏈夌殑绮掑瓙閮借兘鏆撮湶鍦ㄥ叆灏勫厜涓嬬殑锛屽苟涓斿湪鍒拌揪妫€娴嬪櫒鐨勯€斿緞涓紝鍏朵粬绮掑瓙鐨勬暎灏勫厜琚樆纰嶃€備竴涓彲闈犵殑娴嬮噺鎵€鑳芥祴閲忕殑澶ф暎灏勬祳搴﹀€兼槸1750-2000 NTU銆傚繀椤荤敤鑷冲皯4涓祿搴︽瀯寤烘爣鍑嗘洸绾挎潵璇佹槑绾挎€с€侟/span>

Turbidimetry

The optical property expressed as turbidity is the interaction between light and suspended particles in liquid. 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 transmitted light. 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.

閫忓皠娴婂害娉曞湪娑蹭綋涓偓娴婄矑瀛愬拰鍏変箣闂村瓨鍦ㄧ浉鍏虫€э紝杩欎竴鍏夊鐗规€ц〃绀轰负娴婂害銆傝〃绀虹殑鏄厜鍦ㄧ洿绾挎柟鍚戜笂鍙戠敓鐨勬暎灏勫拰鍚告敹锛岃€屼笉鏄厜鐩寸嚎閫氳繃鏍峰搧鐨勯€忓皠鍏夊鐗规€э紝閫氳繃娴嬮噺閫忓皠鍏夋潵娴嬪畾娣锋偓娑蹭腑鍥轰綋鐗╄川鐨勯噺銆傚綋娣锋偓娑蹭腑绮掑瓙鐨勫ぇ灏忓潎涓€涓旀€ц川鐩稿悓锛屽彲鑾峰緱娴婂害鍜屾祿搴︿箣闂寸殑绾挎€у叧绯汇€備粎浠呭湪寰堢█鐨勫惈鏈夊皯閲忕矑瀛愮殑娣锋偓娑蹭腑锛屾墠鍙疄鐜扮嚎鎬с€傚繀椤讳娇鐢ㄨ嚦灏?涓祿搴︽瀯寤烘爣鍑嗘洸绾挎潵璇佹槑娴婂害鍜屾祿搴﹂棿鍛堢嚎鎬с€侟/span>

Ratio Turbidimetry

In ratio turbidimetry the relationship of the transmission measurement to the 90掳 scattered light measurement is determined. This procedure compensates for the light that is diminished by the colour of the sample. The influence of the colour of the sample may also be eliminated by using an infrared light-emitting diode (IR LED) at 860 nm as the light source of the instrument. The instrument鈥檚 photodiode detectors receive and measure scattered light at a 90掳 angle from the sample as well as measuring the forward scatter (light reflected) 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掳 angle scattered light measured to the sum of the components of forward scattered and transmitted light values. In ratio turbidimetry the influence of stray light becomes negligible. Nephelometers are used for measurements ofthedegreeofopalescenceof锛涙瘮鐜囬€忓皠姣旀祳娉曟祴瀹氱殑鏄€忚鍏夌殑娴嬮噺鍜?0掳鏂瑰悜涓婏紱

Table 2.2.1.-2

INSTRUMENTAL DETERMINATION OF OPALESCENCE

涔冲厜鐨勪华鍣ㄦ祴瀹欬/span>

Requirements in monographs are expressed in terms of the visual examination method with the defined reference suspensions. 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.

涔冲厜鐨勪华鍣ㄦ祴瀹氬湪鐢ㄥ噯纭殑鍙傛瘮娣锋偓娑插畾涔夊彲瑙佹柟娉曟椂宸茶〃鏄庝簡瑕佹眰銆備竴鏃﹀悗闈㈡墍瑙勫畾鐨勫缓绔嬩簡浠櫒鐨勯€傚簲鎬э紝骞剁敤鍙傛瘮娣锋偓娑睮-IV鍜屾按鎴栦娇鐢ㄧ殑婧跺墏杩涜鏍℃锛屾枃涓殑鏂规硶涔熶娇鐢ㄤ簬浠櫒鏍℃銆侟/span>

Apparatus. Ratio turbidimeters or nephelometers with selectable ratio application use as light source a tungsten lamp with spectral sensitivity at about 550 nm operating at a filament colour temperature of 2700 K, or IR LED having an emission maximum at 860 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 卤 2.5掳 is detected by

the primary detector. 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 specifications in the individual monographs.

