Clinomel - Names and Identifiers
Clinomel - Physico-chemical Properties
| Molecular Formula | RCHNH2COOH
|
| Physical and Chemical Properties | Organic compounds containing one amino and carboxyl group. The general formula is: H2N · R · COOH. Colorless crystals, melting point is quite a lot. Both the nature of the amine, and the nature of the carboxylic acid. According to the position of the amino group on the carbon chain from the terminal carboxyl group, can be divided into α-, β-, γ-, ω-amino acids. |
| Use | Amino acids are the basic components of proteins, and one of their main physiological functions is as a raw material for protein synthesis. In vivo in a free or bound state. Proteins in the human body are broken down to produce the following amino acids: alanine, arginine, aspartic acid, asparagine, cysteine, lysine, methionine, phenylalanine, serine, threonine, tryptophan, tyrosine, valine. |
Clinomel - Upstream Downstream Industry
Clinomel - Compound Amino Acid Injection(18AA)
Authoritative Data Verified Data
This product is a sterilized aqueous solution of 18 kinds of amino acids and sorbitol. Except cystine, the remaining amino acids should be 80.0% ~ 0.0 of the labeled amount. The sorbitol content shall be 90. 0% to 110% of that of the labeled child.
prescription
5% 12%
Proline (C5H9N02) l.OOg 2.40g
Serine (C3H7NO3) l.OOg 2.40g
Alanine (C3H7NO2) 2.OOg 4.80g
Isoleucine (C6H13NO2) 3.52g 8.45G
Leucine (C6H13NO2) 4.90G 11.76G
Aspartic acid (C4H7NO4) 2.50g 6.oog
Tyrosine (C9H11NO3) 0.25g 0.60G
Glutamic acid (C5H9NO4) 0.75g 1.80G
Phenylalanine (C9H11N02) 5.33G 12.80G
Arginine hydrochloride (C6H14N4O2 • HC1) 5.OOg 12.oog
Lysine hydrochloride (C6H14N202 • HCl) 4.30g 10.32G
Valine (C5H11N02) 3.60G 8.64G
threonine (C4H9N03) 2.50g 6.oog
Histidine hydrochloride (C6H9N302 • HCI • H20) 2. 50g 6. OOg
Tryptophan (C11H12N202) 0.90g 2.16g
Methionine (C5H1N02S) 2.25g 5.40G
Cystine (C6H12NO204S2 ) 0.10g 0.24g
Glycine (C2H5N02) 7.60G 18.24G
Sorbitol (C6H1406) 50.OOg 50.OOg
Sodium bisulfite (NaHS03) 0.4g or 0.5g 0.5g
Appropriate amount of water for injection
Full Volume 1000ml 1000ml
trait
This product is colorless to yellowish clear liquid.
identification
- take 1ml of this product, add 10ml of water, shake well, add about 3mg of ninhydrin, heat, the solution shows blue purple.
- in the chromatogram recorded under the content determination item, the retention time of each amino acid peak in the test solution should be consistent with the retention time of each corresponding amino acid peak in the control solution.
- take 1ml of this product, add 3ml of new 10% catechol solution, shake well, and add 6mL of sulfuric acid to show pink color.
examination
- the pH value should be 5.0 to 7.0 (General 0631).
- light transmittance of this product, according to ultraviolet-visible spectrophotometry (General rule 0401), the light transmittance is measured at the wavelength of 430nm, not less than 97.0%.
- sodium bisulfite precision quantity appropriate amount of this product, with 0.01% ethylenediaminetetraacetic acid disodium solution quantitative dilution to prepare about 1 mL solution containing sodium bisulfite lug, as a test solution; in addition, an appropriate amount of sodium bisulfite reference substance was accurately weighed, and 0.01% ethylene diamine tetraacetic acid disodium solution was added to dissolve and quantitatively dilute to prepare a solution containing about 1 ml per 1 ml as a reference solution. Take 10ml of each sample solution and reference solution respectively, put them into 50ml test tubes, and add 0.05% basic fuchsin hydrochloric acid solution successively (take 0.LG of basic fuchsin, Add 10ml of hydrochloric acid to dissolve, add water to 200ml). 1 ml and 0.3% formaldehyde solution (take 2ml of formaldehyde solution, dilute to ML with water) 1 ml, shake well, heat in a 37°C water bath for 10 minutes, remove and cool. Another 10ml of 0.01% ethylenediaminetetraacetic acid disodium solution was used as a blank solution, and the absorbance was measured at a wavelength of 0401 NM according to ultraviolet-visible spectrophotometry (general rule) and calculated. The content of sodium bisulfite shall not exceed 110.0% of the labeled amount.
- osmolality this product shall be taken for inspection according to law (General rule 0632), and the osmolality shall be 690 ~ 850mOSmol kg (specification of concentration of 5%),1390 ~ 1700mosmol/kg (concentration of 12% of the specification).
