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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
Relugolix Impurity 66 Relugolix Impurity 66 2591260-06-7 C25H24F2N2O6S
methyl 3-(4-(2-hydroxy-3-(isopropylamino)propoxy)phenyl)-3- oxopropanoate methyl 3-(4-(2-hydroxy-3-(isopropylamino)propoxy)phenyl)-3- oxopropanoate
Δ3-7-ACT Δ3-7-ACT
methyl 5-methyl-3'-nitro-3-oxo-1,2,3,6-tetrahydro-[1,1'-biphenyl]-2-carboxylate methyl 5-methyl-3'-nitro-3-oxo-1,2,3,6-tetrahydro-[1,1'-biphenyl]-2-carboxylate 2469735-68-8 C15H15NO5
Pregn-4-ene-3,20-dione, 9-fluoro-11-hydroxy-16,17-[(1-methylethylidene)bis(oxy)]-, (11β,16α)- Pregn-4-ene-3,20-dione, 9-fluoro-11-hydroxy-16,17-[(1-methylethylidene)bis(oxy)]-, (11β,16α)- 3093-36-5 C24H33FO5
3-Isoquinolinecarboxylic acid, 7-(4-chlorophenoxy)-4-hydroxy-, methyl ester 3-Isoquinolinecarboxylic acid, 7-(4-chlorophenoxy)-4-hydroxy-, methyl ester 2711953-58-9 C17H12ClNO4
(2-(2-((tert-butoxycarbonyl)(methyl)amino)-N-methylacetamido)pyridin-3-yl)methyl N-(tert-butoxycarbonyl)-N-methylglycinate (2-(2-((tert-butoxycarbonyl)(methyl)amino)-N-methylacetamido)pyridin-3-yl)methyl N-(tert-butoxycarbonyl)-N-methylglycinate
Benzoic acid, 3-(aminosulfonyl)-2,4-dichloro- Benzoic acid, 3-(aminosulfonyl)-2,4-dichloro- 1870323-25-3 C7H5Cl2NO4S
Benzeneacetamide, N,α,α-trimethyl-N-[6-(4-methyl-1,4-dioxido-1-piperazinyl)-4-(2-methylphenyl)-3-pyridinyl]-3,5-bis(trifluoromethyl)- Benzeneacetamide, N,α,α-trimethyl-N-[6-(4-methyl-1,4-dioxido-1-piperazinyl)-4-(2-methylphenyl)-3-pyridinyl]-3,5-bis(trifluoromethyl)- 1431216-61-3 C30H32F6N4O3
1,3-Dioxane-4-acetic acid, 6-[2-[2-(4-fluorophenyl)-5-(1-methylethyl)-3-phenyl-4-[(phenylamino)carbonyl]-1H-pyrrol-1-yl]ethyl]-2,2-dimethyl-, sodium salt (1:1), (4R,6R)- 1,3-Dioxane-4-acetic acid, 6-[2-[2-(4-fluorophenyl)-5-(1-methylethyl)-3-phenyl-4-[(phenylamino)carbonyl]-1H-pyrrol-1-yl]ethyl]-2,2-dimethyl-, sodium salt (1:1), (4R,6R)- 862260-38-6 C36H40FN2NaO5
Avatrombopag Impurity 54 Avatrombopag Impurity 54
Atorvastatin Impurity 45 (Sodium Salt) Atorvastatin Impurity 45 (Sodium Salt)
3-[3-(tert-butylamino)-2-hydroxypropoxy]-4-morpholino-1,2,5-thiadiazole monomaleate 3-[3-(tert-butylamino)-2-hydroxypropoxy]-4-morpholino-1,2,5-thiadiazole monomaleate 57073-55-9 C17H28N4O7S
2-(3-(4-(1-(3-(cyanomethyl)-1-(ethylsulfonyl)azetidin-3-yl)-1H-pyrazol-4-yl)-7H-pyrrolo[2,3-d]pyrimidin-7-yl)-1-(ethylsulfonyl)azetidin-3-yl)acetonitrile 2-(3-(4-(1-(3-(cyanomethyl)-1-(ethylsulfonyl)azetidin-3-yl)-1H-pyrazol-4-yl)-7H-pyrrolo[2,3-d]pyrimidin-7-yl)-1-(ethylsulfonyl)azetidin-3-yl)acetonitrile 2402776-84-3 C23H27N9O4S2