浠櫒锛氫娇鐢ㄥ彲閫夋嫨鐨勬瘮鐜囨祳搴﹁鍜屾祳搴﹁鏃讹紝鐢ㄩ挩鐏綔鍏夋簮锛屽湪2700K鐨勮氨绾挎爣璁版俯搴︽椂锛岄挩鐏湪澶х害550nm澶勬湁鐗规畩閫夋嫨鎬э紝鎴栬€呯敤鍦?60nm澶勬湁澶у彂灏勫苟涓旀湁60nm鍏夎氨瀹藉害鐨勭孩澶栧彂鍏変簩绾х銆備篃鍙互浣跨敤鍏朵粬鍚堥€傜殑鍏夋簮銆傚父鐢ㄧ鍒跺厜鐢典簩鏋佺鍜屽厜鐢靛€嶅绠′綔妫€娴嬪櫒锛屽苟璁板綍鍥犳牱鍝佷骇鐢熺殑鍏夋暎灏勬垨鍏夐€忓皠鐨勬敼鍙樸€備富瑕佹娴嬪櫒妫€娴嬪湪90 卤 2.5掳鏂瑰悜涓婄殑鍏夋暎灏勩€傚叾浠栫殑妫€娴嬪櫒妫€娴嬫湞鍚庡拰鏈濆墠鐨勫厜鏁ｅ皠锛屽氨鍍忔祴鍏夐€忓皠涓€鏍枫€備娇鐢ㄧ殑浠櫒鐢ㄥ凡鐭ユ祳搴︾殑鏍囧噯婧舵恫鏉ユ牎姝ｏ紝骞惰兘澶熻嚜鍔ㄦ祴瀹氭祳搴︺€備粠浠櫒涓婄洿鎺ヨ幏寰楃敤NTU鍗曚綅琛ㄧず鐨勬祴瀹氱粨鏋滐紝骞朵笖锛屽湪涓埆鏂囦腑涓庤瀹氳繘琛屾瘮杈冦€侟/span>

Instruments complying with the following specifications are suitable.

鏍规嵁鍚庨潰鐨勮鏄庝娇鐢ㄤ华鍣?/span>

鈥 Measuring units: NTU. NTU is based on the turbidity of a primary reference standard of formazin. FTU (Formazin Turbidity Units) or FNU (Formazin Nephelometry Units) are also used, and are equivalent to NTU in low regions (up to 40 NTU). These units are used in all 3 instrumental methods (nephelometry, turbidimetry and ratio turbidimetry).

鈥?nbsp;娴嬮噺鍗曚綅锛歂TU锛孨TU鏍规嵁鐨勬槸绂忓皵椹偧鏍囧噯鍌ㄥ娑茬殑娴婂害銆傛恫浣跨敤FTU锛堢灏旈┈鑲兼祳搴﹀崟浣嶏級鎴朏NU锛堢灏旈┈鑲兼暎灏勬祴娴婃硶鍗曚綅锛夊崟浣嶏紝鍦ㄤ綆娴婂害鑼冨洿鍐呯瓑浜嶯TU锛堝ぇ浜?0NTU锛夈€傝繖浜涘崟浣嶅湪鏁ｅ皠娴嬫祳娉曘€佹祳搴︽硶銆佹瘮鐜囨祳搴︽硶锛屼笁绉嶄华鍣ㄦ柟娉曚腑鍧囧彲浣跨敤銆侟/span>

鈥 Measuring range: 0.01-1100 NTU.

鈥?nbsp;娴嬮噺鑼冨洿锛?.01-1100NTU

鈥 Resolution: 0.01 NTU within the range of 0-10 NTU, 0.1 NTU within the range of 10-100 NTU, and 1 NTU for the range > 100 NTU. The instrument is calibrated and controlled with reference standards of formazin.

鈥?nbsp;鍒嗚鲸鐜囷細鍦?-10NTU鑼冨洿鍐呭垎杈ㄧ巼涓?.01NTU锛屽湪10-100NTU鑼冨洿鍐呭垎杈ㄧ巼涓?nbsp;0.1NTU锛屽湪>100NTU鑼冨洿鍐呭垎杈ㄧ巼涓?NTU銆傜敤绂忓皵椹偧鐨勫弬姣旀爣鍑嗘牎姝ｅ拰鎺у埗浠櫒銆侟/span>

鈥 Accuracy: 0-10 NTU: 卤 (2 per cent of reading + 0.01) NTU. 10-1000 NTU: 卤 5 percent.

