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Standard

In the analysis work, it often demanded to apply high-quality compound with the exact content being accurate in order to be compared as the detection control or used to calibrate the instrument, the compound is known as standard sample.
Standard refers to the standard substance used for measuring the potency of biological products. When the production department submits to a higher authority for approval of the quality standard of the biological product, they should also provide the standard sample (indicated in unit (μ)) used for measuring the potency of the tested product.

According to different application, the verification products can be divided into biological standard for the testing of biological products, endocrine drugs, antibiotics and other bioassay and chemical standards including:
1 chemical standards used for calibration of the instrument;
2 chemical reference standards used for calibration of the ultraviolet or infrared spectrum of the drugs;
3 control standards used for the purity test of drugs as well as the impurity control or as the control standards for content determination of the medicine.

In the page 67 of the appendix in the People's Republic of China Pharmacopoeia 1990 1st edition, we can find hundreds kinds of standards including bornyl ester acetate, eugenol and panaxadiol as well as 39 kinds of control medicine for the purify inspection of traditional Chinese medicine, impurity control or the content determination.

International standards
This refers to standard sample, with the potency units of the existing international standard sample potency units as baseline, undergoing further calibration of its potency units on the basis of a wide range of international cooperation. Its potency is expressed in 1U. For a certain product, for the establishment of the first international standard sample, the determination of its potency units should be consulted and decided by the Committee of Experts before the announcement. The international standard is a standard reference substance for worldwide preparation of national standards, so that the international standards can achieve unity.

Reagents and standards
All reagents in the food analysis laboratories should be clearly labeled to indicate the following: 1 name; 2 the date of preparation; 3 Signature from the people in charge; 4 if necessary, we need to add content such as safety and validity and so on.
Most food analysis should use standard sample as reference for qualitative and quantitative determination. The standard sample should be classified according to the following classification methods: 1 international standard; 2 national standards; 3 internal standard; 4 other standards.
Receptacle for reference standards should be clearly affixed to the label, to indicate the following: 1 name; 2 standard document number; 3 Opening times; 4 Validity; 5 Signature.
In addition, the laboratory should keep all the necessary specific files for all the necessary reference standards.
