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  • Amidopirina HEBEI JIHENG FT (1.1) (VIGENTE)

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    YUNE GAVIRIA
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    Amidopirina HEBEI JIHENG FT (1.1) (VIGENTE) (1)

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    9 views4 pages

    Amidopirina HEBEI JIHENG FT (1.1) (VIGENTE)

    Uploaded by

    YUNE GAVIRIA

    Copyright:

    © All Rights Reserved
    Download as PDF or read online from Scribd
    Flag for inappropriate content
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    HEBEI JIHENG PHARMACEUTICAL CO., LTD Hk RHA HARA A ADD.: No.1 Weiwu Street, Hengshui Industri bei Province, China STAG Ae Bik TK HS 1 Aminopyrine (BPCS4) specification Sanderd Official Standard In house standard tem a Colorless or white | Colorless or white erystalline exystalline powder powder Identification = Positive action Melting point 107~ 109°C 107~109°C Chloride = 0.002% “Antipyrine and#-amino Not more color than the antipyrine reference Readily carbonizable y = Almost colorless substance Residue on ignition 1% 20.1% Heavy metal — SIS ppm 20% ethanol solution clarity os — clear, <1.Sml and color Color point aoe Assay, _ 299.0% Test procedure 1 Character: Colorless or white erystalline powder. 2. melting point :107~109°C Turning on the microcomputer melting point meter to set the starting temperature to 97°C, raising the temperature of the microcomputer melting point meter, taking the proper amount of the dried sample into the capillary tube, taking the long and clean glass tube and placing it vertically on the table, and putting the sample capillary tube from one end free falling to the other end, When the microcomputer melting point meter is stable at about 97°C, the temperature rise rate is adjusted to 1°C per minute, and when the temperature rises to 97°C, the capillary tube is inserted into the instrument. The instrument automatically shows the initial melting and its average value 3. Residue on ignition Procedure—Accurately weigh 1.0g of the sample into a crucible which has been ignited to a HEBEI JIHENG PHARMACEUTICAL CO., LTD Wt ke AWK AR A ADD.: No.1 Weiwu Street, Hengshui Industrial Park, Hebei Province, China SLAG 9 BAT PT 1 constant weight, accurately weigh, wet the sample with a small amount of sulfuric acid at low temperature to gradually heat up until the sample is carbonized, after cooling, wet the sample with a small amount of sulfuric acid, and gradually heated until white smoke is no longer produced. Ignite it to completely carbonize at 700-800°C, transfer it into a desiccator, coo! it at room temperature, accurately weigh, and then ignite it to constant weight at 700-800°C. Calculate: [(m2-mo)/(mi-me)]*100% ‘mo---weight of empty crucible before ignited, g; my—weight of empty crucible and the sample before ignited, g; ‘mz-—weight of crucible and residue after ignited, g; 4. Identification take the substance about 0.6g,dissolve with water 1Sml,then test according to the following procedures. 4.1 To 5.0ml of solution ,add 3 drops dilute hydrochloric acid and 1.0m! of ferric trichloride,turn purple violet,then add 1.0mI of dilute sulphuric acid ,a purple colour develops. 4.2 To 5.0ml of solution, add 5 drops silver nitrate solution, develops purple yellow, black metallic silver precipitate gradually. 43 To 5.0ml of solution,add dilute potassium ferricyanide solution, which was dark blue or precipitate. 5 Chlorides Take the substance 0.5g, dissolves with 1Sml water, add dilute nitric acid 3.0ml,shake well with silver nitrate solution 1.0ml, if there is percipitation,compare with standard sodium chloride solution of 1.0ml, shall not be thicker (0.002%). 6 — Antipyrine and amino-antipyrine Take this product 0.1g, add 0.1g vanillin and (2+7)7ml_ sulfuric acid solution,in water bath heating for 5 minutes , shake at the same time, if appears color, compare with the reference solution {0.1 g vanillin and sulfuric acid solution (2—+7)7ml ] ,in water bath heating for 5 minutes, and shake at the same time], shall not be deeper HEBEI JIHENG PHARMACEUTICAL CO., LTD Heke BUR AR A A ADD.: No.1 Weiwu Street, Hengshui Industrial Park, Province, Chi tke Bik TH BT 1 7 Easily carbonate substance Add Sml of sulphuric acid in a colorimetric tube, add 0.5g the sample which has been grinded into fine powder,vibrate to dissolve, the solution should be almost colorless. "Almost colorless amidopyrine solution" refers to, Yellow 0.5 standard colorimetric fluid.(Take 0.125ml yellow stock solution add water to 5.0m!) 8 Heavy metal 8.1 Take three 25m] nessler tubes, Numbers for a, b, c. 8.2 Tube a, added 1 Sm lead standard solution (10 ppm) and acetate buffer (pH3.5) 2m, dilute with ‘water up to 25m! 8.3 Add Lg sample in tube b, add hydrochloric acid (Imol/1) 4m and dissolve with water to 25ml. 8.4 Tube ¢, add the same amount of test samples of tube b , add hydrochloric acid (1 mol/L) 4ml and dissolved with water, add the same amount of standard lead solution and acetate buffer (pH3.5) 2ml with tube a, dilute with water to 25m 8.5 If test solution with color, can add a small amount of dilute caramel solution or other organic solution without interference in tube a, make its colour is consistent with tube b and tube 8.6 Respectively add thioacetamide test solution 2m! in a, b, ¢ three tube, shake well, placed for 2 ‘minutes, place on white lining board, see from up to down, tube ¢ shows the color not more deeper than tube a, tube b shows the color not more deeper than tube a, If tube ¢ shows the color lighter than tube a, test according to the second method, 2.9 20% ethanol solution Clarity and colour (internally control ) Take the sample Sg in a 50m! colorimetric tube, add ethanol to 25ml, vibrate to dissolve, the solution should be clear and colorless, it the solution shows colour, compare with the reference solution( take 13 # color liquid, measuring respectively 0.5m, 1.0ml, 1.Sml, 2.0ml and 2.5ml , into

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