鈥?nbsp;搴︼細0-10 NTU卤锛?%娴嬮噺璇绘暟+0.01锛塏TU锛?0-1000 NTU: 卤 5%

鈥 Repeatability: 0-10 NTU: 卤 0.01 NTU. 10-1000 NTU: 卤 2 per cent of the measured value.

鈥?nbsp;閲嶅鎬э細0-10 NTU卤 0.01 NTU锛?0-1000 NTU卤 2%鐨勬祴閲忓€稽/span>

鈥 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.

鈥?nbsp;鏍℃锛氱敤鍦ㄦ劅鍏磋叮鑼冨洿鍐呯殑4涓灏旈┈鑲煎弬姣旀贩鎮恫銆傚彲浠ョ敤鎸夋湰绔犺瀹氱殑鍙傛瘮娣锋偓娑叉垨鍚堥€傜殑鐩稿浜庡弬姣旀贩鎮恫鍌ㄥ娑叉爣鏈夊埢搴︾殑鍙傛瘮鏍囧噯鏉ユ牎姝ｃ€侟/span>

鈥 Stray light: this is a significant source of error in low level turbidimetric measurement;

stray light reaches the detector of an optical system, but does not come from the sample; < 0.15 NTU for the range 0-10 NTU, < 0.5 NTU for the range 10-1000 NTU. 鈥?nbsp;鏉傛暎鍏夛細鍦ㄤ綆姘村钩鐨勬祳搴︽祴瀹氫腑锛屾潅鏁ｅ厜鏄富瑕佺殑璇樊鏉ユ簮銆傛潅鏁ｅ厜灏辨槸鑳藉埌杈惧厜瀛︾郴

缁熺殑妫€娴嬪櫒锛屼絾涓嶆槸鐢变簬鏍峰搧鑰屼骇鐢熺殑鍏夈€?-10 NTU鐨勮寖鍥村唴鏉傛暎鍏?lt; 0.15 NTU锛?0-100NTU鐨勮寖鍥村唴鏉傛暎鍏?lt; 0.5 NTU銆侟/span>

Instruments complying with the above characteristics and verified using the reference suspensions described under Visual method may be used instead of visual examination for determination of compliance with monograph requirements.

绗﹀悎涓婇潰鐨勭壒鎬э紝骞剁敤鍦ㄥ彲瑙佹柟娉曚笅瑙勫畾鐨勫弬姣旀贩鎮恫杩涜鏍℃鐨勪华鍣紝鍦ㄨ繖鑼冨洿鍐咃紝杩欎簺浠櫒鍙浛浠ｅ彲瑙嗘鏌ワ紝杩欎簺妫€鏌ュ拰鏂囦腑瑕佹眰涓€鑷淬€侟/span>

Instruments with range or resolution, accuracy and repeatability capabilities other than those mentioned above may be used provided they are sufficiently validated and are capable for the intended use. The test methodology for the specific substance/product to be analysed must also be validated to demonstrate its analytical capability. The instrument and methodology should be consistent with the attributes of the product to be tested.

鎵€鎻愪緵鐨勪华鍣ㄧ殑浣跨敤鑼冨洿銆佸垎杈ㄧ巼銆佸噯纭害銆侀噸澶嶆€с€佸閲忓強鍏跺畠涓婇潰鎻愬埌鐨勫弬鏁帮紝杩欎簺鏄崄鍒嗘湁鏁堢殑骞惰兘澶熼鏈熶娇鐢ㄣ€傚浜庡垎鏋愮壒娈婄殑鐗╄川/浜у搧锛屼篃蹇呴』杩涜璇曢獙鏂规硶瀛﹂獙璇佹潵璇存槑鍏跺垎鏋愯兘鍔涖€備华鍣ㄥ拰鏂规硶瀛﹀簲璇ュ拰娴嬭瘯鏍峰搧鐨勭壒鎬т竴鑷淬€侟/span>

涓婃捣鑳ょ厡绉戞妧鏈夐檺鍏徃鍙互鎻愪緵涓撲笟鐨勬緞娓呭害妫€娴嬭澶囷紝娆㈣繋澶у鍜ㄨ銆侟/span>