Capacity analysis standard solution should also be strictly managed. It should be clearly posted on all the standard solution containers with labels to indicate: 1 name; 2 concentration; 3 formulation date; 4 No of formulated procedures; 5 storage conditions; 6 validity; 7 Signature from people in charge.

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Structure Chemical Name CAS MF
CitalopraM IMpurity CitalopraM IMpurity
3-(5-Methyl-3-phenylisoxazol-4-yl)benzenesulfonaMide 3-(5-Methyl-3-phenylisoxazol-4-yl)benzenesulfonaMide C16H14N2O3S
Tigecycline Tigecycline
1-((2R,3R,4R,5R)-3-chloro-4-hydroxy-5-(hydroxyMethyl)-3-Methyltetrahydrofuran-2-yl)pyriMidine-2,4(1H,3H)-dione 1-((2R,3R,4R,5R)-3-chloro-4-hydroxy-5-(hydroxyMethyl)-3-Methyltetrahydrofuran-2-yl)pyriMidine-2,4(1H,3H)-dione 1496551-72-4 C10H13ClN2O5
1-NaphthaleneMethanaMine, 7,8-dihydro-α-Methyl-N-[3-[3-(trifluoroMethyl)phenyl]propyl]-, hydrochloride (1:1), (αR)- 1-NaphthaleneMethanaMine, 7,8-dihydro-α-Methyl-N-[3-[3-(trifluoroMethyl)phenyl]propyl]-, hydrochloride (1:1), (αR)- 1020414-33-8 C22H25ClF3N
4,6-dichloro-2-(propylsulfinyl)pyriMidin-5-aMine 4,6-dichloro-2-(propylsulfinyl)pyriMidin-5-aMine 1823431-32-8 C7H9Cl2N3OS
Acetic acid, [[(3aR,4S,6R,6aS)-tetrahydro-2,2-diMethyl-6-[[(phenylMethoxy)carbonyl]aMino]-4H-cyclopenta-1,3-dioxol-4-yl]oxy]-, ethyl ester Acetic acid, [[(3aR,4S,6R,6aS)-tetrahydro-2,2-diMethyl-6-[[(phenylMethoxy)carbonyl]aMino]-4H-cyclopenta-1,3-dioxol-4-yl]oxy]-, ethyl ester 866551-95-3 C20H27NO7
4',6'-Dinitro-2'-phenoxymethanesulfonanilide 4',6'-Dinitro-2'-phenoxymethanesulfonanilide 51765-56-1 C13H11N3O7S
5-[1-Hydroxy-2-[(1-methyl-3-phenylpropyl)amino]ethyl]salicylic acid methyl ester hydrochloride 5-[1-Hydroxy-2-[(1-methyl-3-phenylpropyl)amino]ethyl]salicylic acid methyl ester hydrochloride 33778-93-7 C20H26ClNO4
Blonanserin Impurity I Blonanserin Impurity I
25,26,26,26,27,27-hexadeuterocholest-5-ene-3,27-diol 25,26,26,26,27,27-hexadeuterocholest-5-ene-3,27-diol 1246302-95-3 C27H40D6O2
2-Azabicyclo[3.1.0]hexane-3-carbonitrile, 2-[(2R)-2-aMino-2-(3-hydroxytricyclo[3.3.1.13,7]dec-1-yl)acetyl]-, (1R,3R,5R)- 2-Azabicyclo[3.1.0]hexane-3-carbonitrile, 2-[(2R)-2-aMino-2-(3-hydroxytricyclo[3.3.1.13,7]dec-1-yl)acetyl]-, (1R,3R,5R)- 1564265-95-7 C18H25N3O2
(1S,5R,6R)-5-Hydroxy-7-oxabicyclo[4.1.0]hept-3-ene-3-carboxylic Acid Ethyl Ester (1S,5R,6R)-5-Hydroxy-7-oxabicyclo[4.1.0]hept-3-ene-3-carboxylic Acid Ethyl Ester 876014-27-6 C9H12O4
(3R,5R)-Rosuvastatin Lactone (3R,5R)-Rosuvastatin Lactone 1422954-11-7 C22H26FN3O5S
(S)-4,5,6,7-Tetrahydro-2,6-benzothiazolediamine (S)-4,5,6,7-Tetrahydro-2,6-benzothiazolediamine 1867177-06-7 C9H13N3OS
Letrozole Impurity Letrozole Impurity
Alogliptin Impurity C Alogliptin Impurity C 1108731-49-2 C20H23N5O3
Alogliptin Impurity C Alogliptin Impurity C 1108731-49-2 C20H23N5O3
Parecoxib Impurity J Parecoxib Impurity J
