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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
Rivaroxaban Impurity 11 Rivaroxaban Impurity 11 1411775-06-8 C14H17N3O4
(R)-2-(3-(diisopropylamino)-1-phenylpropyl)-4-(hydroxymethyl)phenyl propionate (R)-2-(3-(diisopropylamino)-1-phenylpropyl)-4-(hydroxymethyl)phenyl propionate C25H35NO3
Flomoxef Impurity 4 Flomoxef Impurity 4
Nicardipine Impurity 5 Nicardipine Impurity 5
11,11'-(PIPERAZINE-1,4-DIYL)-BIS-8-CHLORO-5H-DIBENZE[B,E][1,4]-DIAZEPINE 11,11'-(PIPERAZINE-1,4-DIYL)-BIS-8-CHLORO-5H-DIBENZE[B,E][1,4]-DIAZEPINE 263366-81-0 C30H24Cl2N6
Sacubitril Impurity 7 Sacubitril Impurity 7 149709-44-4 C22H25NO5
Valsartan Impurity 5 Valsartan Impurity 5 1266616-11-8 C18H21N5
3-Hydroxy Agomelatine 3-Hydroxy Agomelatine 166526-99-4 C15H17NO3
Milnacipran Impurity 4 Milnacipran Impurity 4 1353644-49-1 C15H21NO2
(3S,5R)-Atorvastatin (3S,5R)-Atorvastatin 887324-52-9 C33H35FN2O5
Heptyl Deoctyl Fingolimod Hydrochloride Heptyl Deoctyl Fingolimod Hydrochloride 745767-97-9 C18H31NO2
Tenofovir Fumarate Tenofovir Fumarate 1246812-23-6 C21H34N5O9P
Prucalopride Impurity C Prucalopride Impurity C 1599434-55-5 C17H24ClN3O3
1-cyclopropyl-7-fluoro-8-methoxy-6-((4aS,7aS)-octahydro-6H-pyrrolo[3,4-b]pyridin-6-yl)-4-oxo-1,4-dihydroquinoline-3-carboxylic acid 1-cyclopropyl-7-fluoro-8-methoxy-6-((4aS,7aS)-octahydro-6H-pyrrolo[3,4-b]pyridin-6-yl)-4-oxo-1,4-dihydroquinoline-3-carboxylic acid 2205053-60-5 C21H24FN3O4
Brexpiprazole N-Oxide Brexpiprazole N-Oxide 1191900-58-9 C25H27N3O3S
2,6-Dibenzyloxyacetophenone 2,6-Dibenzyloxyacetophenone 3886-19-9 C22H20O3
ethyl(4aS,9bR)-6-bromo-1,3,4,4a,5,9b-hexahydro-2H-pyrido[4,3-b]indole-2-carboxylate ethyl(4aS,9bR)-6-bromo-1,3,4,4a,5,9b-hexahydro-2H-pyrido[4,3-b]indole-2-carboxylate 1059630-08-8 C14H17BrN2O2
diphenhydramine impurity diphenhydramine impurity C17H21NO
Pyridine, 4-chloro-2-(chloromethyl)-3,5-dimethyl-, hydrochloride Pyridine, 4-chloro-2-(chloromethyl)-3,5-dimethyl-, hydrochloride 143016-68-6 C8H10Cl3N
1,1-dimethyl-4-(2-methyl-10H-benzo[b]thieno[2,3-e][1,4]diazepin-4-yl)piperazin-1-ium iodide 1,1-dimethyl-4-(2-methyl-10H-benzo[b]thieno[2,3-e][1,4]diazepin-4-yl)piperazin-1-ium iodide C18H23IN4S
2-(4-butoxy-3-cyanophenyl)-4-methylthiazole-5-carboxylic acid 2-(4-butoxy-3-cyanophenyl)-4-methylthiazole-5-carboxylic acid 1657014-33-9 C16H16N2O3S
vildagliptin Impurity O vildagliptin Impurity O 2253194-12-4 C12H18N4O2
methyl (41R,12S,13aR)-13a-ethyl-12-hydroxy-2,3,41,5,6,12,13,13a-octahydro-1H-indolo[3,2,1-de]pyrido[3,2,1-ij][1,5]naphthyridine-12-carboxylate methyl (41R,12S,13aR)-13a-ethyl-12-hydroxy-2,3,41,5,6,12,13,13a-octahydro-1H-indolo[3,2,1-de]pyrido[3,2,1-ij][1,5]naphthyridine-12-carboxylate 38990-17-9 C21H26N2O3