- abnormal toxicity take this product, diluted with Sterile Water for Injection to make a solution containing 5% of total amino acids, check according to law (General rule 1141), slow injection by intravenous injection, should comply with the provisions.
- bacterial endotoxin this product, according to the law to check (General 1143), the amount of endotoxin per lml should be less than 0.50EU.
- antihypertensive substances take this product, check according to law (General rule 1145), the dose according to the cat weight per lkg injection 0.5, should comply with the provisions.
- sterile take this product, by membrane filtration method, with Staphylococcus aureus as positive control bacteria, according to law inspection (General Principles 1101), should comply with the provisions.
- others should comply with the relevant provisions under injection (General 0102).
Content determination
- amino acid take this product, with the appropriate amino acid analyzer or high performance liquid chromatography for separation and determination; Take the corresponding amino acid reference, make the corresponding concentration of the reference solution, the same method for determination. The content of each amino acid was calculated by peak area according to external standard method. If the content of tryptophan cannot be measured at the same time, it is measured by the following method. Take 2ml of tryptophan in a 100ml measuring flask, dilute it to the scale with 0.lmol/L sodium hydroxide solution, and shake it to be used as a test solution.
Precision weighing tryptophan control and tyrosine control, adding 0.1 mol/L sodium hydroxide solution dissolved and quantitatively diluted to make about 18.0ug of tryptophan and tyrosine per 1 ml 5.Oug solution, shake, respectively, as a control solution (1) and control solution (2).
- 5ml of sorbitol was accurately measured and added to the ion exchange column (the inner diameter of the exchange column was 10mm and the height was 25cm), fill the converted and treated to neutral sodium-type sulfonate cation exchange resin in about 10g) to 1.5-2 per minute. A flow rate of 0ML was passed through the column. The effluent was collected in a 250ml measuring flask, and then washed with 10ml of water for three times, and finally washed with 60ml of water. The washing liquid and the effluent were combined, diluted to the scale with water, and shaken to be used as a test solution. Add Sodium periodate sulfuric acid solution [take sulfuric acid solution (1-20)80ml and high sodium gallate solution (1-1000) 120ml acidified with sulfuric acid, mix well] 50ml, it was heated on a water bath for 15 minutes and allowed to cool. Add lg of potassium halide, pack, place for 5 minutes, titrate with sodium thiosulfate titration solution (0.05mol/L), add 2ml of starch indicator solution near the end point, continue titration until the blue color disappears, the results of the titration were corrected by a blank test. Each 1 ml of sodium thiosulfate titration solution (0.05mol/L) corresponds to 0.9109mg of C6H1406.
category
amino acid drugs.
specification
by total amino acids (l)250ml:12.5g (2)500ml:25g (3)250ml:30g
storage
sealed storage.
Note:
- preparation of standard solution for determination of osmolality precision weighing 500g of sodium for reference gasification which is dried at 650-1.592°C for 40-50 minutes and left to cool to room temperature in a dryer (silica gel), respectively, 3.223g and 6.437g were dissolved and diluted to 500 ml by adding water, and the mixture was shaken uniformly (the osmolality was 1000, 2000 and mosmol/kg, respectively).
- for the determination of the concentration of 5% of the specification of the sample, with 500, 1000mOsmol/kg standard solution calibration instrument; Determination of the concentration of 12% of the specification of the sample, with 1000, 2000 m0smol/kg standard solution calibration instrument.
Last Update：2022-01-01 13:43:34
Clinomel - Compound amino acid injection (18AA- I)
Authoritative Data Verified Data
This product is 18 kinds of amino acids and potassium, sodium, calcium, magnesium and other inorganic salts prepared by the sterilization of aqueous solution. With the exception of cysteine hydrochloride, the content of tyrosine shall be 80.0%-120.0% of the labeled amount, the remaining amino acids shall be 85.0%-115.0% of the labeled amount, and the content of sodium shall be 45-55mmol/L, potassium (K) should be 18~22mmol/L, calcium (Ca) should be 2.2~2.8mmol/L, magnesium (Mg) should be 1.3~1.7mmol/L, chloride shall not exceed 60mmol/L as chlorine (C1).
trait
This product is colorless to yellowish clear liquid.
identification
- take lml of this product, add 10ml of water, shake well, add about 3mg of ninhydrin, heat, the solution shows blue purple.
- in the chromatogram recorded under the content determination item, the retention time of each amino acid peak in the test solution should be consistent with the retention time of each corresponding amino acid peak in the control solution.
- take 4ml of this product, put it in a test tube, add 4ml of 15% potassium carbonate solution, heat to boiling, filter, take 4ml of filtrate, add 4ml of potassium pyroantimonate solution, heat to boiling, cool in ice water, rub the inner wall of the test tube with a glass rod, and a dense precipitate should be generated.
- Take 2ml of this product, add 1 ml of 0.1% Sodium tetraphenylborate solution and 0.5ml of dilute acetic acid to form white precipitate.
- take 2ml of this product and identify the reaction of (2) with calcium salt (General rule 0301).