Cyclopentanecarboxylic acid, 3-[(1S)-1-(acetylamino)-2-ethylbutyl]-4-[(aminocarbonyl)amino]-2-hydroxy-, (1S,2S,3R,4R)- Cyclopentanecarboxylic acid, 3-[(1S)-1-(acetylamino)-2-ethylbutyl]-4-[(aminocarbonyl)amino]-2-hydroxy-, (1S,2S,3R,4R)- 2597901-48-7 C15H27N3O5
Tafluprost Impurity 15 Tafluprost Impurity 15
Rosuvastatin Impurity 159 (Sodium salt) Rosuvastatin Impurity 159 (Sodium salt)
Rosuvastatin Impurity 140 Rosuvastatin Impurity 140
Rosuvastatin Impurity 130 Rosuvastatin Impurity 130
Terlipressin Impurity 1 (des-Gly1) Terlipressin Impurity 1 (des-Gly1)
Brivaracetam Impurity 66 Brivaracetam Impurity 66
2-Acetoxymethyl1-3-Methyl-4- 2-Acetoxymethyl1-3-Methyl-4- 112525-75-4 C11H12F3NO3
N-(7-chloro-4-((3-chloro-4-fluorophenyl)amino)quinazolin-6-yl)-4-(dimethylamino)butanamide N-(7-chloro-4-((3-chloro-4-fluorophenyl)amino)quinazolin-6-yl)-4-(dimethylamino)butanamide
Ertapenem Impurity D(USP) Ertapenem Impurity D(USP)
3-(N-Benzyl-N-methylamino)propiophenone hydrochloride 3-(N-Benzyl-N-methylamino)propiophenone hydrochloride 5409-62-1 C17H20ClNO
2(1H)-Isoquinolinecarboxylic acid, 3,4-dihydro-4-hydroxy-1-phenyl-, (3R)-1-azabicyclo[2.2.2]oct-3-yl ester, (1S,4S)- 2(1H)-Isoquinolinecarboxylic acid, 3,4-dihydro-4-hydroxy-1-phenyl-, (3R)-1-azabicyclo[2.2.2]oct-3-yl ester, (1S,4S)- 869884-24-2 C23H26N2O3
Azilsartan Medoxomil Potassium impurity209 Azilsartan Medoxomil Potassium impurity209
Nelarabine impurity 01 Nelarabine impurity 01
Pyridine, 2-(diethylboryl)- (9CI) Pyridine, 2-(diethylboryl)- (9CI) 385804-67-1 C9H14BN
Cyclopropanamine, 2-(3-fluorophenyl)-, (1R,2S)- (9CI) Cyclopropanamine, 2-(3-fluorophenyl)-, (1R,2S)- (9CI) 220353-83-3 C9H10FN
Dobutamine Impurity 15 Dobutamine Impurity 15
2,3'-Bipyridine, 5-chloro-6'-methyl-3-[4-(methylthio)phenyl]-, hydrochloride (1:1) 2,3'-Bipyridine, 5-chloro-6'-methyl-3-[4-(methylthio)phenyl]-, hydrochloride (1:1) 1447814-82-5 C18H16Cl2N2S
Pitavastatin Impurity 104 Pitavastatin Impurity 104
Tegoprazan Impurity 8 Tegoprazan Impurity 8
Atomoxetine EP Impurity G DiHCl (Mixture of Diastereomers) Atomoxetine EP Impurity G DiHCl (Mixture of Diastereomers) 2706536-33-4 C27H34N2O2
Nirmatrelvir Impurity 10 Nirmatrelvir Impurity 10
Levosimendan Nitrosogenin Impurities Levosimendan Nitrosogenin Impurities
7-(ALPHA-BROMOACETAMIDO)CEPHALOSPORANIC ACID 7-(ALPHA-BROMOACETAMIDO)CEPHALOSPORANIC ACID 26973-80-8 C12H13BrN2O6S
Bumetanide Impurity 20 Bumetanide Impurity 20
Rocuronium Bromide Impurity 28 、29 Rocuronium Bromide Impurity 28 、29
Roxadustat Impurity 22 Roxadustat Impurity 22
	Olaparib Impurity 41 Olaparib Impurity 41