6-(4-(4-(benzo[b]thiophen-4-yl)piperazin-1-yl)butoxy)-1-(4-(2-oxo-1,2-dihydroquinolin-7-yloxy)butyl)quinolin-2(1H)-one 6-(4-(4-(benzo[b]thiophen-4-yl)piperazin-1-yl)butoxy)-1-(4-(2-oxo-1,2-dihydroquinolin-7-yloxy)butyl)quinolin-2(1H)-one C38H40N4O4S
Atracurium Impurity F Atracurium Impurity F
Linagliptin Impurity J Linagliptin Impurity J
Linagliptin Impurity Q Linagliptin Impurity Q
(R)-2-(((1-(3-(2-cyano-5-fluorobenzyl)-1-methyl-2,6-dioxo-1,2,3,6-tetrahydropyrimidin-4-yl)piperidin-3-yl)amino)methyl)-4-fluorobenzonitrile (R)-2-(((1-(3-(2-cyano-5-fluorobenzyl)-1-methyl-2,6-dioxo-1,2,3,6-tetrahydropyrimidin-4-yl)piperidin-3-yl)amino)methyl)-4-fluorobenzonitrile C26H24F2N6O2
Rosuvastatin Calcium Impurity Rosuvastatin Calcium Impurity
Canagliflozin Monoacetyl Impurity Canagliflozin Monoacetyl Impurity
Etoricoxib Impurity 13 Etoricoxib Impurity 13 1817735-82-2 C25H20ClN3O3S
Mirabegron Impurity 11 Mirabegron Impurity 11 1684452-85-4 C21H24N4O2S
Riociguat Impurtiy 2 Riociguat Impurtiy 2
Topiroxostat Impurity 9 Topiroxostat Impurity 9 577778-82-6 C13H8N6O
Vonoprazan Impurity F Vonoprazan Impurity F
Vortioxetine Impurity 15 Vortioxetine Impurity 15 2099147-02-9 C28H34N4S2
Dapagliflozin Impurity H Dapagliflozin Impurity H
Dapoxetine Impurity C Dapoxetine Impurity C
Eltrombopag Impurity 4 Eltrombopag Impurity 4
Iodixanol Impurity Iodixanol Impurity
Levothyroxine EP Impurity B Levothyroxine EP Impurity B 1628720-66-0 C15H11ClI3NO4
Ribavirin Imp. EP) Ribavirin Imp. EP)
Sertraline EP Impurity Sertraline EP Impurity C17H17Cl2N
Vildagliptin Related Compound G Vildagliptin Related Compound G 1616662-84-0 C12H20N4O3
3-ethyl 5-isopropyl 2-((2-aminoethoxy)methyl)-4-(2-chlorophenyl)-6-methyl-1,4-dihydropyridine-3,5-dicarboxylate 3-ethyl 5-isopropyl 2-((2-aminoethoxy)methyl)-4-(2-chlorophenyl)-6-methyl-1,4-dihydropyridine-3,5-dicarboxylate 158151-92-9 C22H29ClN2O5
Methyl 3-acetamido-4-(2,4,5-trifluorophenyl)but-2-enoate Methyl 3-acetamido-4-(2,4,5-trifluorophenyl)but-2-enoate 1234321-81-3 C13H12F3NO3
Cycloastragenol-6-O-β-D-glucoside Cycloastragenol-6-O-β-D-glucoside 86764-12-7 C36H60O10
FG-4592 intermediate 8 FG-4592 intermediate 8 1509958-20-6 C20H17NO6
Parecoxib Sodium Imp.E Parecoxib Sodium Imp.E
Trelagliptin Impurity 7 Trelagliptin Impurity 7
erythro-Guaiacylglycerol β-sinapyl ether 7-O-glucoside erythro-Guaiacylglycerol β-sinapyl ether 7-O-glucoside 412029-03-9 C27H36O13
Ofloxacin/Levofloxacin Impurity B Ofloxacin/Levofloxacin Impurity B
Pramipexole impurity II Pramipexole impurity II
5-(hydroxymethyl)-1,2-dihydro-1,2,4-triazol-3-one 5-(hydroxymethyl)-1,2-dihydro-1,2,4-triazol-3-one 24021-90-7 C3H5N3O2
( 2-{4-[N-(5,6-diphenylpyrazin-2-yl)-N-isopropylamino]butyloxy}acetic acid tert-butylester ) ( 2-{4-[N-(5,6-diphenylpyrazin-2-yl)-N-isopropylamino]butyloxy}acetic acid tert-butylester ) 475084-96-9 C29H37N3O3
N-(4-Hydroxymethylbenzyl) Cyclam N-(4-Hydroxymethylbenzyl) Cyclam 176252-20-3 C18H32N4O
Alvimopan Impurity 3 Alvimopan Impurity 3
Nicergoline Impurity G Nicergoline Impurity G
2’-Deschloro-2’-hydroxy Dasatinib 2’-Deschloro-2’-hydroxy Dasatinib 1159977-25-9 C22H27N7O3S