- take 2ml of this product and identify the reaction of (1) with chloride (General rule 0301).
examination
- the pH value should be 5.0 to 5.4 (General 0631).
- light transmittance this product, according to UV-visible spectrophotometry (General 0401), determination of light transmittance at the wavelength of 430mn, not less than 95.0%.
- preparation of sodium metabisulfite and sodium sulfite control solution precise weighing anhydrous sodium sulfite (if necessary, according to the method under the determination of anhydrous sodium sulfite content) 0.440g, add 0.04% ethylenediamine tetraacetic acid disodium solution to dissolve and dilute to make a solution containing 0.44mg per 1 ml (phase 3 contains Na2S205 0.33mg per 1 ml, ready to use new system).
- precise measurement of acid fuchsin solution (precise weighing 0.34g of acid fuchsin, adding 1ml of sulfuric acid, adding water to dissolve 1000ml, within 7 days of use) 5ml, a total of 2, two 50ml measuring flasks for A and B were added with human acetate buffer solution (0.4g of disodium ethylenediamine tetraacetate and 136 of sodium acetate). lg and glacial acetic acid 57ml, add water to dissolve into 1000ml) about 40ml, add sodium sulfite control solution 2ml in a bottle, add 2ml in B bottle, dilute to the scale with acetate buffer, shake well, after 25 minutes, the absorbance was measured at the wavelength of 549mn by UV-Vis spectrophotometry (General 0401) with acetate buffer as blank, the absorbance of the solution in the B bottle should not be lower than that of the solution in the bottle.
- osmolality the osmolality shall be 0632-530 m0smol/kg for determination according to law (General rule 720).
- abnormal toxicity take this product, diluted with Sterile Water for Injection to make a solution containing 5% of total amino acids, check according to law (General rule 1141 ), slow injection by intravenous injection, should comply with the provisions.
- bacterial endotoxin this product, according to the law to check (General 1143), the amount of endotoxin per lml should be less than 0.50EU.
- antihypertensive substances take this product, according to the law inspection (General rule 1145 ), dose according to the cat weight per lkg injection 0.5ml, should comply with the provisions.
- sterile take this product, by membrane filtration method, with pH 7.0 sterile egg A peptone-sodium chloride grade rinse (each membrane is not less than 300ml), with Staphylococcus aureus as positive control bacteria, inspection in accordance with the law (General rule 1101 ) , should comply with the provisions.
- others should comply with the relevant provisions under injection (General 0102).
Content determination
- amino acid take this product, with the goods amino acid analyzer or high performance liquid chromatography for separation and determination; Take the corresponding amino acid control, made the corresponding concentration of the reference solution, the same method for determination. The content of each amino acid was calculated by peak area according to external standard method.
- Take 2ml of wood product with a precise amount of tryptophan, put it in a 100ml measuring flask, and use O.lmol/L sodium solution of atmospheric Terbium was diluted to scale, and then shaken well to be used as test solution. In addition, the appropriate amount of reference sample of tryptophan and tyrosine dried at 105°C for 3 hours was accurately weighed, add 0.1 mol/L sodium chloride solution dissolved and quantitatively diluted to contain about 18.0ug of tryptophan and tyrosine per 1 ml 5.Oug solution, shake, respectively, as a reference solution (1) and reference solution (2), according to UV-visible spectrophotometry (General 0401), take the reference solution (2), 280nm was used as the measurement wavelength. The isoabsorbance point wavelength and the reference wavelength (A,) were selected near the wavelength of 303nm (at an interval of 0.2nm). AA = AA2-AA1 = 0 is required, and absorbance of the reference solution (1) and the test solution is measured at the wavelengths of A2 and A1, respectively, and the respective absorbance difference (AA) is obtained and calculated.
- preparation of sodium reference solution about 130g of sodium chloride dried to constant weight at 1.27°C was accurately weighed, put into a 500ml children's bottle, dissolved with water and diluted to the scale, and shaken, precision take appropriate amount, diluted with water, respectively, made of sodium in each lml about 2.0,4.0,6.0,8.Oug's solution, shake. For the preparation of sample solution precision take this product 1ml, 200ml flask, diluted with water to the scale, shake.
- measurement method the control solution and the test solution were taken, measured at a wavelength of 0406 Mn by atomic absorption spectrophotometry (general rule, first method), and calculated.
- preparation of potassium reference solution about 1.14g of potassium chloride dried at 130°C to constant weight was accurately weighed, placed in a 1000ml measuring flask, dissolved with water, diluted to the scale, and shaken, take appropriate amount of precision, dilute with water, respectively, to make about 6.0, 12.0, 18.0, 24.0ug of potassium solution per 1 ml, shake.
- preparation of test solution: take 2ml of this product, put it in a 100ml measuring flask, dilute it with water to the scale, and shake it well.
- measurement the control solution and the test solution were taken, measured at a wavelength of 766.5nm by atomic absorption spectrophotometry (the first method of general rule 0406), and calculated.