1-(3-ethoxy-4-methoxyphenyl)-2-(methylsulfonyl)ethenamine 1-(3-ethoxy-4-methoxyphenyl)-2-(methylsulfonyl)ethenamine 1450657-31-4 C12H17NO4S
Apremilast Impurity D Apremilast Impurity D
Canagliflozin Impurity 17 Canagliflozin Impurity 17 1951467-28-9 C24H23FO6S
Canagliflozin Impurity 22 Canagliflozin Impurity 22
Carfilzomib Impurity 3 Carfilzomib Impurity 3
Dolutegravir Impurity 4 Dolutegravir Impurity 4
Febuxostat Impurity 20 Febuxostat Impurity 20
Lenvatinib Impurity 1 Lenvatinib Impurity 1
methyl (41S,12S,13aR)-13a-ethyl-12-hydroxy-2,3,41,5,6,12,13,13a-octahydro-1H-indolo[3,2,1-de]pyrido[3,2,1-ij][1,5]naphthyridine-12-carboxylate methyl (41S,12S,13aR)-13a-ethyl-12-hydroxy-2,3,41,5,6,12,13,13a-octahydro-1H-indolo[3,2,1-de]pyrido[3,2,1-ij][1,5]naphthyridine-12-carboxylate 83508-82-1 C21H26N2O3
4-[6-[(8-cyclopentyl-6-ethenyl-7,8-dihydro-5-methyl-7-oxopyrido[2,3-d]pyrimidin-2-yl)amino]-3-pyridinyl]-1-piperazinecarboxylic acid tert-butyl ester 4-[6-[(8-cyclopentyl-6-ethenyl-7,8-dihydro-5-methyl-7-oxopyrido[2,3-d]pyrimidin-2-yl)amino]-3-pyridinyl]-1-piperazinecarboxylic acid tert-butyl ester 1941177-45-2 C29H37N7O3
Cabozantinib impurity 1 Cabozantinib impurity 1 748707-58-6 C17H16N2O3
Amlodipine Impurity 19 Amlodipine Impurity 19 C26H31ClN2O8S
Amlodipine Impurity 9 Amlodipine Impurity 9 90445-05-9 C26H31ClN2O8S
Clopidogrel Impurity 7 Clopidogrel Impurity 7 444728-13-6 C15H15ClN2OS
Rivaroxaban Impurity 36 Rivaroxaban Impurity 36 1770812-39-9 C19H17Cl2N3O5S
(S)-methyl 2-((2'-(2H-tetrazol-5-yl)biphenyl-4-yl)methylamino)-3-methylbutanoate (S)-methyl 2-((2'-(2H-tetrazol-5-yl)biphenyl-4-yl)methylamino)-3-methylbutanoate 1111177-24-2 C20H23N5O2
Clopidogrel Impurity C Clopidogrel Impurity C 1346605-15-9 C16H18ClNO2S
Nilotinib genotoxic impurity 2 Nilotinib genotoxic impurity 2 1157857-29-8 C19H15F3N4O3
NCFJJNFEEPMRAQ-XMMPIXPASA-N NCFJJNFEEPMRAQ-XMMPIXPASA-N 1453221-45-8 C35H41F6N3O6
Gliclazide Impurity E Gliclazide Impurity E
Ethyl 1-butanesulfonate Ethyl 1-butanesulfonate 2374-68-7 C6H14O3S
OLANEXIDINE intermediate OLANEXIDINE intermediate 60852-95-1 C10H20N4
1H-Isoindole, octahydro-, trans- 1H-Isoindole, octahydro-, trans- 10479-63-7 C8H15N
1H-Purine-2,6-dione,8-[2-(3,4-dihydroxyphenyl)ethenyl]-1,3-diethyl-3,7-dihydro-7-methyl-, (E)-(9CI) 1H-Purine-2,6-dione,8-[2-(3,4-dihydroxyphenyl)ethenyl]-1,3-diethyl-3,7-dihydro-7-methyl-, (E)-(9CI) 155272-03-0 C18H20N4O4
Hexanoicacid, 3-(2-amino-2-oxoethyl)-5-methyl-, (3S)- Hexanoicacid, 3-(2-amino-2-oxoethyl)-5-methyl-, (3S)- 181289-34-9 C9H17NO3
Ethanedioic acid, monoethyl ester, 2-(4-methoxyphenyl)hydrazide Ethanedioic acid, monoethyl ester, 2-(4-methoxyphenyl)hydrazide 2614-10-0 C11H14N2O4