Perospirone Impurity 22 Perospirone Impurity 22
Perospirone Impurity 14 Perospirone Impurity 14 87691-94-9 C15H20BrN3S
Dolutegravir Impurity 22 Dolutegravir Impurity 22
Paxlovid Impurity 20 Paxlovid Impurity 20
Related impurities 7 of fluoxetine sodium Related impurities 7 of fluoxetine sodium
Revefenacin Impurity 16 Revefenacin Impurity 16
Fondaparinux sodium impurity 8 Fondaparinux sodium impurity 8 2088176-32-1 C30H50N2O46S7
Fondaparinux sodium impurity 14 Fondaparinux sodium impurity 14
Fondaparinux Sodium Impurity 9 Fondaparinux Sodium Impurity 9
Oxacillin sodium  Impurity D Oxacillin sodium Impurity D
Piracetam      IMPURITY Piracetam IMPURITY
Nilotinib N-Oxide Impurity 4 Nilotinib N-Oxide Impurity 4
OCTAKIS-6-BROMO-6-DEOXY-GAMMA-CYCLODEXTRIN OCTAKIS-6-BROMO-6-DEOXY-GAMMA-CYCLODEXTRIN 53784-84-2 C48H72Br8O32
2-Ethynylaniline 2-Ethynylaniline 52670-38-9 C8H7N
METOPROLOL IMPURITY A METOPROLOL IMPURITY A C15H25NO3
NICERGOLINE IMPURITY A NICERGOLINE IMPURITY A
AZITHROMYCIN IMPURITY B AZITHROMYCIN IMPURITY B 307974-61-4 C38H72N2O11
1026009-77-7 1026009-77-7 1026009-77-7 C20H22N2O
α,α,α'',5-Tetramethyl-1,3-benzenediacetonitrile α,α,α'',5-Tetramethyl-1,3-benzenediacetonitrile 120512-38-1 C14H16N2
α,α,α'',5-Tetramethyl-1,3-benzenediacetonitrile α,α,α'',5-Tetramethyl-1,3-benzenediacetonitrile 120512-38-1 C14H16N2
Pyrido[4,3-d]pyrimidine-2,4,7(1H,3H,6H)-trione, 1-(3-aminophenyl)-3-cyclopropyl-5-[(2-fluoro-4-iodophenyl)amino]-6,8-dimethyl- Pyrido[4,3-d]pyrimidine-2,4,7(1H,3H,6H)-trione, 1-(3-aminophenyl)-3-cyclopropyl-5-[(2-fluoro-4-iodophenyl)amino]-6,8-dimethyl- 871701-87-0 C24H21FIN5O3
Regorafenib Impurity MJ Regorafenib Impurity MJ
Aztreonam Open-Ring Desulfurization Impurity Aztreonam Open-Ring Desulfurization Impurity
L-Cefadroxil Oxide Impurity L-Cefadroxil Oxide Impurity
Cefixime Polymer Impurity B Cefixime Polymer Impurity B
Azlocillin dioxide Impurity Azlocillin dioxide Impurity
Azlocillin dioxide Impurity Azlocillin dioxide Impurity
7-(2-methoxypropanoyl)-5H-chromeno[2,3-b]pyridin-5-one 7-(2-methoxypropanoyl)-5H-chromeno[2,3-b]pyridin-5-one
Ibrutinib Impurity 42 Ibrutinib Impurity 42 2031255-24-8 C25H23N5O3
Pramipexole Impurity N Pramipexole Impurity N
Hydroxychloroquine Impurity 12 Hydrochloride Hydroxychloroquine Impurity 12 Hydrochloride 2411340-31-1 C18H26ClN3O
Verteporfin impurity Verteporfin impurity 121310-58-5 C40H40N4O8
Peramivir Impurity 25 Peramivir Impurity 25
Peramivir Impurity 33 Peramivir Impurity 33 2758048-78-9 C18H34N2O5
Imatinib impurity XT Imatinib impurity XT