- preparation of calcium reference solution about 105g of calcium carbonate dried at 0.25 ° C. To constant weight was precisely weighed, placed in a 1000ml measuring flask, and a small amount of hydrochloric acid was added to dissolve, add water to dissolve and dilute to the scale, shake, Take 5, 10, 15ml, respectively, 50ml flask, add cesium chloride solution (take cesium chloride 6.35g, add water to dissolve 100ml)2ml, strontium chloride solution [take strontium chloride (SrCl2.6H2O) 15.25g, add water to dissolve 100ml]2ml, dilute with water to the scale, shake.
- preparation of test solution: take 10ml of this product, put it in a 50ml measuring flask, add 2ml of cesium chloride solution and 2ml of strontium chloride solution, dilute it to the scale with water, and shake it well.
- measurement the control solution and the test solution were taken, measured at a wavelength of 422.7nm according to Atomic Absorption Spectrophotometry (the first method in general rule 0406), and calculated.
- preparation of magnesium control solution about 1 was taken as magnesium sulfate. Olg, precision weighing, put in 100ml measuring flask, add water to dissolve and dilute to scale, shake well, take 5ml into 100ml measuring flask, dilute to scale with water, shake well, take 0, 2, 4, 6 and 8ml respectively in a 100ml measuring flask, add each 5ml of the above strontium chloride solution, dilute to the scale with water, and shake well.
- preparation of test solution: take 5ml of this product, put it in a 100ml measuring flask, add 5ml of cesium chloride solution, dilute it with water to the scale, and shake it well.
- measurement method the control solution and the test solution were taken, measured at a wavelength of 0406 NM according to Atomic Absorption Spectrophotometry (the first method of general rule), and calculated.
- preparation of chloride test solution: take 25ml of this product, put it in a 50ml beaker, add 2ml of 4% potassium permanganate solution and 1 ml of 1 mol/L sulfuric acid solution, heat to near-boiling (I. E., when the first bubble appears) and immediately cool, transfer the solution to a 50ml measuring flask, dilute to the mark with water, and shake.
- determination precision: 20ml of test solution was measured by potentiometric titration (General rule 0701), using silver electrode as indicator electrode and potassium nitrate salt bridge-saturated calomel electrode as reference electrode, with silver nitrate titration solution (0.lmol/L) titration. Each 1 ml of silver nitrate titration solution (0.1 mol/ L corresponds to 3.545mg of Cl.
category
amino acid drugs.
specification
by total amino acids (l ) 250ml:17.5g(2)500ml:35g
storage
sealed storage below 25°C. Do not freeze, avoid direct sunlight.
Last Update：2022-01-01 13:43:35
Clinomel - Compound amino acid injection (18AA-I I)
Authoritative Data Verified Data
This product is a sterilized aqueous solution prepared from 18 kinds of amino acids. The content of tyrosine and cystine shall be 80.0% to 120.0% of the labeled amount, and the remaining amino acids shall be 85.0% to 115.0% of the labeled amount.
trait
This product is colorless to yellowish clear liquid.
identification
- take 1ml of this product, about 3mg of ninhydrin, shake well, heat, the solution appears blue-purple.
- in the chromatogram recorded under the content determination item, the retention time of each amino acid peak in the test solution should be consistent with the retention time of each corresponding amino acid peak in the control solution.
examination
- the pH value should be 5.0 to 6.2 (General 0631).
- light transmittance of this product, according to ultraviolet-visible spectrophotometry (General rule 0401), the light transmittance is measured at the wavelength of 430nm, not less than 95.0%.
- preparation of sodium metabisulfite and sodium sulfite control solution precise weighing appropriate amount of anhydrous sodium sulfite (if necessary, according to the calibration method under the item of anhydrous sodium sulfite content determination) and ethylenediamine tetraacetic acid disodium 0.14g, adding water to dissolve to make 250ml, take 5ml, dilute to 0.04% ml with 0.33 ethylenediamine tetraacetic acid disodium solution, make each ml contain 8.5% mg (5 %), 0.033mg (11.4% and 0.03 containing sodium metabisulfite mg/ml) or 0.044mg(8.5% and 11.4% containing sodium metabisulfite 0.04 mg/mL) Na2S205 (with new system).
- preparation of acid fuchsin solution 0.34g of acid fuchsin was accurately weighed, 1 ml of sulfuric acid was added, and ml of water was added for dissolution (used within 7 days).
- measuring method: take 5ml( 5%) or 2mL (8.5%, 11.4%) of acid fuchsin solution, and place it in two 50ml measuring flasks of A and B respectively, add human acetate buffer solution (0.4g of disodium ethylenediamine tetraacetate and 136 of sodium acetate). lg and glacial acetic acid 57ml, add water to dissolve into 1000ml) about 40ml, at 28°C water bath for 10 minutes, a bottle of precision plus sodium sulfite control solution 2ml, B bottle of Precision Plus this product 2ml, immediately Time, dilute to the scale with acetate buffer solution, shake well, place in 28°C water bath for 15 minutes, and accurately react with acetate buffer solution as blank, according to UV-Vis spectrophotometry (General rule 0401), the absorbance is measured at a wavelength of 549nm, and the absorbance of the solution in the B- bottle should not be lower than that of the solution in the-bottle.