rac Benzyl Phenylephrine rac Benzyl Phenylephrine 1159977-09-9 C16H19NO2
 Atorvastatin Acetonide Atorvastatin Acetonide 581772-29-4 C36H39FN2O5
Isavuconazole Impurity 1 Isavuconazole Impurity 1 2069200-13-9 C13H12F2N4O
Sofosbuvir Impurity23 Sofosbuvir Impurity23
Tacrolimus Impurity 1 Tacrolimus Impurity 1
Bisoprolol EP Impurity F Bisoprolol EP Impurity F 1798418-82-2 C18H31NO4
Pantoprazole EP Impurity F Pantoprazole EP Impurity F 721924-06-7 C17H17F2N3O4S
Rosuvastatin EP Impurity E Rosuvastatin EP Impurity E
Tiotropium EP Impurity C Tiotropium EP Impurity C 136310-95-7 C19H22BrNO3S2
Eliglustat intermediate 4 Eliglustat intermediate 4 491833-27-3 C23H30N2O4
2-[(4-Acetylphenyl)methyl]cyclopentan-1-one 2-[(4-Acetylphenyl)methyl]cyclopentan-1-one 96824-28-1 C14H16O2
Dapoxetine Impurity 1 Dapoxetine Impurity 1 119357-22-1 C22H25NO
Mirabegron Impurity 5 Mirabegron Impurity 5
Milrinone Impurity 5 Milrinone Impurity 5
Solifenacin Related Compound 20 Solifenacin Related Compound 20 1300713-32-9 C17H17NO
Cefuroxime Impurity 2 Cefuroxime Impurity 2 C16H16N4O8S
Cefoxitin Impurity 1 Cefoxitin Impurity 1
Cefazolin Impurity 1 Cefazolin Impurity 1
Umeclidinium Bromide Impurity 8 Umeclidinium Bromide Impurity 8 869113-10-0 C27H30BrNO
Nifuratel impurity E Nifuratel impurity E
Valsartan Impurity 14 Valsartan Impurity 14 C24H29N5O3
Istradefylline Impurity 4 Istradefylline Impurity 4
Zolmitriptan Impurity 2 Zolmitriptan Impurity 2
Atazanavir Impurity  6 Atazanavir Impurity 6 1006868-81-0 C32H42N4O5
Palbociclib Impurity 9 Palbociclib Impurity 9 2204368-66-9 C24H29N7O2
Solifenacin Impurity 1 Solifenacin Impurity 1 1353274-25-5 C19H21NO2
Vildagliptin Methyl Ester Vildagliptin Methyl Ester
Flucloxacillin Impurity B Flucloxacillin Impurity B
Ropinirole impurity Ropinirole impurity
Mupirocin iMpurity B Mupirocin iMpurity B C26H44O9
Nicorandil Impurity 2 Nicorandil Impurity 2
Piperacillin Impurity 7 Piperacillin Impurity 7
Defluoro Paroxetine Hydrochloride Defluoro Paroxetine Hydrochloride 1394842-91-1
Afatinib Impurity 15 Afatinib Impurity 15
Milnacipran Impurity 11 Milnacipran Impurity 11 1410831-12-7 C11H10O2
Mirabegron Impurity 18 Mirabegron Impurity 18
Atorvastatin lactone Atorvastatin lactone 125995-03-1 C33H33FN2O4
Prucalopride Impurity F Prucalopride Impurity F 1900715-98-1 C18H26ClN3O4
tert-butyl (R)-3-(hydroxymethyl)hexanoate tert-butyl (R)-3-(hydroxymethyl)hexanoate 1928755-17-2 C11H22O3
Alfuzosin Alfuzosin 19216-53-6 C12H16N4O2
Alfuzosin Alfuzosin 19216-53-6 C12H16N4O2
4-[[3-Chloro-4-(2-pyridinylmethoxy)phenyl]amino]-7-ethoxy-6-[(1-methyl-2-pyrrolidinylidene)amino]-3-quinolinecarbonitrile 4-[[3-Chloro-4-(2-pyridinylmethoxy)phenyl]amino]-7-ethoxy-6-[(1-methyl-2-pyrrolidinylidene)amino]-3-quinolinecarbonitrile 1144516-21-1 C29H27ClN6O2
Sofosbuvir Impurity 5 Sofosbuvir Impurity 5
ethyl (S)-2-(2-oxopyrrolidin-1-yl)butanoate ethyl (S)-2-(2-oxopyrrolidin-1-yl)butanoate 1862335-58-7 C9H16ClNO3
vildagliptin Impurity R vildagliptin Impurity R 1803168-09-3 C7H8Cl2N2O
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