4-Pyridinecarboxamide, N-[2-(nitrooxy)ethyl]-, mononitrate 4-Pyridinecarboxamide, N-[2-(nitrooxy)ethyl]-, mononitrate 65141-48-2 C8H10N4O7
1-[3,4-dihydroxy-5-(hydroxymethyl)oxolan-2-yl]-5-hydroxy-pyrimidine-2,4-dione 1-[3,4-dihydroxy-5-(hydroxymethyl)oxolan-2-yl]-5-hydroxy-pyrimidine-2,4-dione 69321-95-5 C9H12N2O7
2-(ACETOXYMETHYL)-4-METHOXY-3,5-DIMETHYLPYRIDINE 2-(ACETOXYMETHYL)-4-METHOXY-3,5-DIMETHYLPYRIDINE 91219-90-8 C11H15NO3
4,4'-(4H-1,2,4-TRIAZOL-4-YLMETHYLENE)BIS BENZONITRILE 4,4'-(4H-1,2,4-TRIAZOL-4-YLMETHYLENE)BIS BENZONITRILE 112809-52-6 C17H11N5
(S)-1-(2-Aminoacetyl)-pyrrolidine-2-carbonitrile (S)-1-(2-Aminoacetyl)-pyrrolidine-2-carbonitrile 914070-99-8 C7H11N3O
(1R,2R)-2-(3,4-difluorophenyl)cyclopropanecarboxylic acid (1R,2R)-2-(3,4-difluorophenyl)cyclopropanecarboxylic acid 220352-36-3 C10H8F2O2
Pregna-1,4,9(11)-triene-3,20-dione,21-(acetyloxy)-17-hydroxy-6-methyl-, (6a)- Pregna-1,4,9(11)-triene-3,20-dione,21-(acetyloxy)-17-hydroxy-6-methyl-, (6a)- 93239-37-3 C24H30O5
Tadalafil EP impurity E Tadalafil EP impurity E
4'-chloro-7H-4,7'-bipyrrolo[2,3-d]pyrimidine 4'-chloro-7H-4,7'-bipyrrolo[2,3-d]pyrimidine 134965-85-8 C12H7ClN6
myricetin 3-O-β-D-xylopyranosyl(1-2)-β-D-glucopyranoside myricetin 3-O-β-D-xylopyranosyl(1-2)-β-D-glucopyranoside 142449-93-2 C26H28O17
1-(4-fluorobenzyl)-3-(4-isobutoxybenzyl)urea 1-(4-fluorobenzyl)-3-(4-isobutoxybenzyl)urea 1388858-78-3 C19H23FN2O2
1,4,7,10-Tetraazabicyclo[8.2.2]tetradecan-11-one 1,4,7,10-Tetraazabicyclo[8.2.2]tetradecan-11-one 220182-11-6 C10H20N4O
Ropivacaine EP Impurity D Ropivacaine EP Impurity D 98626-59-6 C16H24N2O
Bendamustine Impurity 16 Bendamustine Impurity 16 914626-65-6 C19H18N6O4
(S)-N-methyl-3-(naphthalen-1-yloxy)-3-(thiophen-3-yl)propan-1-amine  hydrochloride (S)-N-methyl-3-(naphthalen-1-yloxy)-3-(thiophen-3-yl)propan-1-amine hydrochloride 959392-22-4 C18H19NOS
phenyl (R)-methyl(3-(naphthalen-1-yloxy)-3-(thiophen-2-yl)propyl)carbamate phenyl (R)-methyl(3-(naphthalen-1-yloxy)-3-(thiophen-2-yl)propyl)carbamate 603996-87-8 C8H11NO2S
Aprepitant Impurity 23 Aprepitant Impurity 23
Canagliflozin impurity H Canagliflozin impurity H
Cefazolin Impurity 9 Cefazolin Impurity 9 1322626-65-2 C14H15N9O3S3
Dapagliflozin Impurity 20 Dapagliflozin Impurity 20 2040305-09-5 C29H33ClO10
Edaravone Impurity 10 Edaravone Impurity 10 710307-89-4 C10H12N2O2
Empagliflozin Impurity 23 Empagliflozin Impurity 23
Entecavir Impurity 3 Entecavir Impurity 3 1391053-94-3 C12H15N5O4
IBrutinib Impurity C IBrutinib Impurity C
Imatinib impurity 12 Imatinib impurity 12
Isavuconazole Impurity 20 Isavuconazole Impurity 20
Isavuconazole Impurity 26 Isavuconazole Impurity 26
Istradefylline impurity D Istradefylline impurity D