- The osmolality shall be determined according to law (General rule 0632), and the osmolality shall be 400-490 m0smol/kg ( 5% ) ; 700-860 MOS mol/kg(8.5% ) ; 960-1180 MOS mol/kg( 11.4%).
- abnormal toxicity take this product, diluted with Sterile Water for Injection to make a solution containing 5% of total amino acids, check according to law (General rule 1141), slow injection by intravenous injection, should comply with the provisions.
- bacterial endotoxin this product, according to the law to check (General 1143), the amount of endotoxin per lml should be less than 0.50EU.
- antihypertensive substances take this product, check according to law (General rule 1145), the dose according to the cat weight per lkg injection 0.5, should comply with the provisions.
- sterile take this product, by membrane filtration method, with Staphylococcus aureus as positive control bacteria, according to law inspection (General Principles 1101), should comply with the provisions.
- others should comply with the relevant provisions under injection (General 0102).
Content determination
The amino acid is taken from this product, and the appropriate amino acid analyzer or high performance liquid chromatography is used for separation and determination; The corresponding amino acid reference substance is taken to make the corresponding concentration of the reference solution, and the same method is used for determination. The content of each amino acid was calculated by peak area according to external standard method.
category
amino acid drugs.
specification
by total amino acids (l) 250ml:12.5g(2)500ml:25g (3) 250ml:21.25g (4) 500ml:42.5g(5)250ml:28.5g C6)500ml:57G
storage
The patient was placed at 5-25°C for shading, and was stored in a sealed manner.
note
- preparation of standard solution for determination of osmolality precision weighing 500g of sodium for reference gasification which is dried at 650-1.592°C for 40-50 minutes and left to cool to room temperature in a dryer (silica gel), respectively, 3.223g and 6.437g were dissolved and diluted to 500 ml by adding water, and the mixture was shaken uniformly (the osmolality was 1000, 2000 and mosmol/kg, respectively).
- when measuring the sample with the concentration of 8.5%, the instrument is calibrated with the standard solution of 500 and 1000 m0smol/kg; When measuring the sample with the concentration of 11.4%, the instrument is calibrated with the standard solution of 1000, 2000 m0smol/kg standard solution calibration instrument.
Last Update：2022-01-01 13:43:36
Clinomel - Compound amino acid injection (18AA-III)
Authoritative Data Verified Data
This product is a sterilized aqueous solution prepared from 18 kinds of crystalline amino acids. The cysteine content shall be no less than 60% of the indicated amount, and the content of each other amino acid shall be 85.0%-115.0% of the indicated amount.
trait
This product is colorless or yellowish clear liquid.
identification
- take 1ml of this product, add a small amount of ninhydrin solution, heat, the solution showed blue purple.
- in the chromatogram recorded under the content determination item, the retention time of each amino acid peak in the test solution should be consistent with the retention time of each corresponding amino acid peak in the control solution.
examination
- the pH value should be 5.2 to 6.8 (General 0631).
- light transmittance of this product, according to ultraviolet-visible spectrophotometry (General rule 0401), the light transmittance is measured at the wavelength of 430nm, not less than 95.0%.
- osmolality the osmolality shall be 0632-810 m0smol/kg for determination according to law (General rule 990).
- preparation of stock solution for reference substance of sodium bisulfite an appropriate amount of anhydrous sodium bisulfite was accurately weighed (if necessary, it was calibrated according to the method under determination of anhydrous sodium sulfite content), A solution containing about 33ug of sodium bisulfite per 1 ml was prepared by dissolving and diluting 0.01% of ethylene diamine tetraacetic acid disodium solution as a reference stock solution.
- preparation of sample solution precise amount of this product, diluted with 0.01% ethylenediamine tetraacetic acid disodium solution to prepare a solution containing about lug of sodium bisulfite per 1 ml, and then obtained by shaking.
- preparation of standard curve: take the stock solution of the reference substance 0, 1.0, 2.0, 3.0, 4.0, 5.0 and 6.0ml respectively, and dilute it to 100ml with 0.01% disodium ethylenediamine tetraacetate solution, take 10ml of each reference solution of the above concentration respectively and put it in a 25ml cuvette. Add 0.05% basic fuchsin solution (take 0.05g basic fuchsin and put it in a measuring flask), add 5ml hydrochloric acid to dissolve, dilute to the scale with water, shake well) 1ml and 0.2% formaldehyde solution 1ml, plug, shake well, and place for 40 min, according to UV-visible spectrophotometry (General rule 0401), the absorbance was measured at a wavelength of 557nm, and the linear regression equation was calculated from the measured absorbance and the corresponding concentration.