IOHEXOL RELATED COMPOUND C (100 MG) (N,N'- BIS(2,3-DIHYDROXYPROPYL)-5-NITRO-1,3-BENZENEDI- CARBOXAMIDE) IOHEXOL RELATED COMPOUND C (100 MG) (N,N'- BIS(2,3-DIHYDROXYPROPYL)-5-NITRO-1,3-BENZENEDI- CARBOXAMIDE)
N-(4-AMINO-6,7-DIMETHOXYQUINAZOL-2-YL)-N-METHYL-PROPYLENEDIAMINE, HYDROCHLORIDE N-(4-AMINO-6,7-DIMETHOXYQUINAZOL-2-YL)-N-METHYL-PROPYLENEDIAMINE, HYDROCHLORIDE 81403-69-2 C14H22ClN5O2
N-(4-AMINO-6,7-DIMETHOXYQUINAZOL-2-YL)-N-METHYL-PROPYLENEDIAMINE, HYDROCHLORIDE N-(4-AMINO-6,7-DIMETHOXYQUINAZOL-2-YL)-N-METHYL-PROPYLENEDIAMINE, HYDROCHLORIDE 81403-69-2 C14H22ClN5O2
FAMOTIDINE RELATED COMPOUND B FAMOTIDINE RELATED COMPOUND B 89268-62-2 C16H23N11O2S5
TIZOXANIDE GLUCURONIDE, SODIUM SALT TIZOXANIDE GLUCURONIDE, SODIUM SALT 221287-83-8 C16H14N3NaO10S
ETHYL (2E)-CHLORO(PHENYLHYDRAZONO)ACETATE ETHYL (2E)-CHLORO(PHENYLHYDRAZONO)ACETATE 28663-68-5 C10H11ClN2O2
Sugammadex sodium Impurity 50 Sugammadex sodium Impurity 50
Cabozantinib impurity 39 Cabozantinib impurity 39
Cabozantinib impurity 53 Cabozantinib impurity 53
1-(2-chloro-2-(2,4-difluorophenyl)ethyl)-1H-1,2,4-triazole 1-(2-chloro-2-(2,4-difluorophenyl)ethyl)-1H-1,2,4-triazole 206050-24-0 C10H8ClF2N3
methyl 1-phenylethanesulfonate methyl 1-phenylethanesulfonate 883835-57-2 C9H12O3S
Doxofylline Impurity 22 Doxofylline Impurity 22
Dapoxetine impurity 61 Dapoxetine impurity 61
Dapoxetine impurity 55 Dapoxetine impurity 55
1-METHYLBIGUANIDE SULPHATE 1-METHYLBIGUANIDE SULPHATE 1609-00-3 C3H9N5
1-(3,5-DIHYDROXYPHENYL)-2-[(1,1-DIMETHYLETHYL)AMINO]-ETHANONE, HYDROCHLORIDE 1-(3,5-DIHYDROXYPHENYL)-2-[(1,1-DIMETHYLETHYL)AMINO]-ETHANONE, HYDROCHLORIDE 1246815-70-2 C12H18ClNO3
tert-Butyl 4-bromobutanoate tert-Butyl 4-bromobutanoate 110611-91-1 C71H110NO15P
Oxacillin Impurity H Oxacillin Impurity H
(2S,3R)-3-(6-(1-(6-chloro-5-fluoropyrimidin-4-yl)ethyl)-5-fluoropyrimidin-4-yl)-2-(2,4-difluorophenyl)-1-(1H-1,2,4-triazol-1-yl)butan-2-ol (2S,3R)-3-(6-(1-(6-chloro-5-fluoropyrimidin-4-yl)ethyl)-5-fluoropyrimidin-4-yl)-2-(2,4-difluorophenyl)-1-(1H-1,2,4-triazol-1-yl)butan-2-ol
4-(6'-oxo-1'-phenyl-1',6'-dihydro-[2,3'-bipyridin]-5'-yl)benzonitrile 4-(6'-oxo-1'-phenyl-1',6'-dihydro-[2,3'-bipyridin]-5'-yl)benzonitrile 380918-54-7 C23H15N3O
Empagliflozin Impurity 79 Empagliflozin Impurity 79
Empagliflozin Impurity 89 Empagliflozin Impurity 89 2452301-32-3 C23H25ClO7
sodium (6R,7S)-7-amino-7-methoxy-6-methyl-3-(((1-methyl-1H-tetrazol-5-yl)thio)methyl)-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylate sodium (6R,7S)-7-amino-7-methoxy-6-methyl-3-(((1-methyl-1H-tetrazol-5-yl)thio)methyl)-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylate
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