Leuprorelin EP Impurity F Leuprorelin EP Impurity F 1872435-00-1 C59H84N16O12
Linagliptin Impurity 40 Linagliptin Impurity 40
Minocycline N-Hydroxymethyl Impurity Minocycline N-Hydroxymethyl Impurity 1075240-33-3 C24H29N3O8
Mivacurium Chloride Impurity 3 Mivacurium Chloride Impurity 3 740777-60-0 C33H46NO9+
Mupirocin EP Impurity E Mupirocin EP Impurity E 71087-96-2 C26H44O9
N-Acetyl-Phe-Octreotide N-Acetyl-Phe-Octreotide 83795-61-3 C51H68N10O11S2
MFFANMLJBOSKIX-UHFFFAOYSA-N MFFANMLJBOSKIX-UHFFFAOYSA-N 352457-34-2 C9H13N5O2
4,4',4''-Methylidenetrisbenzonitrile 4,4',4''-Methylidenetrisbenzonitrile 113402-31-6 C22H13N3
methyl (2E)-3-(methylamino)but-2-enoate methyl (2E)-3-(methylamino)but-2-enoate 21759-69-3 C6H11NO2
Entecavir Impurity 5 Entecavir Impurity 5 84868-56-4 C21H20O2
Bisoprolol-d5 Bisoprolol-d5 1189881-87-5 C18H31NO4
4-(2-HYDROXY-3-ISOPROPYLAMINO-PROPOXY)-BENZOIC ACID METHYL ESTER 4-(2-HYDROXY-3-ISOPROPYLAMINO-PROPOXY)-BENZOIC ACID METHYL ESTER 33947-97-6 C14H21NO4
5-METHYL-3-NITROMETHYL-HEXANOIC ACID 5-METHYL-3-NITROMETHYL-HEXANOIC ACID 181289-21-4 C8H15NO4
4(3,4-DICHLOROPHENYL)1,2,3,4-TETRAHYDRO-N-METHYL-1-NAPHTHALENE AMINE RACEMATE 4(3,4-DICHLOROPHENYL)1,2,3,4-TETRAHYDRO-N-METHYL-1-NAPHTHALENE AMINE RACEMATE 140631-53-4 C17H17Cl2N
(3R,5R)-tert-butyl 7-(2,3-bis(4-fluorophenyl)-5-isopropyl-4-(phenylcarbamoyl)-1H-pyrrol-1-yl)-3,5-dihydroxyheptanoate (3R,5R)-tert-butyl 7-(2,3-bis(4-fluorophenyl)-5-isopropyl-4-(phenylcarbamoyl)-1H-pyrrol-1-yl)-3,5-dihydroxyheptanoate 2588261-40-7 C37H42F2N2O5
(S)-ethyl 2-(4-hydroxy-2-oxopyrrolidin-1-yl)acetate (S)-ethyl 2-(4-hydroxy-2-oxopyrrolidin-1-yl)acetate 870695-39-9 C8H13NO4
4-(3-(4-(cyclopropanecarbonyl)piperazine-1-carbonyl)-4-hydroxybenzyl)phthalazin-1(2H)-one 4-(3-(4-(cyclopropanecarbonyl)piperazine-1-carbonyl)-4-hydroxybenzyl)phthalazin-1(2H)-one C24H24N4O4
Diquafosol Impurity 2 Diquafosol Impurity 2 63785-59-1 C18H25N4O20P3
N-((3R,4R)-1-benzyl-4-methylpiperidin-3-yl)-2,2'-dichloro-N-methyl-7H-[4,7'-bipyrrolo[2,3-d]pyrimidin]-4'-amine N-((3R,4R)-1-benzyl-4-methylpiperidin-3-yl)-2,2'-dichloro-N-methyl-7H-[4,7'-bipyrrolo[2,3-d]pyrimidin]-4'-amine 2459302-87-3 C26H26Cl2N8
(1R,3R)-1-(benzo[d][1,3]dioxol-5-yl)-2-(2,2-dichloroacetyl) -2,3,4,9-tetrahydro-1H-pyrido[3,4-b]indole-3-carboxylate (1R,3R)-1-(benzo[d][1,3]dioxol-5-yl)-2-(2,2-dichloroacetyl) -2,3,4,9-tetrahydro-1H-pyrido[3,4-b]indole-3-carboxylate 1598416-08-0 C22H18Cl2N2O5
PANTOPRAZOLE N-OXIDE SODIUM SALT PANTOPRAZOLE N-OXIDE SODIUM SALT 1279822-90-0 C16H16F2N3NaO5S
3-HYDROXY-THIOBENZAMIDE 3-HYDROXY-THIOBENZAMIDE 104317-54-6 C7H7NOS
Tadalafil impurity 38 Tadalafil impurity 38 185750-07-6 C14H15ClN2O3
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