- measurement method: take 10ml of the test solution and place it in a 25ml cuvette, according to the preparation item of the standard curve, from "1 ml of 0.05% basic fuchsin solution and 1 ml of 0.2% formaldehyde solution are accurately added sequentially", the same method is operated, the absorbance is measured, and the amount of sodium bisulfite is calculated from the regression equation. Sodium bisulfite should not exceed 0.55mg per 1 ml.
- abnormal toxicity take this product, diluted with Sterile Water for Injection to make a solution containing 5% of total amino acids, check according to law (General rule 1141), slow injection by intravenous injection, should comply with the provisions.
- bacterial endotoxin this product, according to the law to check (General 1143), the amount of endotoxin per lml should be less than 0.50EU.
- antihypertensive substances take this product, check according to law (General rule 1145 ), the dose according to the cat weight per lkg injection 0.5, should comply with the provisions.
- sterile take this product, through the membrane filtration method, with Staphylococcus aureus as the positive control bacteria, according to the law (General Principles 1101), should comply with the provisions.
- others should comply with the relevant provisions under injection (General 0102).
Content determination
- tyrosine and tryptophan were measured by high performance liquid chromatography (General 0512).
- chromatographic conditions and system suitability test using eighteen alkyl silane bonded silica as filler; Methanol-water (10:90)(containing 0.008mol/L potassium dihydrogen phosphate) as mobile phase; the detection wavelength was 280mn. The number of theoretical plates shall not be less than 4000 calculated by tryptophan peak, and the separation degree between peaks shall meet the requirements.
- preparation of control solution the appropriate amounts of tyrosine control and tryptophan control were accurately weighed and O was added. Olmol/L hydrochloric acid solution was dissolved and diluted to make a control solution containing 0.175mg of tyrosine and 0.65mg of tryptophan per 1 ml. Take 3ml of the solution for precise measurement, put it in a 50ml measuring flask, and dilute it to the scale with mobile phase, shake well.
- preparation of test solution: Take 3ml of the product, put it in a 100ml measuring flask, dilute it to the scale with mobile phase, and shake it well.
- determination precision: 20 u1 of the reference solution and 20 u1 of the test solution were respectively injected into the human liquid chromatograph, and the chromatogram was recorded; The peak area was calculated according to the external standard method.
- preparation of cysteine control solution an appropriate amount of the cysteine control was accurately weighed, dissolved by adding water, and diluted to prepare a solution containing 1 mg per 1 ml.
- determination precision: take 1ml of this product and 1ml of reference solution respectively, put them in 100ml measuring bottles, add 1.5ml of formic acid and 1ml of 30% hydrogen peroxide solution respectively, place them for 30 minutes, dilute them to the scale with water, and shake them well, the determination was carried out with an appropriate amino acid analyzer and calculated.
- other amino acids are determined by appropriate amino acid analysis or by high performance liquid chromatography (General 0512).
- chromatographic conditions and system suitability test using eighteen alkyl silane bonded silica as filler; 0.1 mol/L sodium acetate solution (adjusted to pH 6.5 with dilute acetic acid)-acetonitrile (93:7) as mobile phase A, acetonitrile-water (80:20) as mobile Phase B, gradient elution was performed; Column temperature was 40°C; Detection wavelength was 254nm. The degree of separation between peaks shall meet the requirements.
- preparation of internal standard solution an appropriate amount of norleucine was taken, dissolved by adding water, diluted to prepare a solution containing about 0.8mg per 1 ml, and shaken.
- measuring method: take 3ml of this product, put it in a 50ml measuring flask, dilute it to the scale with water, shake it well, take 3ml of the product, put it in a 10ml measuring flask, and add 2ml of the internal standard solution precisely, dilute with water to scale, shake, as a test solution; Take about 50mg of isoleucine control, about lOOmg of leucine control, about lOOmg of lysine acetate control, about 30mg of methanoic acid control, about 80mg for the phenylpropanoic Acid Control, about 55mg for the threonine control, about 40mg for the valine control, about 55mg for the alanine control, about 70mg for the arginine control, about 35mg for the aspartate control, about 55mg for the glutamate control, about 50mg of histidine reference, about 30mg of proline reference, about 20mg of serine reference and about 90mg of glycine reference, precision weighing, put in the same 250ml measuring flask, add appropriate amount of water to dissolve and dilute to the scale, shake well; Take 5ml with precision, put it in a 10ml measuring flask, add 2ml of internal standard solution with precision, dilute it with water to scale, shake well, and use it as a reference solution. 2ml of the test solution and 2ml of the reference solution were respectively put into 20ml plug test tubes, and 1 mol/L triethylamine solution-acetonitrile (14:86) 1ml,0.1 mol/L phenyl isothiocyanate acetonitrile solution 1ml, shake well, react in 50°C water bath for 45 minutes, take it out, let it cool, then add 1ml of n-hexane respectively, shake well, after standing for 30 minutes (the solution is clear), 2 u1 of each clear lower liquid is injected into human liquid chromatograph respectively, and the chromatogram is recorded. According to the internal standard method to calculate the peak area, that is.
category
amino acid drugs.
specification
250ml:25.90g (by total amino acids)
storage
keep in cool dark place.
note
preparation of standard solution for determination of osmolality precision weighing 500g of reference sodium chloride respectively after drying at 650~1.592°C for 40~50 minutes and cooling to room temperature in a desiccator (silica gel), 3.223g, dissolved by adding water, diluted to 500 ml, and shaken well (osmolality = 1000, mosmol/kg, respectively).
Last Update：2022-01-01 13:43:38
Clinomel - Compound amino acid injection (18AA-IV)
Authoritative Data Verified Data
This product is a sterilized aqueous solution of 18 kinds of amino acids and glucose. In addition to cysteine hydrochloride, containing other amino acids should be 85.0% ~ 115.0% of the label amount. The glucose content (C6H12O6 • H20) shall be between 90.0% and 110.0% of the indicated amount.
trait
This product is colorless to yellowish clear liquid.
identification
- the product is slowly dropped into a warm alkaline copper tartrate test solution, which produces a red precipitate of cuprous oxide.
- take 5ml of this product, add 2ml of 10% sodium hydroxide solution, and add 2 drops of sodium nitroprusside test solution, which will produce red-purple color.
- in the chromatogram recorded under the content determination item, the retention time of each amino acid peak in the test solution should be consistent with the retention time of each corresponding amino acid peak in the control solution.
examination
- the pH value should be 3.5 to 0631 (general).
- light transmittance of this product, according to ultraviolet-visible spectrophotometry (General rule 0401), the light transmittance is measured at the wavelength of 430nm, not less than 93.0%.
- S-hydroxymethyl furfural take this product (equivalent to lg of glucose), place it in a test tube with a plug, add about 9g of ammonium sulfate, fully shake to make it saturated, and let it stand for 2 minutes, add 5ml of diethyl ether, shake several times, then place for 2 minutes, take 2ml of diethyl ether layer, put it in another test tube, add 1 ml of hydrochloric acid solution of 1% resorcinol, and immediately produce slight pink, cherry Red should not be produced.
- take 40ml of heavy metal, put it in 50ml Nessler's colorimetric tube, add 5ml of sodium hydroxide solution and add water to the scale, shake well; Take 2ml of standard lead solution, treat with the same method and add appropriate amount of diluted caramel solution to make the same color as the sample, and check according to law (General rule 0821 third method), containing no more than of heavy metals.
- The osmolality shall be 0632-770mosmol/kg. The osmolality shall be checked according to law (General rule 630).
- preparation of stock solution for reference substance of sodium metabisulfite after standardization, an appropriate amount of analytical pure sodium metabisulfite shall be accurately weighed and dissolved with 0.01% ethylenediamine tetraacetic acid disodium solution, A solution containing 20ug of sodium metabisulfite per 1 ml was prepared and diluted.
- preparation of test solution precision take 2ml of this product, dilute with 0.01% ethylenediamine tetraacetic acid disodium solution to ML, shake. 3ml of the above solution was accurately weighed and diluted to 50ml with 0.01% ethylenediamine tetraacetic acid disodium solution.
- preparation of standard curve: take 0, 1.0,2.0, 3.0, 4.0 and 5.0ml of the stock solution of the reference substance and put it into a 50ml measuring flask, dilute to the scale with 0.01% ethylenediamine tetraacetic acid disodium solution and shake. Take 10ml of each of the above series of reference solutions, place them in test tubes respectively, and add 0.05% basic fuchsin solution (take 0.05g of basic fuchsin, add 5ml of hydrochloric acid to dissolve, and dilute to 100ml with water) with 0.2% formaldehyde solution of 1 ml, fully shake, placed for 40 minutes, with 0 tube as blank, according to UV-visible spectrophotometry (General 0401), the absorbance was measured at a wavelength of 555nm, and the regression equation was calculated from the measured absorbance to the corresponding concentration.
- precision measurement: 10ml of the test solution was measured according to the method under the standard curve, starting from "adding 0.05% subtractive fuchsin solution, by the regression equation to calculate the amount of sodium metabisulfite, this product per lml containing sodium metabisulfite shall not be 1.lmg.
- (note: The standardization method of analytical pure sodium metabisulfite can refer to the method under the determination of sodium metabisulfite content)
- abnormal toxicity take this product, diluted with Sterile Water for Injection to make a solution containing 5% of total amino acids, check according to law (General rule 1141), slow injection by intravenous injection, should comply with the provisions.
- bacterial endotoxin this product, according to the law to check (General 1143), the amount of endotoxin per lml should be less than 0.50EU.
- antihypertensive substances take this product, check according to law (General rule 1145), the dose according to the cat weight per lkg injection 0.5, should comply with the provisions.
- sterile take this product, by membrane filtration method, with Staphylococcus aureus as positive control bacteria, according to law inspection (General Principles 1101), should comply with the provisions.
- others should comply with the relevant provisions under injection (General 0102).
Content determination
- amino acid and N-acetyl-L-tryptophan were measured by high performance liquid chromatography (General 0512).
- chromatographic conditions and system suitability test using eighteen alkyl silane bonded silica gel as filler; Methanol -0.008mol/L potassium dihydrogen phosphate solution (10:90) as mobile phase; The detection wavelength was 280mn. The number of theoretical plates shall not be less than 2000 based on the peak of acetyl-L-tryptophan, and the separation degree between peaks shall meet the requirements.
- preparation of reference solution about 29 mg of the tyrosine reference sample and about 130mg of the N-acetyl-L-tryptophan reference sample dried at 105°C for 3 hours were accurately weighed and placed in the same 250ml measuring flask, add the mobile phase to dissolve and dilute to the scale, shake.
- precision children take 2ml, put it in a 25ml measuring flask, dilute it to the scale with mobile phase, and shake it well. Preparation of test solution precision children take 2ml of this product, put it in a 25ml children's bottle, dilute it with mobile phase to the scale, and shake it well.
- The standard solution and the test solution of 20 u1 were respectively injected into the human liquid chromatograph, and the chromatogram was recorded. The peak area was calculated according to the external standard method.
- other amino acids are determined by appropriate amino acid analysis or high performance liquid chromatography (General 0512).
- chromatographic conditions and system suitability test using eighteen alkyl silane bonded silica as filler; 0.1 mol/L sodium acetate solution (adjusted to pH 6.5 with dilute acetic acid)-acetonitrile (93:7) as mobile phase A, acetonitrile-water (80:20) as mobile Phase B, the gradient elution was carried out as follows; The column temperature was 40°C; The detection wavelength was 254mn.
- the theoretical plate number of each amino acid peak should be greater than 2000, and the degree of separation between peaks should meet the requirements.
- preparation of internal standard solution an appropriate amount of norleucine was taken, dissolved and diluted with water to prepare a solution containing about 0.8mg per 1 ml, and then obtained by shaking.
- determination precision measure 5ml of the product, put it in a 50ml measuring flask, dilute it to the scale with water, and shake it well; Take 5ml for precision measurement, put it in a 10ml measuring flask, and add 2ml of internal standard solution precisely, dilute with water to scale, shake, as a test solution; Take about 50mg of isoleucine control, about lOOmg of leucine control, about lOOmg of Gallic acid lysine control, about 30mg of methionine control, phenylalanine control about 80mg, threonine control about 55mg, valine control about 40mg, alanine control about 55mg, arginine control about 70mg, aspartate control about 35mg, glutamate control about 55mg, about 50mg of histidine reference, about 30mg of proline reference, about 20mg of serine reference, and about 90mg of glycine reference, precision weighing and placing in the same 250ml measuring flask, adding appropriate amount of water to dissolve, and diluting to the scale with water, shake well; Take 5ml with precision, put it in a 10ml measuring flask, add 2ml of internal standard solution with precision, dilute it with water to scale, shake well, and use it as a reference solution.
- 2ml of the test solution and 2ml of the reference solution were respectively placed in a 20ml stopper test tube, and 1 ml of 1 mol/L triethylamine-acetonitrile (14:86) solution was added. 1 mol/L phenyl isothiocyanate acetonitrile solution (1 ml), shake well, react in 50°C water bath for 45 minutes, take out, let cool, then add n-hexane (1 ml) respectively, shake well, after standing for 30 minutes (the solution was clear), 2u1 of each of the clear lower liquid was injected into human liquid chromatograph respectively, and the chromatogram was recorded. According to the internal standard method to calculate the peak area, that is.
- glucose: take 10ml of the product and place it in the cation exchange column (the inner diameter of the exchange column is 10mm and the height is 22cm), fill the transformed and treated to neutral sodium sulfonate cation exchange resin about 10g), at a flow rate of 0.5-0.7ml per minute through the column, collect the effluent in a 50ml measuring flask, the column was washed with water for 3 times, 10ml each time. The washing liquid was combined with the effluent, diluted with water to the scale, and shaken. The optical rotation (General rule 0621) is measured according to the law, and multiplied by 10.426 to obtain the content (g) of C6H1206 · H20 in of the test product.
category
amino acid drugs.
specification
by total amino acids (1 )250ml:8.70g (2)500ml:17.40g
storage
keep in cool dark place.
note
preparation of standard solution for determination of osmolality precision weighing 500g of reference sodium chloride respectively after drying at 650~1.592°C for 40~50 minutes and cooling to room temperature in a desiccator (silica gel), 3.223g, dissolved by adding water, diluted to 500 ml, and shaken well (osmolality = 1000, mosmol/kg, respectively).
Last Update：2022-01-01 13:43:39
Clinomel - Reference Information
Last Update：2024-04-09 20:49:11